Trial Outcomes & Findings for Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents (NCT NCT01302847)
NCT ID: NCT01302847
Last Updated: 2024-12-12
Results Overview
All grade 3 or higher signs/symptoms, diagnoses, and laboratory AEs were included. AE grading was based on DAIDS AE Grading Table, Version 1.0, December 2004 (Clarification, August 2009). A 2-sided 95% Confidence Interval (CI) was calculated for the percentage using the binominal exact method.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
181 participants
Primary outcome timeframe
From treatment initiation through Weeks 24 and 48
Results posted on
2024-12-12
Participant Flow
Participants were enrolled from April 20, 2011 to February 19, 2020. Participants were recruited from 9 countries in North America, South America, Africa, and Asia.
There was no study randomization. A participant was enrolled to a cohort based on their age at study entry.
Participant milestones
| Measure |
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
Children 6 months to younger than 2 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
15
|
17
|
7
|
36
|
35
|
25
|
|
Overall Study
COMPLETED
|
10
|
16
|
14
|
15
|
5
|
31
|
30
|
20
|
|
Overall Study
NOT COMPLETED
|
13
|
7
|
1
|
2
|
2
|
5
|
5
|
5
|
Reasons for withdrawal
| Measure |
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
Children 6 months to younger than 2 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Pregnancy
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Virologic failure
|
0
|
2
|
0
|
2
|
1
|
3
|
1
|
2
|
|
Overall Study
Severe debilitation, unable to continue
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Not able to get to clinic
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Site closing
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Not willing to adhere to requirements
|
5
|
0
|
1
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Site unable to contact participant
|
2
|
1
|
0
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
Baseline characteristics by cohort
| Measure |
Cohort I
n=23 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=23 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=15 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=17 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=36 Participants
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=35 Participants
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=25 Participants
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
14.26 years
STANDARD_DEVIATION 1.79 • n=23 Participants
|
8.96 years
STANDARD_DEVIATION 1.99 • n=23 Participants
|
7.73 years
STANDARD_DEVIATION 1.79 • n=15 Participants
|
3.59 years
STANDARD_DEVIATION 1.00 • n=17 Participants
|
1.14 years
STANDARD_DEVIATION 0.41 • n=7 Participants
|
3.25 years
STANDARD_DEVIATION 1.18 • n=36 Participants
|
1.13 years
STANDARD_DEVIATION 0.44 • n=35 Participants
|
0.03 years
STANDARD_DEVIATION 0.01 • n=25 Participants
|
4.84 years
STANDARD_DEVIATION 4.78 • n=181 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=23 Participants
|
7 Participants
n=23 Participants
|
3 Participants
n=15 Participants
|
8 Participants
n=17 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=36 Participants
|
20 Participants
n=35 Participants
|
12 Participants
n=25 Participants
|
86 Participants
n=181 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=23 Participants
|
16 Participants
n=23 Participants
|
12 Participants
n=15 Participants
|
9 Participants
n=17 Participants
|
2 Participants
n=7 Participants
|
23 Participants
n=36 Participants
|
15 Participants
n=35 Participants
|
13 Participants
n=25 Participants
|
95 Participants
n=181 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=23 Participants
|
6 Participants
n=23 Participants
|
4 Participants
n=15 Participants
|
8 Participants
n=17 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=36 Participants
|
4 Participants
n=35 Participants
|
2 Participants
n=25 Participants
|
37 Participants
n=181 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=23 Participants
|
13 Participants
n=23 Participants
|
6 Participants
n=15 Participants
|
6 Participants
n=17 Participants
|
6 Participants
n=7 Participants
|
28 Participants
n=36 Participants
|
31 Participants
n=35 Participants
|
23 Participants
n=25 Participants
|
129 Participants
n=181 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=23 Participants
|
4 Participants
n=23 Participants
|
5 Participants
n=15 Participants
|
3 Participants
n=17 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=25 Participants
|
15 Participants
n=181 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=181 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=23 Participants
|
3 Participants
n=23 Participants
|
3 Participants
n=15 Participants
|
2 Participants
n=17 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=36 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=25 Participants
|
25 Participants
n=181 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=23 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=181 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=23 Participants
|
12 Participants
n=23 Participants
|
10 Participants
n=15 Participants
|
11 Participants
n=17 Participants
|
3 Participants
n=7 Participants
|
25 Participants
n=36 Participants
|
30 Participants
n=35 Participants
|
20 Participants
n=25 Participants
|
123 Participants
n=181 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=23 Participants
|
3 Participants
n=23 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=17 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=35 Participants
|
0 Participants
n=25 Participants
|
15 Participants
n=181 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=23 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=35 Participants
|
2 Participants
n=25 Participants
|
9 Participants
n=181 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=23 Participants
|
3 Participants
n=23 Participants
|
2 Participants
n=15 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=25 Participants
|
8 Participants
n=181 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=23 Participants
|
16 Participants
n=23 Participants
|
5 Participants
n=15 Participants
|
5 Participants
n=17 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=35 Participants
|
0 Participants
n=25 Participants
|
51 Participants
n=181 Participants
|
|
Region of Enrollment
Botswana
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=25 Participants
|
5 Participants
n=181 Participants
|
|
Region of Enrollment
Tanzania
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=35 Participants
|
3 Participants
n=25 Participants
|
10 Participants
n=181 Participants
|
|
Region of Enrollment
Brazil
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
2 Participants
n=15 Participants
|
5 Participants
n=17 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=36 Participants
|
2 Participants
n=35 Participants
|
3 Participants
n=25 Participants
|
19 Participants
n=181 Participants
|
|
Region of Enrollment
South Africa
|
0 Participants
n=23 Participants
|
4 Participants
n=23 Participants
|
6 Participants
n=15 Participants
|
4 Participants
n=17 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=36 Participants
|
4 Participants
n=35 Participants
|
2 Participants
n=25 Participants
|
28 Participants
n=181 Participants
|
|
Region of Enrollment
Uganda
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=35 Participants
|
1 Participants
n=25 Participants
|
3 Participants
n=181 Participants
|
|
Region of Enrollment
Zimbabwe
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=36 Participants
|
15 Participants
n=35 Participants
|
10 Participants
n=25 Participants
|
28 Participants
n=181 Participants
|
|
Region of Enrollment
Kenya
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=36 Participants
|
5 Participants
n=35 Participants
|
1 Participants
n=25 Participants
|
14 Participants
n=181 Participants
|
|
Region of Enrollment
Thailand
|
3 Participants
n=23 Participants
|
3 Participants
n=23 Participants
|
2 Participants
n=15 Participants
|
2 Participants
n=17 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=36 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=25 Participants
|
23 Participants
n=181 Participants
|
|
Weight
|
55.1 kg
STANDARD_DEVIATION 15.6 • n=23 Participants
|
30.1 kg
STANDARD_DEVIATION 10.4 • n=23 Participants
|
23.0 kg
STANDARD_DEVIATION 4.6 • n=15 Participants
|
14.4 kg
STANDARD_DEVIATION 2.9 • n=17 Participants
|
8.4 kg
STANDARD_DEVIATION 2.0 • n=7 Participants
|
13.7 kg
STANDARD_DEVIATION 2.6 • n=36 Participants
|
8.5 kg
STANDARD_DEVIATION 1.8 • n=35 Participants
|
5.7 kg
STANDARD_DEVIATION 1.1 • n=25 Participants
|
19.6 kg
STANDARD_DEVIATION 17.0 • n=181 Participants
|
|
Height
|
155.4 cm
STANDARD_DEVIATION 8.9 • n=23 Participants
|
131.1 cm
STANDARD_DEVIATION 14.0 • n=23 Participants
|
121.2 cm
STANDARD_DEVIATION 9.6 • n=15 Participants
|
95.9 cm
STANDARD_DEVIATION 8.7 • n=17 Participants
|
71.0 cm
STANDARD_DEVIATION 6.0 • n=7 Participants
|
93.4 cm
STANDARD_DEVIATION 8.9 • n=36 Participants
|
71.9 cm
STANDARD_DEVIATION 5.7 • n=35 Participants
|
59.2 cm
STANDARD_DEVIATION 3.7 • n=25 Participants
|
98.9 cm
STANDARD_DEVIATION 32.4 • n=181 Participants
|
|
CD4 Cell Count
|
466.0 cells/mm^3
n=23 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
645.0 cells/mm^3
n=23 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
749.0 cells/mm^3
n=15 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
900.0 cells/mm^3
n=17 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
1482.5 cells/mm^3
n=6 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
1049.5 cells/mm^3
n=36 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
2121.0 cells/mm^3
n=35 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
1916.0 cells/mm^3
n=25 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
1053.0 cells/mm^3
n=180 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
|
CD4 Percent
|
22.0 Percentage of total lymphocytes
n=23 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
24.0 Percentage of total lymphocytes
n=23 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
25.3 Percentage of total lymphocytes
n=15 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
25.0 Percentage of total lymphocytes
n=17 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
20.7 Percentage of total lymphocytes
n=6 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
24.0 Percentage of total lymphocytes
n=36 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
24.2 Percentage of total lymphocytes
n=35 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
22.7 Percentage of total lymphocytes
n=25 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
24.0 Percentage of total lymphocytes
n=180 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
|
CD8 Cell Count
|
1009.0 cells/mm^3
n=23 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
1089.0 cells/mm^3
n=23 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
1103.0 cells/mm^3
n=15 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
1730.0 cells/mm^3
n=17 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
1888.5 cells/mm^3
n=6 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
1725.0 cells/mm^3
n=36 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
2922.0 cells/mm^3
n=35 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
2435.0 cells/mm^3
n=25 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
1679.0 cells/mm^3
n=180 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
|
CD8 Percent
|
49.5 Percentage of total lymphocytes
n=23 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
53.0 Percentage of total lymphocytes
n=23 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
48.0 Percentage of total lymphocytes
n=15 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
39.7 Percentage of total lymphocytes
n=17 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
28.5 Percentage of total lymphocytes
n=6 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
42.2 Percentage of total lymphocytes
n=36 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
39.4 Percentage of total lymphocytes
n=35 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
31.6 Percentage of total lymphocytes
n=25 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
43.0 Percentage of total lymphocytes
n=180 Participants • Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
|
|
Baseline Plasma HIV-1 RNA (copies/mL)
<400
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=25 Participants
|
6 Participants
n=181 Participants
|
|
Baseline Plasma HIV-1 RNA (copies/mL)
400 - <1,000
|
0 Participants
n=23 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=25 Participants
|
6 Participants
n=181 Participants
|
|
Baseline Plasma HIV-1 RNA (copies/mL)
1,000 - <5,000
|
2 Participants
n=23 Participants
|
3 Participants
n=23 Participants
|
1 Participants
n=15 Participants
|
2 Participants
n=17 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=36 Participants
|
7 Participants
n=35 Participants
|
7 Participants
n=25 Participants
|
27 Participants
n=181 Participants
|
|
Baseline Plasma HIV-1 RNA (copies/mL)
5,000 - <10,000
|
4 Participants
n=23 Participants
|
1 Participants
n=23 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=35 Participants
|
3 Participants
n=25 Participants
|
15 Participants
n=181 Participants
|
|
Baseline Plasma HIV-1 RNA (copies/mL)
10,000 - <25,000
|
8 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
3 Participants
n=15 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=36 Participants
|
4 Participants
n=35 Participants
|
2 Participants
n=25 Participants
|
21 Participants
n=181 Participants
|
|
Baseline Plasma HIV-1 RNA (copies/mL)
25,000 - <50,000
|
5 Participants
n=23 Participants
|
4 Participants
n=23 Participants
|
1 Participants
n=15 Participants
|
2 Participants
n=17 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=36 Participants
|
3 Participants
n=35 Participants
|
1 Participants
n=25 Participants
|
22 Participants
n=181 Participants
|
|
Baseline Plasma HIV-1 RNA (copies/mL)
50,000 - <100,000
|
2 Participants
n=23 Participants
|
3 Participants
n=23 Participants
|
6 Participants
n=15 Participants
|
5 Participants
n=17 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=36 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=25 Participants
|
22 Participants
n=181 Participants
|
|
Baseline Plasma HIV-1 RNA (copies/mL)
>=100,000
|
2 Participants
n=23 Participants
|
11 Participants
n=23 Participants
|
2 Participants
n=15 Participants
|
7 Participants
n=17 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=36 Participants
|
14 Participants
n=35 Participants
|
11 Participants
n=25 Participants
|
62 Participants
n=181 Participants
|
|
HIV-1 log10 RNA
|
4.3 log10 copies/mL
STANDARD_DEVIATION 0.5 • n=23 Participants
|
4.9 log10 copies/mL
STANDARD_DEVIATION 1.0 • n=23 Participants
|
4.4 log10 copies/mL
STANDARD_DEVIATION 0.8 • n=15 Participants
|
4.9 log10 copies/mL
STANDARD_DEVIATION 0.9 • n=17 Participants
|
4.5 log10 copies/mL
STANDARD_DEVIATION 1.4 • n=7 Participants
|
4.5 log10 copies/mL
STANDARD_DEVIATION 1.2 • n=36 Participants
|
4.6 log10 copies/mL
STANDARD_DEVIATION 1.1 • n=35 Participants
|
4.6 log10 copies/mL
STANDARD_DEVIATION 1.4 • n=25 Participants
|
4.6 log10 copies/mL
STANDARD_DEVIATION 1.1 • n=181 Participants
|
|
Class of Prior Antiretroviral Therapy (ART)
Nucleoside reverse transcriptase inhibitor (NRTI)
|
23 Participants
n=23 Participants
|
23 Participants
n=23 Participants
|
14 Participants
n=15 Participants
|
17 Participants
n=17 Participants
|
6 Participants
n=7 Participants
|
30 Participants
n=36 Participants
|
29 Participants
n=35 Participants
|
23 Participants
n=25 Participants
|
165 Participants
n=181 Participants
|
|
Class of Prior Antiretroviral Therapy (ART)
Non-nucleoside reverse transcriptase inhibitor (NNRTI)
|
12 Participants
n=23 Participants
|
13 Participants
n=23 Participants
|
10 Participants
n=15 Participants
|
5 Participants
n=17 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=36 Participants
|
18 Participants
n=35 Participants
|
15 Participants
n=25 Participants
|
92 Participants
n=181 Participants
|
|
Class of Prior Antiretroviral Therapy (ART)
Protease inhibitor (PI)
|
18 Participants
n=23 Participants
|
17 Participants
n=23 Participants
|
10 Participants
n=15 Participants
|
15 Participants
n=17 Participants
|
5 Participants
n=7 Participants
|
25 Participants
n=36 Participants
|
28 Participants
n=35 Participants
|
20 Participants
n=25 Participants
|
138 Participants
n=181 Participants
|
|
Class of Prior Antiretroviral Therapy (ART)
Fusion inhibitor (FI)
|
2 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=25 Participants
|
2 Participants
n=181 Participants
|
PRIMARY outcome
Timeframe: From treatment initiation through Weeks 24 and 48Population: Participants who received at least one dose of DTG and were deemed safety evaluable by the protocol team.
All grade 3 or higher signs/symptoms, diagnoses, and laboratory AEs were included. AE grading was based on DAIDS AE Grading Table, Version 1.0, December 2004 (Clarification, August 2009). A 2-sided 95% Confidence Interval (CI) was calculated for the percentage using the binominal exact method.
Outcome measures
| Measure |
Cohort I
n=23 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=23 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=15 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=17 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=36 Participants
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=35 Participants
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=25 Participants
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Grade 3 or Higher Adverse Events (AEs)
Through Week 24
|
4.3 percentage of participants
Interval 0.1 to 22.0
|
8.7 percentage of participants
Interval 1.1 to 28.0
|
6.7 percentage of participants
Interval 0.2 to 32.0
|
29.4 percentage of participants
Interval 10.3 to 56.0
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
38.9 percentage of participants
Interval 23.1 to 56.5
|
42.9 percentage of participants
Interval 26.3 to 60.7
|
60 percentage of participants
Interval 38.7 to 78.9
|
|
Percentage of Participants With Grade 3 or Higher Adverse Events (AEs)
Through Week 48
|
8.7 percentage of participants
Interval 1.1 to 28.0
|
17.4 percentage of participants
Interval 5.0 to 38.8
|
13.3 percentage of participants
Interval 1.7 to 40.5
|
35.3 percentage of participants
Interval 14.2 to 61.7
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
41.7 percentage of participants
Interval 25.5 to 59.2
|
51.4 percentage of participants
Interval 34.0 to 68.6
|
64 percentage of participants
Interval 42.5 to 82.0
|
PRIMARY outcome
Timeframe: From treatment initiation through Weeks 24 and 48Population: Participants who received at least one dose of DTG and were deemed safety evaluable by the protocol team.
All grade 3 or higher signs/symptoms, diagnoses, and laboratory AEs were included. AE grading was based on DAIDS AE Grading Table, Version 1.0, December 2004 (Clarification, August 2009). A 2-sided 95% Confidence Interval (CI) was calculated for the percentage using the binominal exact method.
Outcome measures
| Measure |
Cohort I
n=23 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=23 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=15 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=17 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=36 Participants
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=35 Participants
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=25 Participants
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Grade 3 or Higher Adverse Events (AEs) Assessed as Related to Study Drug
Through Week 24
|
0 percentage of participants
Interval 0.0 to 14.8
|
0 percentage of participants
Interval 0.0 to 14.8
|
0 percentage of participants
Interval 0.0 to 21.8
|
0 percentage of participants
Interval 0.0 to 19.5
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
0 percentage of participants
Interval 0.0 to 9.7
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 13.7
|
|
Percentage of Participants With Grade 3 or Higher Adverse Events (AEs) Assessed as Related to Study Drug
Through Week 48
|
0 percentage of participants
Interval 0.0 to 14.8
|
0 percentage of participants
Interval 0.0 to 14.8
|
0 percentage of participants
Interval 0.0 to 21.8
|
0 percentage of participants
Interval 0.0 to 19.5
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
0 percentage of participants
Interval 0.0 to 9.7
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 13.7
|
PRIMARY outcome
Timeframe: From treatment initiation through Weeks 24 and 48Population: Participants who received at least one dose of DTG and were deemed safety evaluable by the protocol team.
Number of participants with permanent discontinuation of study drug due to AEs assessed by the site investigator as related to the study drug.
Outcome measures
| Measure |
Cohort I
n=23 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=23 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=15 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=17 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=36 Participants
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=35 Participants
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=25 Participants
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Permanent Discontinuation of Study Drug Due to Adverse Events (AEs) Assessed as Related to Study Drug
Through Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Permanent Discontinuation of Study Drug Due to Adverse Events (AEs) Assessed as Related to Study Drug
Through Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From treatment initiation through Weeks 24 and 48Population: Participants who received at least one dose of DTG and were deemed safety evaluable by the protocol team.
Number of participants who died were summarized
Outcome measures
| Measure |
Cohort I
n=23 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=23 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=15 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=17 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=36 Participants
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=35 Participants
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=25 Participants
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Died
Through Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Died
Through Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosingPopulation: Participants with intensive pharmacokinetic (PK) data at the proposed dose for Cohorts I, IIA, III-DT, IV-DT, and V-DT.
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). AUC0-24 was determined using linear up-log down estimation in WinNonlin.
Outcome measures
| Measure |
Cohort I
n=9 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=5 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=17 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=13 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=13 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Area-under-the-curve From 0 to 24 Hours (AUC0-24)
|
52.98 hr*mg/L
Standard Deviation 23.11
|
68.33 hr*mg/L
Standard Deviation 43.33
|
63.16 hr*mg/L
Standard Deviation 37.77
|
82.67 hr*mg/L
Standard Deviation 47.05
|
71.45 hr*mg/L
Standard Deviation 28.21
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From treatment initiation through Week 192. AEs after that time were censored.Population: All participants
Percentage and exact 95% Confidence Interval (CI) of participants with Grade 3 or higher AEs. AEs were graded based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009 (see References). All grade 3 or higher signs, symptoms, and laboratory toxicities were included.
Outcome measures
| Measure |
Cohort I
n=23 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=23 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=15 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=17 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=36 Participants
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=35 Participants
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=25 Participants
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Grade 3 or Higher Adverse Events (AEs)
|
34.8 percentage of participants
Interval 16.4 to 57.3
|
30.4 percentage of participants
Interval 13.2 to 52.9
|
20 percentage of participants
Interval 4.3 to 48.1
|
52.9 percentage of participants
Interval 27.8 to 77.0
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
58.3 percentage of participants
Interval 40.8 to 74.5
|
51.4 percentage of participants
Interval 34.0 to 68.6
|
64 percentage of participants
Interval 42.5 to 82.0
|
SECONDARY outcome
Timeframe: From treatment initiation through Week 192. AEs after that time were censored.Population: All participants
Percentage and exact 95% Confidence Interval (CI) of participants with Grade 3 or higher AEs assessed by the site investigator as related to the study drug.
Outcome measures
| Measure |
Cohort I
n=23 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=23 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=15 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=17 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=36 Participants
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=35 Participants
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=25 Participants
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Grade 3 or Higher Adverse Events (AEs) Assessed as Related to Study Drug
|
0 percentage of participants
Interval 0.0 to 14.8
|
0 percentage of participants
Interval 0.0 to 14.8
|
0 percentage of participants
Interval 0.0 to 21.8
|
0 percentage of participants
Interval 0.0 to 19.5
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
0 percentage of participants
Interval 0.0 to 9.7
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 13.7
|
SECONDARY outcome
Timeframe: From treatment initiation through Week 192. AEs after that time were censored.Population: All participants
Number of participants with permanent discontinuation of study drug due to AEs assessed by the site investigator as related to the study drug.
Outcome measures
| Measure |
Cohort I
n=23 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=23 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=15 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=17 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=36 Participants
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=35 Participants
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=25 Participants
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Permanent Discontinuation of Study Drug Due to Adverse Events (AEs) Assessed as Related to Study Drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From treatment initiation through Week 192. AEs after that time were censored.Population: All participants
Number of participants who died were summarized.
Outcome measures
| Measure |
Cohort I
n=23 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=23 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=15 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=17 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=36 Participants
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=35 Participants
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=25 Participants
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Died
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 24 and Week 48Population: Participants who received at least one dose of DTG.
Virologic responses were assessed at weeks 24 and 48 as percentages of participants and exact 95% Confidence Interval (CI). The virologic response or virologic failure was defined and calculated according to FDA's Snapshot algorithm.
Outcome measures
| Measure |
Cohort I
n=23 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=23 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=15 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=17 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=36 Participants
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=35 Participants
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=25 Participants
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA Less Than 400 Copies/ml
Week 24
|
82.6 percentage of participants
Interval 61.2 to 95.0
|
78.3 percentage of participants
Interval 56.3 to 92.5
|
100 percentage of participants
Interval 78.2 to 100.0
|
88.2 percentage of participants
Interval 63.6 to 98.5
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
86.1 percentage of participants
Interval 70.5 to 95.3
|
88.6 percentage of participants
Interval 73.3 to 96.8
|
68 percentage of participants
Interval 46.5 to 85.1
|
|
Percentage of Participants With Plasma HIV-1 RNA Less Than 400 Copies/ml
Week 48
|
73.9 percentage of participants
Interval 51.6 to 89.8
|
78.3 percentage of participants
Interval 56.3 to 92.5
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
86.1 percentage of participants
Interval 70.5 to 95.3
|
85.7 percentage of participants
Interval 69.7 to 95.2
|
72 percentage of participants
Interval 50.6 to 87.9
|
SECONDARY outcome
Timeframe: Week 24 and Week 48Population: Participants who received at least one dose of DTG.
Virologic responses were assessed at weeks 24 and 48 as percentages of participants and exact 95% Confidence Interval (CI), The virologic response or virologic failure was defined and calculated according to FDA's Snapshot algorithm.
Outcome measures
| Measure |
Cohort I
n=23 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=23 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=15 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=17 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=36 Participants
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=35 Participants
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=25 Participants
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/ml
Week 24
|
69.6 percentage of participants
Interval 47.1 to 86.8
|
60.9 percentage of participants
Interval 38.5 to 80.3
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
58.8 percentage of participants
Interval 32.9 to 81.6
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
61.1 percentage of participants
Interval 43.5 to 76.9
|
51.4 percentage of participants
Interval 34.0 to 68.6
|
32 percentage of participants
Interval 14.9 to 53.5
|
|
Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/ml
Week 48
|
60.9 percentage of participants
Interval 38.5 to 80.3
|
69.6 percentage of participants
Interval 47.1 to 86.8
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
64.7 percentage of participants
Interval 38.3 to 85.8
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
69.4 percentage of participants
Interval 51.9 to 83.7
|
65.7 percentage of participants
Interval 47.8 to 80.9
|
36 percentage of participants
Interval 18.0 to 57.5
|
SECONDARY outcome
Timeframe: One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosingPopulation: Participants with intensive pharmacokinetic (PK) data at the proposed dose for Cohorts I, IIA, III-DT, IV-DT, and V-DT.
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). C24h was taken directly from the observed concentration-time data or estimated using the elimination rate constant.
Outcome measures
| Measure |
Cohort I
n=9 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=5 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=17 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=13 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=13 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Plasma Concentration Observed at End of 24 Hour Dosing Interval (C24h)
|
1145.36 ng/mL
Standard Deviation 659.65
|
1475.46 ng/mL
Standard Deviation 1139.52
|
1065.12 ng/mL
Standard Deviation 1112.46
|
1488.24 ng/mL
Standard Deviation 1175.44
|
1765.19 ng/mL
Standard Deviation 929.97
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosingPopulation: Participants with intensive pharmacokinetic (PK) data at the proposed dose for Cohorts I, IIA, III-DT, IV-DT, and V-DT.
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). C0h was taken directly from the observed concentration-time data.
Outcome measures
| Measure |
Cohort I
n=9 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=5 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=17 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=13 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=13 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Plasma Concentration Observed Immediately to Dosing of 24 Hour Dosing Interval (C0h)
|
1429.09 ng/mL
Standard Deviation 738.69
|
1508.44 ng/mL
Standard Deviation 1271.93
|
944.22 ng/mL
Standard Deviation 549.36
|
1584.29 ng/mL
Standard Deviation 1388.27
|
1376.15 ng/mL
Standard Deviation 1132.28
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosingPopulation: Participants with intensive pharmacokinetic (PK) data at the proposed dose for Cohorts I, IIA, III-DT, IV-DT, and V-DT.
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ) and were performed in real-time. Cmin was taken directly from the observed concentration-time data.
Outcome measures
| Measure |
Cohort I
n=9 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=5 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=17 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=13 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=13 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Minimum Plasma Concentration (Cmin)
|
1193.94 ng/mL
Standard Deviation 668.76
|
1155.52 ng/mL
Standard Deviation 1152.98
|
757.92 ng/mL
Standard Deviation 439.83
|
1343.74 ng/mL
Standard Deviation 1370.79
|
1213.68 ng/mL
Standard Deviation 886.21
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosingPopulation: Participants with intensive pharmacokinetic (PK) data at the proposed dose for Cohorts I, IIA, III-DT, IV-DT, and V-DT.
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). Cmax was taken directly from the observed concentration-time data.
Outcome measures
| Measure |
Cohort I
n=9 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=5 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=17 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=13 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=13 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Maximum Plasma Concentration (Cmax)
|
3945.97 ng/mL
Standard Deviation 1499.34
|
5111.10 ng/mL
Standard Deviation 2459.92
|
5530.16 ng/mL
Standard Deviation 2466.62
|
6256.67 ng/mL
Standard Deviation 2508.57
|
4832.58 ng/mL
Standard Deviation 1679.69
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosingPopulation: Participants with intensive pharmacokinetic (PK) data at the proposed dose for Cohorts I, IIA, III-DT, IV-DT, and V-DT.
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). CL/F was calculated as Dose/AUC.
Outcome measures
| Measure |
Cohort I
n=9 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=5 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=17 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=13 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=13 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Apparent Clearance (CL/F)
|
1.29 L/h
Standard Deviation 1.03
|
1.11 L/h
Standard Deviation 0.92
|
0.49 L/h
Standard Deviation 0.31
|
0.23 L/h
Standard Deviation 0.11
|
0.11 L/h
Standard Deviation 0.05
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosingPopulation: Participants with intensive pharmacokinetic (PK) data at the proposed dose for Cohorts I, IIA, III-DT, IV-DT, and V-DT.
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). Vz/F was calculated as Dose/(ke x AUC).
Outcome measures
| Measure |
Cohort I
n=9 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=5 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=17 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=13 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=13 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Apparent Volume of Distribution (Vz/F)
|
21.95 L
Standard Deviation 13.71
|
19.11 L
Standard Deviation 16.51
|
5.75 L
Standard Deviation 3.66
|
3.19 L
Standard Deviation 1.50
|
2.37 L
Standard Deviation 1.04
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosingPopulation: Participants with intensive pharmacokinetic (PK) data at the proposed dose for Cohorts I, IIA, III-DT, IV-DT, and V-DT.
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). t1/2 was calculated as ln(2)/ke.
Outcome measures
| Measure |
Cohort I
n=9 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=5 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=17 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=13 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=13 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Terminal Half-life (t1/2)
|
13.21 h
Standard Deviation 5.51
|
12.22 h
Standard Deviation 2.63
|
9.10 h
Standard Deviation 3.40
|
9.93 h
Standard Deviation 2.58
|
16.85 h
Standard Deviation 8.22
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Day 0, Week 24, and Week 48Population: Participants who received at least one dose of DTG. Study participants who had non-missing values were summarized.
The median differences between CD4 count at Week 24 and 48 minus at the Day 0 (baseline), and Interquartile Ranges (IQRs) are presented.
Outcome measures
| Measure |
Cohort I
n=23 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=23 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=15 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=17 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=36 Participants
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=35 Participants
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=25 Participants
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Summary of Changes in CD4 Count From Baseline
From baseline to Week 24
|
63 cells/mm^3
Interval -56.0 to 180.0
|
209 cells/mm^3
Interval 30.0 to 403.0
|
268 cells/mm^3
Interval 142.0 to 372.0
|
199 cells/mm^3
Interval -59.0 to 644.0
|
472 cells/mm^3
Interval -20.0 to 883.0
|
249 cells/mm^3
Interval 47.0 to 535.0
|
110 cells/mm^3
Interval -284.0 to 434.0
|
441 cells/mm^3
Interval -114.0 to 1023.0
|
|
Summary of Changes in CD4 Count From Baseline
From baseline to Week 48
|
84 cells/mm^3
Interval -81.0 to 238.0
|
387 cells/mm^3
Interval 49.0 to 575.0
|
246 cells/mm^3
Interval 160.0 to 466.0
|
134.5 cells/mm^3
Interval -183.5 to 569.5
|
577 cells/mm^3
Interval 135.0 to 777.0
|
191 cells/mm^3
Interval -202.0 to 541.0
|
-1 cells/mm^3
Interval -449.0 to 577.0
|
721 cells/mm^3
Interval -114.0 to 972.0
|
SECONDARY outcome
Timeframe: Measured at Day 0, Week 24, and Week 48Population: Participants who received at least one dose of DTG. Study participants who had non-missing values were summarized.
The median differences between CD4 percent at Week 24 and 48 minus at the Day 0 (baseline), and Interquartile Ranges (IQRs) are presented.
Outcome measures
| Measure |
Cohort I
n=23 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=23 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=15 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=17 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=36 Participants
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=35 Participants
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=25 Participants
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Summary of Changes in CD4 Percent From Baseline
From baseline to Week 24
|
4.9 Percentage of total lymphocytes
Interval 1.0 to 8.0
|
8 Percentage of total lymphocytes
Interval 5.0 to 11.0
|
6 Percentage of total lymphocytes
Interval 3.3 to 9.1
|
6 Percentage of total lymphocytes
Interval 4.5 to 9.0
|
5.7 Percentage of total lymphocytes
Interval 3.9 to 8.1
|
6.1 Percentage of total lymphocytes
Interval 3.4 to 10.9
|
6 Percentage of total lymphocytes
Interval 2.5 to 12.0
|
5.1 Percentage of total lymphocytes
Interval 1.0 to 10.0
|
|
Summary of Changes in CD4 Percent From Baseline
From baseline to Week 48
|
4.7 Percentage of total lymphocytes
Interval 0.0 to 9.4
|
9 Percentage of total lymphocytes
Interval 7.0 to 14.0
|
9.2 Percentage of total lymphocytes
Interval 5.0 to 11.9
|
5.6 Percentage of total lymphocytes
Interval 1.5 to 11.0
|
9.9 Percentage of total lymphocytes
Interval 8.5 to 10.0
|
9.1 Percentage of total lymphocytes
Interval 4.4 to 13.4
|
8.8 Percentage of total lymphocytes
Interval 0.7 to 14.0
|
9.7 Percentage of total lymphocytes
Interval 4.1 to 11.0
|
SECONDARY outcome
Timeframe: Measured at Day 0, Week 24, and Week 48Population: Participants who received at least one dose of DTG. Study participants who had non-missing values were summarized.
The median differences between CD8 count at Week 24 and 48 minus at the Day 0 (baseline), and Interquartile Ranges (IQRs) are presented.
Outcome measures
| Measure |
Cohort I
n=23 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=23 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=15 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=17 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=36 Participants
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=35 Participants
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=25 Participants
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Summary of Changes in CD8 Count From Baseline
From baseline to Week 24
|
-36 cells/mm^3
Interval -371.0 to 30.0
|
-147 cells/mm^3
Interval -804.0 to 30.0
|
-43 cells/mm^3
Interval -247.0 to 151.0
|
-282 cells/mm^3
Interval -533.0 to 176.0
|
223 cells/mm^3
Interval -592.0 to 668.0
|
-395 cells/mm^3
Interval -732.0 to 69.0
|
-813 cells/mm^3
Interval -2013.0 to -65.0
|
-210 cells/mm^3
Interval -1206.0 to 910.0
|
|
Summary of Changes in CD8 Count From Baseline
From baseline to Week 48
|
-52.5 cells/mm^3
Interval -365.0 to 105.0
|
-117 cells/mm^3
Interval -607.0 to 131.0
|
-126 cells/mm^3
Interval -302.0 to 166.0
|
-431.5 cells/mm^3
Interval -782.0 to -169.5
|
-376 cells/mm^3
Interval -411.0 to 21.0
|
-464 cells/mm^3
Interval -1013.0 to -94.0
|
-1242 cells/mm^3
Interval -2433.0 to -280.0
|
-442 cells/mm^3
Interval -1435.0 to 870.0
|
SECONDARY outcome
Timeframe: Measured at Day 0, Week 24, and Week 48Population: Participants who received at least one dose of DTG. Study participants who had non-missing values were summarized.
The median differences between CD8 percent at Week 24 and 48 minus at the Day 0 (baseline), and Interquartile Ranges (IQRs) are presented.
Outcome measures
| Measure |
Cohort I
n=23 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=23 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=15 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=17 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=36 Participants
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=35 Participants
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=25 Participants
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Summary of Changes in CD8 Percent From Baseline
From baseline to Week 24
|
-5 Percentage of total lymphocytes
Interval -9.7 to -2.3
|
-10 Percentage of total lymphocytes
Interval -17.4 to -6.0
|
-7 Percentage of total lymphocytes
Interval -9.2 to -4.0
|
-6.8 Percentage of total lymphocytes
Interval -9.9 to 2.5
|
-2 Percentage of total lymphocytes
Interval -4.1 to 3.5
|
-3 Percentage of total lymphocytes
Interval -9.0 to 0.1
|
-4.2 Percentage of total lymphocytes
Interval -9.9 to -1.3
|
-4 Percentage of total lymphocytes
Interval -10.2 to 2.0
|
|
Summary of Changes in CD8 Percent From Baseline
From baseline to Week 48
|
-6 Percentage of total lymphocytes
Interval -12.0 to -2.4
|
-11.4 Percentage of total lymphocytes
Interval -22.0 to -7.0
|
-8 Percentage of total lymphocytes
Interval -15.0 to -5.0
|
-6.5 Percentage of total lymphocytes
Interval -14.5 to -3.0
|
-1.8 Percentage of total lymphocytes
Interval -4.0 to 0.3
|
-6.5 Percentage of total lymphocytes
Interval -10.0 to -1.9
|
-9 Percentage of total lymphocytes
Interval -15.2 to -4.9
|
-3.5 Percentage of total lymphocytes
Interval -11.5 to 1.7
|
SECONDARY outcome
Timeframe: At baselinePopulation: All participants with a confirmed decrease in HIV RNA of \< 1.0 log10 at or after week 12 unless the HIV RNA is \< 400 copies/mL, or a confirmed HIV RNA \> 400 copies/mL starting at Week 24 or beyond on 2 consecutive measurements at least 1 week and within 4 weeks apart
Genes were sequenced and compared to a reference sequence to identify mutations
Outcome measures
| Measure |
Cohort I
n=56 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Genotypic Measures of Resistance to Integrase
A128T
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
Gene not found
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
L74I
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
L74I,S230N
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
S230N
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
T97A
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
V151I
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
None
|
40 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at virological failure visit at or prior to Week 192Population: All participants with a confirmed decrease in HIV RNA of \< 1.0 log10 at or after week 12 unless the HIV RNA is \< 400 copies/mL, or a confirmed HIV RNA \> 400 copies/mL starting at Week 24 or beyond on 2 consecutive measurements at least 1 week and within 4 weeks apart
Genes were sequenced and compared to a reference sequence to identify mutations
Outcome measures
| Measure |
Cohort I
n=56 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Genotypic Measures of Resistance to Integrase
A128T
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
A128T,S153AFSV
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
E138AEKT,E138T,S147G,S147GS,R263K,R263KR
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
E138K,Q148K
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
E157Q
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
E92EG,T97A,N155H,N155HN
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
E92EQ,G118GR
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
H51HY
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
L74I
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
L74I,G118R
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
L74I,S230N
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
L74M,G118R
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
R263K
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
S230N
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
T66I,G118R,E138A
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
T66I,L74I,G118R
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
T97A,G118R,E138EK,S147G,V151I,N155H
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
missing
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Integrase
None
|
25 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at baselinePopulation: all participants with a confirmed decrease in HIV RNA of \< 1.0 log10 at or after week 12 unless the HIV RNA is \< 400 copies/mL, or a confirmed HIV RNA \> 400 copies/mL starting at Week 24 or beyond on 2 consecutive measurements at least 1 week and within 4 weeks apart
Genes were sequenced and compared to a reference sequence to identify mutations
Outcome measures
| Measure |
Cohort I
n=56 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Genotypic Measures of Resistance to Protease
A71T
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
D30N,A71T,N88D
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
D30N,M46I,Q58EQ,A71T,N88D
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
I84V
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
K20I
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
K20I,V82I
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
K20R
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
K20R,A71T
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
K20R,L33F,M46I,I50V,I54V,T74P,V82A
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
K20R,T74S
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
K20R,T74S,V82A
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
K20T,V82I
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
K43T,A71T,V82A
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
L10I,K20KR,M46LM,I54IL,A71AV,V82AFSV
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
L10I
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
L10V
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
T74S
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
None
|
26 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at virological failures at or prior to Week 192Population: all participants with a confirmed decrease in HIV RNA of \< 1.0 log10 at or after week 12 unless the HIV RNA is \< 400 copies/mL, or a confirmed HIV RNA \> 400 copies/mL starting at Week 24 or beyond on 2 consecutive measurements at least 1 week and within 4 weeks apart
Genes were sequenced and compared to a reference sequence to identify mutations
Outcome measures
| Measure |
Cohort I
n=56 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Genotypic Measures of Resistance to Protease
A71T
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
D30N,A71T,N88D
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
D30N,M46I,Q58E,Q58EQ,A71T,N88D
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
I84V
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
K20I
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
K20R
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
K20R,T74S
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
K20R,T74S,V82A
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
K20T,V82I
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
L10I
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
L10I,K20R
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
L10I,K43T,I54V,A71T,V82A
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
L10I,L10IV
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
L10IL,K20KR,L33FL,M46IM,I50IV,I54IV,T74PT,V82AV
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
L10V
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
L10V,K20IV,K20V
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
T74S
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
V11IV,K20I,V82I
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
missing
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Protease
None
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at baselinePopulation: all participants with a confirmed decrease in HIV RNA of \< 1.0 log10 at or after week 12 unless the HIV RNA is \< 400 copies/mL, or a confirmed HIV RNA \> 400 copies/mL starting at Week 24 or beyond on 2 consecutive measurements at least 1 week and within 4 weeks apart
Genes were sequenced and compared to a reference sequence to identify mutations
Outcome measures
| Measure |
Cohort I
n=56 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Genotypic Measures of Resistance to Reverse Transcriptase
A62V,K65R,S68G,K70R,V75I,F77L,K101Q,K103N,F116Y,Q151M,P225H
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
D67DN,K238R
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
D67DN,V179I,V179IV,M184V,K219Q,N348I
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
E138A
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
E44D,K103N,M184V
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K103N
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K103N,M184V
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K103N,M184V,M184MV
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K103N,P225H
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K103N,V179I
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K103N,V179I,M184V
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K103N,Y181C
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K103S,V179I,G190A,Y318F
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K65R,V106M,G190A
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K70KR,T215F,T215FIST,K238R
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
L74LV,Y181CY,M184V
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
L74V,K103N,E138G,M184V,M230L
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
L74V,V106M,Y181C
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
M184V
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
M184V,H221Y
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
M184V,K238R
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
M41L,D67N,T69N,K70R,L74I,A98G,M184V,T215F,K219Q,K238R
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
M41L,K101E,V179I,M184V,G190A,T215F
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
M41L,T215L
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
S68G,K103N,E138Q,M184V,Y318F
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
S68G,V106I,K238R
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
S68G,V90I,K103N,V179I
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
T69D
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V118I,E138A
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V118IV,V179I,M184V
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V179E,P225H
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V179I
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V179I,M184V
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V179I,M184V,G190A,K219R
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V179I,M184V,K238R
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V179I,M184V,Y188L
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V179S
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V75M,K103N
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V90I
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
Y181C
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
None
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at virologic failure at or prior to Week 192Population: all participants with a confirmed decrease in HIV RNA of \< 1.0 log10 at or after week 12 unless the HIV RNA is \< 400 copies/mL, or a confirmed HIV RNA \> 400 copies/mL starting at Week 24 or beyond on 2 consecutive measurements at least 1 week and within 4 weeks apart
Genes were sequenced and compared to a reference sequence to identify mutations
Outcome measures
| Measure |
Cohort I
n=56 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Genotypic Measures of Resistance to Reverse Transcriptase
101i,V179I,M184V
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
A62V,K65R,S68G,K70R,V75I,F77L,K101Q,K103N,F116Y,Q151M,P225H
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
D67N,K219Q,N348I
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
E138A
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
E44D,E44DE,K103N,M184V
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
E44DE
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K103KN,K103N,M184V
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K103N
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K103N,M184V
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K103N,V179I
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K103N,V179I,M184V
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K103S,M184V,G190A,Y318F
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K238R
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
K238R,M41LM,D67DN,T69NT,K70KR,L74IL,A98AG,M184MV,T215FIST,K219Q,M230IM
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
L74IL,L74V,K103N,E138G,M184V,M230L
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
M184V
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
M184V,H221Y
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
M184V,K238R
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
M41L,T215FL
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
M41LM,M184V,S68G,S68GS,Y181CY,M184MV
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
S68G,V106I,K238R
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
S68G,V90I,K103N,V179I,M184V
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
S68GS,K103KN,K238KR,K238R
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
T69NT,K103N,P225H
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V106M,Y181C,P236LP
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V179D,V179DV,G190A,G190AG
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V179E,P225H
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V179I
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V179I,M184V
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V179I,M184V,G190A,K219R
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V179I,M184V,K238R
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V179I,M184V,Y188L
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V179S,M184V
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V75M,K103N
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
V90I
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
missing
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Genotypic Measures of Resistance to Reverse Transcriptase
None
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Whenever virological failures took place from baseline to week 192Population: Protocol defined virological failure population for which drug susceptibility was measured
The participant viral culture is considered to be reduced susceptibility if more DTG is needed to inactivate 50% of the participant viral culture compared to the control viral specimen
Outcome measures
| Measure |
Cohort I
n=11 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=5 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=1 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=3 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=3 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=10 Participants
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=11 Participants
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=12 Participants
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Phenotypic Measures of Resistance
Sensitive to DTG
|
8 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
9 Participants
|
|
Phenotypic Measures of Resistance
Reduced susceptibility to DTG
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phenotypic Measures of Resistance
missing
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From baseline through Week 192Population: All participants enrolled into the study
Disease progression as measured by change from baseline to the worst case CDC HIV classification status
Outcome measures
| Measure |
Cohort I
n=74 Participants
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=37 Participants
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=21 Participants
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=32 Participants
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 Participants
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=10 Participants
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Worst Case CDC HIV Classification Status
Not symptomatic at entry
|
74 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Worst Case CDC HIV Classification Status
Mildly symptomatic at entry
|
0 Participants
|
37 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Worst Case CDC HIV Classification Status
Moderately symptomatic at entry
|
0 Participants
|
0 Participants
|
20 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Worst Case CDC HIV Classification Status
Severely symptomatic at entry
|
0 Participants
|
0 Participants
|
0 Participants
|
31 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Worst Case CDC HIV Classification Status
Stage III at entry
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
—
|
—
|
|
Worst Case CDC HIV Classification Status
Stage I or II at entry
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
10 Participants
|
—
|
—
|
Adverse Events
Cohort I
Serious events: 8 serious events
Other events: 23 other events
Deaths: 0 deaths
Cohort IIA
Serious events: 5 serious events
Other events: 23 other events
Deaths: 1 deaths
Cohort IIB
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort III
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
Cohort IV
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort III-DT
Serious events: 12 serious events
Other events: 36 other events
Deaths: 1 deaths
Cohort IV-DT
Serious events: 8 serious events
Other events: 35 other events
Deaths: 1 deaths
Cohort V-DT
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort I
n=23 participants at risk
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=23 participants at risk
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=15 participants at risk
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=17 participants at risk
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 participants at risk
Children 6 months to younger than 2 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=36 participants at risk
Children 2 to younger than 6 years of age who received DTG dispersible tablets. DTG dispersible tables initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=35 participants at risk
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tables initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=25 participants at risk
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tables initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Disseminated mycobacterium avium complex infection
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Lipase increased
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Cataract
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Gastritis
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Death
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Drowning
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Pyrexia
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Atypical mycobacterial lymphadenitis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
COVID-19
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.7%
2/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Herpes zoster
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Influenza
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Ophthalmic herpes simplex
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Pelvic inflammatory disease
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Plasmodium falciparum infection
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Pneumonia adenoviral
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Sepsis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Sinusitis bacterial
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Viral rash
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Neutrophil count decreased
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retinoblastoma
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Psychiatric disorders
Suicide attempt
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Surgical and medical procedures
Abortion induced
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Vascular disorders
Deep vein thrombosis
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
Other adverse events
| Measure |
Cohort I
n=23 participants at risk
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIA
n=23 participants at risk
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at \~1 mg/kg with a maximum dose of 50 mg; orally once daily.
|
Cohort IIB
n=15 participants at risk
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III
n=17 participants at risk
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort IV
n=7 participants at risk
Children 6 months to younger than 2 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at \~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
|
Cohort III-DT
n=36 participants at risk
Children 2 to younger than 6 years of age who received DTG dispersible tablets. DTG dispersible tables initial starting dose of \~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort IV-DT
n=35 participants at risk
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tables initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
Cohort V-DT
n=25 participants at risk
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tables initial starting dose of \~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.7%
2/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
12.0%
3/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
30.4%
7/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
30.4%
7/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
20.0%
3/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.6%
2/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
16.7%
6/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.0%
2/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.6%
2/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Cardiac disorders
Tachycardia
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.7%
2/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Congenital, familial and genetic disorders
Craniosynostosis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Ear and labyrinth disorders
Ear pain
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.4%
4/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
23.5%
4/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.9%
5/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Ear and labyrinth disorders
Noninfective myringitis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.7%
2/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Ear and labyrinth disorders
Tympanic membrane hyperaemia
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Blepharitis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Chalazion
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Conjunctival hyperaemia
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Conjunctival pallor
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.6%
2/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.7%
2/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
12.0%
3/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Eye discharge
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.6%
3/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
5/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Eye movement disorder
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Eye opacity
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Eye pain
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Eye pruritus
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Ocular hyperaemia
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.4%
4/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Pterygium
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Scleritis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
30.4%
7/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
19.4%
7/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
17.4%
4/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Anal erythema
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Constipation
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
34.8%
8/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
26.1%
6/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
52.9%
9/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
57.1%
4/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
27.8%
10/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
54.3%
19/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
24.0%
6/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Dysphagia
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Gingival ulceration
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Infantile vomiting
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.4%
4/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
16.0%
4/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Lip pain
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Lip ulceration
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Nausea
|
34.8%
8/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Oral disorder
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Oral mucosal eruption
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Oral pain
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.7%
2/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Toothache
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Vomiting
|
26.1%
6/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.4%
4/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
40.0%
6/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
41.2%
7/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
42.9%
3/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
30.6%
11/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
40.0%
14/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
32.0%
8/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Chest discomfort
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Chest pain
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Fatigue
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Feeling hot
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.3%
3/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.4%
4/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Influenza like illness
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Malaise
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Medical device site pain
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Pain
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Peripheral swelling
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Pyrexia
|
34.8%
8/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
30.4%
7/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
33.3%
5/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
52.9%
9/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
85.7%
6/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
50.0%
18/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
37.1%
13/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.0%
7/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Ulcer
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Immune system disorders
Immune reconstitution inflammatory syndrome
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Acarodermatitis
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.4%
4/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Adenoiditis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Anal candidiasis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.6%
2/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Ascariasis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Bacterial vaginosis
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Balanitis candida
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Body tinea
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.9%
5/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.6%
3/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.0%
2/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Bronchitis
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Cellulitis
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Conjunctivitis
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
5/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Gastroenteritis
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
29.4%
5/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.3%
3/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
22.9%
8/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.0%
2/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Giardiasis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
HIV-associated neurocognitive disorder
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Helminthic infection
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Herpangina
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Impetigo
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
23.5%
4/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
42.9%
3/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
16.7%
6/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.4%
4/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Influenza
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Lice infestation
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Measles
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Molluscum contagiosum
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
42.9%
3/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.3%
3/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Oral candidiasis
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.4%
4/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.0%
2/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Oral herpes
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Otitis media
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
23.5%
4/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.9%
5/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.4%
4/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.0%
2/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Pharyngitis
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
20.0%
3/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
23.5%
4/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
22.2%
8/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
5/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.0%
2/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.0%
2/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Pustule
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.0%
2/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
5/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.0%
2/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Schistosomiasis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Septic rash
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Sinusitis bacterial
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Subcutaneous abscess
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.4%
4/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.9%
5/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
5/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.0%
2/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Tinea faciei
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.1%
4/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Tinea infection
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.3%
3/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.6%
3/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.9%
5/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.6%
3/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.6%
2/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
25.0%
9/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.6%
10/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
16.0%
4/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
5/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Varicella
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Viral infection
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Adverse event following immunisation
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.0%
2/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Alanine aminotransferase increased
|
21.7%
5/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
34.8%
8/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
26.7%
4/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
29.4%
5/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
42.9%
3/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
19.4%
7/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.7%
2/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
16.0%
4/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Aspartate aminotransferase increased
|
21.7%
5/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
30.4%
7/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
20.0%
3/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
47.1%
8/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
42.9%
3/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
33.3%
12/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
22.9%
8/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
12.0%
3/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood albumin decreased
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.4%
4/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.6%
2/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
16.7%
6/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
34.3%
12/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
44.0%
11/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
21.7%
5/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
26.7%
4/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.6%
3/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
42.9%
3/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
30.6%
11/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
20.0%
7/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
24.0%
6/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood bicarbonate decreased
|
47.8%
11/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
43.5%
10/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
40.0%
6/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
76.5%
13/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
85.7%
6/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
91.7%
33/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
97.1%
34/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
92.0%
23/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood bilirubin increased
|
21.7%
5/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
26.1%
6/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
20.0%
3/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood calcium increased
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood cholesterol increased
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
16.7%
6/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood creatinine increased
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.0%
2/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood glucose decreased
|
34.8%
8/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
52.2%
12/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
46.7%
7/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
47.1%
8/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
42.9%
3/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
27.8%
10/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.6%
10/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
20.0%
5/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood glucose increased
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.4%
4/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
42.9%
3/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
36.1%
13/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
37.1%
13/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
24.0%
6/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood phosphorus decreased
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.3%
3/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
5/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
20.0%
5/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood potassium decreased
|
17.4%
4/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.4%
4/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood potassium increased
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.6%
3/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
27.8%
10/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
31.4%
11/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
56.0%
14/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.3%
3/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood pressure increased
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood sodium decreased
|
26.1%
6/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
34.8%
8/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
60.0%
9/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
47.1%
8/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
100.0%
7/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
66.7%
24/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
77.1%
27/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
56.0%
14/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood sodium increased
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.3%
3/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
16.0%
4/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood urine present
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Cardiac murmur
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Haemoglobin decreased
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
26.1%
6/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
29.4%
5/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
42.9%
3/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
38.9%
14/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
68.6%
24/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
80.0%
20/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Lipase increased
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.6%
3/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.6%
2/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
16.7%
6/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
22.9%
8/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
12.0%
3/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Low density lipoprotein increased
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.9%
5/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Neutrophil count decreased
|
17.4%
4/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
26.1%
6/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
46.7%
7/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
35.3%
6/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
42.9%
3/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
52.8%
19/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
57.1%
20/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
76.0%
19/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Platelet count decreased
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.6%
3/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.0%
2/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Urine output decreased
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Weight decreased
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.6%
3/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.6%
3/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
White blood cell count decreased
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.4%
7/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
20.0%
3/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
29.4%
5/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
71.4%
5/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.1%
4/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.6%
10/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
16.0%
4/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.7%
2/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.7%
2/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.7%
2/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.0%
2/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Poor feeding infant
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
5/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Underweight
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.0%
2/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.4%
4/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.4%
4/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
26.1%
6/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.3%
3/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.7%
2/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Clonus
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Dizziness
|
17.4%
4/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Headache
|
34.8%
8/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
26.1%
6/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
33.3%
5/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.6%
3/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.1%
4/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Meningism
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Motor developmental delay
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Seizure
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.7%
2/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Psychiatric disorders
Adjustment disorder with disturbance of conduct
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Psychiatric disorders
Anxiety
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Psychiatric disorders
Depression
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.4%
4/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Psychiatric disorders
Reading disorder
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Renal and urinary disorders
Dysuria
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.7%
2/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Renal and urinary disorders
Pollakiuria
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Renal and urinary disorders
Proteinuria
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Perineal erythema
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
17.4%
4/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial wall thickening
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Childhood asthma
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
60.9%
14/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
65.2%
15/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
53.3%
8/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
88.2%
15/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
85.7%
6/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
80.6%
29/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
60.0%
21/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
60.0%
15/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.6%
2/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.6%
3/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Mouth breathing
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
43.5%
10/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
43.5%
10/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
33.3%
5/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
35.3%
6/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
57.1%
4/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
22.2%
8/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
5/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
20.0%
5/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discharge discolouration
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
47.8%
11/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
21.7%
5/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
26.7%
4/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
27.8%
10/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.7%
2/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal plaque
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.6%
3/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.6%
2/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
16.7%
6/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
22.9%
8/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
12.0%
3/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal ulceration
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.6%
2/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.3%
3/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
21.7%
5/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
23.5%
4/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
27.8%
10/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
30.4%
7/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
34.8%
8/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
53.3%
8/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
58.8%
10/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
71.4%
5/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
41.7%
15/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
31.4%
11/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
24.0%
6/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
20.0%
3/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.6%
3/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
42.9%
3/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.1%
4/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.7%
2/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
17.4%
4/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
12.0%
3/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar inflammation
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Use of accessory respiratory muscles
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.6%
2/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.6%
3/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.3%
3/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.4%
4/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Blister
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.7%
2/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.4%
4/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.0%
2/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.8%
2/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.3%
3/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Macule
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Papule
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
29.4%
5/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.6%
2/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.3%
3/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.4%
4/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
12.0%
3/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
26.1%
6/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
20.0%
3/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
16.7%
6/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
20.0%
7/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.7%
5/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
30.4%
7/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
40.0%
6/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
17.6%
3/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.6%
2/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
30.6%
11/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
37.1%
13/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
28.0%
7/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.0%
2/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.1%
4/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
11.4%
4/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
14.3%
1/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.6%
2/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
4.3%
1/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.0%
3/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.3%
2/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
13.9%
5/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
4.0%
1/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
8.7%
2/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.8%
1/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Vascular disorders
Flushing
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
6.7%
1/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
|
Vascular disorders
Pallor
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/23 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/15 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
5.9%
1/17 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/7 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/36 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
2.9%
1/35 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/25 • From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
|
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