Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3389404 in Chronic Hepatitis B (CHB) Subjects (NCT NCT03020745)
NCT ID: NCT03020745
Last Updated: 2020-10-01
Results Overview
SBP and DBP were measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
Baseline (Day 1 pre-dose), Day 1: 1 hour, Day 1: 2 hours, Day 1: 4 hours, Day 1: 8 hours, Day 3, Day 8 and Day 30
Results posted on
2020-10-01
Participant Flow
This was a Phase 2a study examining the first administration of GSK3389404 in participants with chronic hepatitis B (CHB). The study was conducted in 2 parts- Part 1 (dose escalation) and Part 2 (dose expansion and optional follow-up period).
A total of 106 participants were screened, of which 78 participants (12 participants in Part 1 and 66 participants in Part 2) were enrolled and received either GSK3389404 or placebo. No participants were enrolled in two cohorts of Part 1 (GSK3389404 60 milligram \[mg\] and GSK3389404 240 mg) as per decision made by the dose escalation committee.
Participant milestones
| Measure |
Part 1: Placebo
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 60 mg
Participants received a single dose of GSK3389404 60 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 1: GSK3389404 240 mg
Participants received a single dose of GSK3389404 240 mg via SC route on Day 1.
|
Part 2: Placebo
Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 30 mg Weekly
Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 60 mg Weekly
Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 (Up to 60 Days)
STARTED
|
3
|
3
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 (Up to 60 Days)
COMPLETED
|
3
|
3
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 (Up to 60 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 (Up to 169 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
10
|
6
|
20
|
15
|
15
|
|
Part 2 (Up to 169 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
10
|
6
|
19
|
14
|
15
|
|
Part 2 (Up to 169 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Part 2:Optional FU (Up to 450 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
10
|
5
|
17
|
13
|
15
|
|
Part 2:Optional FU (Up to 450 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
9
|
5
|
17
|
10
|
15
|
|
Part 2:Optional FU (Up to 450 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
Part 1: Placebo
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 60 mg
Participants received a single dose of GSK3389404 60 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 1: GSK3389404 240 mg
Participants received a single dose of GSK3389404 240 mg via SC route on Day 1.
|
Part 2: Placebo
Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 30 mg Weekly
Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 60 mg Weekly
Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2 (Up to 169 Days)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 2 (Up to 169 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 2:Optional FU (Up to 450 Days)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Part 2:Optional FU (Up to 450 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3389404 in Chronic Hepatitis B (CHB) Subjects
Baseline characteristics by cohort
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: Placebo
n=10 Participants
Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 30 mg Weekly
n=6 Participants
Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 60 mg Weekly
n=20 Participants
Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
75 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
23 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
55 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian-East Asian Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
37 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian-Japanese Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
25 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian-South East Asian Heritage
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Mixed Asian Race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Day 1: 1 hour, Day 1: 2 hours, Day 1: 4 hours, Day 1: 8 hours, Day 3, Day 8 and Day 30Population: Safety Population comprised of all participants who received at least one dose of the study treatment (including placebo). Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
SBP and DBP were measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP, Day 1: 1 hour, n=3,3,6
|
-3.67 Millimeters of mercury (mmHg)
Standard Deviation 16.073
|
3.00 Millimeters of mercury (mmHg)
Standard Deviation 7.550
|
0.50 Millimeters of mercury (mmHg)
Standard Deviation 11.554
|
—
|
—
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP, Day 1: 2 hour, n=3,3,6
|
-5.33 Millimeters of mercury (mmHg)
Standard Deviation 9.018
|
-3.33 Millimeters of mercury (mmHg)
Standard Deviation 3.055
|
-4.33 Millimeters of mercury (mmHg)
Standard Deviation 8.847
|
—
|
—
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP, Day 1: 4 hour, n=3,3,6
|
-8.50 Millimeters of mercury (mmHg)
Standard Deviation 7.365
|
-7.67 Millimeters of mercury (mmHg)
Standard Deviation 1.528
|
-10.50 Millimeters of mercury (mmHg)
Standard Deviation 6.626
|
—
|
—
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP, Day 1: 8 hour, n=3,3,6
|
-7.17 Millimeters of mercury (mmHg)
Standard Deviation 16.510
|
-0.50 Millimeters of mercury (mmHg)
Standard Deviation 2.784
|
-3.17 Millimeters of mercury (mmHg)
Standard Deviation 7.414
|
—
|
—
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP, Day 3, n=3,3,6
|
-7.00 Millimeters of mercury (mmHg)
Standard Deviation 20.075
|
-5.83 Millimeters of mercury (mmHg)
Standard Deviation 5.107
|
-2.33 Millimeters of mercury (mmHg)
Standard Deviation 5.538
|
—
|
—
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP, Day 8, n=2,3,6
|
-7.50 Millimeters of mercury (mmHg)
Standard Deviation 20.506
|
-1.00 Millimeters of mercury (mmHg)
Standard Deviation 7.000
|
-1.50 Millimeters of mercury (mmHg)
Standard Deviation 9.731
|
—
|
—
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP, Day 30, n=3,3,6
|
-6.33 Millimeters of mercury (mmHg)
Standard Deviation 19.604
|
-6.00 Millimeters of mercury (mmHg)
Standard Deviation 1.000
|
-3.00 Millimeters of mercury (mmHg)
Standard Deviation 10.431
|
—
|
—
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP, Day 1: 1 hour, n=3,3,6
|
-0.17 Millimeters of mercury (mmHg)
Standard Deviation 4.072
|
5.72 Millimeters of mercury (mmHg)
Standard Deviation 9.595
|
-2.33 Millimeters of mercury (mmHg)
Standard Deviation 16.367
|
—
|
—
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP, Day 1: 2 hour, n=3,3,6
|
-3.83 Millimeters of mercury (mmHg)
Standard Deviation 17.061
|
6.89 Millimeters of mercury (mmHg)
Standard Deviation 13.040
|
-6.00 Millimeters of mercury (mmHg)
Standard Deviation 12.083
|
—
|
—
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP, Day 1: 4 hour, n=3,3,6
|
-13.33 Millimeters of mercury (mmHg)
Standard Deviation 14.012
|
0.06 Millimeters of mercury (mmHg)
Standard Deviation 6.646
|
-8.00 Millimeters of mercury (mmHg)
Standard Deviation 14.269
|
—
|
—
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP, Day 1: 8 hour, n=3,3,6
|
-5.50 Millimeters of mercury (mmHg)
Standard Deviation 13.611
|
0.89 Millimeters of mercury (mmHg)
Standard Deviation 4.550
|
-5.67 Millimeters of mercury (mmHg)
Standard Deviation 12.644
|
—
|
—
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP, Day 3, n=3,3,6
|
-3.00 Millimeters of mercury (mmHg)
Standard Deviation 21.633
|
-7.94 Millimeters of mercury (mmHg)
Standard Deviation 3.084
|
-0.83 Millimeters of mercury (mmHg)
Standard Deviation 9.261
|
—
|
—
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP, Day 8, n=2,3,6
|
6.00 Millimeters of mercury (mmHg)
Standard Deviation 32.527
|
4.06 Millimeters of mercury (mmHg)
Standard Deviation 5.149
|
0.17 Millimeters of mercury (mmHg)
Standard Deviation 4.070
|
—
|
—
|
|
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP, Day 30, n=3,3,6
|
-2.00 Millimeters of mercury (mmHg)
Standard Deviation 26.514
|
4.89 Millimeters of mercury (mmHg)
Standard Deviation 12.303
|
3.67 Millimeters of mercury (mmHg)
Standard Deviation 13.736
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
SBP and DBP were measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
DBP, Day 8, n=10,6,20,15,15
|
5.8 mmHg
Standard Deviation 8.90
|
2.3 mmHg
Standard Deviation 8.71
|
-1.9 mmHg
Standard Deviation 7.13
|
1.0 mmHg
Standard Deviation 8.86
|
-0.7 mmHg
Standard Deviation 8.61
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
DBP, Day 15, n=10,6,20,14,15
|
2.1 mmHg
Standard Deviation 8.46
|
-4.0 mmHg
Standard Deviation 13.02
|
-0.3 mmHg
Standard Deviation 9.09
|
-0.3 mmHg
Standard Deviation 7.09
|
-2.7 mmHg
Standard Deviation 7.32
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
DBP, Day 22, n=10,6,20,14,15
|
3.4 mmHg
Standard Deviation 9.49
|
-2.0 mmHg
Standard Deviation 6.20
|
0.3 mmHg
Standard Deviation 8.77
|
1.6 mmHg
Standard Deviation 9.80
|
-3.0 mmHg
Standard Deviation 9.13
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
DBP, Day 29, n=10,6,20,13,15
|
3.9 mmHg
Standard Deviation 8.77
|
3.3 mmHg
Standard Deviation 2.25
|
-1.7 mmHg
Standard Deviation 8.55
|
2.1 mmHg
Standard Deviation 9.71
|
-0.7 mmHg
Standard Deviation 7.35
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
DBP, Day 36, n=10,6,20,14,15
|
1.8 mmHg
Standard Deviation 8.90
|
-1.7 mmHg
Standard Deviation 9.35
|
-0.8 mmHg
Standard Deviation 8.84
|
1.9 mmHg
Standard Deviation 8.46
|
-0.1 mmHg
Standard Deviation 6.38
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
DBP, Day 43, n=10,6,20,14,15
|
4.2 mmHg
Standard Deviation 12.33
|
0.0 mmHg
Standard Deviation 6.45
|
-0.3 mmHg
Standard Deviation 12.38
|
0.9 mmHg
Standard Deviation 10.99
|
-0.8 mmHg
Standard Deviation 6.12
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
DBP, Day 50, n=10,6,19,14,15
|
11.0 mmHg
Standard Deviation 17.26
|
2.8 mmHg
Standard Deviation 8.93
|
0.1 mmHg
Standard Deviation 9.95
|
1.3 mmHg
Standard Deviation 10.25
|
-3.2 mmHg
Standard Deviation 7.74
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
DBP, Day 57, n=10,6,20,14,15
|
4.0 mmHg
Standard Deviation 9.88
|
-0.2 mmHg
Standard Deviation 8.73
|
-0.5 mmHg
Standard Deviation 9.10
|
1.6 mmHg
Standard Deviation 8.34
|
-0.8 mmHg
Standard Deviation 8.16
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
DBP, Day 64, n=10,6,20,14,15
|
3.2 mmHg
Standard Deviation 9.67
|
0.3 mmHg
Standard Deviation 9.31
|
-1.9 mmHg
Standard Deviation 10.27
|
2.1 mmHg
Standard Deviation 9.71
|
-1.8 mmHg
Standard Deviation 9.93
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
DBP, Day 71, n=10,6,20,14,15
|
2.9 mmHg
Standard Deviation 9.56
|
3.8 mmHg
Standard Deviation 7.11
|
-0.6 mmHg
Standard Deviation 9.83
|
3.1 mmHg
Standard Deviation 9.92
|
1.4 mmHg
Standard Deviation 9.74
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
DBP, Day 78, n=10,6,20,14,15
|
4.6 mmHg
Standard Deviation 5.50
|
1.2 mmHg
Standard Deviation 6.59
|
-0.8 mmHg
Standard Deviation 8.80
|
5.0 mmHg
Standard Deviation 8.71
|
-4.2 mmHg
Standard Deviation 9.85
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
DBP, Day 85, n=10,6,20,14,15
|
4.9 mmHg
Standard Deviation 7.20
|
1.0 mmHg
Standard Deviation 9.47
|
-1.2 mmHg
Standard Deviation 12.35
|
6.4 mmHg
Standard Deviation 11.21
|
-2.3 mmHg
Standard Deviation 10.69
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
DBP, Day 92, n=10,6,19,14,15
|
2.9 mmHg
Standard Deviation 7.39
|
3.8 mmHg
Standard Deviation 7.63
|
-2.2 mmHg
Standard Deviation 9.52
|
3.9 mmHg
Standard Deviation 9.08
|
-1.1 mmHg
Standard Deviation 10.00
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
DBP, Day 99, n=10,6,20,14,15
|
4.3 mmHg
Standard Deviation 10.27
|
3.0 mmHg
Standard Deviation 9.86
|
0.3 mmHg
Standard Deviation 10.80
|
1.3 mmHg
Standard Deviation 10.38
|
0.1 mmHg
Standard Deviation 10.80
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
DBP, Day 113, n=10,6,20,14,15
|
5.9 mmHg
Standard Deviation 9.71
|
2.7 mmHg
Standard Deviation 8.80
|
-1.2 mmHg
Standard Deviation 10.96
|
4.9 mmHg
Standard Deviation 8.28
|
2.9 mmHg
Standard Deviation 8.17
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
DBP, Day 141, n=10,6,20,14,15
|
7.5 mmHg
Standard Deviation 10.20
|
1.2 mmHg
Standard Deviation 8.33
|
0.7 mmHg
Standard Deviation 12.37
|
0.8 mmHg
Standard Deviation 8.51
|
1.1 mmHg
Standard Deviation 11.28
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
DBP, Day 169, n=10,6,19,14,15
|
5.8 mmHg
Standard Deviation 10.13
|
6.3 mmHg
Standard Deviation 11.71
|
0.5 mmHg
Standard Deviation 11.14
|
3.4 mmHg
Standard Deviation 12.07
|
-0.3 mmHg
Standard Deviation 8.83
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP, Day 8, n=10,6,20,15,15
|
7.7 mmHg
Standard Deviation 11.17
|
5.0 mmHg
Standard Deviation 7.40
|
-2.6 mmHg
Standard Deviation 10.45
|
0.8 mmHg
Standard Deviation 14.35
|
2.1 mmHg
Standard Deviation 9.59
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP, Day 15, n=10,6,20,14,15
|
8.0 mmHg
Standard Deviation 11.60
|
1.7 mmHg
Standard Deviation 14.42
|
-0.4 mmHg
Standard Deviation 10.02
|
2.1 mmHg
Standard Deviation 12.77
|
0.1 mmHg
Standard Deviation 11.03
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP, Day 22, n=10,6,20,14,15
|
5.7 mmHg
Standard Deviation 13.72
|
1.5 mmHg
Standard Deviation 6.57
|
-2.2 mmHg
Standard Deviation 8.66
|
2.4 mmHg
Standard Deviation 11.54
|
-2.1 mmHg
Standard Deviation 14.36
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP, Day 29, n=10,6,20,13,15
|
6.1 mmHg
Standard Deviation 13.20
|
1.7 mmHg
Standard Deviation 4.27
|
-3.1 mmHg
Standard Deviation 11.83
|
2.9 mmHg
Standard Deviation 16.89
|
1.5 mmHg
Standard Deviation 10.29
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP, Day 36, n=10,6,20,14,15
|
0.2 mmHg
Standard Deviation 11.43
|
-0.5 mmHg
Standard Deviation 12.05
|
-5.6 mmHg
Standard Deviation 10.54
|
0.4 mmHg
Standard Deviation 16.21
|
2.1 mmHg
Standard Deviation 12.90
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP, Day 43, n=10,6,20,14,15
|
5.6 mmHg
Standard Deviation 9.91
|
4.7 mmHg
Standard Deviation 13.22
|
-0.6 mmHg
Standard Deviation 11.89
|
1.7 mmHg
Standard Deviation 16.11
|
0.0 mmHg
Standard Deviation 12.53
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP, Day 50, n=10,6,19,14,15
|
5.2 mmHg
Standard Deviation 14.88
|
4.7 mmHg
Standard Deviation 9.65
|
-3.4 mmHg
Standard Deviation 11.93
|
1.6 mmHg
Standard Deviation 12.74
|
-2.2 mmHg
Standard Deviation 11.36
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP, Day 57, n=10,6,20,14,15
|
1.7 mmHg
Standard Deviation 13.86
|
2.5 mmHg
Standard Deviation 13.40
|
-4.2 mmHg
Standard Deviation 10.21
|
0.1 mmHg
Standard Deviation 14.91
|
0.9 mmHg
Standard Deviation 17.26
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP, Day 64, n=10,6,20,14,15
|
5.1 mmHg
Standard Deviation 11.98
|
0.2 mmHg
Standard Deviation 9.11
|
-4.1 mmHg
Standard Deviation 9.17
|
1.4 mmHg
Standard Deviation 16.29
|
0.5 mmHg
Standard Deviation 15.50
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP, Day 71, n=10,6,20,14,15
|
4.6 mmHg
Standard Deviation 11.98
|
5.0 mmHg
Standard Deviation 10.22
|
-2.2 mmHg
Standard Deviation 11.97
|
4.8 mmHg
Standard Deviation 17.68
|
4.2 mmHg
Standard Deviation 12.46
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP, Day 78, n=10,6,20,14,15
|
5.2 mmHg
Standard Deviation 12.28
|
5.0 mmHg
Standard Deviation 6.16
|
-4.4 mmHg
Standard Deviation 10.09
|
4.1 mmHg
Standard Deviation 13.95
|
-0.1 mmHg
Standard Deviation 12.99
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP, Day 85, n=10,6,20,14,15
|
7.2 mmHg
Standard Deviation 15.22
|
5.2 mmHg
Standard Deviation 9.06
|
-5.0 mmHg
Standard Deviation 12.73
|
6.2 mmHg
Standard Deviation 15.62
|
-3.5 mmHg
Standard Deviation 14.30
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP, Day 92, n=10,6,19,14,15
|
5.0 mmHg
Standard Deviation 12.57
|
4.3 mmHg
Standard Deviation 8.50
|
-4.1 mmHg
Standard Deviation 12.60
|
4.6 mmHg
Standard Deviation 13.87
|
-0.1 mmHg
Standard Deviation 12.14
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP, Day 99, n=10,6,20,14,15
|
7.1 mmHg
Standard Deviation 16.84
|
3.3 mmHg
Standard Deviation 15.45
|
-0.5 mmHg
Standard Deviation 14.05
|
1.6 mmHg
Standard Deviation 16.46
|
2.2 mmHg
Standard Deviation 16.34
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP, Day 113, n=10,6,20,14,15
|
7.3 mmHg
Standard Deviation 13.30
|
5.7 mmHg
Standard Deviation 9.35
|
-3.2 mmHg
Standard Deviation 11.64
|
4.9 mmHg
Standard Deviation 12.07
|
6.6 mmHg
Standard Deviation 10.72
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP, Day 141, n=10,6,20,14,15
|
10.9 mmHg
Standard Deviation 11.51
|
3.5 mmHg
Standard Deviation 9.81
|
-0.9 mmHg
Standard Deviation 12.77
|
2.9 mmHg
Standard Deviation 15.93
|
4.6 mmHg
Standard Deviation 16.85
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP, Day 169, n=10,6,19,14,15
|
11.8 mmHg
Standard Deviation 12.41
|
9.7 mmHg
Standard Deviation 12.45
|
0.8 mmHg
Standard Deviation 11.61
|
5.1 mmHg
Standard Deviation 17.41
|
4.9 mmHg
Standard Deviation 12.85
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Day 270 and Day 450Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
SBP and DBP were measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=1 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=1 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 450-Optional Follow-up)
DBP, Day 270, n=1,0,0,0,0
|
-9.0 mmHg
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 450-Optional Follow-up)
DBP, Day 450, n=0,0,1,0,0
|
—
|
—
|
7.0 mmHg
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
—
|
—
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 450-Optional Follow-up)
SBP, Day 270, n=1,0,0,0,0
|
-18.0 mmHg
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 450-Optional Follow-up)
SBP, Day 450, n=0,0,1,0,0
|
—
|
—
|
3.0 mmHg
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Day 1: 1 hour, Day 1: 2 hours, Day 1: 4 hours, Day 1: 8 hours, Day 3, Day 8 and Day 30Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Heart rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Heart Rate at Indicated Time Points
Day 1: 1 hour, n=3,3,6
|
4.78 Beats per minute
Standard Deviation 3.977
|
1.44 Beats per minute
Standard Deviation 8.694
|
-5.00 Beats per minute
Standard Deviation 2.530
|
—
|
—
|
|
Part 1: Change From Baseline in Heart Rate at Indicated Time Points
Day 1: 2 hour, n=3,3,6
|
13.94 Beats per minute
Standard Deviation 12.537
|
4.61 Beats per minute
Standard Deviation 17.472
|
-2.17 Beats per minute
Standard Deviation 6.338
|
—
|
—
|
|
Part 1: Change From Baseline in Heart Rate at Indicated Time Points
Day 1: 4 hour, n=3,3,6
|
8.11 Beats per minute
Standard Deviation 3.564
|
-0.22 Beats per minute
Standard Deviation 16.201
|
-0.17 Beats per minute
Standard Deviation 7.055
|
—
|
—
|
|
Part 1: Change From Baseline in Heart Rate at Indicated Time Points
Day 1: 8 hour, n=3,3,6
|
5.61 Beats per minute
Standard Deviation 5.029
|
-5.22 Beats per minute
Standard Deviation 15.827
|
-0.17 Beats per minute
Standard Deviation 3.430
|
—
|
—
|
|
Part 1: Change From Baseline in Heart Rate at Indicated Time Points
Day 3, n=3,3,6
|
12.11 Beats per minute
Standard Deviation 4.439
|
2.11 Beats per minute
Standard Deviation 3.657
|
2.50 Beats per minute
Standard Deviation 9.503
|
—
|
—
|
|
Part 1: Change From Baseline in Heart Rate at Indicated Time Points
Day 8, n=2,3,6
|
8.00 Beats per minute
Standard Deviation 4.243
|
-2.89 Beats per minute
Standard Deviation 13.104
|
2.00 Beats per minute
Standard Deviation 10.863
|
—
|
—
|
|
Part 1: Change From Baseline in Heart Rate at Indicated Time Points
Day 30, n=3,3,6
|
6.44 Beats per minute
Standard Deviation 16.194
|
3.28 Beats per minute
Standard Deviation 14.958
|
1.50 Beats per minute
Standard Deviation 10.134
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Heart rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 169, n=10,6,19,14,15
|
7.9 Beats per minute
Standard Deviation 16.31
|
2.8 Beats per minute
Standard Deviation 13.04
|
4.3 Beats per minute
Standard Deviation 9.59
|
4.7 Beats per minute
Standard Deviation 8.72
|
3.1 Beats per minute
Standard Deviation 6.75
|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 99, n=10,6,20,14,15
|
3.9 Beats per minute
Standard Deviation 11.93
|
6.7 Beats per minute
Standard Deviation 11.27
|
4.0 Beats per minute
Standard Deviation 12.09
|
2.5 Beats per minute
Standard Deviation 8.23
|
4.5 Beats per minute
Standard Deviation 10.59
|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 8, n=10,6,20,15,15
|
9.9 Beats per minute
Standard Deviation 9.22
|
6.2 Beats per minute
Standard Deviation 9.15
|
2.8 Beats per minute
Standard Deviation 9.92
|
5.7 Beats per minute
Standard Deviation 8.96
|
5.2 Beats per minute
Standard Deviation 8.97
|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 15, n=10,6,20,14,15
|
9.2 Beats per minute
Standard Deviation 13.89
|
-3.0 Beats per minute
Standard Deviation 6.90
|
3.6 Beats per minute
Standard Deviation 10.64
|
2.1 Beats per minute
Standard Deviation 6.92
|
2.3 Beats per minute
Standard Deviation 9.54
|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 22, n=10,6,20,14,15
|
6.3 Beats per minute
Standard Deviation 13.53
|
4.7 Beats per minute
Standard Deviation 7.89
|
3.8 Beats per minute
Standard Deviation 11.57
|
2.6 Beats per minute
Standard Deviation 7.78
|
1.6 Beats per minute
Standard Deviation 9.52
|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 29, n=10,6,20,13,15
|
5.5 Beats per minute
Standard Deviation 11.32
|
3.5 Beats per minute
Standard Deviation 7.92
|
1.2 Beats per minute
Standard Deviation 10.25
|
1.8 Beats per minute
Standard Deviation 8.99
|
1.3 Beats per minute
Standard Deviation 6.84
|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 36, n=10,6,20,14,15
|
7.8 Beats per minute
Standard Deviation 10.99
|
5.7 Beats per minute
Standard Deviation 11.69
|
2.1 Beats per minute
Standard Deviation 7.32
|
4.0 Beats per minute
Standard Deviation 9.97
|
1.5 Beats per minute
Standard Deviation 8.70
|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 43, n=10,6,20,14,15
|
5.1 Beats per minute
Standard Deviation 13.76
|
5.0 Beats per minute
Standard Deviation 11.03
|
2.8 Beats per minute
Standard Deviation 12.53
|
3.0 Beats per minute
Standard Deviation 11.57
|
4.8 Beats per minute
Standard Deviation 9.92
|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 50, n=10,6,19,14,15
|
7.9 Beats per minute
Standard Deviation 12.52
|
5.3 Beats per minute
Standard Deviation 11.38
|
2.6 Beats per minute
Standard Deviation 10.89
|
4.6 Beats per minute
Standard Deviation 11.47
|
1.5 Beats per minute
Standard Deviation 9.85
|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 57, n=10,6,20,14,15
|
2.9 Beats per minute
Standard Deviation 12.78
|
-4.0 Beats per minute
Standard Deviation 11.01
|
1.1 Beats per minute
Standard Deviation 10.19
|
2.1 Beats per minute
Standard Deviation 8.39
|
1.1 Beats per minute
Standard Deviation 8.33
|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 64, n=10,6,20,14,15
|
5.1 Beats per minute
Standard Deviation 13.24
|
-1.2 Beats per minute
Standard Deviation 9.43
|
3.0 Beats per minute
Standard Deviation 10.50
|
4.5 Beats per minute
Standard Deviation 11.35
|
1.9 Beats per minute
Standard Deviation 7.90
|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 71, n=10,6,20,14,15
|
4.8 Beats per minute
Standard Deviation 14.30
|
-2.2 Beats per minute
Standard Deviation 9.58
|
4.7 Beats per minute
Standard Deviation 12.01
|
0.6 Beats per minute
Standard Deviation 9.70
|
2.5 Beats per minute
Standard Deviation 9.13
|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 78, n=10,6,20,14,15
|
3.9 Beats per minute
Standard Deviation 13.70
|
0.2 Beats per minute
Standard Deviation 10.80
|
5.5 Beats per minute
Standard Deviation 10.31
|
2.4 Beats per minute
Standard Deviation 6.59
|
3.0 Beats per minute
Standard Deviation 7.63
|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 85, n=10,6,20,14,15
|
7.2 Beats per minute
Standard Deviation 15.30
|
-0.2 Beats per minute
Standard Deviation 10.38
|
3.6 Beats per minute
Standard Deviation 10.63
|
1.4 Beats per minute
Standard Deviation 8.04
|
0.5 Beats per minute
Standard Deviation 9.56
|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 92, n=10,6,19,14,15
|
6.4 Beats per minute
Standard Deviation 14.01
|
1.2 Beats per minute
Standard Deviation 8.95
|
4.6 Beats per minute
Standard Deviation 10.23
|
4.3 Beats per minute
Standard Deviation 10.29
|
0.5 Beats per minute
Standard Deviation 9.23
|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 113, n=10,6,20,14,15
|
7.5 Beats per minute
Standard Deviation 15.92
|
3.8 Beats per minute
Standard Deviation 9.33
|
1.5 Beats per minute
Standard Deviation 9.14
|
3.6 Beats per minute
Standard Deviation 6.50
|
4.8 Beats per minute
Standard Deviation 8.54
|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 141, n=10,6,20,14,15
|
5.7 Beats per minute
Standard Deviation 16.89
|
0.8 Beats per minute
Standard Deviation 14.74
|
3.4 Beats per minute
Standard Deviation 8.32
|
5.1 Beats per minute
Standard Deviation 8.77
|
4.3 Beats per minute
Standard Deviation 10.22
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Day 270 and Day 450Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Heart rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=1 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=1 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 450-Optional Follow-up)
Day 270, n=1,0,0,0,0
|
-26.0 Beats per minute
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 450-Optional Follow-up)
Day 450, n=0,0,1,0,0
|
—
|
—
|
-11.0 Beats per minute
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 3, 8 and 30Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Respiratory rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Respiratory Rate at Indicated Time Points
Day 3, n=3,3,6
|
-0.67 Breaths per minute
Standard Deviation 0.577
|
-1.00 Breaths per minute
Standard Deviation 1.732
|
-0.33 Breaths per minute
Standard Deviation 1.862
|
—
|
—
|
|
Part 1: Change From Baseline in Respiratory Rate at Indicated Time Points
Day 8, n=2,3,6
|
-0.50 Breaths per minute
Standard Deviation 0.707
|
-1.00 Breaths per minute
Standard Deviation 1.000
|
0.00 Breaths per minute
Standard Deviation 2.280
|
—
|
—
|
|
Part 1: Change From Baseline in Respiratory Rate at Indicated Time Points
Day 30, n=3,3,6
|
-1.33 Breaths per minute
Standard Deviation 1.155
|
-0.67 Breaths per minute
Standard Deviation 1.528
|
0.50 Breaths per minute
Standard Deviation 2.258
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Respiratory rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 8, n=10,6,20,15,15
|
0.00 Breaths per minute
Standard Deviation 1.94
|
-0.8 Breaths per minute
Standard Deviation 4.49
|
0.5 Breaths per minute
Standard Deviation 1.82
|
-0.3 Breaths per minute
Standard Deviation 1.35
|
-0.3 Breaths per minute
Standard Deviation 1.94
|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 15, n=10,6,20,14,15
|
-0.2 Breaths per minute
Standard Deviation 2.25
|
-1.3 Breaths per minute
Standard Deviation 5.28
|
-0.1 Breaths per minute
Standard Deviation 0.91
|
-0.3 Breaths per minute
Standard Deviation 1.64
|
-0.6 Breaths per minute
Standard Deviation 2.53
|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 22, n=10,6,20,14,15
|
0.1 Breaths per minute
Standard Deviation 2.77
|
-1.3 Breaths per minute
Standard Deviation 5.28
|
0.6 Breaths per minute
Standard Deviation 1.36
|
-0.4 Breaths per minute
Standard Deviation 1.28
|
-0.2 Breaths per minute
Standard Deviation 1.74
|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 29, n=10,6,20,13,15
|
-0.6 Breaths per minute
Standard Deviation 2.37
|
0.2 Breaths per minute
Standard Deviation 3.71
|
-0.7 Breaths per minute
Standard Deviation 2.49
|
-0.9 Breaths per minute
Standard Deviation 1.61
|
-0.7 Breaths per minute
Standard Deviation 2.23
|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 36, n=10,6,20,14,15
|
-0.3 Breaths per minute
Standard Deviation 3.27
|
-0.8 Breaths per minute
Standard Deviation 5.00
|
0.6 Breaths per minute
Standard Deviation 1.23
|
-0.7 Breaths per minute
Standard Deviation 1.49
|
0.2 Breaths per minute
Standard Deviation 1.90
|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 43, n=10,6,20,14,15
|
0.0 Breaths per minute
Standard Deviation 2.36
|
-0.8 Breaths per minute
Standard Deviation 5.00
|
0.2 Breaths per minute
Standard Deviation 1.46
|
-0.3 Breaths per minute
Standard Deviation 1.27
|
-0.1 Breaths per minute
Standard Deviation 1.41
|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 50, n=10,6,19,14,15
|
-0.2 Breaths per minute
Standard Deviation 2.44
|
-1.0 Breaths per minute
Standard Deviation 5.51
|
0.4 Breaths per minute
Standard Deviation 1.07
|
-0.5 Breaths per minute
Standard Deviation 1.34
|
0.1 Breaths per minute
Standard Deviation 1.39
|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 57, n=10,6,20,14,15
|
-0.3 Breaths per minute
Standard Deviation 3.09
|
0.0 Breaths per minute
Standard Deviation 3.85
|
0.5 Breaths per minute
Standard Deviation 1.64
|
0.0 Breaths per minute
Standard Deviation 1.04
|
0.2 Breaths per minute
Standard Deviation 2.54
|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 64, n=10,6,20,14,15
|
0.0 Breaths per minute
Standard Deviation 2.45
|
-0.7 Breaths per minute
Standard Deviation 4.89
|
0.4 Breaths per minute
Standard Deviation 1.10
|
-0.3 Breaths per minute
Standard Deviation 1.27
|
0.2 Breaths per minute
Standard Deviation 1.74
|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 71, n=10,6,20,14,15
|
-0.1 Breaths per minute
Standard Deviation 2.38
|
-0.7 Breaths per minute
Standard Deviation 4.89
|
0.2 Breaths per minute
Standard Deviation 1.24
|
-0.2 Breaths per minute
Standard Deviation 1.31
|
0.4 Breaths per minute
Standard Deviation 1.50
|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 78, n=10,6,20,14,15
|
0.2 Breaths per minute
Standard Deviation 2.78
|
-1.0 Breaths per minute
Standard Deviation 5.51
|
0.5 Breaths per minute
Standard Deviation 1.50
|
0.3 Breaths per minute
Standard Deviation 1.64
|
-0.7 Breaths per minute
Standard Deviation 2.06
|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 85, n=10,6,20,14,15
|
0.4 Breaths per minute
Standard Deviation 2.63
|
-0.8 Breaths per minute
Standard Deviation 5.19
|
0.3 Breaths per minute
Standard Deviation 1.63
|
0.1 Breaths per minute
Standard Deviation 1.49
|
0.0 Breaths per minute
Standard Deviation 1.31
|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 92, n=10,6,19,14,15
|
0.4 Breaths per minute
Standard Deviation 2.01
|
-1.3 Breaths per minute
Standard Deviation 5.50
|
0.1 Breaths per minute
Standard Deviation 1.37
|
-0.4 Breaths per minute
Standard Deviation 1.79
|
0.3 Breaths per minute
Standard Deviation 1.29
|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 99, n=10,6,20,14,15
|
0.2 Breaths per minute
Standard Deviation 2.15
|
-1.0 Breaths per minute
Standard Deviation 4.29
|
-0.1 Breaths per minute
Standard Deviation 1.85
|
0.1 Breaths per minute
Standard Deviation 1.54
|
0.5 Breaths per minute
Standard Deviation 1.46
|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 113, n=10,6,20,14,15
|
0.7 Breaths per minute
Standard Deviation 3.09
|
-1.0 Breaths per minute
Standard Deviation 4.90
|
0.3 Breaths per minute
Standard Deviation 1.38
|
-0.1 Breaths per minute
Standard Deviation 1.44
|
0.0 Breaths per minute
Standard Deviation 1.93
|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 141, n=10,6,20,14,15
|
0.5 Breaths per minute
Standard Deviation 3.27
|
-1.0 Breaths per minute
Standard Deviation 4.90
|
0.4 Breaths per minute
Standard Deviation 1.19
|
-0.2 Breaths per minute
Standard Deviation 1.42
|
-0.1 Breaths per minute
Standard Deviation 2.03
|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 169, n=10,6,19,14,15
|
0.1 Breaths per minute
Standard Deviation 2.69
|
-1.0 Breaths per minute
Standard Deviation 4.90
|
0.6 Breaths per minute
Standard Deviation 1.30
|
0.0 Breaths per minute
Standard Deviation 1.36
|
0.1 Breaths per minute
Standard Deviation 2.15
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Day 270 and Day 450Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Respiratory rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=1 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=1 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 450-Optional Follow-up)
Day 270, n=1,0,0,0,0
|
0.0 Breaths per minute
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 450-Optional Follow-up)
Day 450, n=0,0,1,0,0
|
—
|
—
|
2.0 Breaths per minute
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 3, 8 and 30Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Body temperature was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Body Temperature at Indicated Time Points
Day 3, n=3,3,6
|
0.10 Degrees Celsius
Standard Deviation 0.100
|
0.37 Degrees Celsius
Standard Deviation 0.306
|
0.25 Degrees Celsius
Standard Deviation 0.345
|
—
|
—
|
|
Part 1: Change From Baseline in Body Temperature at Indicated Time Points
Day 8, n=2,3,6
|
0.20 Degrees Celsius
Standard Deviation 0.283
|
-0.03 Degrees Celsius
Standard Deviation 0.351
|
0.08 Degrees Celsius
Standard Deviation 0.343
|
—
|
—
|
|
Part 1: Change From Baseline in Body Temperature at Indicated Time Points
Day 30, n=3,3,6
|
0.10 Degrees Celsius
Standard Deviation 0.173
|
0.20 Degrees Celsius
Standard Deviation 0.361
|
0.10 Degrees Celsius
Standard Deviation 0.358
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Body temperature was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 169, n=10,6,19,14,15
|
0.12 Degrees Celsius
Standard Deviation 0.592
|
-0.08 Degrees Celsius
Standard Deviation 0.240
|
0.21 Degrees Celsius
Standard Deviation 0.494
|
-0.02 Degrees Celsius
Standard Deviation 0.412
|
0.04 Degrees Celsius
Standard Deviation 0.612
|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 57, n=10,6,20,14,15
|
0.06 Degrees Celsius
Standard Deviation 0.395
|
0.02 Degrees Celsius
Standard Deviation 0.366
|
0.15 Degrees Celsius
Standard Deviation 0.380
|
-0.06 Degrees Celsius
Standard Deviation 0.332
|
0.07 Degrees Celsius
Standard Deviation 0.575
|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 64, n=10,6,20,14,15
|
0.07 Degrees Celsius
Standard Deviation 0.581
|
-0.03 Degrees Celsius
Standard Deviation 0.301
|
0.17 Degrees Celsius
Standard Deviation 0.386
|
-0.04 Degrees Celsius
Standard Deviation 0.393
|
-0.01 Degrees Celsius
Standard Deviation 0.536
|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 71, n=10,6,20,14,15
|
0.26 Degrees Celsius
Standard Deviation 0.599
|
-0.25 Degrees Celsius
Standard Deviation 0.207
|
0.26 Degrees Celsius
Standard Deviation 0.425
|
-0.14 Degrees Celsius
Standard Deviation 0.413
|
0.08 Degrees Celsius
Standard Deviation 0.684
|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 50, n=10,6,19,14,15
|
0.12 Degrees Celsius
Standard Deviation 0.609
|
0.07 Degrees Celsius
Standard Deviation 0.258
|
0.26 Degrees Celsius
Standard Deviation 0.352
|
-0.12 Degrees Celsius
Standard Deviation 0.428
|
-0.07 Degrees Celsius
Standard Deviation 0.746
|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 8, n=10,6,20,15,15
|
0.24 Degrees Celsius
Standard Deviation 0.366
|
-0.02 Degrees Celsius
Standard Deviation 0.366
|
0.18 Degrees Celsius
Standard Deviation 0.466
|
-0.15 Degrees Celsius
Standard Deviation 0.385
|
-0.11 Degrees Celsius
Standard Deviation 0.337
|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 15, n=10,6,20,14,15
|
0.18 Degrees Celsius
Standard Deviation 0.447
|
-0.12 Degrees Celsius
Standard Deviation 0.397
|
0.07 Degrees Celsius
Standard Deviation 0.443
|
-0.07 Degrees Celsius
Standard Deviation 0.350
|
0.08 Degrees Celsius
Standard Deviation 0.428
|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 22, n=10,6,20,14,15
|
0.01 Degrees Celsius
Standard Deviation 0.692
|
0.07 Degrees Celsius
Standard Deviation 0.344
|
0.06 Degrees Celsius
Standard Deviation 0.491
|
0.05 Degrees Celsius
Standard Deviation 0.277
|
-0.09 Degrees Celsius
Standard Deviation 0.350
|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 29, n=10,6,20,13,15
|
0.21 Degrees Celsius
Standard Deviation 0.370
|
-0.13 Degrees Celsius
Standard Deviation 0.423
|
0.19 Degrees Celsius
Standard Deviation 0.433
|
0.00 Degrees Celsius
Standard Deviation 0.430
|
0.05 Degrees Celsius
Standard Deviation 0.505
|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 36, n=10,6,20,14,15
|
0.25 Degrees Celsius
Standard Deviation 0.354
|
0.15 Degrees Celsius
Standard Deviation 0.266
|
0.15 Degrees Celsius
Standard Deviation 0.501
|
-0.09 Degrees Celsius
Standard Deviation 0.421
|
-0.10 Degrees Celsius
Standard Deviation 0.606
|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 43, n=10,6,20,14,15
|
0.10 Degrees Celsius
Standard Deviation 0.365
|
0.05 Degrees Celsius
Standard Deviation 0.243
|
0.25 Degrees Celsius
Standard Deviation 0.399
|
-0.15 Degrees Celsius
Standard Deviation 0.313
|
-0.04 Degrees Celsius
Standard Deviation 0.557
|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 78, n=10,6,20,14,15
|
0.14 Degrees Celsius
Standard Deviation 0.450
|
-0.13 Degrees Celsius
Standard Deviation 0.216
|
0.20 Degrees Celsius
Standard Deviation 0.349
|
-0.08 Degrees Celsius
Standard Deviation 0.283
|
0.00 Degrees Celsius
Standard Deviation 0.679
|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 85, n=10,6,20,14,15
|
0.19 Degrees Celsius
Standard Deviation 0.716
|
0.08 Degrees Celsius
Standard Deviation 0.240
|
0.25 Degrees Celsius
Standard Deviation 0.412
|
-0.09 Degrees Celsius
Standard Deviation 0.398
|
0.04 Degrees Celsius
Standard Deviation 0.622
|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 92, n=10,6,19,14,15
|
-0.11 Degrees Celsius
Standard Deviation 0.729
|
-0.07 Degrees Celsius
Standard Deviation 0.280
|
0.24 Degrees Celsius
Standard Deviation 0.356
|
-0.14 Degrees Celsius
Standard Deviation 0.337
|
0.01 Degrees Celsius
Standard Deviation 0.645
|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 99, n=10,6,20,14,15
|
0.16 Degrees Celsius
Standard Deviation 0.443
|
0.15 Degrees Celsius
Standard Deviation 0.259
|
0.26 Degrees Celsius
Standard Deviation 0.378
|
-0.13 Degrees Celsius
Standard Deviation 0.305
|
-0.04 Degrees Celsius
Standard Deviation 0.505
|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 113, n=10,6,20,14,15
|
0.03 Degrees Celsius
Standard Deviation 0.397
|
0.05 Degrees Celsius
Standard Deviation 0.281
|
0.20 Degrees Celsius
Standard Deviation 0.419
|
-0.03 Degrees Celsius
Standard Deviation 0.327
|
-0.10 Degrees Celsius
Standard Deviation 0.535
|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 141, n=10,6,20,14,15
|
0.14 Degrees Celsius
Standard Deviation 0.556
|
-0.13 Degrees Celsius
Standard Deviation 0.320
|
0.14 Degrees Celsius
Standard Deviation 0.547
|
-0.19 Degrees Celsius
Standard Deviation 0.366
|
-0.03 Degrees Celsius
Standard Deviation 0.635
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Day 270 and Day 450Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Body temperature was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=1 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=1 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 450-Optional Follow-up)
Day 270, n=1,0,0,0,0
|
-0.40 Degrees Celsius
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 450-Optional Follow-up)
Day 450, n=0,0,1,0,0
|
—
|
—
|
0.40 Degrees Celsius
Standard Deviation NA
NA indicates that the data is not available since standard deviation could not be calculated for a single participant.
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 60Population: Safety Population. Data was not collected and not captured in the database.
Physical examinations included assessment of the dermatologic, cardiovascular, respiratory, gastrointestinal, and neurological systems. Data was not collected and not captured in the database.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 169Population: Safety Population. Data was not collected and not captured in the database.
Physical examinations included assessment of the dermatologic, cardiovascular, respiratory, gastrointestinal, and neurological systems. Data was not collected and not captured in the database.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 450Population: Safety Population. Data was not collected and not captured in the database.
Physical examinations included assessment of the dermatologic, cardiovascular, respiratory, gastrointestinal, and neurological systems. Data was not collected and not captured in the database.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 60Population: Safety Population
Blood samples were collected for the analysis of following hematology and coagulation parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils, Platelets, Activated partial thromboplastin time (aPTT), Prothrombin international normalized ratio (INR) and Prothrombin time (PT). Laboratory parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those hematology and coagulation parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Platelet, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Platelet, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Platelet, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
aPTT, Grade 1
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
aPTT, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
aPTT, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
aPTT, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Prothrombin INR, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Prothrombin INR, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Prothrombin INR, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Prothrombin INR, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
PT, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
PT, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
PT, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
PT, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Hemoglobin, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Hemoglobin, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Hemoglobin, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Hemoglobin, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Leukocyte, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Leukocyte, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Leukocyte, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Leukocyte, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Lymphocyte, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Lymphocyte, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Lymphocyte, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Lymphocyte, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Neutrophil, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Neutrophil, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Neutrophil, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Neutrophil, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Platelet, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 169Population: Safety Population
Blood samples were collected for the analysis of following hematology and coagulation parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils, Platelets, aPTT, Prothrombin INR and PT. Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those hematology and coagulation parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Platelet, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Hemoglobin, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Hemoglobin, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Hemoglobin, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Hemoglobin, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Leukocyte, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Leukocyte, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Leukocyte, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
aPTT, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Leukocyte, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Lymphocyte, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Lymphocyte, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Lymphocyte, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Platelet, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Lymphocyte, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Neutrophil, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Neutrophil, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Neutrophil, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Neutrophil, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Platelet, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Platelet, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
aPTT, Grade 1
|
1 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
aPTT, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
aPTT, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Prothrombin INR, Grade 1
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Prothrombin INR, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Prothrombin INR, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Prothrombin INR, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
PT, Grade 1
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
5 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
PT, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
PT, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
PT, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 450Population: Safety Population
Blood samples were collected for the analysis of following hematology and coagulation parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils, Platelets, aPTT, Prothrombin INR and PT. Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those hematology and coagulation parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Hemoglobin, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Leukocyte, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Leukocyte, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Leukocyte, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Leukocyte, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Lymphocyte, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Lymphocyte, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Lymphocyte, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Lymphocyte, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Hemoglobin, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Hemoglobin, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Hemoglobin, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
aPTT, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Platelet, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Neutrophil, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Neutrophil, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Neutrophil, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Neutrophil, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Platelet, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Platelet, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Platelet, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
aPTT, Grade 1
|
1 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
aPTT, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
aPTT, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Prothrombin INR, Grade 1
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Prothrombin INR, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Prothrombin INR, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Prothrombin INR, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
PT, Grade 1
|
0 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
5 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
PT, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
PT, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
PT, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 60Population: Safety Population
Blood samples were collected from participants to assess complement C3 and complement C4 levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points
Complement C3
|
-8.7 Milligram per deciliter
Standard Deviation 11.24
|
-13.0 Milligram per deciliter
Standard Deviation 3.00
|
-16.3 Milligram per deciliter
Standard Deviation 7.74
|
—
|
—
|
|
Part 1: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points
Complement C4
|
-2.0 Milligram per deciliter
Standard Deviation 2.00
|
-2.3 Milligram per deciliter
Standard Deviation 0.58
|
-4.2 Milligram per deciliter
Standard Deviation 3.76
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 169Population: Safety Population
Blood samples were collected from participants to assess complement C3 and complement C4 levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 169-Interim Analysis)
Complement C3
|
-11.0 Milligram per deciliter
Standard Deviation 16.10
|
-13.5 Milligram per deciliter
Standard Deviation 9.14
|
-11.3 Milligram per deciliter
Standard Deviation 10.38
|
-10.9 Milligram per deciliter
Standard Deviation 15.19
|
-17.7 Milligram per deciliter
Standard Deviation 13.98
|
|
Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 169-Interim Analysis)
Complement C4
|
-3.5 Milligram per deciliter
Standard Deviation 2.12
|
-4.7 Milligram per deciliter
Standard Deviation 4.41
|
-3.8 Milligram per deciliter
Standard Deviation 2.57
|
-3.4 Milligram per deciliter
Standard Deviation 2.13
|
-5.6 Milligram per deciliter
Standard Deviation 3.07
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 450Population: Safety Population. Data was not collected for this outcome measure during optional follow-up period.
Blood samples were planned to be collected from participants to evaluate change from Baseline in complement C3 and complement C4 levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 60Population: Safety Population
Blood samples were collected from participants to assess complement Bb levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Complement Bb Level at Indicated Time Points
|
0.193 Milligram per liter
Standard Deviation 0.2409
|
0.023 Milligram per liter
Standard Deviation 0.0950
|
0.150 Milligram per liter
Standard Deviation 0.2119
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 169Population: Safety Population
Blood samples were collected from participants to assess complement Bb levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 169-Interim Analysis)
|
0.245 Milligram per liter
Standard Deviation 0.319
|
0.198 Milligram per liter
Standard Deviation 0.143
|
0.315 Milligram per liter
Standard Deviation 0.740
|
0.115 Milligram per liter
Standard Deviation 0.222
|
-0.007 Milligram per liter
Standard Deviation 0.30
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 450Population: Safety Population
Blood samples were collected from participants to evaluate change from Baseline in complement Bb levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 450-Optional Follow-up)
|
0.304 Milligram per liter
Standard Deviation 0.295
|
0.365 Milligram per liter
Standard Deviation 0.269
|
0.436 Milligram per liter
Standard Deviation 0.679
|
0.173 Milligram per liter
Standard Deviation 0.213
|
0.107 Milligram per liter
Standard Deviation 0.367
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 60Population: Safety Population
Blood samples were collected from participants to assess complement C5a levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Complement C5a Level at Indicated Time Points
|
1.497 Microgram per liter
Standard Deviation 0.6306
|
0.373 Microgram per liter
Standard Deviation 0.9952
|
-1.267 Microgram per liter
Standard Deviation 5.7581
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 169Population: Safety Population
Blood samples were collected from participants to assess complement C5a levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 169-Interim Analysis)
|
1.112 Microgram per liter
Standard Deviation 1.481
|
0.860 Microgram per liter
Standard Deviation 1.625
|
1.781 Microgram per liter
Standard Deviation 2.524
|
0.353 Microgram per liter
Standard Deviation 1.323
|
-0.093 Microgram per liter
Standard Deviation 1.54
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 450Population: Safety Population
Blood samples were collected from participants to evaluate change from Baseline in complement C5a levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 450-Optional Follow-up)
|
1.324 Milligrams per liter
Standard Deviation 1.415
|
2.053 Milligrams per liter
Standard Deviation 3.456
|
2.040 Milligrams per liter
Standard Deviation 2.481
|
0.470 Milligrams per liter
Standard Deviation 1.205
|
0.567 Milligrams per liter
Standard Deviation 1.354
|
PRIMARY outcome
Timeframe: Up to Day 60Population: Safety Population
Blood samples were collected for the analysis of following clinical chemistry parameters: Alanine aminotransferase, Albumin, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Calcium (high), Calcium (low), Creatine kinase, Creatinine, Glucose (high), Glucose (low), Magnesium, Phosphate, Potassium (high), Potassium (low), Sodium (high), Sodium (low) and Urate. Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those clinical chemistry parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Potassium (low), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Urate, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Creatinine, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Glucose (high), Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Glucose (high), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Alanine aminotransferase, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Alanine aminotransferase, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Glucose (high), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Alanine aminotransferase, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Glucose (high), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Alanine aminotransferase, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Glucose (low), Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Albumin, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Albumin, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Albumin, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Albumin, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Glucose (low), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Alkaline phosphatase, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Glucose (low), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Alkaline phosphatase, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Alkaline phosphatase, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Alkaline phosphatase, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Aspartate aminotransferase, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Aspartate aminotransferase, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Glucose (low), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Magnesium, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Aspartate aminotransferase, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Aspartate aminotransferase, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Urate, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Magnesium, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Bilirubin, Grade 1
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Bilirubin, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Bilirubin, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Magnesium, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Bilirubin, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Calcium (high), Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Calcium (high), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Calcium (high), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Calcium (high), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Calcium (low), Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Magnesium, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Calcium (low), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Calcium (low), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Calcium (low), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Creatine kinase, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Creatine kinase, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Creatine kinase, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Creatine kinase, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Creatinine, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Creatinine, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Creatinine, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Phosphate, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Phosphate, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Phosphate, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Phosphate, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Potassium (high), Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Potassium (high), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Potassium (high), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Potassium (high), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Potassium (low), Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Potassium (low), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Potassium (low), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Sodium (high), Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Sodium (high), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Sodium (high), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Sodium (high), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Sodium (low), Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Sodium (low), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Sodium (low), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Sodium (low), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Urate, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Urate, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 169Population: Safety Population
Blood samples were collected for the analysis of following clinical chemistry parameters: Alanine aminotransferase, Albumin, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Calcium (high), Calcium (low), Creatine kinase, Creatinine, Glucose (high), Glucose (low), Magnesium, Phosphate, Potassium (high), Potassium (low), Sodium (high), Sodium (low), Urate and glomerular filtration rate (GFR). Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those clinical chemistry parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Glucose (high), Grade 1
|
6 Participants
|
5 Participants
|
10 Participants
|
6 Participants
|
7 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Alkaline phosphatase, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Alkaline phosphatase, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Aspartate aminotransferase, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Bilirubin, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Glucose (low), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Magnesium, Grade 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Magnesium, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Magnesium, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Phosphate, Grade 1
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Phosphate, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Potassium (high), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Urate, Grade 1
|
2 Participants
|
1 Participants
|
1 Participants
|
8 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Potassium (high), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Phosphate, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Potassium (high), Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Potassium (high), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Potassium (low), Grade 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Potassium (low), Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Potassium (low), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Potassium (low), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Alanine aminotransferase, Grade 1
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Alanine aminotransferase, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Sodium (high), Grade 1
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Sodium (high), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Sodium (high), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Sodium (high), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Sodium (low), Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Alanine aminotransferase, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Alanine aminotransferase, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Sodium (low), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Albumin, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Sodium (low), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Albumin, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Sodium (low), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Albumin, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Albumin, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Alkaline phosphatase, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Alkaline phosphatase, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Aspartate aminotransferase, Grade 1
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Aspartate aminotransferase, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Aspartate aminotransferase, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Bilirubin, Grade 1
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Bilirubin, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Bilirubin, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Calcium (high), Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Calcium (high), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Calcium (high), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Calcium (high), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Calcium (low), Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Calcium (low), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Calcium (low), Grade 3
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Calcium (low), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Creatine kinase, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Creatine kinase, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Creatine kinase, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Creatine kinase, Grade 4
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Creatinine, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Creatinine, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Creatinine, Grade 3
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Creatinine, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Glucose (high), Grade 2
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Glucose (high), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Glucose (high), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Glucose (low), Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Glucose (low), Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Glucose (low), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Magnesium, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Urate, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
GFR, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
GFR, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
GFR, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
GFR, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Urate, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Urate, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Phosphate, Grade 2
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 450Population: Safety Population
Blood samples were collected for the analysis of following clinical chemistry parameters: Alanine aminotransferase, Albumin, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Calcium (high), Calcium (low), Creatine kinase, Creatinine, Glucose (high), Glucose (low), Magnesium, Phosphate, Potassium (high), Potassium (low), Sodium (high), Sodium (low), Urate and glomerular filtration rate (GFR). Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those clinical chemistry parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Albumin, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Aspartate aminotransferase, Grade 1
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Creatine kinase, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Glucose (low), Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Glucose (low), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Glucose (low), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Magnesium, Grade 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Magnesium, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Magnesium, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Magnesium, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Phosphate, Grade 1
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Phosphate, Grade 2
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Phosphate, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Phosphate, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Potassium (high), Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Potassium (high), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Potassium (high), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Potassium (high), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Potassium (low), Grade 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Potassium (low), Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Potassium (low), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Potassium (low), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Sodium (high), Grade 1
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Sodium (high), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Sodium (low), Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Sodium (low), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Sodium (low), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Sodium (low), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Urate, Grade 1
|
2 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
GFR, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
GFR, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Alanine aminotransferase, Grade 1
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Alanine aminotransferase, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Alanine aminotransferase, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Alanine aminotransferase, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Albumin, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Albumin, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Albumin, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Alkaline phosphatase, Grade 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Alkaline phosphatase, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Alkaline phosphatase, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Alkaline phosphatase, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Aspartate aminotransferase, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Aspartate aminotransferase, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Aspartate aminotransferase, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Bilirubin, Grade 1
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Bilirubin, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Bilirubin, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Bilirubin, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Calcium (high), Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Calcium (high), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Calcium (high), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Calcium (high), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Calcium (low), Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Calcium (low), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Calcium (low), Grade 3
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Calcium (low), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Creatine kinase, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Creatine kinase, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Creatine kinase, Grade 4
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Creatinine, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Creatinine, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Creatinine, Grade 3
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Creatinine, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Glucose (high), Grade 1
|
6 Participants
|
5 Participants
|
11 Participants
|
6 Participants
|
7 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Glucose (high), Grade 2
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Glucose (high), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Glucose (high), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Glucose (low), Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Sodium (high), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Sodium (high), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Urate, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Urate, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Urate, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
GFR, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
GFR, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8, 30 and Follow-up (Day 60)Population: Safety Population
Urine samples were collected from participants to assess urine albumin levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Urine Albumin at Indicated Time Points
Day 8
|
-0.090 Milligram per deciliter
Standard Deviation 0.1559
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
-0.003 Milligram per deciliter
Standard Deviation 0.0082
|
—
|
—
|
|
Part 1: Change From Baseline in Urine Albumin at Indicated Time Points
Day 30
|
-0.090 Milligram per deciliter
Standard Deviation 0.1559
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
-0.003 Milligram per deciliter
Standard Deviation 0.0082
|
—
|
—
|
|
Part 1: Change From Baseline in Urine Albumin at Indicated Time Points
Follow-up (Day 60)
|
-0.083 Milligram per deciliter
Standard Deviation 0.1620
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
-0.003 Milligram per deciliter
Standard Deviation 0.0082
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 15, 29, 43, 57, 71, 85, 92, 99, 113, 141 and 169Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Urine samples were collected from participants to assess urine albumin levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=14 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 29, n=10,6,20,13,15
|
-0.038 Milligram per deciliter
Standard Deviation 0.1202
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.102 Milligram per deciliter
Standard Deviation 0.4265
|
-0.100 Milligram per deciliter
Standard Deviation 0.4276
|
-0.293 Milligram per deciliter
Standard Deviation 1.2710
|
|
Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 15, n=10,6,20,14,14
|
0.484 Milligram per deciliter
Standard Deviation 1.5305
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.004 Milligram per deciliter
Standard Deviation 0.0157
|
-0.044 Milligram per deciliter
Standard Deviation 0.3593
|
0.054 Milligram per deciliter
Standard Deviation 2.1129
|
|
Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 43, n=9,6,20,14,15
|
-0.076 Milligram per deciliter
Standard Deviation 0.2267
|
0.027 Milligram per deciliter
Standard Deviation 0.0653
|
0.047 Milligram per deciliter
Standard Deviation 0.2247
|
1.356 Milligram per deciliter
Standard Deviation 5.1498
|
-0.263 Milligram per deciliter
Standard Deviation 1.2876
|
|
Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 57, n=10,6,20,14,15
|
-0.068 Milligram per deciliter
Standard Deviation 0.2150
|
0.252 Milligram per deciliter
Standard Deviation 0.6165
|
0.157 Milligram per deciliter
Standard Deviation 0.6699
|
7.142 Milligram per deciliter
Standard Deviation 27.1610
|
-0.345 Milligram per deciliter
Standard Deviation 1.2457
|
|
Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 71, n=10,6,20,14,15
|
-0.068 Milligram per deciliter
Standard Deviation 0.2150
|
0.147 Milligram per deciliter
Standard Deviation 0.3593
|
0.067 Milligram per deciliter
Standard Deviation 0.2858
|
-0.108 Milligram per deciliter
Standard Deviation 0.4036
|
-0.276 Milligram per deciliter
Standard Deviation 1.2739
|
|
Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 85, n=10,6,20,14,15
|
-0.068 Milligram per deciliter
Standard Deviation 0.2150
|
0.260 Milligram per deciliter
Standard Deviation 0.6369
|
0.105 Milligram per deciliter
Standard Deviation 0.3408
|
-0.028 Milligram per deciliter
Standard Deviation 0.5206
|
-0.249 Milligram per deciliter
Standard Deviation 1.2805
|
|
Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 92, n=10,6,19,14,15
|
0.386 Milligram per deciliter
Standard Deviation 1.4751
|
0.088 Milligram per deciliter
Standard Deviation 0.1613
|
0.031 Milligram per deciliter
Standard Deviation 0.1811
|
-0.034 Milligram per deciliter
Standard Deviation 0.1256
|
-0.113 Milligram per deciliter
Standard Deviation 1.6274
|
|
Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 99, n=10,6,20,14,15
|
-0.068 Milligram per deciliter
Standard Deviation 0.2150
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.287 Milligram per deciliter
Standard Deviation 1.1198
|
-0.028 Milligram per deciliter
Standard Deviation 0.4733
|
-0.307 Milligram per deciliter
Standard Deviation 1.2558
|
|
Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 113, n=10,6,19,13,15
|
-0.020 Milligram per deciliter
Standard Deviation 0.2766
|
0.057 Milligram per deciliter
Standard Deviation 0.1388
|
0.376 Milligram per deciliter
Standard Deviation 1.1353
|
-0.060 Milligram per deciliter
Standard Deviation 0.4801
|
-0.342 Milligram per deciliter
Standard Deviation 1.2507
|
|
Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 141, n=10,6,20,14,15
|
-0.068 Milligram per deciliter
Standard Deviation 0.2150
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.061 Milligram per deciliter
Standard Deviation 0.2350
|
0.014 Milligram per deciliter
Standard Deviation 0.3879
|
-0.317 Milligram per deciliter
Standard Deviation 1.2571
|
|
Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 169, n=10,6,19,14,15
|
-0.068 Milligram per deciliter
Standard Deviation 0.2150
|
0.223 Milligram per deciliter
Standard Deviation 0.5471
|
0.436 Milligram per deciliter
Standard Deviation 1.3939
|
-0.095 Milligram per deciliter
Standard Deviation 0.3555
|
-0.317 Milligram per deciliter
Standard Deviation 1.2678
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 450Population: Safety Population. Data was not collected for this outcome measure during optional follow-up period.
Urine samples were planned to be collected from participants to evaluate change from Baseline in urine albumin levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8, 30 and Follow-up (Day 60)Population: Safety Population
Urine samples were collected from participants to assess urine creatinine levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Urine Creatinine at Indicated Time Points
Follow-up (Day 60)
|
1.800 Millimoles per liter
Standard Deviation 14.5000
|
-12.500 Millimoles per liter
Standard Deviation 12.4386
|
-1.917 Millimoles per liter
Standard Deviation 6.3031
|
—
|
—
|
|
Part 1: Change From Baseline in Urine Creatinine at Indicated Time Points
Day 8
|
-6.333 Millimoles per liter
Standard Deviation 4.8003
|
-7.500 Millimoles per liter
Standard Deviation 10.8586
|
-0.500 Millimoles per liter
Standard Deviation 5.4468
|
—
|
—
|
|
Part 1: Change From Baseline in Urine Creatinine at Indicated Time Points
Day 30
|
-4.133 Millimoles per liter
Standard Deviation 7.2947
|
-7.467 Millimoles per liter
Standard Deviation 12.1763
|
-0.533 Millimoles per liter
Standard Deviation 5.5824
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 15, 29, 43, 57, 71, 85, 92, 99, 113, 141 and 169Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Urine samples were collected from participants to assess urine creatinine levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=14 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 43, n=9,6,20,14,15
|
-1.989 Millimoles per liter
Standard Deviation 7.6522
|
1.933 Millimoles per liter
Standard Deviation 3.4518
|
-0.615 Millimoles per liter
Standard Deviation 3.4238
|
-1.614 Millimoles per liter
Standard Deviation 8.1636
|
-0.160 Millimoles per liter
Standard Deviation 5.5418
|
|
Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 141, n=10,6,20,14,15
|
-3.440 Millimoles per liter
Standard Deviation 8.1759
|
-0.150 Millimoles per liter
Standard Deviation 4.7218
|
1.090 Millimoles per liter
Standard Deviation 4.9374
|
0.464 Millimoles per liter
Standard Deviation 7.7548
|
-0.713 Millimoles per liter
Standard Deviation 5.9545
|
|
Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 15, n=10,6,20,14,14
|
1.250 Millimoles per liter
Standard Deviation 3.9769
|
3.100 Millimoles per liter
Standard Deviation 7.2812
|
1.620 Millimoles per liter
Standard Deviation 5.9265
|
0.621 Millimoles per liter
Standard Deviation 6.6401
|
1.129 Millimoles per liter
Standard Deviation 7.8266
|
|
Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 29, n=10,6,20,13,15
|
-0.250 Millimoles per liter
Standard Deviation 8.1437
|
-1.183 Millimoles per liter
Standard Deviation 2.2516
|
1.645 Millimoles per liter
Standard Deviation 4.2540
|
0.185 Millimoles per liter
Standard Deviation 6.7815
|
0.307 Millimoles per liter
Standard Deviation 6.2369
|
|
Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 57, n=10,6,20,14,15
|
0.730 Millimoles per liter
Standard Deviation 6.3381
|
4.283 Millimoles per liter
Standard Deviation 6.9975
|
-0.005 Millimoles per liter
Standard Deviation 4.1111
|
-2.336 Millimoles per liter
Standard Deviation 7.3438
|
-0.707 Millimoles per liter
Standard Deviation 5.1370
|
|
Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 71, n=10,6,20,14,15
|
-0.420 Millimoles per liter
Standard Deviation 8.0098
|
3.383 Millimoles per liter
Standard Deviation 4.1427
|
1.625 Millimoles per liter
Standard Deviation 7.4370
|
-2.571 Millimoles per liter
Standard Deviation 5.5116
|
-0.560 Millimoles per liter
Standard Deviation 4.8550
|
|
Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 85, n=10,6,20,14,15
|
-0.380 Millimoles per liter
Standard Deviation 5.2742
|
-0.350 Millimoles per liter
Standard Deviation 3.1507
|
1.335 Millimoles per liter
Standard Deviation 6.3596
|
-1.500 Millimoles per liter
Standard Deviation 7.3661
|
0.127 Millimoles per liter
Standard Deviation 5.1497
|
|
Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 92, n=10,6,19,14,15
|
1.900 Millimoles per liter
Standard Deviation 6.0566
|
3.367 Millimoles per liter
Standard Deviation 4.6224
|
1.353 Millimoles per liter
Standard Deviation 5.6700
|
-0.679 Millimoles per liter
Standard Deviation 8.1936
|
-1.013 Millimoles per liter
Standard Deviation 5.4487
|
|
Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 99, n=10,6,20,14,15
|
1.180 Millimoles per liter
Standard Deviation 6.5445
|
-0.833 Millimoles per liter
Standard Deviation 2.7500
|
1.775 Millimoles per liter
Standard Deviation 4.6852
|
-1.593 Millimoles per liter
Standard Deviation 7.3409
|
0.020 Millimoles per liter
Standard Deviation 5.1870
|
|
Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 113, n=10,6,19,13,15
|
1.640 Millimoles per liter
Standard Deviation 12.4484
|
-0.200 Millimoles per liter
Standard Deviation 1.9819
|
0.395 Millimoles per liter
Standard Deviation 4.2339
|
-0.515 Millimoles per liter
Standard Deviation 8.9447
|
-1.273 Millimoles per liter
Standard Deviation 4.9312
|
|
Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 169, n=10,6,19,14,15
|
-1.520 Millimoles per liter
Standard Deviation 6.5367
|
2.150 Millimoles per liter
Standard Deviation 2.6251
|
2.484 Millimoles per liter
Standard Deviation 5.4097
|
0.386 Millimoles per liter
Standard Deviation 7.7418
|
-2.980 Millimoles per liter
Standard Deviation 5.0428
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 450Population: Safety Population. Data was not collected for this outcome measure during optional follow-up period.
Urine samples were planned to be collected from participants to evaluate change from Baseline in urine creatinine levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 3, 8, 30 and Follow-up (Day 60)Population: Safety Population
Urine samples were collected from participants to assess urine pH levels. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points
Day 8
|
0.000 pH
Standard Deviation 0.0000
|
1.000 pH
Standard Deviation 0.5000
|
0.333 pH
Standard Deviation 0.6831
|
—
|
—
|
|
Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points
Day 30
|
0.167 pH
Standard Deviation 0.2887
|
0.333 pH
Standard Deviation 1.0408
|
0.167 pH
Standard Deviation 0.5164
|
—
|
—
|
|
Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points
Follow-up (Day 60)
|
0.167 pH
Standard Deviation 0.2887
|
0.500 pH
Standard Deviation 1.0000
|
0.250 pH
Standard Deviation 0.5244
|
—
|
—
|
|
Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points
Day 3
|
0.333 pH
Standard Deviation 0.2887
|
0.167 pH
Standard Deviation 0.2887
|
0.083 pH
Standard Deviation 0.4916
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Urine samples were collected from participants to assess urine pH levels. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=19 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=14 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=14 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 8, n=10,6,19,14,13
|
0.300 pH
Standard Deviation 0.9487
|
-0.333 pH
Standard Deviation 0.8165
|
-0.132 pH
Standard Deviation 0.7040
|
-0.071 pH
Standard Deviation 0.4746
|
-0.077 pH
Standard Deviation 0.6405
|
|
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 15, n=10,6,19,13,14
|
0.200 pH
Standard Deviation 0.6325
|
-0.500 pH
Standard Deviation 1.0488
|
-0.026 pH
Standard Deviation 0.6341
|
-0.154 pH
Standard Deviation 0.6887
|
0.000 pH
Standard Deviation 0.5547
|
|
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 22, n=9,6,19,13,14
|
0.333 pH
Standard Deviation 0.7071
|
-0.667 pH
Standard Deviation 0.5164
|
-0.211 pH
Standard Deviation 0.7133
|
-0.308 pH
Standard Deviation 0.6304
|
-0.143 pH
Standard Deviation 1.0271
|
|
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 29, n=10,6,19,12,14
|
0.200 pH
Standard Deviation 0.6325
|
-0.167 pH
Standard Deviation 0.7528
|
0.000 pH
Standard Deviation 0.4714
|
0.000 pH
Standard Deviation 0.7385
|
-0.286 pH
Standard Deviation 0.6112
|
|
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 36, n=10,6,19,13,14
|
0.050 pH
Standard Deviation 0.8960
|
-0.333 pH
Standard Deviation 1.0328
|
-0.105 pH
Standard Deviation 0.4588
|
-0.077 pH
Standard Deviation 0.6405
|
-0.107 pH
Standard Deviation 0.7888
|
|
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 43, n=9,6,19,13,14
|
0.111 pH
Standard Deviation 0.7817
|
-0.167 pH
Standard Deviation 0.7528
|
0.000 pH
Standard Deviation 0.5774
|
0.077 pH
Standard Deviation 0.8623
|
-0.214 pH
Standard Deviation 0.6993
|
|
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 50, n=9,6,18,13,14
|
0.000 pH
Standard Deviation 0.7071
|
-0.167 pH
Standard Deviation 1.1690
|
0.000 pH
Standard Deviation 0.5941
|
-0.231 pH
Standard Deviation 0.7250
|
0.036 pH
Standard Deviation 0.8872
|
|
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 57, n=10,6,19,13,14
|
0.100 pH
Standard Deviation 0.9944
|
-0.167 pH
Standard Deviation 0.7528
|
0.000 pH
Standard Deviation 0.4714
|
0.077 pH
Standard Deviation 0.7596
|
-0.071 pH
Standard Deviation 0.4746
|
|
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 64, n=10,6,19,13,14
|
0.200 pH
Standard Deviation 0.6325
|
-0.167 pH
Standard Deviation 0.7528
|
-0.105 pH
Standard Deviation 0.6578
|
0.000 pH
Standard Deviation 0.5774
|
-0.214 pH
Standard Deviation 0.5789
|
|
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 71, n=10,6,19,13,14
|
0.200 pH
Standard Deviation 0.7888
|
-0.167 pH
Standard Deviation 0.7528
|
0.000 pH
Standard Deviation 0.4714
|
0.077 pH
Standard Deviation 0.6405
|
-0.071 pH
Standard Deviation 0.7300
|
|
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 78, n=10,6,19,13,14
|
0.100 pH
Standard Deviation 0.5676
|
0.000 pH
Standard Deviation 0.6325
|
-0.053 pH
Standard Deviation 0.5243
|
0.000 pH
Standard Deviation 0.7071
|
0.143 pH
Standard Deviation 0.7703
|
|
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 85, n=10,6,19,13,14
|
0.000 pH
Standard Deviation 1.0541
|
0.000 pH
Standard Deviation 0.8944
|
-0.105 pH
Standard Deviation 0.6578
|
0.000 pH
Standard Deviation 0.5774
|
-0.214 pH
Standard Deviation 0.5789
|
|
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 92, n=10,6,18,13,14
|
0.000 pH
Standard Deviation 0.8165
|
0.167 pH
Standard Deviation 0.4082
|
0.056 pH
Standard Deviation 0.5393
|
0.000 pH
Standard Deviation 0.7071
|
-0.214 pH
Standard Deviation 0.6993
|
|
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 99, n=10,6,19,13,14
|
0.100 pH
Standard Deviation 0.5676
|
0.167 pH
Standard Deviation 0.9832
|
-0.158 pH
Standard Deviation 0.5015
|
-0.154 pH
Standard Deviation 0.9871
|
-0.214 pH
Standard Deviation 0.5789
|
|
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 113, n=10,6,17,12,14
|
0.000 pH
Standard Deviation 0.8165
|
0.000 pH
Standard Deviation 0.6325
|
-0.176 pH
Standard Deviation 0.5286
|
0.000 pH
Standard Deviation 0.9535
|
-0.143 pH
Standard Deviation 0.9493
|
|
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 141, n=10,6,19,13,14
|
0.300 pH
Standard Deviation 0.6749
|
0.167 pH
Standard Deviation 0.7528
|
0.053 pH
Standard Deviation 0.6213
|
-0.077 pH
Standard Deviation 0.6405
|
-0.143 pH
Standard Deviation 0.7703
|
|
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 169, n=10,6,18,13,14
|
-0.200 pH
Standard Deviation 0.7888
|
0.000 pH
Standard Deviation 0.6325
|
-0.278 pH
Standard Deviation 0.4609
|
0.077 pH
Standard Deviation 0.6405
|
-0.071 pH
Standard Deviation 0.4746
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 450Population: Safety Population. Data was not collected for this outcome measure during optional follow-up period.
Urine samples were planned to be collected from participants to evaluate change from Baseline in urine pH levels. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 3, 8, 30 and Follow-up (Day 60)Population: Safety Population
Urine samples were collected from participants to assess urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points
Day 3
|
0.005 Ratio
Standard Deviation 0.0091
|
-0.011 Ratio
Standard Deviation 0.0061
|
-0.001 Ratio
Standard Deviation 0.0029
|
—
|
—
|
|
Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points
Day 8
|
0.003 Ratio
Standard Deviation 0.0081
|
-0.014 Ratio
Standard Deviation 0.0151
|
0.000 Ratio
Standard Deviation 0.0087
|
—
|
—
|
|
Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points
Day 30
|
-0.001 Ratio
Standard Deviation 0.0112
|
-0.013 Ratio
Standard Deviation 0.0175
|
0.000 Ratio
Standard Deviation 0.0066
|
—
|
—
|
|
Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points
Follow-up (Day 60)
|
0.006 Ratio
Standard Deviation 0.0125
|
-0.014 Ratio
Standard Deviation 0.0123
|
-0.001 Ratio
Standard Deviation 0.0079
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Urine samples were collected from participants to assess urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 8, n=10,6,19,15,14
|
-0.001 Ratio
Standard Deviation 0.0080
|
0.004 Ratio
Standard Deviation 0.0049
|
-0.001 Ratio
Standard Deviation 0.0060
|
0.000 Ratio
Standard Deviation 0.0055
|
0.000 Ratio
Standard Deviation 0.0063
|
|
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 15, n=10,6,20,14,15
|
0.002 Ratio
Standard Deviation 0.0054
|
0.004 Ratio
Standard Deviation 0.0085
|
0.001 Ratio
Standard Deviation 0.0058
|
0.000 Ratio
Standard Deviation 0.0083
|
0.000 Ratio
Standard Deviation 0.0088
|
|
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 22, n=10,6,20,14,15
|
-0.001 Ratio
Standard Deviation 0.0082
|
0.003 Ratio
Standard Deviation 0.0045
|
-0.001 Ratio
Standard Deviation 0.0073
|
0.001 Ratio
Standard Deviation 0.0063
|
0.000 Ratio
Standard Deviation 0.0070
|
|
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 29, n=10,6,20,13,15
|
0.001 Ratio
Standard Deviation 0.0098
|
-0.001 Ratio
Standard Deviation 0.0060
|
0.001 Ratio
Standard Deviation 0.0052
|
0.000 Ratio
Standard Deviation 0.0051
|
0.001 Ratio
Standard Deviation 0.0064
|
|
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 36, n=10,6,20,14,15
|
0.004 Ratio
Standard Deviation 0.0100
|
0.002 Ratio
Standard Deviation 0.0067
|
-0.002 Ratio
Standard Deviation 0.0065
|
-0.001 Ratio
Standard Deviation 0.0067
|
-0.003 Ratio
Standard Deviation 0.0082
|
|
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 43, n=9,6,20,14,15
|
-0.003 Ratio
Standard Deviation 0.0098
|
0.002 Ratio
Standard Deviation 0.0060
|
0.000 Ratio
Standard Deviation 0.0050
|
-0.001 Ratio
Standard Deviation 0.0070
|
0.000 Ratio
Standard Deviation 0.0064
|
|
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 50, n=9,6,19,14,15
|
-0.003 Ratio
Standard Deviation 0.0081
|
0.002 Ratio
Standard Deviation 0.0079
|
-0.002 Ratio
Standard Deviation 0.0065
|
-0.001 Ratio
Standard Deviation 0.0095
|
0.000 Ratio
Standard Deviation 0.0076
|
|
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 57, n=10,6,20,14,15
|
0.000 Ratio
Standard Deviation 0.0082
|
0.005 Ratio
Standard Deviation 0.0078
|
-0.001 Ratio
Standard Deviation 0.0044
|
-0.003 Ratio
Standard Deviation 0.0073
|
0.000 Ratio
Standard Deviation 0.0069
|
|
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 78, n=10,6,20,14,15
|
-0.002 Ratio
Standard Deviation 0.0069
|
0.002 Ratio
Standard Deviation 0.0022
|
0.000 Ratio
Standard Deviation 0.0078
|
-0.004 Ratio
Standard Deviation 0.0085
|
-0.001 Ratio
Standard Deviation 0.0081
|
|
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 85, n=10,6,20,14,15
|
0.001 Ratio
Standard Deviation 0.0074
|
-0.002 Ratio
Standard Deviation 0.0023
|
0.000 Ratio
Standard Deviation 0.0057
|
-0.003 Ratio
Standard Deviation 0.0074
|
0.000 Ratio
Standard Deviation 0.0058
|
|
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 92, n=10,6,19,14,15
|
0.001 Ratio
Standard Deviation 0.0070
|
0.002 Ratio
Standard Deviation 0.0051
|
0.001 Ratio
Standard Deviation 0.0063
|
-0.002 Ratio
Standard Deviation 0.0079
|
0.000 Ratio
Standard Deviation 0.0058
|
|
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 99, n=10,6,20,14,15
|
0.002 Ratio
Standard Deviation 0.0081
|
-0.001 Ratio
Standard Deviation 0.0039
|
0.001 Ratio
Standard Deviation 0.0050
|
-0.002 Ratio
Standard Deviation 0.0061
|
0.000 Ratio
Standard Deviation 0.0048
|
|
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 169, n=10,6,19,14,15
|
-0.001 Ratio
Standard Deviation 0.0072
|
0.002 Ratio
Standard Deviation 0.0053
|
0.001 Ratio
Standard Deviation 0.0047
|
0.000 Ratio
Standard Deviation 0.0077
|
-0.003 Ratio
Standard Deviation 0.0052
|
|
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 64, n=10,6,20,14,15
|
-0.002 Ratio
Standard Deviation 0.0103
|
0.003 Ratio
Standard Deviation 0.0093
|
0.000 Ratio
Standard Deviation 0.0055
|
-0.001 Ratio
Standard Deviation 0.0059
|
0.001 Ratio
Standard Deviation 0.0052
|
|
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 71, n=10,6,20,14,15
|
-0.001 Ratio
Standard Deviation 0.0100
|
0.003 Ratio
Standard Deviation 0.0052
|
0.001 Ratio
Standard Deviation 0.0072
|
-0.003 Ratio
Standard Deviation 0.0059
|
0.001 Ratio
Standard Deviation 0.0053
|
|
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 113, n=10,6,18,13,15
|
0.000 Ratio
Standard Deviation 0.0101
|
0.000 Ratio
Standard Deviation 0.0043
|
0.000 Ratio
Standard Deviation 0.0054
|
-0.001 Ratio
Standard Deviation 0.0090
|
-0.001 Ratio
Standard Deviation 0.0047
|
|
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 141, n=10,6,20,14,15
|
-0.003 Ratio
Standard Deviation 0.0107
|
-0.001 Ratio
Standard Deviation 0.0068
|
0.001 Ratio
Standard Deviation 0.0056
|
0.000 Ratio
Standard Deviation 0.0086
|
0.000 Ratio
Standard Deviation 0.0066
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 450Population: Safety Population. Data was not collected for this outcome measure during optional follow-up period.
Urine samples were planned to be collected from participants to evaluate change from Baseline in urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 3, 8, 30 and Follow-up (Day 60)Population: Safety Population
Urine samples were collected from participants to assess urobilinogen levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Urobilinogen at Indicated Time Points
Day 3
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
—
|
—
|
|
Part 1: Change From Baseline in Urobilinogen at Indicated Time Points
Follow-up (Day 60)
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
—
|
—
|
|
Part 1: Change From Baseline in Urobilinogen at Indicated Time Points
Day 8
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
—
|
—
|
|
Part 1: Change From Baseline in Urobilinogen at Indicated Time Points
Day 30
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Urine samples were collected from participants to assess urobilinogen levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 15, n=10,6,20,14,15
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.090 Milligram per deciliter
Standard Deviation 0.4025
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
|
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 8, n=10,6,19,15,14
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
|
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 29, n=10,6,20,13,15
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.120 Milligram per deciliter
Standard Deviation 0.4648
|
|
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 36, n=10,6,20,14,15
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.120 Milligram per deciliter
Standard Deviation 0.4648
|
|
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 43, n=9,6,20,14,15
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.180 Milligram per deciliter
Standard Deviation 0.5540
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
|
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 50, n=9,6,19,14,15
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
|
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 57, n=10,6,20,14,15
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.090 Milligram per deciliter
Standard Deviation 0.4025
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
|
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 64, n=10,6,20,14,15
|
0.180 Milligram per deciliter
Standard Deviation 0.5692
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.180 Milligram per deciliter
Standard Deviation 0.5540
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.240 Milligram per deciliter
Standard Deviation 0.6334
|
|
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 71, n=10,6,19,14,15
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.240 Milligram per deciliter
Standard Deviation 0.6334
|
|
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 92, n=10,6,19,14,15
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.189 Milligram per deciliter
Standard Deviation 0.5675
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
|
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 99, n=10,6,19,14,15
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.120 Milligram per deciliter
Standard Deviation 0.4648
|
|
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 113, n=10,6,17,13,15
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.106 Milligram per deciliter
Standard Deviation 0.4366
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
|
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 141, n=10,6,19,14,15
|
0.180 Milligram per deciliter
Standard Deviation 0.5692
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.095 Milligram per deciliter
Standard Deviation 0.4129
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
|
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 169, n=10,6,19,14,14
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.095 Milligram per deciliter
Standard Deviation 0.4129
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.129 Milligram per deciliter
Standard Deviation 0.4811
|
|
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 22, n=10,6,20,14,15
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
|
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 78, n=10,6,20,14,15
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.180 Milligram per deciliter
Standard Deviation 0.5540
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
|
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 85, n=10,6,20,14,14
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.090 Milligram per deciliter
Standard Deviation 0.4025
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
0.000 Milligram per deciliter
Standard Deviation 0.0000
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 450Population: Safety Population. Data was not collected for this outcome measure during optional follow-up period.
Urine samples were planned to be collected from participants to evaluate change from Baseline in urobilinogen. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1: 2 hours, Day 1: 4 hours, Day 1: 8 hours, Day 3, Day 8 and Day 30Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Electrocardiograms were obtained after 5 minutes of rest in the semi-supine or supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Abnormal NCS, Day 1: 2 hour, n=3,3,6
|
2 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Abnormal CS, Day 1: 2 hour, n=3,3,6
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Abnormal NCS, Day 1: 4 hour, n=3,3,6
|
2 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Abnormal NCS, Day 1: 8 hour, n=3,3,6
|
2 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Abnormal CS, Day 1: 8 hour, n=3,3,6
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Abnormal NCS, Day 3, n=3,3,6
|
2 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Abnormal CS, Day 3, n=3,3,6
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Abnormal NCS, Day 8, n=2,3,6
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Abnormal CS, Day 8, n=2,3,6
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Abnormal NCS, Day 30, n=3,3,6
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Abnormal CS, Day 1: 4 hour, n=3,3,6
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Abnormal CS, Day 30, n=3,3,6
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 29, 57, 85 and 169Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Electrocardiogram were obtained after 5 minutes of rest in the semi-supine or supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF intervals. CS and NCS abnormal ECG findings have been presented. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=14 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis)
Day 57, NCS, n=10,6,20,14,15
|
5 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis)
Day 85, NCS, n=10,6,20,14,15
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis)
Day 29, NCS, n=10,6,20,13,15
|
2 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
|
Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis)
Day 29, CS, n=10,6,20,13,15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis)
Day 57, CS, n=10,6,20,14,15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis)
Day 85, CS, n=10,6,20,14,15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis)
Day 169, NCS, n=10,6,19,14,15
|
2 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis)
Day 169, CS, n=10,6,19,14,15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 270, 360 and 450Population: Safety Population. Data was not collected for this outcome measure during optional follow-up period.
ECGs were planned to be obtained after 5 minutes of rest in the semi-supine or supine position using ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTcF intervals.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 60Population: Safety Population
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 169Population: Safety Population
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Number of Participants With AEs and SAEs (Up to Day 169-Interim Analysis)
AEs
|
9 Participants
|
4 Participants
|
16 Participants
|
11 Participants
|
12 Participants
|
|
Part 2: Number of Participants With AEs and SAEs (Up to Day 169-Interim Analysis)
SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 450Population: Safety Population
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Number of Participants With AEs and SAEs (Up to Day 450-Optional Follow-up)
AEs
|
9 Participants
|
4 Participants
|
18 Participants
|
11 Participants
|
12 Participants
|
|
Part 2: Number of Participants With AEs and SAEs (Up to Day 450-Optional Follow-up)
SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30Population: Pharmacokinetic Population comprised of all participants in the Safety population for whom at least one evaluable pharmacokinetic sample were obtained and analyzed.
Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Quantifiable Concentration (AUC[0-t]) for GSK3389404
|
1230 Hours*nanogram per milliliter
Geometric Coefficient of Variation 14.3
|
17000 Hours*nanogram per milliliter
Geometric Coefficient of Variation 39.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
n=6 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=3 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=3 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: AUC (0-t) for GSK3389404
|
1930 Hours*nanogram per milliliter
Geometric Coefficient of Variation 21.4
|
5920 Hours*nanogram per milliliter
Geometric Coefficient of Variation 36.2
|
12000 Hours*nanogram per milliliter
Geometric Coefficient of Variation 38.5
|
14400 Hours*nanogram per milliliter
Geometric Coefficient of Variation 49.1
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure AUC (0-infinity) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
n=2 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) for GSK3389404
|
1460 Hours*nanogram per milliliter
Geometric Coefficient of Variation 15.5
|
17100 Hours*nanogram per milliliter
Geometric Coefficient of Variation 23.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure AUC (0-infinity) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
n=6 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=3 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=3 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: AUC (0-infinity) for GSK3389404
|
2030 Hours*nanogram per milliliter
Geometric Coefficient of Variation 17.7
|
5990 Hours*nanogram per milliliter
Geometric Coefficient of Variation 35.3
|
12300 Hours*nanogram per milliliter
Geometric Coefficient of Variation 37.5
|
14600 Hours*nanogram per milliliter
Geometric Coefficient of Variation 47.3
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30Population: Pharmacokinetic Population
Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3389404
|
227 Nanogram per milliliter
Geometric Coefficient of Variation 11.0
|
1880 Nanogram per milliliter
Geometric Coefficient of Variation 72.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
n=6 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=3 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=3 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Cmax of GSK3389404
|
214 Nanogram per milliliter
Geometric Coefficient of Variation 54.3
|
865 Nanogram per milliliter
Geometric Coefficient of Variation 41.3
|
1660 Nanogram per milliliter
Geometric Coefficient of Variation 34.4
|
1940 Nanogram per milliliter
Geometric Coefficient of Variation 78.2
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30Population: Pharmacokinetic Population
Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Time to Achieve Cmax (Tmax) of GSK3389404
|
1.40 Hours
Interval 1.33 to 2.0
|
3.50 Hours
Interval 1.93 to 6.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
n=6 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=3 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=3 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Tmax of GSK3389404
|
2.04 Hours
Interval 0.9 to 3.98
|
3.46 Hours
Interval 1.98 to 5.98
|
4.05 Hours
Interval 2.02 to 6.03
|
4.02 Hours
Interval 2.98 to 4.07
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
n=2 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Apparent Terminal Phase Half-life(t1/2) of GSK3389404
|
3.12 Hours
Geometric Coefficient of Variation 54.7
|
4.31 Hours
Geometric Coefficient of Variation 3.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
n=6 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=3 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=3 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: t1/2 of GSK3389404
|
3.90 Hours
Geometric Coefficient of Variation 55.0
|
3.24 Hours
Geometric Coefficient of Variation 26.0
|
4.24 Hours
Geometric Coefficient of Variation 29.5
|
2.89 Hours
Geometric Coefficient of Variation 48.4
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure CL/F at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
n=2 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Apparent Subcutaneous Plasma Clearance (CL/F) of GSK3389404
|
20.6 Liters per hour
Interval -7.914 to 49.34
|
7.03 Liters per hour
Interval 3.09 to 11.22
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure CL/F at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
n=6 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=3 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=3 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: CL/F of GSK3389404
|
14.8 Liters per hour
Interval 12.37 to 17.57
|
10.0 Liters per hour
Interval 6.96 to 14.03
|
9.75 Liters per hour
Interval 1.914 to 18.41
|
8.23 Liters per hour
Interval 0.02305 to 17.51
|
—
|
PRIMARY outcome
Timeframe: Up to Day 60Population: Intent-To-Treat (ITT) Population comprised of all randomized participants.
The RR was based on the proportion of participants with at least a 1.5 logarithm to the base 10 (log10) international units per milliliter (IU/mL) reduction of HBsAg levels from Baseline at any time up to Day 60. Number of participants who achieved \>1.5 log10 IU/mL decrease in HBsAg levels at any time up to Day 60 are presented.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Number of Participants Achieving Response Rate (RR) Based on Reduction of Hepatitis B Surface Antigen (HBsAg) Level From Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 85Population: ITT Population. Data is presented only for interim analysis; since this analysis was not planned for optional follow-up period (up to Day 450).
The RR was based on the proportion of participants with at least a 1.5 log10 IU/mL reduction of HBsAg levels from Baseline at any time up to Day 85. Number of participants who achieved \>1.5 log10 IU/mL decrease in HBsAg levels at any time up to Day 85 are presented.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Number of Participants Achieving RR Based on Reduction of HBsAg Level From Baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Day 1: 8 hours, Days 3, 8, 15, 22, 30 and 60Population: Pharmacodynamic Population comprised of all participants in the Safety Population who provided evaluable pharmacodynamic data. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected from participants to assess HBV DNA viral load. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Outcome measures
| Measure |
Part 1: Placebo
n=2 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points
Day 60, n=2,3,6
|
-0.30 Log10 (IU/mL)
Standard Deviation 0.292
|
-0.04 Log10 (IU/mL)
Standard Deviation 0.075
|
0.12 Log10 (IU/mL)
Standard Deviation 0.199
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points
Day 1: 8 hour, n=2,3,5
|
-0.19 Log10 (IU/mL)
Standard Deviation 0.202
|
-0.03 Log10 (IU/mL)
Standard Deviation 0.055
|
0.50 Log10 (IU/mL)
Standard Deviation 0.716
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points
Day 3, n=2,3,6
|
-0.06 Log10 (IU/mL)
Standard Deviation 0.065
|
0.41 Log10 (IU/mL)
Standard Deviation 0.754
|
0.20 Log10 (IU/mL)
Standard Deviation 0.539
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points
Day 8, n=2,3,6
|
0.06 Log10 (IU/mL)
Standard Deviation 0.265
|
0.37 Log10 (IU/mL)
Standard Deviation 0.788
|
-0.02 Log10 (IU/mL)
Standard Deviation 0.075
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points
Day 15, n=2,3,6
|
0.17 Log10 (IU/mL)
Standard Deviation 0.173
|
-0.05 Log10 (IU/mL)
Standard Deviation 0.086
|
-0.17 Log10 (IU/mL)
Standard Deviation 0.317
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points
Day 22, n=2,3,6
|
0.16 Log10 (IU/mL)
Standard Deviation 0.224
|
-0.07 Log10 (IU/mL)
Standard Deviation 0.114
|
-0.09 Log10 (IU/mL)
Standard Deviation 0.165
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points
Day 30, n=2,3,6
|
-0.12 Log10 (IU/mL)
Standard Deviation 0.077
|
0.34 Log10 (IU/mL)
Standard Deviation 0.821
|
0.13 Log10 (IU/mL)
Standard Deviation 0.573
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 169Population: ITT Population
Blood samples were collected from participants to assess HBV DNA viral load. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
|
-0.128 Log10 (IU/mL)
Standard Deviation 0.4044
|
-0.426 Log10 (IU/mL)
Standard Deviation 0.6603
|
-0.643 Log10 (IU/mL)
Standard Deviation 0.6594
|
-0.341 Log10 (IU/mL)
Standard Deviation 0.7591
|
-0.256 Log10 (IU/mL)
Standard Deviation 0.5295
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 450Population: ITT Population
Blood samples were collected from participants to assess HBV DNA viral load. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up)
|
-0.128 Log10 (IU/mL)
Standard Deviation 0.4044
|
-0.426 Log10 (IU/mL)
Standard Deviation 0.6603
|
-0.643 Log10 (IU/mL)
Standard Deviation 0.6594
|
-0.426 Log10 (IU/mL)
Standard Deviation 0.7893
|
-0.256 Log10 (IU/mL)
Standard Deviation 0.5295
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Day 1: 8 hours, Days 3, 8, 15, 22, 30 and 60Population: Pharmacodynamic Population
Blood samples were collected from participants to assess HBsAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points
Day 1: 8 hour
|
-0.03 Log10 (IU/mL)
Standard Deviation 0.027
|
0.02 Log10 (IU/mL)
Standard Deviation 0.023
|
-0.02 Log10 (IU/mL)
Standard Deviation 0.032
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points
Day 3
|
0.01 Log10 (IU/mL)
Standard Deviation 0.016
|
0.00 Log10 (IU/mL)
Standard Deviation 0.014
|
-0.05 Log10 (IU/mL)
Standard Deviation 0.038
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points
Day 8
|
-0.01 Log10 (IU/mL)
Standard Deviation 0.078
|
0.01 Log10 (IU/mL)
Standard Deviation 0.051
|
-0.09 Log10 (IU/mL)
Standard Deviation 0.079
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points
Day 15
|
0.00 Log10 (IU/mL)
Standard Deviation 0.066
|
-0.02 Log10 (IU/mL)
Standard Deviation 0.043
|
-0.10 Log10 (IU/mL)
Standard Deviation 0.075
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points
Day 22
|
0.03 Log10 (IU/mL)
Standard Deviation 0.052
|
-0.04 Log10 (IU/mL)
Standard Deviation 0.066
|
-0.14 Log10 (IU/mL)
Standard Deviation 0.114
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points
Day 30
|
-0.01 Log10 (IU/mL)
Standard Deviation 0.038
|
-0.02 Log10 (IU/mL)
Standard Deviation 0.021
|
-0.12 Log10 (IU/mL)
Standard Deviation 0.139
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points
Day 60
|
-0.00 Log10 (IU/mL)
Standard Deviation 0.064
|
0.01 Log10 (IU/mL)
Standard Deviation 0.057
|
-0.05 Log10 (IU/mL)
Standard Deviation 0.038
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected from participants to assess HBsAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=20 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 8, n=10,6,20,15,15
|
-0.0149 Log10 (IU/mL)
Standard Deviation 0.07545
|
-0.0057 Log10 (IU/mL)
Standard Deviation 0.05207
|
-0.0376 Log10 (IU/mL)
Standard Deviation 0.08685
|
-0.0573 Log10 (IU/mL)
Standard Deviation 0.03889
|
-0.0944 Log10 (IU/mL)
Standard Deviation 0.08417
|
|
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 15, n=10,6,20,14,15
|
-0.0175 Log10 (IU/mL)
Standard Deviation 0.07296
|
-0.0296 Log10 (IU/mL)
Standard Deviation 0.03871
|
-0.0872 Log10 (IU/mL)
Standard Deviation 0.12991
|
-0.0690 Log10 (IU/mL)
Standard Deviation 0.06427
|
-0.2103 Log10 (IU/mL)
Standard Deviation 0.13356
|
|
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 22, n=10,6,20,15,15
|
-0.0248 Log10 (IU/mL)
Standard Deviation 0.06304
|
-0.0302 Log10 (IU/mL)
Standard Deviation 0.03943
|
-0.1543 Log10 (IU/mL)
Standard Deviation 0.16457
|
-0.1200 Log10 (IU/mL)
Standard Deviation 0.09169
|
-0.3345 Log10 (IU/mL)
Standard Deviation 0.17978
|
|
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 29, n=10,6,20,13,15
|
-0.0252 Log10 (IU/mL)
Standard Deviation 0.06330
|
-0.0416 Log10 (IU/mL)
Standard Deviation 0.07503
|
-0.2197 Log10 (IU/mL)
Standard Deviation 0.25896
|
-0.1793 Log10 (IU/mL)
Standard Deviation 0.08003
|
-0.4512 Log10 (IU/mL)
Standard Deviation 0.22095
|
|
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 36, n=10,6,20,14,15
|
-0.0280 Log10 (IU/mL)
Standard Deviation 0.06764
|
-0.0895 Log10 (IU/mL)
Standard Deviation 0.06557
|
-0.2650 Log10 (IU/mL)
Standard Deviation 0.28541
|
-0.2105 Log10 (IU/mL)
Standard Deviation 0.08617
|
-0.4798 Log10 (IU/mL)
Standard Deviation 0.21487
|
|
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 43, n=10,6,20,14,15
|
-0.0334 Log10 (IU/mL)
Standard Deviation 0.08425
|
-0.1010 Log10 (IU/mL)
Standard Deviation 0.06003
|
-0.2671 Log10 (IU/mL)
Standard Deviation 0.31301
|
-0.2370 Log10 (IU/mL)
Standard Deviation 0.12134
|
-0.4923 Log10 (IU/mL)
Standard Deviation 0.23961
|
|
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 50, n=10,6,19,14,15
|
-0.0118 Log10 (IU/mL)
Standard Deviation 0.06170
|
-0.0959 Log10 (IU/mL)
Standard Deviation 0.06731
|
-0.3131 Log10 (IU/mL)
Standard Deviation 0.28058
|
-0.2603 Log10 (IU/mL)
Standard Deviation 0.10027
|
-0.5600 Log10 (IU/mL)
Standard Deviation 0.31750
|
|
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 57, n=10,6,20,14,15
|
-0.0307 Log10 (IU/mL)
Standard Deviation 0.05677
|
-0.1250 Log10 (IU/mL)
Standard Deviation 0.08371
|
-0.3171 Log10 (IU/mL)
Standard Deviation 0.27547
|
-0.2925 Log10 (IU/mL)
Standard Deviation 0.09666
|
-0.5962 Log10 (IU/mL)
Standard Deviation 0.34848
|
|
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 64, n=10,6,20,14,15
|
-0.0178 Log10 (IU/mL)
Standard Deviation 0.07303
|
-0.1388 Log10 (IU/mL)
Standard Deviation 0.08620
|
-0.3307 Log10 (IU/mL)
Standard Deviation 0.25414
|
-0.3628 Log10 (IU/mL)
Standard Deviation 0.20369
|
-0.6261 Log10 (IU/mL)
Standard Deviation 0.40132
|
|
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 71, n=10,6,20,14,15
|
-0.0124 Log10 (IU/mL)
Standard Deviation 0.06586
|
-0.1689 Log10 (IU/mL)
Standard Deviation 0.13050
|
-0.3249 Log10 (IU/mL)
Standard Deviation 0.24978
|
-0.3722 Log10 (IU/mL)
Standard Deviation 0.28298
|
-0.6357 Log10 (IU/mL)
Standard Deviation 0.42715
|
|
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 78, n=10,6,19,14,15
|
-0.0130 Log10 (IU/mL)
Standard Deviation 0.08312
|
-0.1065 Log10 (IU/mL)
Standard Deviation 0.09399
|
-0.3438 Log10 (IU/mL)
Standard Deviation 0.29089
|
-0.4532 Log10 (IU/mL)
Standard Deviation 0.46786
|
-0.7088 Log10 (IU/mL)
Standard Deviation 0.57034
|
|
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 85, n=9,6,20,14,14
|
-0.0212 Log10 (IU/mL)
Standard Deviation 0.08048
|
-0.1312 Log10 (IU/mL)
Standard Deviation 0.06855
|
-0.3374 Log10 (IU/mL)
Standard Deviation 0.31804
|
-0.4429 Log10 (IU/mL)
Standard Deviation 0.50368
|
-0.7531 Log10 (IU/mL)
Standard Deviation 0.64776
|
|
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 92, n=10,6,19,14,13
|
-0.0462 Log10 (IU/mL)
Standard Deviation 0.12954
|
-0.1431 Log10 (IU/mL)
Standard Deviation 0.08963
|
-0.3411 Log10 (IU/mL)
Standard Deviation 0.22578
|
-0.4291 Log10 (IU/mL)
Standard Deviation 0.56931
|
-0.6794 Log10 (IU/mL)
Standard Deviation 0.62942
|
|
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 99, n=10,6,20,14,15
|
-0.0502 Log10 (IU/mL)
Standard Deviation 0.10885
|
-0.1084 Log10 (IU/mL)
Standard Deviation 0.06213
|
-0.3018 Log10 (IU/mL)
Standard Deviation 0.20862
|
-0.4327 Log10 (IU/mL)
Standard Deviation 0.55294
|
-0.5981 Log10 (IU/mL)
Standard Deviation 0.48977
|
|
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 113, n=10,6,20,14,15
|
-0.0395 Log10 (IU/mL)
Standard Deviation 0.08067
|
-0.0874 Log10 (IU/mL)
Standard Deviation 0.05607
|
-0.2389 Log10 (IU/mL)
Standard Deviation 0.12015
|
-0.3612 Log10 (IU/mL)
Standard Deviation 0.55395
|
-0.4228 Log10 (IU/mL)
Standard Deviation 0.36072
|
|
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 141, n=10,6,20,14,15
|
-0.0132 Log10 (IU/mL)
Standard Deviation 0.09127
|
-0.0417 Log10 (IU/mL)
Standard Deviation 0.04609
|
-0.1420 Log10 (IU/mL)
Standard Deviation 0.10442
|
-0.2246 Log10 (IU/mL)
Standard Deviation 0.38875
|
-0.2729 Log10 (IU/mL)
Standard Deviation 0.23994
|
|
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 169, n=10,6,19,14,15
|
-0.0046 Log10 (IU/mL)
Standard Deviation 0.09142
|
-0.0295 Log10 (IU/mL)
Standard Deviation 0.03644
|
-0.0975 Log10 (IU/mL)
Standard Deviation 0.08478
|
-0.1038 Log10 (IU/mL)
Standard Deviation 0.22824
|
-0.1822 Log10 (IU/mL)
Standard Deviation 0.21674
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Day 270, Day 360 and Day 450Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected from participants to assess HBsAg level. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=5 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=17 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=13 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up)
Day 270, n=10,5,17,13,15
|
-0.0177 Log10 (IU/mL)
Standard Deviation 0.08736
|
0.0308 Log10 (IU/mL)
Standard Deviation 0.07338
|
0.0627 Log10 (IU/mL)
Standard Deviation 0.21462
|
0.0400 Log10 (IU/mL)
Standard Deviation 0.05783
|
-0.0047 Log10 (IU/mL)
Standard Deviation 0.35902
|
|
Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up)
Day 450, n=9,5,17,11,15
|
-0.1282 Log10 (IU/mL)
Standard Deviation 0.09933
|
-0.0551 Log10 (IU/mL)
Standard Deviation 0.11173
|
-0.0615 Log10 (IU/mL)
Standard Deviation 0.08487
|
-0.0350 Log10 (IU/mL)
Standard Deviation 0.08041
|
-0.1557 Log10 (IU/mL)
Standard Deviation 0.18720
|
|
Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up)
Day 360, n=10,5,17,12,14
|
-0.0723 Log10 (IU/mL)
Standard Deviation 0.11352
|
-0.0397 Log10 (IU/mL)
Standard Deviation 0.06918
|
-0.0265 Log10 (IU/mL)
Standard Deviation 0.08988
|
-0.0239 Log10 (IU/mL)
Standard Deviation 0.07252
|
-0.1175 Log10 (IU/mL)
Standard Deviation 0.21454
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Day 1: 8 hours, Days 3, 8, 15, 22, 30 and 60Population: Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected from participants to assess HBeAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=5 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points
Day 1: 8 hour, n=3,3,5
|
0.15 Log10 (IU/mL)
Standard Deviation 0.237
|
-0.03 Log10 (IU/mL)
Standard Deviation 0.053
|
0.00 Log10 (IU/mL)
Standard Deviation 0.000
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points
Day 3, n=3,3,4
|
-0.01 Log10 (IU/mL)
Standard Deviation 0.020
|
-0.02 Log10 (IU/mL)
Standard Deviation 0.039
|
0.00 Log10 (IU/mL)
Standard Deviation 0.000
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points
Day 8, n=3,3,4
|
0.02 Log10 (IU/mL)
Standard Deviation 0.036
|
0.03 Log10 (IU/mL)
Standard Deviation 0.044
|
0.94 Log10 (IU/mL)
Standard Deviation 1.885
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points
Day 15, n=3,3,4
|
0.02 Log10 (IU/mL)
Standard Deviation 0.036
|
-0.01 Log10 (IU/mL)
Standard Deviation 0.025
|
0.00 Log10 (IU/mL)
Standard Deviation 0.000
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points
Day 22, n=3,3,4
|
0.03 Log10 (IU/mL)
Standard Deviation 0.052
|
0.01 Log10 (IU/mL)
Standard Deviation 0.012
|
0.08 Log10 (IU/mL)
Standard Deviation 0.151
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points
Day 30, n=3,3,4
|
0.22 Log10 (IU/mL)
Standard Deviation 0.331
|
-0.02 Log10 (IU/mL)
Standard Deviation 0.039
|
0.17 Log10 (IU/mL)
Standard Deviation 0.342
|
—
|
—
|
|
Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points
Day 60, n=3,3,4
|
0.00 Log10 (IU/mL)
Standard Deviation 0.000
|
0.00 Log10 (IU/mL)
Standard Deviation 0.000
|
0.00 Log10 (IU/mL)
Standard Deviation 0.000
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected from participants to assess HBeAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Outcome measures
| Measure |
Part 1: Placebo
n=7 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=15 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=11 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=10 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 8, n=7,6,15,11,10
|
0.039 Log10 (IU/mL)
Standard Deviation 0.0750
|
0.023 Log10 (IU/mL)
Standard Deviation 0.0565
|
0.010 Log10 (IU/mL)
Standard Deviation 0.0555
|
-0.051 Log10 (IU/mL)
Standard Deviation 0.0802
|
0.012 Log10 (IU/mL)
Standard Deviation 0.0586
|
|
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 15, n=7,6,13,10,9
|
0.101 Log10 (IU/mL)
Standard Deviation 0.2223
|
-0.030 Log10 (IU/mL)
Standard Deviation 0.0516
|
-0.020 Log10 (IU/mL)
Standard Deviation 0.0519
|
-0.044 Log10 (IU/mL)
Standard Deviation 0.0728
|
-0.009 Log10 (IU/mL)
Standard Deviation 0.0976
|
|
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 29, n=7,6,13,10,9
|
0.050 Log10 (IU/mL)
Standard Deviation 0.0937
|
0.003 Log10 (IU/mL)
Standard Deviation 0.0552
|
-0.049 Log10 (IU/mL)
Standard Deviation 0.1086
|
-0.059 Log10 (IU/mL)
Standard Deviation 0.0959
|
-0.039 Log10 (IU/mL)
Standard Deviation 0.2732
|
|
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 50, n=7,6,12,10,9
|
0.007 Log10 (IU/mL)
Standard Deviation 0.0186
|
-0.012 Log10 (IU/mL)
Standard Deviation 0.0574
|
-0.091 Log10 (IU/mL)
Standard Deviation 0.1283
|
0.017 Log10 (IU/mL)
Standard Deviation 0.3365
|
-0.122 Log10 (IU/mL)
Standard Deviation 0.1563
|
|
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 57, n=7,6,13,10,9
|
0.002 Log10 (IU/mL)
Standard Deviation 0.0111
|
-0.024 Log10 (IU/mL)
Standard Deviation 0.0592
|
-0.110 Log10 (IU/mL)
Standard Deviation 0.1288
|
-0.040 Log10 (IU/mL)
Standard Deviation 0.1506
|
-0.068 Log10 (IU/mL)
Standard Deviation 0.2413
|
|
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 71, n=7,6,13,10,9
|
0.061 Log10 (IU/mL)
Standard Deviation 0.1113
|
0.001 Log10 (IU/mL)
Standard Deviation 0.0457
|
-0.111 Log10 (IU/mL)
Standard Deviation 0.1141
|
-0.060 Log10 (IU/mL)
Standard Deviation 0.1002
|
-0.101 Log10 (IU/mL)
Standard Deviation 0.1618
|
|
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 78, n=7,6,12,10,9
|
-0.027 Log10 (IU/mL)
Standard Deviation 0.1334
|
0.086 Log10 (IU/mL)
Standard Deviation 0.2363
|
-0.100 Log10 (IU/mL)
Standard Deviation 0.1224
|
-0.071 Log10 (IU/mL)
Standard Deviation 0.1232
|
-0.118 Log10 (IU/mL)
Standard Deviation 0.1636
|
|
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 85, n=6,6,13,10,8
|
0.018 Log10 (IU/mL)
Standard Deviation 0.0438
|
0.059 Log10 (IU/mL)
Standard Deviation 0.1518
|
-0.101 Log10 (IU/mL)
Standard Deviation 0.1161
|
-0.017 Log10 (IU/mL)
Standard Deviation 0.1918
|
-0.117 Log10 (IU/mL)
Standard Deviation 0.1544
|
|
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 64, n=7,6,13,10,9
|
0.008 Log10 (IU/mL)
Standard Deviation 0.0139
|
0.018 Log10 (IU/mL)
Standard Deviation 0.1297
|
-0.120 Log10 (IU/mL)
Standard Deviation 0.1296
|
-0.073 Log10 (IU/mL)
Standard Deviation 0.1216
|
-0.109 Log10 (IU/mL)
Standard Deviation 0.1562
|
|
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 92, n=7,6,12,10,9
|
-0.019 Log10 (IU/mL)
Standard Deviation 0.1253
|
-0.004 Log10 (IU/mL)
Standard Deviation 0.0551
|
-0.089 Log10 (IU/mL)
Standard Deviation 0.0944
|
-0.042 Log10 (IU/mL)
Standard Deviation 0.0926
|
-0.085 Log10 (IU/mL)
Standard Deviation 0.1200
|
|
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 99, n=7,6,13,10,9
|
-0.025 Log10 (IU/mL)
Standard Deviation 0.1243
|
0.010 Log10 (IU/mL)
Standard Deviation 0.0624
|
-0.080 Log10 (IU/mL)
Standard Deviation 0.0946
|
-0.002 Log10 (IU/mL)
Standard Deviation 0.1413
|
-0.085 Log10 (IU/mL)
Standard Deviation 0.1189
|
|
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 22, n=7,6,13,11,9
|
0.008 Log10 (IU/mL)
Standard Deviation 0.0215
|
-0.008 Log10 (IU/mL)
Standard Deviation 0.0203
|
-0.054 Log10 (IU/mL)
Standard Deviation 0.0732
|
-0.068 Log10 (IU/mL)
Standard Deviation 0.1008
|
-0.081 Log10 (IU/mL)
Standard Deviation 0.1414
|
|
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 36, n=7,6,12,10,9
|
0.120 Log10 (IU/mL)
Standard Deviation 0.2791
|
-0.028 Log10 (IU/mL)
Standard Deviation 0.0695
|
-0.129 Log10 (IU/mL)
Standard Deviation 0.2040
|
-0.062 Log10 (IU/mL)
Standard Deviation 0.1232
|
-0.057 Log10 (IU/mL)
Standard Deviation 0.1380
|
|
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 43, n=7,6,13,10,9
|
0.008 Log10 (IU/mL)
Standard Deviation 0.0397
|
-0.006 Log10 (IU/mL)
Standard Deviation 0.0603
|
-0.113 Log10 (IU/mL)
Standard Deviation 0.1285
|
-0.067 Log10 (IU/mL)
Standard Deviation 0.1146
|
0.013 Log10 (IU/mL)
Standard Deviation 0.5325
|
|
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 113, n=7,6,13,10,9
|
0.015 Log10 (IU/mL)
Standard Deviation 0.0628
|
-0.003 Log10 (IU/mL)
Standard Deviation 0.0666
|
-0.040 Log10 (IU/mL)
Standard Deviation 0.0773
|
-0.022 Log10 (IU/mL)
Standard Deviation 0.0543
|
-0.011 Log10 (IU/mL)
Standard Deviation 0.1237
|
|
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 141, n=7,6,13,10,9
|
0.209 Log10 (IU/mL)
Standard Deviation 0.4253
|
0.017 Log10 (IU/mL)
Standard Deviation 0.1427
|
-0.040 Log10 (IU/mL)
Standard Deviation 0.1006
|
-0.020 Log10 (IU/mL)
Standard Deviation 0.0405
|
0.015 Log10 (IU/mL)
Standard Deviation 0.0858
|
|
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Day 169, n=7,6,12,9,9
|
0.093 Log10 (IU/mL)
Standard Deviation 0.1966
|
0.004 Log10 (IU/mL)
Standard Deviation 0.0398
|
-0.099 Log10 (IU/mL)
Standard Deviation 0.2382
|
-0.028 Log10 (IU/mL)
Standard Deviation 0.0556
|
0.022 Log10 (IU/mL)
Standard Deviation 0.0883
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Day 270, Day 360 and Day 450Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected from participants to assess HBeAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Outcome measures
| Measure |
Part 1: Placebo
n=7 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=5 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=12 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=10 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=9 Participants
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up)
Day 360, n=7,5,11,9,9
|
-0.153 Log10 (IU/mL)
Standard Deviation 0.3744
|
-0.122 Log10 (IU/mL)
Standard Deviation 0.2189
|
-0.084 Log10 (IU/mL)
Standard Deviation 0.2531
|
-0.035 Log10 (IU/mL)
Standard Deviation 0.0689
|
-0.003 Log10 (IU/mL)
Standard Deviation 0.1408
|
|
Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up)
Day 450, n=6,5,12,8,9
|
0.000 Log10 (IU/mL)
Standard Deviation 0.0000
|
-0.119 Log10 (IU/mL)
Standard Deviation 0.1866
|
-0.088 Log10 (IU/mL)
Standard Deviation 0.2225
|
-0.155 Log10 (IU/mL)
Standard Deviation 0.2663
|
-0.035 Log10 (IU/mL)
Standard Deviation 0.0627
|
|
Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up)
Day 270, n=7,5,11,10,9
|
0.050 Log10 (IU/mL)
Standard Deviation 0.1771
|
-0.028 Log10 (IU/mL)
Standard Deviation 0.3263
|
-0.120 Log10 (IU/mL)
Standard Deviation 0.3325
|
-0.041 Log10 (IU/mL)
Standard Deviation 0.0670
|
0.014 Log10 (IU/mL)
Standard Deviation 0.0877
|
SECONDARY outcome
Timeframe: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30Population: Pharmacokinetic Population
Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
n=3 Participants
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=6 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: AUC(0-t) for Metabolite of GSK3389404 (ISIS 505358)
|
NA Hours*nanogram per milliliter
Geometric Coefficient of Variation NA
NA indicates that the data is not available since data is below limit of quantification.
|
44.2 Hours*nanogram per milliliter
Geometric Coefficient of Variation 419.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=1 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=1 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=3 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: AUC(0-t) for Metabolite of GSK3389404 (ISIS 505358)
|
—
|
NA Hours*nanogram per milliliter
Geometric Coefficient of Variation NA
NA indicates that the data is not available since data is below limit of quantification.
|
NA Hours*nanogram per milliliter
Geometric Coefficient of Variation NA
NA indicates that the data is not available since data is below limit of quantification.
|
17.1 Hours*nanogram per milliliter
Geometric Coefficient of Variation 169.7
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=5 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Cmax of GSK3389404 Metabolite (ISIS 505358)
|
—
|
2.93 Nanogram per milliliter
Geometric Coefficient of Variation 60.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=1 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=1 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=3 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Cmax of GSK3389404 Metabolite (ISIS 505358)
|
—
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
NA indicates that the data is not available since data is below limit of quantification.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
NA indicates that the data is not available since data is below limit of quantification.
|
2.91 Nanogram per milliliter
Geometric Coefficient of Variation 77.5
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=5 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: Tmax of GSK3389404 Metabolite (ISIS 505358)
|
—
|
7.88 Hours
Interval 4.0 to 48.08
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=1 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=1 Participants
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=3 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: Tmax of GSK3389404 Metabolite (ISIS 505358)
|
—
|
7.93 Hours
Interval 7.93 to 7.93
|
7.93 Hours
Interval 7.93 to 7.93
|
8.00 Hours
Interval 4.05 to 8.02
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=1 Participants
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 1: t1/2 of GSK3389404 Metabolite (ISIS 505358)
|
—
|
18.75 Hours
Geometric Coefficient of Variation NA
NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Placebo
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=1 Participants
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|
|
Part 2: t1/2 of GSK3389404 Metabolite (ISIS 505358)
|
—
|
—
|
—
|
10.66 Hours
Geometric Coefficient of Variation NA
NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant.
|
—
|
Adverse Events
Part 1: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: GSK3389404 30 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: GSK3389404 120 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2: Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 2: GSK3389404 30 mg Weekly
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2: GSK3389404 60 mg Weekly
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Part 2: GSK3389404 120 mg Bi-weekly
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Part 2: GSK3389404 120 mg Weekly
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Placebo
n=3 participants at risk
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 participants at risk
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 participants at risk
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: Placebo
n=10 participants at risk
Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 30 mg Weekly
n=6 participants at risk
Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 60 mg Weekly
n=20 participants at risk
Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 participants at risk
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 participants at risk
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
1/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Nervous system disorders
Putamen haemorrhage
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
Other adverse events
| Measure |
Part 1: Placebo
n=3 participants at risk
Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1.
|
Part 1: GSK3389404 30 mg
n=3 participants at risk
Participants received a single dose of GSK3389404 30 mg via SC route on Day 1.
|
Part 1: GSK3389404 120 mg
n=6 participants at risk
Participants received a single dose of GSK3389404 120 mg via SC route on Day 1.
|
Part 2: Placebo
n=10 participants at risk
Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 30 mg Weekly
n=6 participants at risk
Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 60 mg Weekly
n=20 participants at risk
Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Bi-weekly
n=15 participants at risk
Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
Part 2: GSK3389404 120 mg Weekly
n=15 participants at risk
Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Malaise
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
1/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
20.0%
3/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
1/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
13.3%
2/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
General disorders
Injection site erythema
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
35.0%
7/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
13.3%
2/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
General disorders
Injection site pruritus
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
25.0%
5/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
General disorders
Asthenia
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
General disorders
Injection site pain
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
13.3%
2/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
13.3%
2/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
General disorders
Injection site swelling
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
General disorders
Fatigue
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
General disorders
Injection site rash
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
20.0%
2/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
20.0%
2/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
30.0%
6/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
13.3%
2/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
13.3%
2/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
1/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
1/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
2/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
13.3%
2/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
20.0%
3/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Infections and infestations
Systemic viral infection
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
20.0%
2/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
13.3%
2/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Blood glucose increased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
1/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Liver function test increased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
1/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
1/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
2/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Protein urine present
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Complement factor C3 decreased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
13.3%
2/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Crystal urine present
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
Reticulocyte count increased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
1/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
15.0%
3/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
13.3%
2/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
20.0%
2/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
13.3%
2/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
2/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
1/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
15.0%
3/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
1/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
13.3%
2/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
1/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
1/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
1/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
1/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
16.7%
1/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
13.3%
2/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
13.3%
2/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
13.3%
2/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Eye disorders
Retinal tear
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Eye disorders
Borderline glaucoma
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Endocrine disorders
Thyroid cyst
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
13.3%
2/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Infections and infestations
Mumps
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
1/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
1/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
5.0%
1/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
10.0%
2/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/3 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/10 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/6 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/20 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
0.00%
0/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
6.7%
1/15 • SAEs and non-SAEs were collected from the start of study treatment up to Day 60 for Part 1 and up to Day 450 (inclusion of optional follow-up duration) for Part 2
SAEs and AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in Part 1 GSK3389404 60 mg and 240 mg arm groups hence no SAEs and AEs were reported for these two groups.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER