Trial Outcomes & Findings for First Time in Human (FTIH) Study to Evaluate Safety, Tolerability, Immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3511294 Administered Subcutaneously (SC) in Subjects With Mild to Moderate Asthma (NCT NCT03287310)
NCT ID: NCT03287310
Last Updated: 2021-03-01
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before; is associated with liver injury and impaired liver function.
COMPLETED
PHASE1
50 participants
Up to Week 40
2021-03-01
Participant Flow
This was double-blind, placebo-controlled, single ascending dose study in participants with mild to moderate asthma to assess safety, tolerability, immunogenicity, pharmacokinetics and pharmcodynamics of GSK3511294 administered subcutaneously. The study was conducted in Germany and United Kingdom.
A total of 50 participants were enrolled in this study, of which two did not receive any study treatment and 48 were included in the Safety Population.
Participant milestones
| Measure |
Placebo
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2 mg
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10 mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30 mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100 mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300 mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
6
|
9
|
9
|
6
|
|
Overall Study
COMPLETED
|
12
|
6
|
6
|
9
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
First Time in Human (FTIH) Study to Evaluate Safety, Tolerability, Immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3511294 Administered Subcutaneously (SC) in Subjects With Mild to Moderate Asthma
Baseline characteristics by cohort
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Black/Afr. Amer./White/Caucasian/European Heritage
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=3 Participants
|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 13.37 • n=99 Participants
|
43.5 years
STANDARD_DEVIATION 10.71 • n=107 Participants
|
44.7 years
STANDARD_DEVIATION 13.20 • n=206 Participants
|
44.9 years
STANDARD_DEVIATION 10.23 • n=157 Participants
|
42.0 years
STANDARD_DEVIATION 10.84 • n=390 Participants
|
45.2 years
STANDARD_DEVIATION 11.18 • n=16 Participants
|
44.0 years
STANDARD_DEVIATION 11.17 • n=3 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
2 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
9 Participants
n=157 Participants
|
8 Participants
n=390 Participants
|
5 Participants
n=16 Participants
|
46 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Central/South Asian Heritage
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Black or African American (Afr. Amer.)
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Arabic/North African Heritage
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian/European Heritage
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
7 Participants
n=157 Participants
|
9 Participants
n=390 Participants
|
6 Participants
n=16 Participants
|
42 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Up to Week 40Population: Safety Population comprised of all randomized participants who received at least one dose of the study treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before; is associated with liver injury and impaired liver function.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAE)
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAE)
Any AE
|
11 Participants
|
2 Participants
|
6 Participants
|
8 Participants
|
9 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to Week 40Population: Safety Population.
AESIs were defined as Hypersensitivity (narrow) and Injection site reactions like hematoma and swelling.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESI)
Hypersensitivity
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESI)
Injection Site Reaction: swelling
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESI)
Injection Site Reaction: hematoma
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Blood samples were collected at indicated time-points for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Basophils, Day 2,n=12,6,6,8,9,6
|
-0.006 Giga cells per liter
Standard Deviation 0.0247
|
-0.020 Giga cells per liter
Standard Deviation 0.0297
|
0.003 Giga cells per liter
Standard Deviation 0.0103
|
-0.003 Giga cells per liter
Standard Deviation 0.0238
|
0.001 Giga cells per liter
Standard Deviation 0.0302
|
-0.018 Giga cells per liter
Standard Deviation 0.0160
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Basophils, Week 12,n=12,5,6,9,9,5
|
0.002 Giga cells per liter
Standard Deviation 0.0229
|
-0.014 Giga cells per liter
Standard Deviation 0.0297
|
-0.008 Giga cells per liter
Standard Deviation 0.0147
|
-0.003 Giga cells per liter
Standard Deviation 0.0245
|
-0.004 Giga cells per liter
Standard Deviation 0.0142
|
-0.006 Giga cells per liter
Standard Deviation 0.0055
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Basophils, Week 18,n=12,6,6,9,9,6
|
-0.002 Giga cells per liter
Standard Deviation 0.0229
|
0.010 Giga cells per liter
Standard Deviation 0.0310
|
-0.012 Giga cells per liter
Standard Deviation 0.0160
|
-0.001 Giga cells per liter
Standard Deviation 0.0267
|
0.010 Giga cells per liter
Standard Deviation 0.0278
|
-0.005 Giga cells per liter
Standard Deviation 0.0105
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Eosinophils, Week 18,n=12,6,6,9,9,6
|
0.029 Giga cells per liter
Standard Deviation 0.1263
|
-0.148 Giga cells per liter
Standard Deviation 0.0685
|
-0.208 Giga cells per liter
Standard Deviation 0.1153
|
-0.359 Giga cells per liter
Standard Deviation 0.1445
|
-0.338 Giga cells per liter
Standard Deviation 0.1786
|
-0.253 Giga cells per liter
Standard Deviation 0.1067
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Eosinophils, Week 40,n=2,0,0,0,0,6
|
0.245 Giga cells per liter
Standard Deviation 0.1344
|
—
|
—
|
—
|
—
|
-0.222 Giga cells per liter
Standard Deviation 0.1196
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Lymphocytes, Day 2,n=12,6,6,8,9,6
|
-0.010 Giga cells per liter
Standard Deviation 0.3897
|
0.135 Giga cells per liter
Standard Deviation 0.2886
|
0.108 Giga cells per liter
Standard Deviation 0.2185
|
-0.061 Giga cells per liter
Standard Deviation 0.3165
|
-0.157 Giga cells per liter
Standard Deviation 0.3336
|
0.100 Giga cells per liter
Standard Deviation 0.2804
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Lymphocytes, Day 3,n=12,6,6,9,9,6
|
0.064 Giga cells per liter
Standard Deviation 0.4447
|
0.330 Giga cells per liter
Standard Deviation 0.3571
|
0.143 Giga cells per liter
Standard Deviation 0.1810
|
-0.140 Giga cells per liter
Standard Deviation 0.2382
|
-0.081 Giga cells per liter
Standard Deviation 0.4131
|
0.143 Giga cells per liter
Standard Deviation 0.3296
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Lymphocytes, Day 5,n=11,6,6,9,9,6
|
-0.077 Giga cells per liter
Standard Deviation 0.4746
|
0.108 Giga cells per liter
Standard Deviation 0.2319
|
0.085 Giga cells per liter
Standard Deviation 0.1302
|
-0.253 Giga cells per liter
Standard Deviation 0.2983
|
0.104 Giga cells per liter
Standard Deviation 0.4463
|
0.047 Giga cells per liter
Standard Deviation 0.1226
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Lymphocytes, Week 1,n=12,6,6,9,9,5
|
0.048 Giga cells per liter
Standard Deviation 0.4628
|
0.295 Giga cells per liter
Standard Deviation 0.2404
|
0.058 Giga cells per liter
Standard Deviation 0.4116
|
-0.060 Giga cells per liter
Standard Deviation 0.3248
|
-0.018 Giga cells per liter
Standard Deviation 0.4217
|
-0.154 Giga cells per liter
Standard Deviation 0.2587
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Neutrophil, Day 5,n=11,6,6,9,9,6
|
0.155 Giga cells per liter
Standard Deviation 0.7789
|
0.085 Giga cells per liter
Standard Deviation 0.6109
|
-0.003 Giga cells per liter
Standard Deviation 0.3494
|
0.041 Giga cells per liter
Standard Deviation 0.7075
|
0.184 Giga cells per liter
Standard Deviation 1.0809
|
0.103 Giga cells per liter
Standard Deviation 0.2639
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Monocytes, Week 26,n=12,6,6,9,9,6
|
0.040 Giga cells per liter
Standard Deviation 0.0888
|
-0.037 Giga cells per liter
Standard Deviation 0.1129
|
0.010 Giga cells per liter
Standard Deviation 0.0551
|
0.036 Giga cells per liter
Standard Deviation 0.1267
|
0.121 Giga cells per liter
Standard Deviation 0.1500
|
0.013 Giga cells per liter
Standard Deviation 0.0720
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Monocytes, Week 32,n=6,6,6,0,0,6
|
-0.035 Giga cells per liter
Standard Deviation 0.0817
|
-0.013 Giga cells per liter
Standard Deviation 0.1600
|
0.098 Giga cells per liter
Standard Deviation 0.0783
|
—
|
—
|
-0.012 Giga cells per liter
Standard Deviation 0.0662
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Monocytes, Week 36,n=6,0,0,9,9,0
|
0.067 Giga cells per liter
Standard Deviation 0.0717
|
—
|
—
|
0.053 Giga cells per liter
Standard Deviation 0.1624
|
0.158 Giga cells per liter
Standard Deviation 0.2126
|
—
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Monocytes, Week 40,n=2,0,0,0,0,6
|
0.040 Giga cells per liter
Standard Deviation 0.0566
|
—
|
—
|
—
|
—
|
-0.032 Giga cells per liter
Standard Deviation 0.0873
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Platelet, Day 2,n=12,5,5,9,9,6
|
-9.7 Giga cells per liter
Standard Deviation 19.00
|
-6.8 Giga cells per liter
Standard Deviation 10.40
|
-6.4 Giga cells per liter
Standard Deviation 15.27
|
-6.8 Giga cells per liter
Standard Deviation 17.99
|
6.1 Giga cells per liter
Standard Deviation 22.05
|
-1.5 Giga cells per liter
Standard Deviation 19.32
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Platelet, Day 3,n=12,5,6,9,9,6
|
-2.8 Giga cells per liter
Standard Deviation 16.72
|
-9.4 Giga cells per liter
Standard Deviation 8.29
|
5.7 Giga cells per liter
Standard Deviation 13.00
|
-7.1 Giga cells per liter
Standard Deviation 19.98
|
1.7 Giga cells per liter
Standard Deviation 19.24
|
-0.8 Giga cells per liter
Standard Deviation 19.60
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Basophils, Day 3,n=12,6,6,9,9,6
|
0.002 Giga cells per liter
Standard Deviation 0.0356
|
0.003 Giga cells per liter
Standard Deviation 0.0450
|
0.010 Giga cells per liter
Standard Deviation 0.0126
|
-0.003 Giga cells per liter
Standard Deviation 0.0260
|
-0.003 Giga cells per liter
Standard Deviation 0.0224
|
-0.007 Giga cells per liter
Standard Deviation 0.0121
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Basophils, Day 4,n=12,6,6,8,8,6
|
-0.003 Giga cells per liter
Standard Deviation 0.0296
|
0.002 Giga cells per liter
Standard Deviation 0.0214
|
-0.008 Giga cells per liter
Standard Deviation 0.0325
|
-0.004 Giga cells per liter
Standard Deviation 0.0207
|
-0.001 Giga cells per liter
Standard Deviation 0.0136
|
0.002 Giga cells per liter
Standard Deviation 0.0214
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Basophils, Day 5,n=11,6,6,9,9,6
|
-0.020 Giga cells per liter
Standard Deviation 0.0224
|
-0.008 Giga cells per liter
Standard Deviation 0.0204
|
-0.020 Giga cells per liter
Standard Deviation 0.0141
|
-0.009 Giga cells per liter
Standard Deviation 0.0196
|
-0.003 Giga cells per liter
Standard Deviation 0.0255
|
-0.025 Giga cells per liter
Standard Deviation 0.0164
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Basophils, Week 1,n=12,6,6,9,9,5
|
-0.001 Giga cells per liter
Standard Deviation 0.0257
|
-0.017 Giga cells per liter
Standard Deviation 0.0207
|
-0.018 Giga cells per liter
Standard Deviation 0.0306
|
0.002 Giga cells per liter
Standard Deviation 0.0291
|
0.001 Giga cells per liter
Standard Deviation 0.0162
|
-0.006 Giga cells per liter
Standard Deviation 0.0055
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Basophils, Week 2,n=12,6,5,9,9,6
|
-0.006 Giga cells per liter
Standard Deviation 0.0215
|
-0.018 Giga cells per liter
Standard Deviation 0.0204
|
0.000 Giga cells per liter
Standard Deviation 0.0274
|
-0.004 Giga cells per liter
Standard Deviation 0.0224
|
-0.007 Giga cells per liter
Standard Deviation 0.0158
|
-0.007 Giga cells per liter
Standard Deviation 0.0137
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Basophils, Week 4,n=12,6,5,9,9,6
|
-0.010 Giga cells per liter
Standard Deviation 0.0316
|
-0.002 Giga cells per liter
Standard Deviation 0.0232
|
-0.004 Giga cells per liter
Standard Deviation 0.0167
|
0.002 Giga cells per liter
Standard Deviation 0.0172
|
-0.006 Giga cells per liter
Standard Deviation 0.0265
|
-0.010 Giga cells per liter
Standard Deviation 0.0126
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Basophils, Week 8,n=12,6,6,9,9,6
|
0.005 Giga cells per liter
Standard Deviation 0.0183
|
0.007 Giga cells per liter
Standard Deviation 0.0266
|
-0.022 Giga cells per liter
Standard Deviation 0.0271
|
-0.010 Giga cells per liter
Standard Deviation 0.0122
|
-0.002 Giga cells per liter
Standard Deviation 0.0186
|
-0.015 Giga cells per liter
Standard Deviation 0.0138
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Basophils, Week 24,n=11,6,6,9,9,6
|
-0.005 Giga cells per liter
Standard Deviation 0.0157
|
0.002 Giga cells per liter
Standard Deviation 0.0264
|
-0.005 Giga cells per liter
Standard Deviation 0.0288
|
-0.004 Giga cells per liter
Standard Deviation 0.0313
|
-0.001 Giga cells per liter
Standard Deviation 0.0154
|
-0.018 Giga cells per liter
Standard Deviation 0.0117
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Basophils, Week 26,n=12,6,6,9,9,6
|
-0.004 Giga cells per liter
Standard Deviation 0.0284
|
0.002 Giga cells per liter
Standard Deviation 0.0306
|
0.000 Giga cells per liter
Standard Deviation 0.0219
|
0.008 Giga cells per liter
Standard Deviation 0.0383
|
-0.002 Giga cells per liter
Standard Deviation 0.0199
|
-0.008 Giga cells per liter
Standard Deviation 0.0133
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Basophils, Week 32,n=6,6,6,0,0,6
|
-0.002 Giga cells per liter
Standard Deviation 0.0376
|
0.010 Giga cells per liter
Standard Deviation 0.0210
|
0.005 Giga cells per liter
Standard Deviation 0.0339
|
—
|
—
|
-0.008 Giga cells per liter
Standard Deviation 0.0117
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Basophils, Week 36,n=6,0,0,9,9,0
|
-0.002 Giga cells per liter
Standard Deviation 0.0214
|
—
|
—
|
0.021 Giga cells per liter
Standard Deviation 0.0247
|
-0.002 Giga cells per liter
Standard Deviation 0.0199
|
—
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Basophils, Week 40,n=2,0,0,0,0,6
|
0.000 Giga cells per liter
Standard Deviation 0.0000
|
—
|
—
|
—
|
—
|
-0.012 Giga cells per liter
Standard Deviation 0.0313
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Eosinophils, Day 2,n=12,6,6,8,9,6
|
0.024 Giga cells per liter
Standard Deviation 0.1412
|
-0.120 Giga cells per liter
Standard Deviation 0.0587
|
-0.145 Giga cells per liter
Standard Deviation 0.0797
|
-0.251 Giga cells per liter
Standard Deviation 0.1504
|
-0.208 Giga cells per liter
Standard Deviation 0.1685
|
-0.152 Giga cells per liter
Standard Deviation 0.0794
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Eosinophils, Day 3,n=12,6,6,9,9,6
|
-0.001 Giga cells per liter
Standard Deviation 0.1986
|
-0.167 Giga cells per liter
Standard Deviation 0.0755
|
-0.203 Giga cells per liter
Standard Deviation 0.0876
|
-0.289 Giga cells per liter
Standard Deviation 0.0987
|
-0.287 Giga cells per liter
Standard Deviation 0.1744
|
-0.182 Giga cells per liter
Standard Deviation 0.0920
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Eosinophils, Day 4,n=12,6,6,8,8,6
|
0.014 Giga cells per liter
Standard Deviation 0.1950
|
-0.172 Giga cells per liter
Standard Deviation 0.0749
|
-0.212 Giga cells per liter
Standard Deviation 0.1144
|
-0.348 Giga cells per liter
Standard Deviation 0.1149
|
-0.300 Giga cells per liter
Standard Deviation 0.1829
|
-0.192 Giga cells per liter
Standard Deviation 0.0643
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Eosinophils, Day 5,n=11,6,6,9,9,6
|
-0.034 Giga cells per liter
Standard Deviation 0.1529
|
-0.202 Giga cells per liter
Standard Deviation 0.0799
|
-0.235 Giga cells per liter
Standard Deviation 0.1117
|
-0.326 Giga cells per liter
Standard Deviation 0.1385
|
-0.276 Giga cells per liter
Standard Deviation 0.1351
|
-0.210 Giga cells per liter
Standard Deviation 0.0767
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Eosinophils, Week 1,n=12,6,6,9,9,5
|
0.033 Giga cells per liter
Standard Deviation 0.1461
|
-0.195 Giga cells per liter
Standard Deviation 0.0609
|
-0.242 Giga cells per liter
Standard Deviation 0.1189
|
-0.324 Giga cells per liter
Standard Deviation 0.1350
|
-0.298 Giga cells per liter
Standard Deviation 0.1824
|
-0.206 Giga cells per liter
Standard Deviation 0.0568
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Eosinophils, Week 2,n=12,6,5,9,9,6
|
0.072 Giga cells per liter
Standard Deviation 0.1809
|
-0.212 Giga cells per liter
Standard Deviation 0.0895
|
-0.210 Giga cells per liter
Standard Deviation 0.0886
|
-0.344 Giga cells per liter
Standard Deviation 0.1334
|
-0.307 Giga cells per liter
Standard Deviation 0.1602
|
-0.223 Giga cells per liter
Standard Deviation 0.0952
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Eosinophils, Week 4,n=12,6,5,9,9,6
|
0.025 Giga cells per liter
Standard Deviation 0.1635
|
-0.227 Giga cells per liter
Standard Deviation 0.0712
|
-0.238 Giga cells per liter
Standard Deviation 0.1150
|
-0.366 Giga cells per liter
Standard Deviation 0.1466
|
-0.321 Giga cells per liter
Standard Deviation 0.1969
|
-0.253 Giga cells per liter
Standard Deviation 0.0855
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Eosinophils, Week 8,n=12,6,6,9,9,6
|
0.036 Giga cells per liter
Standard Deviation 0.1486
|
-0.230 Giga cells per liter
Standard Deviation 0.0769
|
-0.280 Giga cells per liter
Standard Deviation 0.1202
|
-0.379 Giga cells per liter
Standard Deviation 0.1519
|
-0.343 Giga cells per liter
Standard Deviation 0.1841
|
-0.252 Giga cells per liter
Standard Deviation 0.1007
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Eosinophils, Week 12,n=12,5,6,9,9,5
|
0.025 Giga cells per liter
Standard Deviation 0.1566
|
-0.174 Giga cells per liter
Standard Deviation 0.0777
|
-0.262 Giga cells per liter
Standard Deviation 0.1087
|
-0.371 Giga cells per liter
Standard Deviation 0.1484
|
-0.336 Giga cells per liter
Standard Deviation 0.1895
|
-0.250 Giga cells per liter
Standard Deviation 0.1245
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Eosinophils, Week 24,n=11,6,6,9,9,6
|
-0.021 Giga cells per liter
Standard Deviation 0.1436
|
-0.072 Giga cells per liter
Standard Deviation 0.0662
|
-0.103 Giga cells per liter
Standard Deviation 0.1916
|
-0.300 Giga cells per liter
Standard Deviation 0.1546
|
-0.334 Giga cells per liter
Standard Deviation 0.1769
|
-0.245 Giga cells per liter
Standard Deviation 0.1017
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Eosinophils, Week 26,n=12,6,6,9,9,6
|
0.035 Giga cells per liter
Standard Deviation 0.1812
|
-0.042 Giga cells per liter
Standard Deviation 0.0571
|
-0.037 Giga cells per liter
Standard Deviation 0.2813
|
-0.273 Giga cells per liter
Standard Deviation 0.1773
|
-0.319 Giga cells per liter
Standard Deviation 0.1724
|
-0.252 Giga cells per liter
Standard Deviation 0.0920
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Eosinophils, Week 32,n=6,6,6,0,0,6
|
0.008 Giga cells per liter
Standard Deviation 0.0935
|
0.042 Giga cells per liter
Standard Deviation 0.1153
|
0.003 Giga cells per liter
Standard Deviation 0.2467
|
—
|
—
|
-0.235 Giga cells per liter
Standard Deviation 0.1205
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Eosinophils, Week 36,n=6,0,0,9,9,0
|
-0.045 Giga cells per liter
Standard Deviation 0.1758
|
—
|
—
|
-0.041 Giga cells per liter
Standard Deviation 0.2734
|
-0.258 Giga cells per liter
Standard Deviation 0.1594
|
—
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Lymphocytes, Day 4,n=12,6,6,8,8,6
|
0.006 Giga cells per liter
Standard Deviation 0.4963
|
0.193 Giga cells per liter
Standard Deviation 0.3242
|
0.172 Giga cells per liter
Standard Deviation 0.3474
|
0.005 Giga cells per liter
Standard Deviation 0.1753
|
0.005 Giga cells per liter
Standard Deviation 0.3798
|
0.210 Giga cells per liter
Standard Deviation 0.2772
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Lymphocytes, Week 2,n=12,6,5,9,9,6
|
-0.133 Giga cells per liter
Standard Deviation 0.4107
|
0.222 Giga cells per liter
Standard Deviation 0.3543
|
0.096 Giga cells per liter
Standard Deviation 0.4117
|
-0.120 Giga cells per liter
Standard Deviation 0.3304
|
-0.068 Giga cells per liter
Standard Deviation 0.4104
|
0.047 Giga cells per liter
Standard Deviation 0.1189
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Lymphocytes, Week 4,n=12,6,5,9,9,6
|
-0.189 Giga cells per liter
Standard Deviation 0.4616
|
0.088 Giga cells per liter
Standard Deviation 0.2938
|
0.056 Giga cells per liter
Standard Deviation 0.2899
|
-0.062 Giga cells per liter
Standard Deviation 0.2346
|
-0.052 Giga cells per liter
Standard Deviation 0.5189
|
-0.137 Giga cells per liter
Standard Deviation 0.2103
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Lymphocytes, Week 8,n=12,6,6,9,9,6
|
-0.057 Giga cells per liter
Standard Deviation 0.4665
|
0.105 Giga cells per liter
Standard Deviation 0.2670
|
-0.107 Giga cells per liter
Standard Deviation 0.3584
|
-0.188 Giga cells per liter
Standard Deviation 0.2277
|
0.052 Giga cells per liter
Standard Deviation 0.3287
|
-0.075 Giga cells per liter
Standard Deviation 0.0672
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Lymphocytes, Week 12,n=12,5,6,9,9,5
|
-0.142 Giga cells per liter
Standard Deviation 0.4107
|
0.228 Giga cells per liter
Standard Deviation 0.1968
|
0.072 Giga cells per liter
Standard Deviation 0.4113
|
0.014 Giga cells per liter
Standard Deviation 0.2490
|
0.048 Giga cells per liter
Standard Deviation 0.3231
|
-0.388 Giga cells per liter
Standard Deviation 0.2237
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Lymphocytes, Week 18,n=12,6,6,9,9,6
|
-0.212 Giga cells per liter
Standard Deviation 0.4094
|
-0.032 Giga cells per liter
Standard Deviation 0.2213
|
-0.042 Giga cells per liter
Standard Deviation 0.3612
|
-0.097 Giga cells per liter
Standard Deviation 0.4088
|
0.050 Giga cells per liter
Standard Deviation 0.4539
|
-0.063 Giga cells per liter
Standard Deviation 0.1788
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Monocytes, Week 2,n=12,6,5,9,9,6
|
0.013 Giga cells per liter
Standard Deviation 0.0945
|
0.050 Giga cells per liter
Standard Deviation 0.1621
|
0.056 Giga cells per liter
Standard Deviation 0.0451
|
0.004 Giga cells per liter
Standard Deviation 0.0975
|
0.118 Giga cells per liter
Standard Deviation 0.1738
|
0.090 Giga cells per liter
Standard Deviation 0.2697
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Monocytes, Week 4,n=12,6,5,9,9,6
|
0.001 Giga cells per liter
Standard Deviation 0.0757
|
0.103 Giga cells per liter
Standard Deviation 0.1382
|
-0.018 Giga cells per liter
Standard Deviation 0.0817
|
0.042 Giga cells per liter
Standard Deviation 0.0559
|
0.041 Giga cells per liter
Standard Deviation 0.1014
|
-0.003 Giga cells per liter
Standard Deviation 0.1201
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Monocytes, Week 8,n=12,6,6,9,9,6
|
0.048 Giga cells per liter
Standard Deviation 0.1377
|
0.123 Giga cells per liter
Standard Deviation 0.1681
|
-0.053 Giga cells per liter
Standard Deviation 0.0484
|
-0.006 Giga cells per liter
Standard Deviation 0.0648
|
0.080 Giga cells per liter
Standard Deviation 0.1211
|
0.058 Giga cells per liter
Standard Deviation 0.1509
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Monocytes, Week 12,n=12,5,6,9,9,5
|
0.007 Giga cells per liter
Standard Deviation 0.1042
|
0.050 Giga cells per liter
Standard Deviation 0.0561
|
-0.013 Giga cells per liter
Standard Deviation 0.0841
|
0.059 Giga cells per liter
Standard Deviation 0.0864
|
0.140 Giga cells per liter
Standard Deviation 0.1734
|
0.084 Giga cells per liter
Standard Deviation 0.1680
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Monocytes, Week 18,n=12,6,6,9,9,6
|
0.042 Giga cells per liter
Standard Deviation 0.0897
|
-0.040 Giga cells per liter
Standard Deviation 0.1362
|
-0.045 Giga cells per liter
Standard Deviation 0.0944
|
0.018 Giga cells per liter
Standard Deviation 0.1475
|
0.092 Giga cells per liter
Standard Deviation 0.0874
|
0.043 Giga cells per liter
Standard Deviation 0.1516
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Monocytes, Week 24,n=11,6,6,9,9,6
|
0.028 Giga cells per liter
Standard Deviation 0.1181
|
-0.013 Giga cells per liter
Standard Deviation 0.0989
|
0.070 Giga cells per liter
Standard Deviation 0.0921
|
0.047 Giga cells per liter
Standard Deviation 0.1301
|
0.159 Giga cells per liter
Standard Deviation 0.2567
|
0.037 Giga cells per liter
Standard Deviation 0.0975
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Platelet, Day 4,n=12,5,5,8,8,6
|
-5.6 Giga cells per liter
Standard Deviation 18.64
|
-5.8 Giga cells per liter
Standard Deviation 3.63
|
6.6 Giga cells per liter
Standard Deviation 15.66
|
-0.4 Giga cells per liter
Standard Deviation 18.86
|
-1.1 Giga cells per liter
Standard Deviation 21.56
|
-0.2 Giga cells per liter
Standard Deviation 6.62
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Platelet, Day 5,n=12,5,6,9,9,6
|
-7.6 Giga cells per liter
Standard Deviation 17.59
|
-3.6 Giga cells per liter
Standard Deviation 13.89
|
-3.0 Giga cells per liter
Standard Deviation 18.11
|
-4.6 Giga cells per liter
Standard Deviation 19.09
|
6.2 Giga cells per liter
Standard Deviation 22.90
|
-2.8 Giga cells per liter
Standard Deviation 18.62
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Platelet, Week 1,n=12,5,6,9,8,6
|
-0.9 Giga cells per liter
Standard Deviation 20.21
|
-10.2 Giga cells per liter
Standard Deviation 11.30
|
5.0 Giga cells per liter
Standard Deviation 21.08
|
-3.9 Giga cells per liter
Standard Deviation 12.41
|
16.8 Giga cells per liter
Standard Deviation 25.37
|
-13.8 Giga cells per liter
Standard Deviation 28.69
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Platelet, Week 2,n=12,5,6,9,9,6
|
3.5 Giga cells per liter
Standard Deviation 16.51
|
2.8 Giga cells per liter
Standard Deviation 13.59
|
-6.3 Giga cells per liter
Standard Deviation 29.38
|
-0.9 Giga cells per liter
Standard Deviation 25.09
|
25.0 Giga cells per liter
Standard Deviation 38.64
|
-15.5 Giga cells per liter
Standard Deviation 39.81
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Platelet, Week 4,n=12,5,4,9,9,6
|
-11.5 Giga cells per liter
Standard Deviation 26.10
|
-6.8 Giga cells per liter
Standard Deviation 20.93
|
1.3 Giga cells per liter
Standard Deviation 37.07
|
-1.6 Giga cells per liter
Standard Deviation 17.61
|
12.3 Giga cells per liter
Standard Deviation 35.87
|
-5.0 Giga cells per liter
Standard Deviation 22.80
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Platelet, Week 8,n=12,5,5,9,9,6
|
4.3 Giga cells per liter
Standard Deviation 22.85
|
11.6 Giga cells per liter
Standard Deviation 23.71
|
2.6 Giga cells per liter
Standard Deviation 29.01
|
-11.3 Giga cells per liter
Standard Deviation 21.03
|
22.0 Giga cells per liter
Standard Deviation 30.81
|
-3.5 Giga cells per liter
Standard Deviation 23.89
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Platelet, Week 12,n=12,5,6,9,9,5
|
-14.8 Giga cells per liter
Standard Deviation 26.42
|
-6.0 Giga cells per liter
Standard Deviation 16.63
|
-9.0 Giga cells per liter
Standard Deviation 26.83
|
-10.8 Giga cells per liter
Standard Deviation 10.15
|
27.4 Giga cells per liter
Standard Deviation 43.23
|
-25.6 Giga cells per liter
Standard Deviation 24.39
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Platelet, Week 18,n=12,5,6,9,9,6
|
-8.6 Giga cells per liter
Standard Deviation 21.65
|
-13.4 Giga cells per liter
Standard Deviation 20.42
|
-14.0 Giga cells per liter
Standard Deviation 9.53
|
1.6 Giga cells per liter
Standard Deviation 19.51
|
15.9 Giga cells per liter
Standard Deviation 22.45
|
2.2 Giga cells per liter
Standard Deviation 28.92
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Platelet, Week 24,n=10,5,6,9,9,6
|
-1.9 Giga cells per liter
Standard Deviation 14.81
|
-7.8 Giga cells per liter
Standard Deviation 18.35
|
-10.0 Giga cells per liter
Standard Deviation 14.97
|
-1.6 Giga cells per liter
Standard Deviation 19.94
|
19.7 Giga cells per liter
Standard Deviation 30.07
|
-5.7 Giga cells per liter
Standard Deviation 39.38
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Platelet, Week 26,n=12,5,6,9,9,6
|
2.4 Giga cells per liter
Standard Deviation 30.14
|
-13.8 Giga cells per liter
Standard Deviation 17.70
|
-19.3 Giga cells per liter
Standard Deviation 13.81
|
-2.4 Giga cells per liter
Standard Deviation 12.21
|
11.8 Giga cells per liter
Standard Deviation 36.37
|
-6.8 Giga cells per liter
Standard Deviation 17.38
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Platelet, Week 32,n=6,5,6,0,0,6
|
5.5 Giga cells per liter
Standard Deviation 18.71
|
-0.6 Giga cells per liter
Standard Deviation 15.37
|
-6.3 Giga cells per liter
Standard Deviation 10.39
|
—
|
—
|
-15.7 Giga cells per liter
Standard Deviation 51.15
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Platelet, Week 36,n=6,0,0,9,9,0
|
-1.8 Giga cells per liter
Standard Deviation 25.65
|
—
|
—
|
-0.3 Giga cells per liter
Standard Deviation 12.37
|
13.9 Giga cells per liter
Standard Deviation 24.15
|
—
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Platelet, Week 40,n=2,0,0,0,0,6
|
-20.0 Giga cells per liter
Standard Deviation 2.83
|
—
|
—
|
—
|
—
|
-11.7 Giga cells per liter
Standard Deviation 30.80
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Neutrophil, Day 2,n=12,6,6,8,9,6
|
-0.078 Giga cells per liter
Standard Deviation 0.8813
|
0.413 Giga cells per liter
Standard Deviation 0.6493
|
-0.005 Giga cells per liter
Standard Deviation 0.9228
|
0.301 Giga cells per liter
Standard Deviation 0.5042
|
0.241 Giga cells per liter
Standard Deviation 0.8219
|
0.102 Giga cells per liter
Standard Deviation 0.4630
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Neutrophil, Day 3,n=12,6,6,9,9,6
|
0.161 Giga cells per liter
Standard Deviation 0.4542
|
0.015 Giga cells per liter
Standard Deviation 0.6691
|
0.225 Giga cells per liter
Standard Deviation 0.6850
|
0.077 Giga cells per liter
Standard Deviation 0.9525
|
0.217 Giga cells per liter
Standard Deviation 1.1014
|
0.038 Giga cells per liter
Standard Deviation 0.5158
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Neutrophil, Day 4,n=12,6,6,8,8,6
|
0.390 Giga cells per liter
Standard Deviation 0.4832
|
0.560 Giga cells per liter
Standard Deviation 0.4666
|
0.438 Giga cells per liter
Standard Deviation 0.9293
|
0.151 Giga cells per liter
Standard Deviation 0.9472
|
0.130 Giga cells per liter
Standard Deviation 1.0414
|
0.215 Giga cells per liter
Standard Deviation 0.4194
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Neutrophil, Week 1,n=12,6,6,9,9,5
|
-0.179 Giga cells per liter
Standard Deviation 0.6365
|
-0.483 Giga cells per liter
Standard Deviation 1.2069
|
-0.160 Giga cells per liter
Standard Deviation 0.3280
|
-0.151 Giga cells per liter
Standard Deviation 0.5955
|
0.174 Giga cells per liter
Standard Deviation 0.8992
|
0.070 Giga cells per liter
Standard Deviation 0.4346
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Neutrophil, Week 2,n=12,6,5,9,9,6
|
-0.209 Giga cells per liter
Standard Deviation 0.4662
|
-0.738 Giga cells per liter
Standard Deviation 0.7110
|
-0.142 Giga cells per liter
Standard Deviation 1.0604
|
-0.192 Giga cells per liter
Standard Deviation 0.9481
|
0.229 Giga cells per liter
Standard Deviation 0.8853
|
-0.310 Giga cells per liter
Standard Deviation 0.6362
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Neutrophil, Week 4,n=12,6,5,9,9,6
|
-0.540 Giga cells per liter
Standard Deviation 0.4797
|
-0.768 Giga cells per liter
Standard Deviation 0.7810
|
-0.156 Giga cells per liter
Standard Deviation 0.9674
|
-0.279 Giga cells per liter
Standard Deviation 0.5859
|
-0.340 Giga cells per liter
Standard Deviation 0.7049
|
0.023 Giga cells per liter
Standard Deviation 0.7539
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Neutrophil, Week 8,n=12,6,6,9,9,6
|
-0.218 Giga cells per liter
Standard Deviation 0.7893
|
0.497 Giga cells per liter
Standard Deviation 1.6165
|
-0.277 Giga cells per liter
Standard Deviation 0.9128
|
-0.069 Giga cells per liter
Standard Deviation 1.0047
|
-0.127 Giga cells per liter
Standard Deviation 0.5829
|
0.258 Giga cells per liter
Standard Deviation 0.5218
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Neutrophil, Week 12,n=12,5,6,9,9,5
|
0.043 Giga cells per liter
Standard Deviation 0.9639
|
-0.712 Giga cells per liter
Standard Deviation 0.5890
|
0.053 Giga cells per liter
Standard Deviation 1.0187
|
-0.180 Giga cells per liter
Standard Deviation 0.4760
|
-0.344 Giga cells per liter
Standard Deviation 0.4840
|
-0.362 Giga cells per liter
Standard Deviation 0.5607
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Neutrophil, Week 18,n=12,6,6,9,9,6
|
-0.093 Giga cells per liter
Standard Deviation 0.9727
|
-0.158 Giga cells per liter
Standard Deviation 0.7786
|
0.015 Giga cells per liter
Standard Deviation 0.7474
|
-0.012 Giga cells per liter
Standard Deviation 0.8076
|
-0.151 Giga cells per liter
Standard Deviation 0.5728
|
-0.027 Giga cells per liter
Standard Deviation 0.6629
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Neutrophil, Week 24,n=11,6,6,9,9,6
|
-0.326 Giga cells per liter
Standard Deviation 0.4501
|
-0.752 Giga cells per liter
Standard Deviation 0.9422
|
-0.370 Giga cells per liter
Standard Deviation 0.3746
|
-0.144 Giga cells per liter
Standard Deviation 0.5243
|
0.140 Giga cells per liter
Standard Deviation 0.5795
|
-0.128 Giga cells per liter
Standard Deviation 0.4311
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Neutrophil, Week 26,n=12,6,6,9,9,6
|
-0.105 Giga cells per liter
Standard Deviation 0.7933
|
-0.527 Giga cells per liter
Standard Deviation 0.6332
|
-0.622 Giga cells per liter
Standard Deviation 0.6065
|
-0.259 Giga cells per liter
Standard Deviation 0.9389
|
0.104 Giga cells per liter
Standard Deviation 0.7127
|
-0.295 Giga cells per liter
Standard Deviation 0.2855
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Neutrophil, Week 32,n=6,6,6,0,0,6
|
-0.393 Giga cells per liter
Standard Deviation 0.8219
|
-0.708 Giga cells per liter
Standard Deviation 0.7757
|
0.880 Giga cells per liter
Standard Deviation 1.9211
|
—
|
—
|
-0.360 Giga cells per liter
Standard Deviation 0.3275
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Neutrophil, Week 36,n=6,0,0,9,9,0
|
-0.163 Giga cells per liter
Standard Deviation 0.8441
|
—
|
—
|
-0.384 Giga cells per liter
Standard Deviation 0.4763
|
-0.004 Giga cells per liter
Standard Deviation 0.9080
|
—
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Neutrophil, Week 40,n=2,0,0,0,0,6
|
-0.005 Giga cells per liter
Standard Deviation 0.1061
|
—
|
—
|
—
|
—
|
0.332 Giga cells per liter
Standard Deviation 0.3452
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Lymphocytes, Week 24,n=11,6,6,9,9,6
|
-0.179 Giga cells per liter
Standard Deviation 0.3876
|
-0.028 Giga cells per liter
Standard Deviation 0.3616
|
-0.040 Giga cells per liter
Standard Deviation 0.2744
|
-0.070 Giga cells per liter
Standard Deviation 0.3102
|
0.052 Giga cells per liter
Standard Deviation 0.9838
|
-0.132 Giga cells per liter
Standard Deviation 0.1619
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Lymphocytes, Week 26,n=12,6,6,9,9,6
|
-0.088 Giga cells per liter
Standard Deviation 0.4361
|
-0.223 Giga cells per liter
Standard Deviation 0.3808
|
-0.138 Giga cells per liter
Standard Deviation 0.3577
|
-0.116 Giga cells per liter
Standard Deviation 0.4946
|
0.018 Giga cells per liter
Standard Deviation 0.5392
|
-0.188 Giga cells per liter
Standard Deviation 0.2566
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Lymphocytes, Week 32,n=6,6,6,0,0,6
|
-0.165 Giga cells per liter
Standard Deviation 0.6851
|
-0.057 Giga cells per liter
Standard Deviation 0.2842
|
-0.197 Giga cells per liter
Standard Deviation 0.5467
|
—
|
—
|
-0.148 Giga cells per liter
Standard Deviation 0.2017
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Lymphocytes, Week 36,n=6,0,0,9,9,0
|
0.007 Giga cells per liter
Standard Deviation 0.1838
|
—
|
—
|
-0.043 Giga cells per liter
Standard Deviation 0.4393
|
0.006 Giga cells per liter
Standard Deviation 0.4176
|
—
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Lymphocytes, Week 40,n=2,0,0,0,0,6
|
0.285 Giga cells per liter
Standard Deviation 0.3465
|
—
|
—
|
—
|
—
|
-0.125 Giga cells per liter
Standard Deviation 0.2966
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Monocytes, Day 2,n=12,6,6,8,9,6
|
-0.002 Giga cells per liter
Standard Deviation 0.0914
|
0.017 Giga cells per liter
Standard Deviation 0.1357
|
0.123 Giga cells per liter
Standard Deviation 0.1240
|
0.015 Giga cells per liter
Standard Deviation 0.1176
|
0.019 Giga cells per liter
Standard Deviation 0.0715
|
0.052 Giga cells per liter
Standard Deviation 0.1947
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Monocytes, Day 3,n=12,6,6,9,9,6
|
0.029 Giga cells per liter
Standard Deviation 0.1001
|
0.028 Giga cells per liter
Standard Deviation 0.1533
|
0.100 Giga cells per liter
Standard Deviation 0.1235
|
-0.028 Giga cells per liter
Standard Deviation 0.0753
|
0.032 Giga cells per liter
Standard Deviation 0.0952
|
0.018 Giga cells per liter
Standard Deviation 0.1514
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Monocytes, Day 4,n=12,6,6,8,8,6
|
0.032 Giga cells per liter
Standard Deviation 0.0936
|
-0.002 Giga cells per liter
Standard Deviation 0.1258
|
0.118 Giga cells per liter
Standard Deviation 0.1057
|
-0.038 Giga cells per liter
Standard Deviation 0.0927
|
0.068 Giga cells per liter
Standard Deviation 0.1074
|
0.050 Giga cells per liter
Standard Deviation 0.0434
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Monocytes, Day 5,n=11,6,6,9,9,6
|
-0.034 Giga cells per liter
Standard Deviation 0.0841
|
-0.025 Giga cells per liter
Standard Deviation 0.0701
|
0.053 Giga cells per liter
Standard Deviation 0.1299
|
-0.100 Giga cells per liter
Standard Deviation 0.1470
|
0.074 Giga cells per liter
Standard Deviation 0.1874
|
-0.035 Giga cells per liter
Standard Deviation 0.0766
|
|
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Monocytes, Week 1,n=12,6,6,9,9,5
|
0.006 Giga cells per liter
Standard Deviation 0.0998
|
0.072 Giga cells per liter
Standard Deviation 0.1127
|
0.057 Giga cells per liter
Standard Deviation 0.1786
|
0.032 Giga cells per liter
Standard Deviation 0.0578
|
0.101 Giga cells per liter
Standard Deviation 0.1039
|
-0.012 Giga cells per liter
Standard Deviation 0.0926
|
PRIMARY outcome
Timeframe: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Blood samples were collected at indicated time-points for analysis of hematology parameters like RBC count. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Red Blood Cell Count (RBC)
Day 2,n=12,6,6,9,9,6
|
-0.08 Trillion cells per liter
Standard Deviation 0.212
|
-0.07 Trillion cells per liter
Standard Deviation 0.197
|
0.08 Trillion cells per liter
Standard Deviation 0.223
|
0.00 Trillion cells per liter
Standard Deviation 0.194
|
0.16 Trillion cells per liter
Standard Deviation 0.246
|
0.05 Trillion cells per liter
Standard Deviation 0.243
|
|
Change From Baseline in Red Blood Cell Count (RBC)
Day 3,n=12,6,6,9,9,6
|
0.03 Trillion cells per liter
Standard Deviation 0.214
|
-0.08 Trillion cells per liter
Standard Deviation 0.133
|
0.13 Trillion cells per liter
Standard Deviation 0.242
|
0.01 Trillion cells per liter
Standard Deviation 0.190
|
0.06 Trillion cells per liter
Standard Deviation 0.133
|
0.03 Trillion cells per liter
Standard Deviation 0.186
|
|
Change From Baseline in Red Blood Cell Count (RBC)
Day 4,n=12,6,6,8,8,6
|
-0.04 Trillion cells per liter
Standard Deviation 0.211
|
-0.08 Trillion cells per liter
Standard Deviation 0.133
|
0.10 Trillion cells per liter
Standard Deviation 0.179
|
-0.03 Trillion cells per liter
Standard Deviation 0.149
|
0.04 Trillion cells per liter
Standard Deviation 0.185
|
0.10 Trillion cells per liter
Standard Deviation 0.141
|
|
Change From Baseline in Red Blood Cell Count (RBC)
Day 5,n=12,6,6,9,9,6
|
-0.18 Trillion cells per liter
Standard Deviation 0.175
|
-0.22 Trillion cells per liter
Standard Deviation 0.133
|
-0.10 Trillion cells per liter
Standard Deviation 0.261
|
-0.08 Trillion cells per liter
Standard Deviation 0.120
|
0.03 Trillion cells per liter
Standard Deviation 0.316
|
0.05 Trillion cells per liter
Standard Deviation 0.187
|
|
Change From Baseline in Red Blood Cell Count (RBC)
Week 1,n=12,6,6,9,9,5
|
-0.15 Trillion cells per liter
Standard Deviation 0.215
|
-0.37 Trillion cells per liter
Standard Deviation 0.175
|
0.00 Trillion cells per liter
Standard Deviation 0.190
|
-0.03 Trillion cells per liter
Standard Deviation 0.218
|
0.07 Trillion cells per liter
Standard Deviation 0.180
|
-0.02 Trillion cells per liter
Standard Deviation 0.147
|
|
Change From Baseline in Red Blood Cell Count (RBC)
Week 2,n=12,6,6,9,9,6
|
-0.11 Trillion cells per liter
Standard Deviation 0.156
|
-0.28 Trillion cells per liter
Standard Deviation 0.133
|
-0.18 Trillion cells per liter
Standard Deviation 0.183
|
-0.07 Trillion cells per liter
Standard Deviation 0.206
|
0.11 Trillion cells per liter
Standard Deviation 0.232
|
-0.08 Trillion cells per liter
Standard Deviation 0.194
|
|
Change From Baseline in Red Blood Cell Count (RBC)
Week 4,n=12,6,5,9,9,6
|
-0.18 Trillion cells per liter
Standard Deviation 0.248
|
-0.35 Trillion cells per liter
Standard Deviation 0.055
|
-0.16 Trillion cells per liter
Standard Deviation 0.230
|
-0.08 Trillion cells per liter
Standard Deviation 0.192
|
0.09 Trillion cells per liter
Standard Deviation 0.293
|
-0.03 Trillion cells per liter
Standard Deviation 0.137
|
|
Change From Baseline in Red Blood Cell Count (RBC)
Week 8,n=12,6,6,9,9,6
|
-0.03 Trillion cells per liter
Standard Deviation 0.253
|
-0.23 Trillion cells per liter
Standard Deviation 0.186
|
-0.02 Trillion cells per liter
Standard Deviation 0.248
|
-0.13 Trillion cells per liter
Standard Deviation 0.200
|
0.18 Trillion cells per liter
Standard Deviation 0.277
|
0.07 Trillion cells per liter
Standard Deviation 0.103
|
|
Change From Baseline in Red Blood Cell Count (RBC)
Week 12,n=12,6,6,9,9,5
|
-0.13 Trillion cells per liter
Standard Deviation 0.176
|
-0.25 Trillion cells per liter
Standard Deviation 0.138
|
-0.05 Trillion cells per liter
Standard Deviation 0.251
|
-0.01 Trillion cells per liter
Standard Deviation 0.237
|
0.19 Trillion cells per liter
Standard Deviation 0.237
|
0.00 Trillion cells per liter
Standard Deviation 0.141
|
|
Change From Baseline in Red Blood Cell Count (RBC)
Week 18,n=12,6,6,9,9,6
|
-0.02 Trillion cells per liter
Standard Deviation 0.292
|
-0.20 Trillion cells per liter
Standard Deviation 0.219
|
-0.08 Trillion cells per liter
Standard Deviation 0.271
|
-0.02 Trillion cells per liter
Standard Deviation 0.228
|
0.27 Trillion cells per liter
Standard Deviation 0.283
|
0.17 Trillion cells per liter
Standard Deviation 0.163
|
|
Change From Baseline in Red Blood Cell Count (RBC)
Week 24,n=11,6,6,9,9,6
|
-0.11 Trillion cells per liter
Standard Deviation 0.221
|
-0.27 Trillion cells per liter
Standard Deviation 0.175
|
-0.05 Trillion cells per liter
Standard Deviation 0.164
|
0.01 Trillion cells per liter
Standard Deviation 0.169
|
0.13 Trillion cells per liter
Standard Deviation 0.229
|
0.17 Trillion cells per liter
Standard Deviation 0.151
|
|
Change From Baseline in Red Blood Cell Count (RBC)
Week 26,n=12,6,6,9,9,6
|
-0.12 Trillion cells per liter
Standard Deviation 0.301
|
-0.33 Trillion cells per liter
Standard Deviation 0.216
|
-0.08 Trillion cells per liter
Standard Deviation 0.204
|
-0.02 Trillion cells per liter
Standard Deviation 0.120
|
0.20 Trillion cells per liter
Standard Deviation 0.194
|
0.12 Trillion cells per liter
Standard Deviation 0.117
|
|
Change From Baseline in Red Blood Cell Count (RBC)
Week 32,n=6,6,6,0,0,6
|
-0.10 Trillion cells per liter
Standard Deviation 0.237
|
-0.18 Trillion cells per liter
Standard Deviation 0.183
|
0.08 Trillion cells per liter
Standard Deviation 0.248
|
—
|
—
|
0.05 Trillion cells per liter
Standard Deviation 0.176
|
|
Change From Baseline in Red Blood Cell Count (RBC)
Week 36,n=6,0,0,9,9,0
|
0.12 Trillion cells per liter
Standard Deviation 0.232
|
—
|
—
|
0.10 Trillion cells per liter
Standard Deviation 0.122
|
0.33 Trillion cells per liter
Standard Deviation 0.357
|
—
|
|
Change From Baseline in Red Blood Cell Count (RBC)
Week 40,n=2,0,0,0,0,6
|
-0.05 Trillion cells per liter
Standard Deviation 0.071
|
—
|
—
|
—
|
—
|
0.12 Trillion cells per liter
Standard Deviation 0.098
|
PRIMARY outcome
Timeframe: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Blood samples were collected at indicated time-points for analysis of hematology parameters like MCV. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Corpuscle Volume (MCV)
Day 2,n=12,6,6,9,9,6
|
0.2 Femtoliters
Standard Deviation 0.94
|
0.2 Femtoliters
Standard Deviation 0.75
|
0.2 Femtoliters
Standard Deviation 0.75
|
0.1 Femtoliters
Standard Deviation 2.85
|
-0.3 Femtoliters
Standard Deviation 1.00
|
1.3 Femtoliters
Standard Deviation 2.16
|
|
Change From Baseline in Mean Corpuscle Volume (MCV)
Day 3,n=12,6,6,9,9,6
|
0.7 Femtoliters
Standard Deviation 1.07
|
-0.3 Femtoliters
Standard Deviation 0.82
|
0.2 Femtoliters
Standard Deviation 0.75
|
0.0 Femtoliters
Standard Deviation 1.32
|
-1.0 Femtoliters
Standard Deviation 1.41
|
0.3 Femtoliters
Standard Deviation 1.37
|
|
Change From Baseline in Mean Corpuscle Volume (MCV)
Day 4,n=12,6,6,8,8,6
|
0.3 Femtoliters
Standard Deviation 0.78
|
-0.5 Femtoliters
Standard Deviation 1.05
|
0.0 Femtoliters
Standard Deviation 1.26
|
-0.1 Femtoliters
Standard Deviation 0.83
|
-1.8 Femtoliters
Standard Deviation 0.89
|
0.2 Femtoliters
Standard Deviation 0.98
|
|
Change From Baseline in Mean Corpuscle Volume (MCV)
Day 5,n=12,6,6,9,9,6
|
1.3 Femtoliters
Standard Deviation 1.92
|
0.5 Femtoliters
Standard Deviation 0.55
|
0.3 Femtoliters
Standard Deviation 0.82
|
2.0 Femtoliters
Standard Deviation 2.92
|
-1.0 Femtoliters
Standard Deviation 3.50
|
0.7 Femtoliters
Standard Deviation 1.75
|
|
Change From Baseline in Mean Corpuscle Volume (MCV)
Week 1,n=12,6,6,9,9,6
|
-0.2 Femtoliters
Standard Deviation 0.94
|
-0.8 Femtoliters
Standard Deviation 1.33
|
0.2 Femtoliters
Standard Deviation 0.75
|
-1.2 Femtoliters
Standard Deviation 1.20
|
-1.7 Femtoliters
Standard Deviation 2.06
|
-0.7 Femtoliters
Standard Deviation 1.21
|
|
Change From Baseline in Mean Corpuscle Volume (MCV)
Week 2,n=12,6,6,9,9,6
|
0.0 Femtoliters
Standard Deviation 1.28
|
-0.3 Femtoliters
Standard Deviation 1.51
|
0.2 Femtoliters
Standard Deviation 0.75
|
-0.9 Femtoliters
Standard Deviation 1.17
|
-1.4 Femtoliters
Standard Deviation 2.51
|
-0.3 Femtoliters
Standard Deviation 1.63
|
|
Change From Baseline in Mean Corpuscle Volume (MCV)
Week 4,n=12,6,5,9,9,6
|
0.7 Femtoliters
Standard Deviation 2.39
|
-0.8 Femtoliters
Standard Deviation 2.14
|
0.2 Femtoliters
Standard Deviation 0.45
|
-0.7 Femtoliters
Standard Deviation 0.87
|
-1.6 Femtoliters
Standard Deviation 2.13
|
-0.2 Femtoliters
Standard Deviation 0.98
|
|
Change From Baseline in Mean Corpuscle Volume (MCV)
Week 8,n=12,6,6,9,9,6
|
0.3 Femtoliters
Standard Deviation 1.23
|
-0.3 Femtoliters
Standard Deviation 1.51
|
0.2 Femtoliters
Standard Deviation 0.75
|
0.0 Femtoliters
Standard Deviation 1.12
|
-2.2 Femtoliters
Standard Deviation 2.91
|
-0.2 Femtoliters
Standard Deviation 1.17
|
|
Change From Baseline in Mean Corpuscle Volume (MCV)
Week 12,n=12,6,6,9,9,5
|
0.5 Femtoliters
Standard Deviation 1.09
|
-1.2 Femtoliters
Standard Deviation 1.94
|
0.2 Femtoliters
Standard Deviation 0.75
|
-0.7 Femtoliters
Standard Deviation 1.87
|
-2.4 Femtoliters
Standard Deviation 2.55
|
-1.2 Femtoliters
Standard Deviation 0.84
|
|
Change From Baseline in Mean Corpuscle Volume (MCV)
Week 18,n=12,6,6,9,9,6
|
-0.4 Femtoliters
Standard Deviation 1.73
|
-0.8 Femtoliters
Standard Deviation 1.33
|
0.5 Femtoliters
Standard Deviation 1.64
|
-1.9 Femtoliters
Standard Deviation 1.05
|
-2.8 Femtoliters
Standard Deviation 3.07
|
-1.0 Femtoliters
Standard Deviation 1.10
|
|
Change From Baseline in Mean Corpuscle Volume (MCV)
Week 24,n=11,6,6,9,9,6
|
-0.8 Femtoliters
Standard Deviation 1.78
|
-0.3 Femtoliters
Standard Deviation 1.86
|
0.8 Femtoliters
Standard Deviation 1.72
|
-1.6 Femtoliters
Standard Deviation 1.51
|
-2.4 Femtoliters
Standard Deviation 3.54
|
-0.7 Femtoliters
Standard Deviation 1.03
|
|
Change From Baseline in Mean Corpuscle Volume (MCV)
Week 26,n=12,6,6,9,9,6
|
-0.5 Femtoliters
Standard Deviation 2.24
|
0.0 Femtoliters
Standard Deviation 2.10
|
0.5 Femtoliters
Standard Deviation 0.84
|
-1.7 Femtoliters
Standard Deviation 1.58
|
-2.3 Femtoliters
Standard Deviation 3.04
|
-0.3 Femtoliters
Standard Deviation 1.03
|
|
Change From Baseline in Mean Corpuscle Volume (MCV)
Week 32,n=6,6,6,0,0,6
|
0.5 Femtoliters
Standard Deviation 1.38
|
0.0 Femtoliters
Standard Deviation 2.45
|
0.8 Femtoliters
Standard Deviation 1.47
|
—
|
—
|
-0.2 Femtoliters
Standard Deviation 0.98
|
|
Change From Baseline in Mean Corpuscle Volume (MCV)
Week 36,n=6,0,0,9,9,0
|
-1.5 Femtoliters
Standard Deviation 1.05
|
—
|
—
|
-1.9 Femtoliters
Standard Deviation 1.05
|
-1.8 Femtoliters
Standard Deviation 2.44
|
—
|
|
Change From Baseline in Mean Corpuscle Volume (MCV)
Week 40,n=2,0,0,0,0,6
|
-0.5 Femtoliters
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
1.2 Femtoliters
Standard Deviation 0.75
|
PRIMARY outcome
Timeframe: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Blood samples were collected at indicated time-points for analysis of hematology parameters like MCH. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Week 4,n=12,6,5,9,9,6
|
0.15 Picograms
Standard Deviation 1.153
|
0.30 Picograms
Standard Deviation 0.374
|
0.12 Picograms
Standard Deviation 0.268
|
-0.29 Picograms
Standard Deviation 0.404
|
-0.06 Picograms
Standard Deviation 0.394
|
-0.22 Picograms
Standard Deviation 0.343
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Day 2,n=12,6,6,9,9,6
|
0.03 Picograms
Standard Deviation 0.588
|
0.23 Picograms
Standard Deviation 0.388
|
0.02 Picograms
Standard Deviation 0.299
|
-0.04 Picograms
Standard Deviation 0.255
|
-0.02 Picograms
Standard Deviation 0.277
|
-0.07 Picograms
Standard Deviation 0.450
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Day 3,n=12,6,6,9,9,6
|
0.13 Picograms
Standard Deviation 0.485
|
0.25 Picograms
Standard Deviation 0.389
|
0.10 Picograms
Standard Deviation 0.283
|
-0.02 Picograms
Standard Deviation 0.228
|
0.20 Picograms
Standard Deviation 0.444
|
-0.08 Picograms
Standard Deviation 0.172
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Day 4,n=12,6,6,8,8,6
|
0.14 Picograms
Standard Deviation 0.542
|
0.17 Picograms
Standard Deviation 0.480
|
0.18 Picograms
Standard Deviation 0.299
|
0.05 Picograms
Standard Deviation 0.351
|
0.01 Picograms
Standard Deviation 0.432
|
0.12 Picograms
Standard Deviation 0.325
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Day 5,n=12,6,6,9,9,6
|
0.08 Picograms
Standard Deviation 0.626
|
0.17 Picograms
Standard Deviation 0.314
|
0.22 Picograms
Standard Deviation 0.449
|
-0.03 Picograms
Standard Deviation 0.346
|
0.02 Picograms
Standard Deviation 0.331
|
-0.22 Picograms
Standard Deviation 0.240
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Week 1,n=12,6,6,9,9,5
|
-0.07 Picograms
Standard Deviation 0.433
|
0.38 Picograms
Standard Deviation 0.542
|
-0.07 Picograms
Standard Deviation 0.273
|
0.00 Picograms
Standard Deviation 0.381
|
0.00 Picograms
Standard Deviation 0.427
|
-0.08 Picograms
Standard Deviation 0.553
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Week 2,n=12,6,6,9,9,6
|
-0.02 Picograms
Standard Deviation 0.495
|
0.33 Picograms
Standard Deviation 0.516
|
0.25 Picograms
Standard Deviation 0.418
|
-0.08 Picograms
Standard Deviation 0.331
|
-0.04 Picograms
Standard Deviation 0.088
|
-0.02 Picograms
Standard Deviation 0.240
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Week 8,n=12,6,6,9,9,6
|
-0.06 Picograms
Standard Deviation 0.429
|
0.25 Picograms
Standard Deviation 0.860
|
0.30 Picograms
Standard Deviation 0.410
|
-0.30 Picograms
Standard Deviation 0.287
|
-0.11 Picograms
Standard Deviation 0.655
|
-0.22 Picograms
Standard Deviation 0.286
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Week 12,n=12,6,6,9,9,5
|
-0.08 Picograms
Standard Deviation 0.583
|
0.32 Picograms
Standard Deviation 0.882
|
0.02 Picograms
Standard Deviation 0.624
|
-0.42 Picograms
Standard Deviation 0.415
|
-0.04 Picograms
Standard Deviation 0.541
|
-0.60 Picograms
Standard Deviation 0.561
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Week 18,n=12,6,6,9,9,6
|
-0.13 Picograms
Standard Deviation 0.805
|
0.78 Picograms
Standard Deviation 0.382
|
-0.10 Picograms
Standard Deviation 0.616
|
-0.37 Picograms
Standard Deviation 0.384
|
0.01 Picograms
Standard Deviation 0.627
|
-0.78 Picograms
Standard Deviation 0.382
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Week 24,n=11,6,6,9,9,6
|
-0.44 Picograms
Standard Deviation 0.883
|
0.87 Picograms
Standard Deviation 0.799
|
0.23 Picograms
Standard Deviation 0.356
|
-0.37 Picograms
Standard Deviation 0.510
|
-0.37 Picograms
Standard Deviation 0.632
|
-0.90 Picograms
Standard Deviation 0.237
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Week 26,n=12,6,6,9,9,6
|
-0.27 Picograms
Standard Deviation 0.946
|
1.05 Picograms
Standard Deviation 0.505
|
0.10 Picograms
Standard Deviation 0.473
|
-0.38 Picograms
Standard Deviation 0.432
|
-0.71 Picograms
Standard Deviation 0.818
|
-1.07 Picograms
Standard Deviation 0.393
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Week 32,n=6,6,6,0,0,6
|
0.22 Picograms
Standard Deviation 0.975
|
0.67 Picograms
Standard Deviation 0.625
|
0.53 Picograms
Standard Deviation 0.909
|
—
|
—
|
-0.58 Picograms
Standard Deviation 0.331
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Week 36,n=6,0,0,9,9,0
|
-1.00 Picograms
Standard Deviation 0.525
|
—
|
—
|
-1.00 Picograms
Standard Deviation 0.403
|
-0.68 Picograms
Standard Deviation 0.438
|
—
|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Week 40,n=2,0,0,0,0,6
|
-0.55 Picograms
Standard Deviation 0.071
|
—
|
—
|
—
|
—
|
-0.68 Picograms
Standard Deviation 0.232
|
PRIMARY outcome
Timeframe: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Blood samples were collected at indicated time-points for analysis of hematology parameters like hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin
Day 2,n=12,6,6,9,9,6
|
-2.4 Grams per liter
Standard Deviation 6.83
|
0.3 Grams per liter
Standard Deviation 6.80
|
3.7 Grams per liter
Standard Deviation 7.09
|
-0.4 Grams per liter
Standard Deviation 6.00
|
4.3 Grams per liter
Standard Deviation 7.12
|
0.2 Grams per liter
Standard Deviation 8.52
|
|
Change From Baseline in Hemoglobin
Day 3,n=12,6,6,9,9,6
|
1.6 Grams per liter
Standard Deviation 6.78
|
-0.5 Grams per liter
Standard Deviation 4.04
|
5.8 Grams per liter
Standard Deviation 8.80
|
0.1 Grams per liter
Standard Deviation 6.62
|
2.2 Grams per liter
Standard Deviation 4.35
|
-0.5 Grams per liter
Standard Deviation 5.82
|
|
Change From Baseline in Hemoglobin
Day 4,n=12,6,6,8,8,6
|
-0.8 Grams per liter
Standard Deviation 6.69
|
-1.3 Grams per liter
Standard Deviation 4.59
|
3.7 Grams per liter
Standard Deviation 6.02
|
-1.0 Grams per liter
Standard Deviation 4.14
|
1.4 Grams per liter
Standard Deviation 5.32
|
3.2 Grams per liter
Standard Deviation 5.12
|
|
Change From Baseline in Hemoglobin
Day 5,n=12,6,6,9,9,6
|
-5.0 Grams per liter
Standard Deviation 4.65
|
-4.8 Grams per liter
Standard Deviation 3.82
|
-0.3 Grams per liter
Standard Deviation 7.84
|
-2.9 Grams per liter
Standard Deviation 4.54
|
0.8 Grams per liter
Standard Deviation 8.86
|
-0.3 Grams per liter
Standard Deviation 5.13
|
|
Change From Baseline in Hemoglobin
Week 1,n=12,6,6,9,9,6
|
-4.9 Grams per liter
Standard Deviation 6.50
|
-8.3 Grams per liter
Standard Deviation 5.28
|
0.2 Grams per liter
Standard Deviation 6.79
|
-1.4 Grams per liter
Standard Deviation 7.00
|
2.0 Grams per liter
Standard Deviation 6.42
|
-1.5 Grams per liter
Standard Deviation 3.27
|
|
Change From Baseline in Hemoglobin
Week 2,n=12,6,6,9,9,6
|
-3.3 Grams per liter
Standard Deviation 5.79
|
-6.2 Grams per liter
Standard Deviation 4.67
|
-3.7 Grams per liter
Standard Deviation 5.72
|
-2.4 Grams per liter
Standard Deviation 6.29
|
3.3 Grams per liter
Standard Deviation 7.73
|
-3.5 Grams per liter
Standard Deviation 6.50
|
|
Change From Baseline in Hemoglobin
Week 4,n=12,6,5,9,9,6
|
-4.2 Grams per liter
Standard Deviation 5.08
|
-8.0 Grams per liter
Standard Deviation 4.10
|
-3.0 Grams per liter
Standard Deviation 7.94
|
-4.2 Grams per liter
Standard Deviation 6.61
|
2.6 Grams per liter
Standard Deviation 10.36
|
-2.5 Grams per liter
Standard Deviation 4.09
|
|
Change From Baseline in Hemoglobin
Week 8,n=12,6,6,9,9,6
|
-1.1 Grams per liter
Standard Deviation 8.83
|
-4.8 Grams per liter
Standard Deviation 4.96
|
1.5 Grams per liter
Standard Deviation 8.71
|
-5.6 Grams per liter
Standard Deviation 6.27
|
4.9 Grams per liter
Standard Deviation 7.80
|
-0.2 Grams per liter
Standard Deviation 2.48
|
|
Change From Baseline in Hemoglobin
Week 12,n=12,6,6,9,9,5
|
-4.3 Grams per liter
Standard Deviation 6.50
|
-4.8 Grams per liter
Standard Deviation 4.49
|
-0.2 Grams per liter
Standard Deviation 9.28
|
-2.8 Grams per liter
Standard Deviation 7.98
|
5.9 Grams per liter
Standard Deviation 6.39
|
-3.6 Grams per liter
Standard Deviation 2.07
|
|
Change From Baseline in Hemoglobin
Week 18,n=12,6,6,9,9,6
|
-1.6 Grams per liter
Standard Deviation 8.47
|
-1.8 Grams per liter
Standard Deviation 6.77
|
-2.3 Grams per liter
Standard Deviation 6.62
|
-2.4 Grams per liter
Standard Deviation 6.09
|
8.3 Grams per liter
Standard Deviation 9.25
|
0.5 Grams per liter
Standard Deviation 4.72
|
|
Change From Baseline in Hemoglobin
Week 24,n=11,6,6,9,9,6
|
-5.3 Grams per liter
Standard Deviation 8.31
|
-3.2 Grams per liter
Standard Deviation 7.99
|
0.5 Grams per liter
Standard Deviation 6.09
|
-1.7 Grams per liter
Standard Deviation 6.36
|
2.4 Grams per liter
Standard Deviation 7.67
|
-0.2 Grams per liter
Standard Deviation 3.37
|
|
Change From Baseline in Hemoglobin
Week 26,n=12,6,6,9,9,6
|
-4.6 Grams per liter
Standard Deviation 9.70
|
-4.5 Grams per liter
Standard Deviation 8.07
|
-1.0 Grams per liter
Standard Deviation 5.76
|
-2.2 Grams per liter
Standard Deviation 3.42
|
2.9 Grams per liter
Standard Deviation 6.23
|
-2.7 Grams per liter
Standard Deviation 4.32
|
|
Change From Baseline in Hemoglobin
Week 32,n=6,6,6,0,0,6
|
-1.7 Grams per liter
Standard Deviation 3.78
|
-1.8 Grams per liter
Standard Deviation 4.79
|
5.2 Grams per liter
Standard Deviation 8.38
|
—
|
—
|
-1.8 Grams per liter
Standard Deviation 5.71
|
|
Change From Baseline in Hemoglobin
Week 36,n=6,0,0,9,9,0
|
-1.8 Grams per liter
Standard Deviation 8.47
|
—
|
—
|
-2.4 Grams per liter
Standard Deviation 3.13
|
6.9 Grams per liter
Standard Deviation 10.67
|
—
|
|
Change From Baseline in Hemoglobin
Week 40,n=2,0,0,0,0,6
|
-3.5 Grams per liter
Standard Deviation 3.54
|
—
|
—
|
—
|
—
|
-0.2 Grams per liter
Standard Deviation 4.17
|
PRIMARY outcome
Timeframe: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Blood samples were collected at indicated time-points for analysis of hematology parameters like hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hematocrit
Week 26,n=12,6,6,9,9,6
|
-0.013 Proportion of red blood cells in blood
Standard Deviation 0.02378
|
-0.029 Proportion of red blood cells in blood
Standard Deviation 0.02593
|
-0.004 Proportion of red blood cells in blood
Standard Deviation 0.01813
|
-0.007 Proportion of red blood cells in blood
Standard Deviation 0.01424
|
0.008 Proportion of red blood cells in blood
Standard Deviation 0.01829
|
0.006 Proportion of red blood cells in blood
Standard Deviation 0.01091
|
|
Change From Baseline in Hematocrit
Week 32,n=6,6,6,0,0,6
|
-0.005 Proportion of red blood cells in blood
Standard Deviation 0.01904
|
-0.015 Proportion of red blood cells in blood
Standard Deviation 0.02220
|
0.009 Proportion of red blood cells in blood
Standard Deviation 0.02413
|
—
|
—
|
0.002 Proportion of red blood cells in blood
Standard Deviation 0.01851
|
|
Change From Baseline in Hematocrit
Week 36,n=6,0,0,9,9,0
|
0.001 Proportion of red blood cells in blood
Standard Deviation 0.01862
|
—
|
—
|
-0.001 Proportion of red blood cells in blood
Standard Deviation 0.01237
|
0.022 Proportion of red blood cells in blood
Standard Deviation 0.03464
|
—
|
|
Change From Baseline in Hematocrit
Day 2,n=12,6,6,9,9,6
|
-0.007 Proportion of red blood cells in blood
Standard Deviation 0.01961
|
-0.001 Proportion of red blood cells in blood
Standard Deviation 0.01884
|
0.009 Proportion of red blood cells in blood
Standard Deviation 0.02262
|
0.000 Proportion of red blood cells in blood
Standard Deviation 0.01500
|
0.011 Proportion of red blood cells in blood
Standard Deviation 0.02356
|
0.007 Proportion of red blood cells in blood
Standard Deviation 0.02689
|
|
Change From Baseline in Hematocrit
Day 3,n=12,6,6,9,9,6
|
0.005 Proportion of red blood cells in blood
Standard Deviation 0.01925
|
-0.007 Proportion of red blood cells in blood
Standard Deviation 0.01374
|
0.014 Proportion of red blood cells in blood
Standard Deviation 0.02667
|
0.001 Proportion of red blood cells in blood
Standard Deviation 0.01634
|
-0.000 Proportion of red blood cells in blood
Standard Deviation 0.01198
|
0.001 Proportion of red blood cells in blood
Standard Deviation 0.01584
|
|
Change From Baseline in Hematocrit
Day 4,n=12,6,6,8,8,6
|
-0.003 Proportion of red blood cells in blood
Standard Deviation 0.01777
|
-0.009 Proportion of red blood cells in blood
Standard Deviation 0.01803
|
0.005 Proportion of red blood cells in blood
Standard Deviation 0.02170
|
-0.003 Proportion of red blood cells in blood
Standard Deviation 0.01663
|
-0.004 Proportion of red blood cells in blood
Standard Deviation 0.01858
|
0.008 Proportion of red blood cells in blood
Standard Deviation 0.01251
|
|
Change From Baseline in Hematocrit
Day 5,n=12,6,6,9,9,6
|
-0.010 Proportion of red blood cells in blood
Standard Deviation 0.01509
|
-0.015 Proportion of red blood cells in blood
Standard Deviation 0.01340
|
-0.004 Proportion of red blood cells in blood
Standard Deviation 0.02743
|
0.001 Proportion of red blood cells in blood
Standard Deviation 0.01970
|
-0.001 Proportion of red blood cells in blood
Standard Deviation 0.03295
|
0.006 Proportion of red blood cells in blood
Standard Deviation 0.01061
|
|
Change From Baseline in Hematocrit
Week 1,n=12,6,6,9,9,6
|
-0.014 Proportion of red blood cells in blood
Standard Deviation 0.01894
|
-0.034 Proportion of red blood cells in blood
Standard Deviation 0.01549
|
0.000 Proportion of red blood cells in blood
Standard Deviation 0.02138
|
-0.008 Proportion of red blood cells in blood
Standard Deviation 0.02644
|
-0.001 Proportion of red blood cells in blood
Standard Deviation 0.02068
|
-0.005 Proportion of red blood cells in blood
Standard Deviation 0.01076
|
|
Change From Baseline in Hematocrit
Week 2,n=12,6,6,9,9,6
|
-0.010 Proportion of red blood cells in blood
Standard Deviation 0.01670
|
-0.025 Proportion of red blood cells in blood
Standard Deviation 0.01626
|
-0.016 Proportion of red blood cells in blood
Standard Deviation 0.01928
|
-0.009 Proportion of red blood cells in blood
Standard Deviation 0.01960
|
0.002 Proportion of red blood cells in blood
Standard Deviation 0.02469
|
-0.011 Proportion of red blood cells in blood
Standard Deviation 0.01759
|
|
Change From Baseline in Hematocrit
Week 4,n=12,6,5,9,9,6
|
-0.011 Proportion of red blood cells in blood
Standard Deviation 0.01840
|
-0.032 Proportion of red blood cells in blood
Standard Deviation 0.01393
|
-0.010 Proportion of red blood cells in blood
Standard Deviation 0.02192
|
-0.010 Proportion of red blood cells in blood
Standard Deviation 0.02063
|
0.001 Proportion of red blood cells in blood
Standard Deviation 0.02962
|
-0.004 Proportion of red blood cells in blood
Standard Deviation 0.01315
|
|
Change From Baseline in Hematocrit
Week 8,n=12,6,6,9,9,6
|
-0.001 Proportion of red blood cells in blood
Standard Deviation 0.02285
|
-0.020 Proportion of red blood cells in blood
Standard Deviation 0.02119
|
-0.000 Proportion of red blood cells in blood
Standard Deviation 0.02367
|
-0.011 Proportion of red blood cells in blood
Standard Deviation 0.01889
|
0.005 Proportion of red blood cells in blood
Standard Deviation 0.03084
|
0.002 Proportion of red blood cells in blood
Standard Deviation 0.00750
|
|
Change From Baseline in Hematocrit
Week 12,n=12,6,6,9,9,5
|
-0.010 Proportion of red blood cells in blood
Standard Deviation 0.01745
|
-0.025 Proportion of red blood cells in blood
Standard Deviation 0.01262
|
-0.001 Proportion of red blood cells in blood
Standard Deviation 0.02587
|
-0.005 Proportion of red blood cells in blood
Standard Deviation 0.02379
|
0.006 Proportion of red blood cells in blood
Standard Deviation 0.02343
|
-0.006 Proportion of red blood cells in blood
Standard Deviation 0.01279
|
|
Change From Baseline in Hematocrit
Week 18,n=12,6,6,9,9,6
|
-0.004 Proportion of red blood cells in blood
Standard Deviation 0.02680
|
-0.020 Proportion of red blood cells in blood
Standard Deviation 0.02140
|
-0.005 Proportion of red blood cells in blood
Standard Deviation 0.03041
|
-0.010 Proportion of red blood cells in blood
Standard Deviation 0.02016
|
0.012 Proportion of red blood cells in blood
Standard Deviation 0.02972
|
0.008 Proportion of red blood cells in blood
Standard Deviation 0.01515
|
|
Change From Baseline in Hematocrit
Week 24,n=11,6,6,9,9,6
|
-0.013 Proportion of red blood cells in blood
Standard Deviation 0.02108
|
-0.023 Proportion of red blood cells in blood
Standard Deviation 0.02325
|
0.001 Proportion of red blood cells in blood
Standard Deviation 0.01955
|
-0.006 Proportion of red blood cells in blood
Standard Deviation 0.01726
|
0.001 Proportion of red blood cells in blood
Standard Deviation 0.02607
|
0.009 Proportion of red blood cells in blood
Standard Deviation 0.01184
|
|
Change From Baseline in Hematocrit
Week 40,n=2,0,0,0,0,6
|
-0.004 Proportion of red blood cells in blood
Standard Deviation 0.00495
|
—
|
—
|
—
|
—
|
0.016 Proportion of red blood cells in blood
Standard Deviation 0.00816
|
PRIMARY outcome
Timeframe: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Blood samples were collected at indicated time-points for analysis of clinical parameters like hsCRP. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)
Day 2,n=12,6,6,9,9,6
|
-0.3443 Milligrams per liter
Standard Deviation 0.44689
|
-0.1217 Milligrams per liter
Standard Deviation 0.28604
|
-0.7367 Milligrams per liter
Standard Deviation 0.90943
|
-0.3178 Milligrams per liter
Standard Deviation 0.45880
|
-1.0956 Milligrams per liter
Standard Deviation 1.50219
|
-0.4867 Milligrams per liter
Standard Deviation 0.50816
|
|
Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)
Day 3,n=11,6,6,9,9,6
|
-0.4376 Milligrams per liter
Standard Deviation 0.43692
|
-0.1417 Milligrams per liter
Standard Deviation 0.25818
|
-0.8200 Milligrams per liter
Standard Deviation 1.10247
|
-0.4367 Milligrams per liter
Standard Deviation 0.71042
|
-1.4100 Milligrams per liter
Standard Deviation 2.19445
|
-0.4817 Milligrams per liter
Standard Deviation 0.53663
|
|
Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)
Day 4,n=12,6,6,9,9,6
|
-0.4570 Milligrams per liter
Standard Deviation 0.42874
|
-0.1917 Milligrams per liter
Standard Deviation 0.23095
|
-0.8683 Milligrams per liter
Standard Deviation 1.21224
|
-0.5356 Milligrams per liter
Standard Deviation 0.91155
|
-1.5311 Milligrams per liter
Standard Deviation 2.32545
|
-0.5867 Milligrams per liter
Standard Deviation 0.66476
|
|
Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)
Day 5,n=12,6,6,9,9,6
|
-0.3953 Milligrams per liter
Standard Deviation 0.37761
|
-0.0117 Milligrams per liter
Standard Deviation 0.31244
|
-0.7150 Milligrams per liter
Standard Deviation 1.23395
|
-0.5322 Milligrams per liter
Standard Deviation 0.95860
|
-1.4289 Milligrams per liter
Standard Deviation 2.35532
|
-0.5867 Milligrams per liter
Standard Deviation 0.77590
|
|
Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)
Week 1,n=11,6,6,9,9,6
|
-0.2176 Milligrams per liter
Standard Deviation 0.37960
|
0.2183 Milligrams per liter
Standard Deviation 0.23086
|
-0.3033 Milligrams per liter
Standard Deviation 1.32284
|
-0.5772 Milligrams per liter
Standard Deviation 0.86704
|
-1.3156 Milligrams per liter
Standard Deviation 2.57735
|
-0.5717 Milligrams per liter
Standard Deviation 0.69534
|
|
Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)
Week 2,n=12,6,6,9,9,6
|
0.0638 Milligrams per liter
Standard Deviation 0.44620
|
0.0167 Milligrams per liter
Standard Deviation 0.21435
|
-0.6967 Milligrams per liter
Standard Deviation 1.30606
|
0.1733 Milligrams per liter
Standard Deviation 0.86781
|
0.2478 Milligrams per liter
Standard Deviation 2.91047
|
-0.0967 Milligrams per liter
Standard Deviation 0.50091
|
|
Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)
Week 4,n=12,6,6,9,9,6
|
-0.1253 Milligrams per liter
Standard Deviation 0.55902
|
0.1433 Milligrams per liter
Standard Deviation 0.66069
|
-0.6433 Milligrams per liter
Standard Deviation 1.28969
|
-0.2689 Milligrams per liter
Standard Deviation 0.86847
|
2.6422 Milligrams per liter
Standard Deviation 11.57024
|
-0.4317 Milligrams per liter
Standard Deviation 0.54653
|
|
Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)
Week 8,n=12,6,6,9,9,6
|
0.5955 Milligrams per liter
Standard Deviation 1.62268
|
1.2817 Milligrams per liter
Standard Deviation 1.79930
|
-0.3633 Milligrams per liter
Standard Deviation 1.66310
|
-0.0878 Milligrams per liter
Standard Deviation 0.61243
|
-1.1656 Milligrams per liter
Standard Deviation 2.91829
|
-0.2517 Milligrams per liter
Standard Deviation 0.74440
|
|
Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)
Week 12,n=12,6,6,9,9,6
|
0.1455 Milligrams per liter
Standard Deviation 1.29507
|
-0.1033 Milligrams per liter
Standard Deviation 0.36784
|
0.1250 Milligrams per liter
Standard Deviation 0.61656
|
0.9089 Milligrams per liter
Standard Deviation 1.31831
|
-0.4067 Milligrams per liter
Standard Deviation 3.85725
|
0.1000 Milligrams per liter
Standard Deviation 0.55274
|
|
Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)
Week 18,n=12,6,6,9,9,6
|
0.1538 Milligrams per liter
Standard Deviation 0.54412
|
0.1883 Milligrams per liter
Standard Deviation 0.22851
|
0.1317 Milligrams per liter
Standard Deviation 1.77035
|
0.0700 Milligrams per liter
Standard Deviation 1.19067
|
-1.1267 Milligrams per liter
Standard Deviation 2.89881
|
-0.3300 Milligrams per liter
Standard Deviation 0.53457
|
|
Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)
Week 24,n=12,6,6,9,9,6
|
0.1163 Milligrams per liter
Standard Deviation 1.06052
|
0.4383 Milligrams per liter
Standard Deviation 1.46248
|
-0.6383 Milligrams per liter
Standard Deviation 1.36902
|
0.1356 Milligrams per liter
Standard Deviation 0.80296
|
-0.7989 Milligrams per liter
Standard Deviation 3.36420
|
-0.2142 Milligrams per liter
Standard Deviation 1.09332
|
|
Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)
Week 26,n=12,6,6,9,9,6
|
0.2438 Milligrams per liter
Standard Deviation 0.75525
|
1.6333 Milligrams per liter
Standard Deviation 3.95614
|
-0.6383 Milligrams per liter
Standard Deviation 1.13732
|
0.3344 Milligrams per liter
Standard Deviation 0.53761
|
-0.6933 Milligrams per liter
Standard Deviation 3.25344
|
0.2400 Milligrams per liter
Standard Deviation 0.76467
|
|
Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)
Week 32,n=6,5,6,0,0,6
|
0.6393 Milligrams per liter
Standard Deviation 1.03514
|
0.2860 Milligrams per liter
Standard Deviation 0.82509
|
-0.2400 Milligrams per liter
Standard Deviation 1.63862
|
—
|
—
|
-0.1367 Milligrams per liter
Standard Deviation 0.73277
|
|
Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)
Week 36,n=6,0,0,9,9,0
|
0.4917 Milligrams per liter
Standard Deviation 1.31750
|
—
|
—
|
-0.5456 Milligrams per liter
Standard Deviation 1.15831
|
-0.1911 Milligrams per liter
Standard Deviation 3.93159
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)
Week 40,n=2,0,0,0,0,6
|
-0.1450 Milligrams per liter
Standard Deviation 0.00707
|
—
|
—
|
—
|
—
|
0.4333 Milligrams per liter
Standard Deviation 1.74105
|
PRIMARY outcome
Timeframe: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Blood samples were collected at indicated time-points for analysis of clinical parameters like total protein and albumin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Albumin, Week 4,n=12,6,6,9,9,6
|
-1.8 Grams per liter
Standard Deviation 2.42
|
-1.0 Grams per liter
Standard Deviation 2.28
|
-0.3 Grams per liter
Standard Deviation 2.88
|
-1.3 Grams per liter
Standard Deviation 1.87
|
-0.6 Grams per liter
Standard Deviation 2.19
|
-1.3 Grams per liter
Standard Deviation 2.73
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Albumin, Week 18,n=12,6,6,9,9,6
|
-0.5 Grams per liter
Standard Deviation 2.35
|
-0.3 Grams per liter
Standard Deviation 2.94
|
-1.5 Grams per liter
Standard Deviation 1.64
|
-0.7 Grams per liter
Standard Deviation 2.06
|
0.2 Grams per liter
Standard Deviation 2.44
|
0.2 Grams per liter
Standard Deviation 1.94
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Total protein, Day 2,n=12,6,5,9,9,6
|
-2.8 Grams per liter
Standard Deviation 3.74
|
-2.3 Grams per liter
Standard Deviation 1.97
|
-0.6 Grams per liter
Standard Deviation 3.36
|
-3.8 Grams per liter
Standard Deviation 3.56
|
0.7 Grams per liter
Standard Deviation 4.90
|
-0.2 Grams per liter
Standard Deviation 4.40
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Total protein, Day 3,n=12,6,6,9,9,6
|
-1.4 Grams per liter
Standard Deviation 3.68
|
-2.5 Grams per liter
Standard Deviation 2.17
|
0.2 Grams per liter
Standard Deviation 3.43
|
-1.7 Grams per liter
Standard Deviation 4.18
|
-0.7 Grams per liter
Standard Deviation 3.16
|
0.0 Grams per liter
Standard Deviation 3.22
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Total protein, Day 4,n=12,6,6,9,9,6
|
-1.8 Grams per liter
Standard Deviation 4.34
|
-1.2 Grams per liter
Standard Deviation 2.14
|
0.3 Grams per liter
Standard Deviation 2.58
|
-2.8 Grams per liter
Standard Deviation 3.46
|
-0.4 Grams per liter
Standard Deviation 2.65
|
1.7 Grams per liter
Standard Deviation 2.88
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Total protein, Day 5,n=12,6,6,9,9,6
|
-3.3 Grams per liter
Standard Deviation 2.77
|
-2.7 Grams per liter
Standard Deviation 2.58
|
-0.7 Grams per liter
Standard Deviation 4.72
|
-3.2 Grams per liter
Standard Deviation 4.02
|
0.1 Grams per liter
Standard Deviation 5.78
|
0.0 Grams per liter
Standard Deviation 3.41
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Total protein, Week 1,n=11,6,6,9,9,5
|
-1.6 Grams per liter
Standard Deviation 2.87
|
-2.3 Grams per liter
Standard Deviation 4.23
|
-2.8 Grams per liter
Standard Deviation 2.99
|
-1.2 Grams per liter
Standard Deviation 4.29
|
-1.1 Grams per liter
Standard Deviation 3.62
|
-1.4 Grams per liter
Standard Deviation 1.95
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Total protein, Week 2,n=12,6,6,9,9,6
|
-1.8 Grams per liter
Standard Deviation 3.28
|
-2.8 Grams per liter
Standard Deviation 4.26
|
-2.8 Grams per liter
Standard Deviation 2.99
|
-1.2 Grams per liter
Standard Deviation 4.29
|
1.1 Grams per liter
Standard Deviation 4.08
|
-1.0 Grams per liter
Standard Deviation 3.58
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Total protein, Week 4,n=12,6,6,9,9,6
|
-2.5 Grams per liter
Standard Deviation 3.48
|
-3.3 Grams per liter
Standard Deviation 3.01
|
-0.8 Grams per liter
Standard Deviation 5.19
|
-1.4 Grams per liter
Standard Deviation 3.09
|
-0.1 Grams per liter
Standard Deviation 4.78
|
-1.0 Grams per liter
Standard Deviation 3.41
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Total protein, Week 8,n=12,6,6,9,9,6
|
-1.0 Grams per liter
Standard Deviation 4.33
|
-0.8 Grams per liter
Standard Deviation 5.15
|
0.2 Grams per liter
Standard Deviation 4.54
|
-3.0 Grams per liter
Standard Deviation 3.94
|
1.4 Grams per liter
Standard Deviation 3.75
|
1.2 Grams per liter
Standard Deviation 3.37
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Total protein, Week 12,n=12,6,6,9,9,6
|
-2.8 Grams per liter
Standard Deviation 2.67
|
-3.5 Grams per liter
Standard Deviation 4.59
|
-0.5 Grams per liter
Standard Deviation 3.62
|
-2.6 Grams per liter
Standard Deviation 3.71
|
2.7 Grams per liter
Standard Deviation 2.78
|
0.0 Grams per liter
Standard Deviation 2.10
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Total protein, Week 18,n=12,6,6,9,9,6
|
-1.3 Grams per liter
Standard Deviation 2.56
|
-1.8 Grams per liter
Standard Deviation 5.23
|
-1.7 Grams per liter
Standard Deviation 3.20
|
-2.0 Grams per liter
Standard Deviation 3.64
|
1.7 Grams per liter
Standard Deviation 3.50
|
1.5 Grams per liter
Standard Deviation 3.08
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Total protein, Week 24,n=12,6,6,9,9,6
|
-3.3 Grams per liter
Standard Deviation 3.79
|
-2.8 Grams per liter
Standard Deviation 4.54
|
-1.0 Grams per liter
Standard Deviation 3.35
|
-2.7 Grams per liter
Standard Deviation 3.04
|
0.6 Grams per liter
Standard Deviation 3.71
|
0.3 Grams per liter
Standard Deviation 2.73
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Total protein, Week 26,n=12,6,6,9,9,6
|
-2.5 Grams per liter
Standard Deviation 3.55
|
-3.5 Grams per liter
Standard Deviation 2.88
|
-2.3 Grams per liter
Standard Deviation 3.39
|
-3.7 Grams per liter
Standard Deviation 1.87
|
1.0 Grams per liter
Standard Deviation 2.40
|
0.3 Grams per liter
Standard Deviation 2.34
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Total protein, Week 32,n=6,6,6,0,0,6
|
-1.7 Grams per liter
Standard Deviation 3.93
|
0.0 Grams per liter
Standard Deviation 3.63
|
0.3 Grams per liter
Standard Deviation 5.09
|
—
|
—
|
-0.7 Grams per liter
Standard Deviation 2.66
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Total protein, Week 36,n=6,0,0,9,9,0
|
-1.5 Grams per liter
Standard Deviation 4.51
|
—
|
—
|
-2.6 Grams per liter
Standard Deviation 3.21
|
1.8 Grams per liter
Standard Deviation 3.77
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Total protein, Week 40,n=2,0,0,0,0,6
|
-2.5 Grams per liter
Standard Deviation 3.54
|
—
|
—
|
—
|
—
|
0.7 Grams per liter
Standard Deviation 1.63
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Albumin, Day 2,n=12,6,5,9,9,6
|
-2.1 Grams per liter
Standard Deviation 2.68
|
-1.3 Grams per liter
Standard Deviation 2.42
|
-1.6 Grams per liter
Standard Deviation 2.07
|
-2.4 Grams per liter
Standard Deviation 2.01
|
-0.6 Grams per liter
Standard Deviation 3.36
|
-0.5 Grams per liter
Standard Deviation 3.39
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Albumin, Day 3,n=12,6,6,9,9,6
|
-0.8 Grams per liter
Standard Deviation 2.70
|
-1.3 Grams per liter
Standard Deviation 1.97
|
-0.2 Grams per liter
Standard Deviation 2.48
|
-1.4 Grams per liter
Standard Deviation 2.83
|
-1.3 Grams per liter
Standard Deviation 2.06
|
-0.3 Grams per liter
Standard Deviation 2.07
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Albumin, Day 4,n=12,6,6,9,9,6
|
-1.3 Grams per liter
Standard Deviation 2.63
|
-0.5 Grams per liter
Standard Deviation 1.22
|
-0.7 Grams per liter
Standard Deviation 1.86
|
-2.2 Grams per liter
Standard Deviation 2.33
|
-1.4 Grams per liter
Standard Deviation 1.81
|
0.3 Grams per liter
Standard Deviation 2.16
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Albumin, Day 5,n=12,6,6,9,9,6
|
-1.6 Grams per liter
Standard Deviation 1.68
|
-1.5 Grams per liter
Standard Deviation 1.87
|
-0.8 Grams per liter
Standard Deviation 3.54
|
-2.3 Grams per liter
Standard Deviation 2.50
|
-0.2 Grams per liter
Standard Deviation 3.49
|
-0.2 Grams per liter
Standard Deviation 2.56
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Albumin, Week 1,n=11,6,6,9,9,5
|
-0.5 Grams per liter
Standard Deviation 2.34
|
-0.2 Grams per liter
Standard Deviation 2.86
|
0.0 Grams per liter
Standard Deviation 2.68
|
-2.2 Grams per liter
Standard Deviation 2.28
|
-1.4 Grams per liter
Standard Deviation 2.07
|
-1.4 Grams per liter
Standard Deviation 2.97
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Albumin, Week 2,n=12,6,6,9,9,6
|
-0.8 Grams per liter
Standard Deviation 2.25
|
-0.2 Grams per liter
Standard Deviation 1.83
|
-1.7 Grams per liter
Standard Deviation 2.16
|
-0.8 Grams per liter
Standard Deviation 2.86
|
0.4 Grams per liter
Standard Deviation 1.88
|
-0.5 Grams per liter
Standard Deviation 1.52
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Albumin, Week 8,n=12,6,6,9,9,6
|
-0.8 Grams per liter
Standard Deviation 2.73
|
-0.3 Grams per liter
Standard Deviation 2.88
|
0.7 Grams per liter
Standard Deviation 2.94
|
-2.0 Grams per liter
Standard Deviation 2.69
|
0.7 Grams per liter
Standard Deviation 2.83
|
0.7 Grams per liter
Standard Deviation 2.34
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Albumin, Week 12,n=12,6,6,9,9,6
|
-1.5 Grams per liter
Standard Deviation 1.73
|
-1.3 Grams per liter
Standard Deviation 2.80
|
0.0 Grams per liter
Standard Deviation 2.45
|
-1.7 Grams per liter
Standard Deviation 2.40
|
0.4 Grams per liter
Standard Deviation 1.33
|
-0.2 Grams per liter
Standard Deviation 2.32
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Albumin, Week 24,n=12,6,6,9,9,6
|
-1.7 Grams per liter
Standard Deviation 2.19
|
0.3 Grams per liter
Standard Deviation 2.73
|
-0.8 Grams per liter
Standard Deviation 2.32
|
-2.0 Grams per liter
Standard Deviation 1.87
|
0.4 Grams per liter
Standard Deviation 2.79
|
-0.2 Grams per liter
Standard Deviation 2.04
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Albumin, Week 26,n=12,6,6,9,9,6
|
-1.6 Grams per liter
Standard Deviation 2.27
|
-0.8 Grams per liter
Standard Deviation 1.72
|
-1.8 Grams per liter
Standard Deviation 2.93
|
-2.1 Grams per liter
Standard Deviation 0.60
|
0.1 Grams per liter
Standard Deviation 1.69
|
-0.3 Grams per liter
Standard Deviation 2.07
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Albumin, Week 32,n=6,6,6,0,0,6
|
-0.5 Grams per liter
Standard Deviation 3.02
|
1.2 Grams per liter
Standard Deviation 3.06
|
-0.2 Grams per liter
Standard Deviation 2.93
|
—
|
—
|
-0.8 Grams per liter
Standard Deviation 2.14
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Albumin, Week 36,n=6,0,0,9,9,0
|
-0.7 Grams per liter
Standard Deviation 2.94
|
—
|
—
|
-1.4 Grams per liter
Standard Deviation 1.67
|
0.6 Grams per liter
Standard Deviation 2.40
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Albumin, Week 40,n=2,0,0,0,0,6
|
-1.0 Grams per liter
Standard Deviation 2.83
|
—
|
—
|
—
|
—
|
-0.3 Grams per liter
Standard Deviation 1.63
|
PRIMARY outcome
Timeframe: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Blood samples were collected at indicated time-points for analysis of clinical parameters like total bilirubin, direct bilirubin and creatinine. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Total bilirubin, Day 2,n=12,6,5,9,9,6
|
-0.8 Micromoles per liter
Standard Deviation 3.86
|
-1.3 Micromoles per liter
Standard Deviation 3.27
|
-1.6 Micromoles per liter
Standard Deviation 4.34
|
-0.2 Micromoles per liter
Standard Deviation 3.23
|
0.0 Micromoles per liter
Standard Deviation 5.20
|
1.0 Micromoles per liter
Standard Deviation 3.03
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Total bilirubin, Day 4,n=12,6,6,9,9,6
|
-1.0 Micromoles per liter
Standard Deviation 3.13
|
-2.7 Micromoles per liter
Standard Deviation 5.01
|
-2.0 Micromoles per liter
Standard Deviation 7.48
|
0.0 Micromoles per liter
Standard Deviation 4.47
|
0.0 Micromoles per liter
Standard Deviation 4.47
|
1.0 Micromoles per liter
Standard Deviation 3.29
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Total bilirubin, Day 5,n=12,6,6,9,9,6
|
-2.3 Micromoles per liter
Standard Deviation 4.58
|
-5.0 Micromoles per liter
Standard Deviation 5.76
|
-2.0 Micromoles per liter
Standard Deviation 3.58
|
-0.9 Micromoles per liter
Standard Deviation 5.49
|
-1.3 Micromoles per liter
Standard Deviation 2.45
|
-0.7 Micromoles per liter
Standard Deviation 3.27
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Total bilirubin, Week 1,n=11,6,6,9,9,5
|
-1.5 Micromoles per liter
Standard Deviation 4.82
|
-0.7 Micromoles per liter
Standard Deviation 4.50
|
1.7 Micromoles per liter
Standard Deviation 1.97
|
-1.1 Micromoles per liter
Standard Deviation 4.91
|
0.4 Micromoles per liter
Standard Deviation 3.84
|
-2.0 Micromoles per liter
Standard Deviation 2.83
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Total bilirubin, Week 2,n=12,6,6,9,9,6
|
-1.2 Micromoles per liter
Standard Deviation 3.46
|
-2.3 Micromoles per liter
Standard Deviation 6.12
|
0.7 Micromoles per liter
Standard Deviation 2.73
|
2.2 Micromoles per liter
Standard Deviation 2.91
|
0.4 Micromoles per liter
Standard Deviation 5.55
|
0.7 Micromoles per liter
Standard Deviation 2.42
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Total bilirubin, Week 4,n=12,6,6,9,9,6
|
-0.7 Micromoles per liter
Standard Deviation 2.15
|
0.3 Micromoles per liter
Standard Deviation 2.34
|
0.3 Micromoles per liter
Standard Deviation 1.97
|
0.0 Micromoles per liter
Standard Deviation 2.45
|
-0.4 Micromoles per liter
Standard Deviation 5.81
|
1.0 Micromoles per liter
Standard Deviation 2.76
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Total bilirubin, Week 8,n=12,6,6,9,9,6
|
-1.2 Micromoles per liter
Standard Deviation 4.04
|
-1.0 Micromoles per liter
Standard Deviation 6.29
|
2.0 Micromoles per liter
Standard Deviation 2.83
|
2.2 Micromoles per liter
Standard Deviation 4.06
|
0.4 Micromoles per liter
Standard Deviation 5.46
|
-1.0 Micromoles per liter
Standard Deviation 4.69
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Total bilirubin, Week 12,n=12,6,6,9,9,6
|
-1.3 Micromoles per liter
Standard Deviation 4.03
|
0.0 Micromoles per liter
Standard Deviation 2.19
|
4.3 Micromoles per liter
Standard Deviation 5.85
|
-0.9 Micromoles per liter
Standard Deviation 2.03
|
0.0 Micromoles per liter
Standard Deviation 4.69
|
-0.7 Micromoles per liter
Standard Deviation 4.50
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Total bilirubin, Week 18,n=12,6,6,9,9,6
|
-0.3 Micromoles per liter
Standard Deviation 3.70
|
-1.3 Micromoles per liter
Standard Deviation 6.53
|
2.0 Micromoles per liter
Standard Deviation 2.83
|
0.7 Micromoles per liter
Standard Deviation 1.73
|
0.4 Micromoles per liter
Standard Deviation 6.23
|
-1.0 Micromoles per liter
Standard Deviation 3.52
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Total bilirubin, Week 24,n=12,6,6,9,9,6
|
-0.8 Micromoles per liter
Standard Deviation 4.47
|
-1.3 Micromoles per liter
Standard Deviation 3.27
|
1.7 Micromoles per liter
Standard Deviation 3.88
|
0.2 Micromoles per liter
Standard Deviation 2.54
|
1.6 Micromoles per liter
Standard Deviation 6.98
|
2.0 Micromoles per liter
Standard Deviation 4.56
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Total bilirubin, Week 32,n=6,6,6,0,0,6
|
0.7 Micromoles per liter
Standard Deviation 2.07
|
-1.0 Micromoles per liter
Standard Deviation 5.62
|
0.0 Micromoles per liter
Standard Deviation 5.22
|
—
|
—
|
0.0 Micromoles per liter
Standard Deviation 4.90
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Total bilirubin, Week 36,n=6,0,0,9,9,0
|
-0.7 Micromoles per liter
Standard Deviation 7.12
|
—
|
—
|
0.4 Micromoles per liter
Standard Deviation 3.13
|
-1.1 Micromoles per liter
Standard Deviation 5.67
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Direct bilirubin, Day 2,n=12,6,5,9,9,6
|
-0.3 Micromoles per liter
Standard Deviation 1.15
|
-0.7 Micromoles per liter
Standard Deviation 1.03
|
-0.4 Micromoles per liter
Standard Deviation 0.89
|
-0.2 Micromoles per liter
Standard Deviation 1.20
|
0.2 Micromoles per liter
Standard Deviation 1.20
|
0.3 Micromoles per liter
Standard Deviation 0.82
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Direct bilirubin, Day 3,n=12,6,6,9,9,6
|
-0.5 Micromoles per liter
Standard Deviation 0.90
|
-0.3 Micromoles per liter
Standard Deviation 0.82
|
-0.3 Micromoles per liter
Standard Deviation 0.82
|
0.4 Micromoles per liter
Standard Deviation 1.67
|
0.0 Micromoles per liter
Standard Deviation 1.00
|
0.0 Micromoles per liter
Standard Deviation 1.26
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Direct bilirubin, Day 4,n=12,6,6,9,9,6
|
-0.5 Micromoles per liter
Standard Deviation 0.90
|
-0.3 Micromoles per liter
Standard Deviation 0.82
|
-0.7 Micromoles per liter
Standard Deviation 1.03
|
0.2 Micromoles per liter
Standard Deviation 1.56
|
0.2 Micromoles per liter
Standard Deviation 1.20
|
-0.3 Micromoles per liter
Standard Deviation 0.82
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Direct bilirubin, Day 5,n=12,6,6,9,9,6
|
-0.7 Micromoles per liter
Standard Deviation 0.98
|
-0.7 Micromoles per liter
Standard Deviation 1.03
|
-0.7 Micromoles per liter
Standard Deviation 1.03
|
0.2 Micromoles per liter
Standard Deviation 1.56
|
0.0 Micromoles per liter
Standard Deviation 1.00
|
-0.7 Micromoles per liter
Standard Deviation 1.03
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Direct bilirubin, Week 4,n=12,6,6,9,9,6
|
0.0 Micromoles per liter
Standard Deviation 0.85
|
0.0 Micromoles per liter
Standard Deviation 1.26
|
0.3 Micromoles per liter
Standard Deviation 0.82
|
0.2 Micromoles per liter
Standard Deviation 1.20
|
0.2 Micromoles per liter
Standard Deviation 1.20
|
0.0 Micromoles per liter
Standard Deviation 1.26
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Direct bilirubin, Week 8,n=12,6,6,9,9,6
|
-0.2 Micromoles per liter
Standard Deviation 1.03
|
0.0 Micromoles per liter
Standard Deviation 0.00
|
0.3 Micromoles per liter
Standard Deviation 0.82
|
0.9 Micromoles per liter
Standard Deviation 1.45
|
0.4 Micromoles per liter
Standard Deviation 1.33
|
-0.7 Micromoles per liter
Standard Deviation 1.03
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Direct bilirubin, Week 12,n=12,6,6,9,9,6
|
-0.5 Micromoles per liter
Standard Deviation 0.90
|
0.0 Micromoles per liter
Standard Deviation 1.26
|
0.3 Micromoles per liter
Standard Deviation 0.82
|
0.2 Micromoles per liter
Standard Deviation 1.20
|
0.2 Micromoles per liter
Standard Deviation 1.20
|
-0.3 Micromoles per liter
Standard Deviation 1.51
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Direct bilirubin, Week 18,n=12,6,6,9,9,6
|
-0.2 Micromoles per liter
Standard Deviation 1.03
|
0.0 Micromoles per liter
Standard Deviation 1.26
|
0.0 Micromoles per liter
Standard Deviation 0.00
|
0.7 Micromoles per liter
Standard Deviation 1.00
|
0.4 Micromoles per liter
Standard Deviation 1.33
|
0.0 Micromoles per liter
Standard Deviation 1.26
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Direct bilirubin, Week 24,n=12,6,6,9,9,6
|
-0.3 Micromoles per liter
Standard Deviation 0.78
|
0.3 Micromoles per liter
Standard Deviation 1.51
|
-0.3 Micromoles per liter
Standard Deviation 0.82
|
0.2 Micromoles per liter
Standard Deviation 1.20
|
0.9 Micromoles per liter
Standard Deviation 1.76
|
0.0 Micromoles per liter
Standard Deviation 1.26
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Direct bilirubin, Week 26,n=12,6,6,9,9,6
|
0.0 Micromoles per liter
Standard Deviation 1.21
|
0.7 Micromoles per liter
Standard Deviation 1.03
|
0.3 Micromoles per liter
Standard Deviation 0.82
|
0.0 Micromoles per liter
Standard Deviation 1.41
|
0.0 Micromoles per liter
Standard Deviation 1.00
|
0.0 Micromoles per liter
Standard Deviation 1.26
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Direct bilirubin, Week 32,n=6,6,6,0,0,6
|
-0.3 Micromoles per liter
Standard Deviation 0.82
|
-0.3 Micromoles per liter
Standard Deviation 0.82
|
-0.3 Micromoles per liter
Standard Deviation 1.51
|
—
|
—
|
0.0 Micromoles per liter
Standard Deviation 1.26
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine, Day 2,n=12,6,5,9,9,6
|
-2.80 Micromoles per liter
Standard Deviation 5.501
|
-1.03 Micromoles per liter
Standard Deviation 3.930
|
-1.42 Micromoles per liter
Standard Deviation 3.512
|
-4.91 Micromoles per liter
Standard Deviation 4.835
|
-0.77 Micromoles per liter
Standard Deviation 4.863
|
-1.63 Micromoles per liter
Standard Deviation 6.417
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine, Day 3,n=12,6,6,9,9,6
|
-3.48 Micromoles per liter
Standard Deviation 6.036
|
-1.78 Micromoles per liter
Standard Deviation 3.571
|
-2.95 Micromoles per liter
Standard Deviation 6.208
|
-1.58 Micromoles per liter
Standard Deviation 4.913
|
-1.87 Micromoles per liter
Standard Deviation 5.026
|
-1.20 Micromoles per liter
Standard Deviation 3.795
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine, Day 4,n=12,6,6,9,9,6
|
0.29 Micromoles per liter
Standard Deviation 6.544
|
-0.73 Micromoles per liter
Standard Deviation 4.126
|
-0.75 Micromoles per liter
Standard Deviation 7.123
|
-4.64 Micromoles per liter
Standard Deviation 6.296
|
-0.88 Micromoles per liter
Standard Deviation 3.180
|
3.68 Micromoles per liter
Standard Deviation 7.962
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine, Day 5,n=12,6,6,9,9,6
|
-2.73 Micromoles per liter
Standard Deviation 5.166
|
0.72 Micromoles per liter
Standard Deviation 1.883
|
-2.53 Micromoles per liter
Standard Deviation 4.541
|
-4.63 Micromoles per liter
Standard Deviation 6.355
|
0.39 Micromoles per liter
Standard Deviation 3.085
|
-1.62 Micromoles per liter
Standard Deviation 5.216
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine, Week 1,n=11,6,6,9,9,5
|
-2.49 Micromoles per liter
Standard Deviation 7.084
|
3.68 Micromoles per liter
Standard Deviation 4.892
|
-2.08 Micromoles per liter
Standard Deviation 6.098
|
-3.06 Micromoles per liter
Standard Deviation 6.393
|
0.59 Micromoles per liter
Standard Deviation 4.303
|
-0.70 Micromoles per liter
Standard Deviation 7.736
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine, Week 8,n=12,6,6,9,9,6
|
-1.40 Micromoles per liter
Standard Deviation 6.462
|
0.28 Micromoles per liter
Standard Deviation 5.062
|
-1.20 Micromoles per liter
Standard Deviation 7.277
|
0.19 Micromoles per liter
Standard Deviation 3.718
|
6.00 Micromoles per liter
Standard Deviation 4.511
|
1.63 Micromoles per liter
Standard Deviation 4.317
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine, Week 12,n=12,6,6,9,9,6
|
-0.30 Micromoles per liter
Standard Deviation 7.643
|
0.88 Micromoles per liter
Standard Deviation 5.043
|
1.03 Micromoles per liter
Standard Deviation 5.846
|
-0.41 Micromoles per liter
Standard Deviation 4.748
|
5.01 Micromoles per liter
Standard Deviation 3.820
|
0.72 Micromoles per liter
Standard Deviation 4.532
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine, Week 32,n=6,6,6,0,0,6
|
0.00 Micromoles per liter
Standard Deviation 5.871
|
0.87 Micromoles per liter
Standard Deviation 5.904
|
6.60 Micromoles per liter
Standard Deviation 6.880
|
—
|
—
|
2.05 Micromoles per liter
Standard Deviation 2.474
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine, Week 4,n=12,6,6,9,9,6
|
-1.28 Micromoles per liter
Standard Deviation 4.730
|
-2.80 Micromoles per liter
Standard Deviation 3.839
|
0.27 Micromoles per liter
Standard Deviation 3.837
|
0.09 Micromoles per liter
Standard Deviation 6.843
|
0.59 Micromoles per liter
Standard Deviation 5.989
|
6.05 Micromoles per liter
Standard Deviation 6.066
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Total bilirubin, Day 3,n=12,6,6,9,9,6
|
-1.3 Micromoles per liter
Standard Deviation 3.45
|
-1.7 Micromoles per liter
Standard Deviation 3.44
|
-1.7 Micromoles per liter
Standard Deviation 4.97
|
0.2 Micromoles per liter
Standard Deviation 3.80
|
-0.4 Micromoles per liter
Standard Deviation 4.77
|
0.3 Micromoles per liter
Standard Deviation 2.34
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Total bilirubin, Week 26,n=12,6,6,9,9,6
|
-1.3 Micromoles per liter
Standard Deviation 4.70
|
2.7 Micromoles per liter
Standard Deviation 3.93
|
0.3 Micromoles per liter
Standard Deviation 3.88
|
-0.2 Micromoles per liter
Standard Deviation 3.80
|
-0.7 Micromoles per liter
Standard Deviation 4.12
|
1.7 Micromoles per liter
Standard Deviation 2.34
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Total bilirubin, Week 40,n=2,0,0,0,0,6
|
2.0 Micromoles per liter
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
0.7 Micromoles per liter
Standard Deviation 2.07
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Direct bilirubin, Week 1,n=11,6,6,9,9,5
|
-0.5 Micromoles per liter
Standard Deviation 0.93
|
-0.3 Micromoles per liter
Standard Deviation 0.82
|
-0.3 Micromoles per liter
Standard Deviation 0.82
|
0.0 Micromoles per liter
Standard Deviation 1.41
|
0.0 Micromoles per liter
Standard Deviation 1.00
|
-0.8 Micromoles per liter
Standard Deviation 1.10
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Direct bilirubin, Week 2,n=12,6,6,9,9,6
|
-0.3 Micromoles per liter
Standard Deviation 1.15
|
0.0 Micromoles per liter
Standard Deviation 0.00
|
0.0 Micromoles per liter
Standard Deviation 0.00
|
0.7 Micromoles per liter
Standard Deviation 1.41
|
0.2 Micromoles per liter
Standard Deviation 1.20
|
0.3 Micromoles per liter
Standard Deviation 1.51
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Direct bilirubin, Week 36,n=6,0,0,9,9,0
|
0.0 Micromoles per liter
Standard Deviation 1.79
|
—
|
—
|
0.0 Micromoles per liter
Standard Deviation 1.00
|
0.4 Micromoles per liter
Standard Deviation 1.67
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Direct bilirubin, Week 40,n=2,0,0,0,0,6
|
-1.0 Micromoles per liter
Standard Deviation 1.41
|
—
|
—
|
—
|
—
|
-0.3 Micromoles per liter
Standard Deviation 0.82
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine, Week 2,n=12,6,6,9,9,6
|
-1.12 Micromoles per liter
Standard Deviation 5.854
|
1.47 Micromoles per liter
Standard Deviation 5.019
|
-0.90 Micromoles per liter
Standard Deviation 6.377
|
-2.67 Micromoles per liter
Standard Deviation 5.702
|
2.27 Micromoles per liter
Standard Deviation 5.322
|
0.73 Micromoles per liter
Standard Deviation 7.868
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine, Week 18,n=12,6,6,9,9,6
|
-1.27 Micromoles per liter
Standard Deviation 7.753
|
1.75 Micromoles per liter
Standard Deviation 4.831
|
2.05 Micromoles per liter
Standard Deviation 7.131
|
2.83 Micromoles per liter
Standard Deviation 5.033
|
4.42 Micromoles per liter
Standard Deviation 5.191
|
1.15 Micromoles per liter
Standard Deviation 6.297
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine, Week 24,n=12,6,6,9,9,6
|
0.89 Micromoles per liter
Standard Deviation 4.393
|
1.77 Micromoles per liter
Standard Deviation 5.597
|
1.60 Micromoles per liter
Standard Deviation 5.877
|
7.07 Micromoles per liter
Standard Deviation 6.581
|
2.66 Micromoles per liter
Standard Deviation 6.005
|
2.20 Micromoles per liter
Standard Deviation 4.431
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine, Week 26,n=12,6,6,9,9,6
|
-2.29 Micromoles per liter
Standard Deviation 5.633
|
-2.22 Micromoles per liter
Standard Deviation 5.017
|
0.27 Micromoles per liter
Standard Deviation 15.342
|
3.16 Micromoles per liter
Standard Deviation 6.620
|
0.69 Micromoles per liter
Standard Deviation 3.857
|
3.22 Micromoles per liter
Standard Deviation 5.653
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine, Week 36,n=6,0,0,9,9,0
|
-0.60 Micromoles per liter
Standard Deviation 4.767
|
—
|
—
|
2.57 Micromoles per liter
Standard Deviation 4.347
|
10.42 Micromoles per liter
Standard Deviation 6.864
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine, Week 40,n=2,0,0,0,0,6
|
1.75 Micromoles per liter
Standard Deviation 2.475
|
—
|
—
|
—
|
—
|
1.60 Micromoles per liter
Standard Deviation 6.174
|
PRIMARY outcome
Timeframe: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Urinary specific gravity measurement is a routine part of urinalysis. 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. The concentration of the excreted molecules determines the urine's specific gravity.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=2 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=1 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=5 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=1 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=1 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Urine Specific Gravity Analysis by Dipstick Method
Day 3,n=2,0,0,1,0,0
|
1.0265 Ratio
Standard Deviation 0.00212
|
—
|
—
|
1.0280 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
—
|
|
Urine Specific Gravity Analysis by Dipstick Method
Week 24,n=1,1,0,4,0,0
|
1.0200 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
1.0230 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
1.0200 Ratio
Standard Deviation 0.00374
|
—
|
—
|
|
Urine Specific Gravity Analysis by Dipstick Method
Week 26,n=0,0,0,2,0,0
|
—
|
—
|
—
|
1.0240 Ratio
Standard Deviation 0.00566
|
—
|
—
|
|
Urine Specific Gravity Analysis by Dipstick Method
Week 32,n=1,0,0,0,0,0
|
1.0150 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
—
|
—
|
—
|
—
|
|
Urine Specific Gravity Analysis by Dipstick Method
Day 2,n=1,2,0,2,0,0
|
1.0200 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
1.0125 Ratio
Standard Deviation 0.00354
|
—
|
1.0120 Ratio
Standard Deviation 0.00283
|
—
|
—
|
|
Urine Specific Gravity Analysis by Dipstick Method
Day 4,n=0,0,1,1,0,0
|
—
|
—
|
1.0150 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
1.0290 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
—
|
|
Urine Specific Gravity Analysis by Dipstick Method
Day 5,n=2,0,0,2,1,0
|
1.0275 Ratio
Standard Deviation 0.00354
|
—
|
—
|
1.0205 Ratio
Standard Deviation 0.00919
|
1.0140 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
|
Urine Specific Gravity Analysis by Dipstick Method
Week 1,n=2,1,1,3,0,0
|
1.0235 Ratio
Standard Deviation 0.00212
|
1.0260 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
1.0250 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
1.0197 Ratio
Standard Deviation 0.00751
|
—
|
—
|
|
Urine Specific Gravity Analysis by Dipstick Method
Week 2,n=1,0,0,4,1,0
|
1.0250 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
—
|
1.0218 Ratio
Standard Deviation 0.00822
|
1.0130 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
|
Urine Specific Gravity Analysis by Dipstick Method
Week 4,n=3,1,1,5,0,1
|
1.0193 Ratio
Standard Deviation 0.00839
|
1.0150 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
1.0250 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
1.0158 Ratio
Standard Deviation 0.01052
|
—
|
1.0270 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
|
Urine Specific Gravity Analysis by Dipstick Method
Week 8,n=1,0,0,2,0,0
|
1.0300 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
—
|
1.0220 Ratio
Standard Deviation 0.00566
|
—
|
—
|
|
Urine Specific Gravity Analysis by Dipstick Method
Week 12,n=0,1,0,1,0,0
|
—
|
1.0180 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
1.0230 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
—
|
|
Urine Specific Gravity Analysis by Dipstick Method
Week 18,n=3,1,0,1,0,0
|
1.0260 Ratio
Standard Deviation 0.00265
|
1.0180 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
1.0230 Ratio
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
SBP and DBP were assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, 2 hours Day1,n=12,6,6,9,9,6
|
-0.3 Millimeters of mercury
Standard Deviation 6.08
|
-2.2 Millimeters of mercury
Standard Deviation 7.47
|
3.3 Millimeters of mercury
Standard Deviation 7.37
|
-0.9 Millimeters of mercury
Standard Deviation 7.18
|
-1.8 Millimeters of mercury
Standard Deviation 7.19
|
-2.0 Millimeters of mercury
Standard Deviation 8.58
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 1,n=12,6,6,9,9,6
|
0.6 Millimeters of mercury
Standard Deviation 5.37
|
3.7 Millimeters of mercury
Standard Deviation 6.98
|
4.3 Millimeters of mercury
Standard Deviation 9.27
|
-0.4 Millimeters of mercury
Standard Deviation 5.68
|
0.8 Millimeters of mercury
Standard Deviation 3.38
|
0.0 Millimeters of mercury
Standard Deviation 5.44
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 2,n=12,6,6,9,9,6
|
1.1 Millimeters of mercury
Standard Deviation 6.23
|
4.7 Millimeters of mercury
Standard Deviation 5.65
|
6.0 Millimeters of mercury
Standard Deviation 8.99
|
1.6 Millimeters of mercury
Standard Deviation 4.36
|
1.9 Millimeters of mercury
Standard Deviation 6.92
|
0.2 Millimeters of mercury
Standard Deviation 4.62
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 24,n=12,6,6,9,9,6
|
-1.6 Millimeters of mercury
Standard Deviation 7.77
|
6.3 Millimeters of mercury
Standard Deviation 5.35
|
4.0 Millimeters of mercury
Standard Deviation 9.78
|
5.3 Millimeters of mercury
Standard Deviation 6.56
|
1.1 Millimeters of mercury
Standard Deviation 9.12
|
2.0 Millimeters of mercury
Standard Deviation 5.66
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 26,n=12,6,6,9,9,6
|
-0.5 Millimeters of mercury
Standard Deviation 7.23
|
3.2 Millimeters of mercury
Standard Deviation 4.36
|
3.8 Millimeters of mercury
Standard Deviation 9.45
|
6.6 Millimeters of mercury
Standard Deviation 8.38
|
1.8 Millimeters of mercury
Standard Deviation 8.61
|
0.2 Millimeters of mercury
Standard Deviation 3.97
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 32,n=6,6,6,0,0,6
|
1.3 Millimeters of mercury
Standard Deviation 2.34
|
-0.2 Millimeters of mercury
Standard Deviation 6.49
|
7.0 Millimeters of mercury
Standard Deviation 4.34
|
—
|
—
|
2.0 Millimeters of mercury
Standard Deviation 7.64
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 36,n=6,0,0,9,9,0
|
2.3 Millimeters of mercury
Standard Deviation 13.13
|
—
|
—
|
3.6 Millimeters of mercury
Standard Deviation 5.64
|
2.3 Millimeters of mercury
Standard Deviation 8.82
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, 8 hours Day1,n=12,6,6,9,9,6
|
0.0 Millimeters of mercury
Standard Deviation 6.00
|
4.2 Millimeters of mercury
Standard Deviation 10.01
|
3.0 Millimeters of mercury
Standard Deviation 8.46
|
1.7 Millimeters of mercury
Standard Deviation 10.69
|
4.9 Millimeters of mercury
Standard Deviation 7.52
|
-2.2 Millimeters of mercury
Standard Deviation 5.64
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 2,n=12,6,6,9,9,6
|
-2.6 Millimeters of mercury
Standard Deviation 5.90
|
1.0 Millimeters of mercury
Standard Deviation 10.22
|
5.8 Millimeters of mercury
Standard Deviation 5.85
|
4.2 Millimeters of mercury
Standard Deviation 10.45
|
0.8 Millimeters of mercury
Standard Deviation 11.04
|
-2.8 Millimeters of mercury
Standard Deviation 9.83
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 2,n=12,6,6,9,9,6
|
-2.5 Millimeters of mercury
Standard Deviation 7.00
|
-0.8 Millimeters of mercury
Standard Deviation 8.08
|
6.0 Millimeters of mercury
Standard Deviation 4.86
|
1.8 Millimeters of mercury
Standard Deviation 9.11
|
6.3 Millimeters of mercury
Standard Deviation 7.42
|
-5.3 Millimeters of mercury
Standard Deviation 4.37
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 3,n=12,6,6,9,9,6
|
2.6 Millimeters of mercury
Standard Deviation 9.21
|
-2.2 Millimeters of mercury
Standard Deviation 7.36
|
3.7 Millimeters of mercury
Standard Deviation 9.16
|
1.0 Millimeters of mercury
Standard Deviation 10.68
|
-0.1 Millimeters of mercury
Standard Deviation 4.43
|
-5.0 Millimeters of mercury
Standard Deviation 6.00
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 4,n=12,6,6,9,9,6
|
0.8 Millimeters of mercury
Standard Deviation 5.75
|
-2.2 Millimeters of mercury
Standard Deviation 6.24
|
2.3 Millimeters of mercury
Standard Deviation 8.09
|
0.3 Millimeters of mercury
Standard Deviation 6.91
|
2.9 Millimeters of mercury
Standard Deviation 6.86
|
-3.3 Millimeters of mercury
Standard Deviation 7.39
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 5,n=12,6,6,9,9,6
|
-3.0 Millimeters of mercury
Standard Deviation 6.05
|
0.8 Millimeters of mercury
Standard Deviation 6.82
|
1.0 Millimeters of mercury
Standard Deviation 7.72
|
-2.8 Millimeters of mercury
Standard Deviation 9.81
|
0.4 Millimeters of mercury
Standard Deviation 3.91
|
-4.7 Millimeters of mercury
Standard Deviation 4.46
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 1,n=12,6,6,9,9,6
|
-0.3 Millimeters of mercury
Standard Deviation 8.86
|
0.3 Millimeters of mercury
Standard Deviation 7.50
|
1.5 Millimeters of mercury
Standard Deviation 6.60
|
-2.7 Millimeters of mercury
Standard Deviation 9.06
|
1.7 Millimeters of mercury
Standard Deviation 5.02
|
0.2 Millimeters of mercury
Standard Deviation 8.13
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 4,n=12,6,6,9,9,6
|
-1.6 Millimeters of mercury
Standard Deviation 8.80
|
0.3 Millimeters of mercury
Standard Deviation 8.82
|
7.0 Millimeters of mercury
Standard Deviation 11.26
|
3.2 Millimeters of mercury
Standard Deviation 14.09
|
0.9 Millimeters of mercury
Standard Deviation 6.11
|
-2.3 Millimeters of mercury
Standard Deviation 7.15
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 8,n=12,6,6,9,9,6
|
0.7 Millimeters of mercury
Standard Deviation 9.71
|
0.0 Millimeters of mercury
Standard Deviation 9.27
|
2.0 Millimeters of mercury
Standard Deviation 12.66
|
3.1 Millimeters of mercury
Standard Deviation 8.52
|
-1.4 Millimeters of mercury
Standard Deviation 6.60
|
-1.8 Millimeters of mercury
Standard Deviation 5.91
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 12,n=12,6,6,9,9,6
|
-0.8 Millimeters of mercury
Standard Deviation 5.13
|
1.2 Millimeters of mercury
Standard Deviation 5.19
|
2.3 Millimeters of mercury
Standard Deviation 9.97
|
5.4 Millimeters of mercury
Standard Deviation 9.41
|
0.0 Millimeters of mercury
Standard Deviation 7.37
|
-4.2 Millimeters of mercury
Standard Deviation 11.18
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 18,n=12,6,6,9,9,6
|
-0.6 Millimeters of mercury
Standard Deviation 6.86
|
4.2 Millimeters of mercury
Standard Deviation 9.15
|
3.8 Millimeters of mercury
Standard Deviation 13.33
|
2.0 Millimeters of mercury
Standard Deviation 8.76
|
2.1 Millimeters of mercury
Standard Deviation 9.52
|
-7.3 Millimeters of mercury
Standard Deviation 15.49
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 24,n=12,6,6,9,9,6
|
-0.8 Millimeters of mercury
Standard Deviation 8.22
|
9.3 Millimeters of mercury
Standard Deviation 10.42
|
3.7 Millimeters of mercury
Standard Deviation 6.59
|
2.9 Millimeters of mercury
Standard Deviation 9.91
|
1.9 Millimeters of mercury
Standard Deviation 12.06
|
-2.2 Millimeters of mercury
Standard Deviation 6.46
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 26,n=12,6,6,9,9,6
|
3.0 Millimeters of mercury
Standard Deviation 11.95
|
3.2 Millimeters of mercury
Standard Deviation 6.11
|
3.2 Millimeters of mercury
Standard Deviation 5.91
|
7.9 Millimeters of mercury
Standard Deviation 10.13
|
2.9 Millimeters of mercury
Standard Deviation 7.56
|
-5.8 Millimeters of mercury
Standard Deviation 6.11
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 32,n=6,6,6,0,0,6
|
3.0 Millimeters of mercury
Standard Deviation 6.90
|
-3.8 Millimeters of mercury
Standard Deviation 12.45
|
8.7 Millimeters of mercury
Standard Deviation 10.61
|
—
|
—
|
-3.3 Millimeters of mercury
Standard Deviation 6.89
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 36,n=6,0,0,9,9,0
|
-3.5 Millimeters of mercury
Standard Deviation 13.72
|
—
|
—
|
2.8 Millimeters of mercury
Standard Deviation 9.59
|
2.8 Millimeters of mercury
Standard Deviation 7.77
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Week 40,n=2,0,0,0,0,6
|
-15.0 Millimeters of mercury
Standard Deviation 14.14
|
—
|
—
|
—
|
—
|
-5.8 Millimeters of mercury
Standard Deviation 17.52
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, 2 hours Day1,n=12,6,6,9,9,6
|
-2.9 Millimeters of mercury
Standard Deviation 5.00
|
3.3 Millimeters of mercury
Standard Deviation 4.89
|
4.3 Millimeters of mercury
Standard Deviation 9.14
|
-2.2 Millimeters of mercury
Standard Deviation 4.18
|
-2.2 Millimeters of mercury
Standard Deviation 6.14
|
-3.8 Millimeters of mercury
Standard Deviation 1.94
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, 8 hours Day1,n=12,6,6,9,9,6
|
-0.6 Millimeters of mercury
Standard Deviation 4.34
|
2.0 Millimeters of mercury
Standard Deviation 7.46
|
0.5 Millimeters of mercury
Standard Deviation 9.52
|
-1.3 Millimeters of mercury
Standard Deviation 4.58
|
-2.0 Millimeters of mercury
Standard Deviation 5.74
|
-1.8 Millimeters of mercury
Standard Deviation 5.56
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 2,n=12,6,6,9,9,6
|
-0.2 Millimeters of mercury
Standard Deviation 4.47
|
0.8 Millimeters of mercury
Standard Deviation 4.49
|
3.0 Millimeters of mercury
Standard Deviation 5.83
|
-1.1 Millimeters of mercury
Standard Deviation 5.67
|
4.7 Millimeters of mercury
Standard Deviation 4.18
|
0.0 Millimeters of mercury
Standard Deviation 4.94
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 3,n=12,6,6,9,9,6
|
0.6 Millimeters of mercury
Standard Deviation 3.99
|
-1.3 Millimeters of mercury
Standard Deviation 7.26
|
3.0 Millimeters of mercury
Standard Deviation 7.04
|
-2.6 Millimeters of mercury
Standard Deviation 5.41
|
-0.3 Millimeters of mercury
Standard Deviation 4.30
|
-0.3 Millimeters of mercury
Standard Deviation 6.44
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 4,n=12,6,6,9,9,6
|
-0.1 Millimeters of mercury
Standard Deviation 5.04
|
2.3 Millimeters of mercury
Standard Deviation 4.80
|
-1.0 Millimeters of mercury
Standard Deviation 5.69
|
-0.2 Millimeters of mercury
Standard Deviation 5.14
|
0.1 Millimeters of mercury
Standard Deviation 3.76
|
-2.8 Millimeters of mercury
Standard Deviation 3.82
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 5,n=12,6,6,9,9,6
|
-1.4 Millimeters of mercury
Standard Deviation 4.40
|
4.8 Millimeters of mercury
Standard Deviation 6.49
|
0.7 Millimeters of mercury
Standard Deviation 8.09
|
-4.1 Millimeters of mercury
Standard Deviation 7.29
|
0.9 Millimeters of mercury
Standard Deviation 4.23
|
-1.5 Millimeters of mercury
Standard Deviation 2.81
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 4,n=12,6,6,9,9,6
|
0.3 Millimeters of mercury
Standard Deviation 6.17
|
1.3 Millimeters of mercury
Standard Deviation 7.74
|
4.2 Millimeters of mercury
Standard Deviation 11.36
|
3.1 Millimeters of mercury
Standard Deviation 6.09
|
1.6 Millimeters of mercury
Standard Deviation 5.41
|
3.8 Millimeters of mercury
Standard Deviation 4.40
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 8,n=12,6,6,9,9,6
|
1.3 Millimeters of mercury
Standard Deviation 3.73
|
5.2 Millimeters of mercury
Standard Deviation 5.49
|
5.5 Millimeters of mercury
Standard Deviation 13.28
|
3.3 Millimeters of mercury
Standard Deviation 4.95
|
0.7 Millimeters of mercury
Standard Deviation 4.21
|
0.5 Millimeters of mercury
Standard Deviation 3.94
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 12,n=12,6,6,9,9,6
|
0.9 Millimeters of mercury
Standard Deviation 6.29
|
3.2 Millimeters of mercury
Standard Deviation 5.91
|
1.7 Millimeters of mercury
Standard Deviation 14.15
|
3.4 Millimeters of mercury
Standard Deviation 5.39
|
3.6 Millimeters of mercury
Standard Deviation 4.72
|
1.3 Millimeters of mercury
Standard Deviation 5.09
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 18,n=12,6,6,9,9,6
|
-2.1 Millimeters of mercury
Standard Deviation 6.63
|
3.3 Millimeters of mercury
Standard Deviation 5.68
|
3.0 Millimeters of mercury
Standard Deviation 12.65
|
0.7 Millimeters of mercury
Standard Deviation 6.84
|
3.8 Millimeters of mercury
Standard Deviation 8.07
|
0.5 Millimeters of mercury
Standard Deviation 7.50
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Week 40,n=2,0,0,0,0,6
|
0.5 Millimeters of mercury
Standard Deviation 4.95
|
—
|
—
|
—
|
—
|
-3.5 Millimeters of mercury
Standard Deviation 6.95
|
PRIMARY outcome
Timeframe: Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Temperature was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Temperature
2 hours Day1,n=12,6,6,9,9,6
|
0.05 Degree Celsius
Standard Deviation 0.419
|
0.32 Degree Celsius
Standard Deviation 0.293
|
0.13 Degree Celsius
Standard Deviation 0.163
|
0.30 Degree Celsius
Standard Deviation 0.474
|
0.03 Degree Celsius
Standard Deviation 0.328
|
0.00 Degree Celsius
Standard Deviation 0.420
|
|
Change From Baseline in Temperature
Category title 2. 8 hours Day1,n=12,6,6,9,9,6
|
0.13 Degree Celsius
Standard Deviation 0.405
|
0.40 Degree Celsius
Standard Deviation 0.410
|
0.07 Degree Celsius
Standard Deviation 0.234
|
0.24 Degree Celsius
Standard Deviation 0.513
|
0.18 Degree Celsius
Standard Deviation 0.291
|
0.35 Degree Celsius
Standard Deviation 0.589
|
|
Change From Baseline in Temperature
Week 24,n=12,6,6,9,9,6
|
-0.07 Degree Celsius
Standard Deviation 0.396
|
0.08 Degree Celsius
Standard Deviation 0.488
|
0.08 Degree Celsius
Standard Deviation 0.319
|
-0.02 Degree Celsius
Standard Deviation 0.367
|
-0.07 Degree Celsius
Standard Deviation 0.316
|
-0.02 Degree Celsius
Standard Deviation 0.133
|
|
Change From Baseline in Temperature
Week 1,n=12,6,6,9,9,6
|
-0.13 Degree Celsius
Standard Deviation 0.293
|
0.32 Degree Celsius
Standard Deviation 0.492
|
0.18 Degree Celsius
Standard Deviation 0.147
|
0.12 Degree Celsius
Standard Deviation 0.399
|
0.01 Degree Celsius
Standard Deviation 0.359
|
0.18 Degree Celsius
Standard Deviation 0.232
|
|
Change From Baseline in Temperature
Category title 3. Day 2,n=12,6,6,9,9,6
|
-0.01 Degree Celsius
Standard Deviation 0.312
|
0.23 Degree Celsius
Standard Deviation 0.437
|
0.10 Degree Celsius
Standard Deviation 0.429
|
-0.03 Degree Celsius
Standard Deviation 0.559
|
-0.01 Degree Celsius
Standard Deviation 0.333
|
-0.05 Degree Celsius
Standard Deviation 0.259
|
|
Change From Baseline in Temperature
Day 3,n=12,6,6,9,9,6
|
-0.10 Degree Celsius
Standard Deviation 0.402
|
0.02 Degree Celsius
Standard Deviation 0.538
|
0.02 Degree Celsius
Standard Deviation 0.256
|
0.13 Degree Celsius
Standard Deviation 0.439
|
0.02 Degree Celsius
Standard Deviation 0.315
|
0.12 Degree Celsius
Standard Deviation 0.343
|
|
Change From Baseline in Temperature
Day 4,n=12,6,6,9,9,6
|
-0.03 Degree Celsius
Standard Deviation 0.260
|
0.15 Degree Celsius
Standard Deviation 0.554
|
0.08 Degree Celsius
Standard Deviation 0.293
|
0.11 Degree Celsius
Standard Deviation 0.382
|
0.22 Degree Celsius
Standard Deviation 0.239
|
0.02 Degree Celsius
Standard Deviation 0.397
|
|
Change From Baseline in Temperature
Day 5,n=12,6,6,9,9,6
|
-0.08 Degree Celsius
Standard Deviation 0.171
|
0.13 Degree Celsius
Standard Deviation 0.516
|
0.25 Degree Celsius
Standard Deviation 0.464
|
-0.07 Degree Celsius
Standard Deviation 0.300
|
-0.04 Degree Celsius
Standard Deviation 0.255
|
0.12 Degree Celsius
Standard Deviation 0.293
|
|
Change From Baseline in Temperature
Week 2,n=12,6,6,9,9,6
|
-0.29 Degree Celsius
Standard Deviation 0.448
|
0.30 Degree Celsius
Standard Deviation 0.460
|
0.03 Degree Celsius
Standard Deviation 0.333
|
0.04 Degree Celsius
Standard Deviation 0.340
|
0.08 Degree Celsius
Standard Deviation 0.441
|
-0.08 Degree Celsius
Standard Deviation 0.319
|
|
Change From Baseline in Temperature
Week 4,n=12,6,6,9,9,6
|
-0.23 Degree Celsius
Standard Deviation 0.172
|
0.20 Degree Celsius
Standard Deviation 0.400
|
-0.02 Degree Celsius
Standard Deviation 0.387
|
-0.09 Degree Celsius
Standard Deviation 0.302
|
0.00 Degree Celsius
Standard Deviation 0.671
|
-0.03 Degree Celsius
Standard Deviation 0.258
|
|
Change From Baseline in Temperature
Week 8,n=12,6,6,9,9,6
|
0.00 Degree Celsius
Standard Deviation 0.280
|
0.32 Degree Celsius
Standard Deviation 0.397
|
-0.18 Degree Celsius
Standard Deviation 0.504
|
0.09 Degree Celsius
Standard Deviation 0.446
|
0.02 Degree Celsius
Standard Deviation 0.282
|
0.13 Degree Celsius
Standard Deviation 0.197
|
|
Change From Baseline in Temperature
Week 12,n=12,6,6,9,9,6
|
-0.10 Degree Celsius
Standard Deviation 0.386
|
0.17 Degree Celsius
Standard Deviation 0.356
|
-0.15 Degree Celsius
Standard Deviation 0.187
|
0.09 Degree Celsius
Standard Deviation 0.337
|
-0.09 Degree Celsius
Standard Deviation 0.355
|
0.00 Degree Celsius
Standard Deviation 0.369
|
|
Change From Baseline in Temperature
Week 18,n=12,6,6,9,9,6
|
-0.07 Degree Celsius
Standard Deviation 0.267
|
0.18 Degree Celsius
Standard Deviation 0.662
|
0.02 Degree Celsius
Standard Deviation 0.407
|
0.13 Degree Celsius
Standard Deviation 0.512
|
0.07 Degree Celsius
Standard Deviation 0.283
|
-0.05 Degree Celsius
Standard Deviation 0.399
|
|
Change From Baseline in Temperature
Week 26,n=12,6,6,9,9,6
|
-0.08 Degree Celsius
Standard Deviation 0.311
|
0.03 Degree Celsius
Standard Deviation 0.441
|
-0.02 Degree Celsius
Standard Deviation 0.504
|
0.08 Degree Celsius
Standard Deviation 0.424
|
0.00 Degree Celsius
Standard Deviation 0.442
|
-0.22 Degree Celsius
Standard Deviation 0.117
|
|
Change From Baseline in Temperature
Week 32,n=6,6,6,0,0,6
|
-0.30 Degree Celsius
Standard Deviation 0.569
|
0.48 Degree Celsius
Standard Deviation 1.363
|
0.02 Degree Celsius
Standard Deviation 0.306
|
—
|
—
|
0.08 Degree Celsius
Standard Deviation 0.331
|
|
Change From Baseline in Temperature
Week 36,n=6,0,0,9,9,0
|
0.22 Degree Celsius
Standard Deviation 0.366
|
—
|
—
|
0.14 Degree Celsius
Standard Deviation 0.433
|
-0.03 Degree Celsius
Standard Deviation 0.212
|
—
|
|
Change From Baseline in Temperature
Week 40,n=2,0,0,0,0,6
|
-0.10 Degree Celsius
Standard Deviation 0.566
|
—
|
—
|
—
|
—
|
-0.05 Degree Celsius
Standard Deviation 0.084
|
PRIMARY outcome
Timeframe: Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Heart rate was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Heart Rate
Week 4,n=12,6,6,9,9,6
|
-3.2 Beats per minute
Standard Deviation 8.46
|
-2.3 Beats per minute
Standard Deviation 2.88
|
-1.5 Beats per minute
Standard Deviation 5.96
|
-1.1 Beats per minute
Standard Deviation 10.54
|
0.8 Beats per minute
Standard Deviation 13.58
|
0.5 Beats per minute
Standard Deviation 9.35
|
|
Change From Baseline in Heart Rate
Week 18,n=12,6,6,9,9,6
|
-3.2 Beats per minute
Standard Deviation 8.56
|
-2.0 Beats per minute
Standard Deviation 7.07
|
-1.7 Beats per minute
Standard Deviation 5.50
|
0.8 Beats per minute
Standard Deviation 10.84
|
1.7 Beats per minute
Standard Deviation 9.10
|
2.5 Beats per minute
Standard Deviation 7.23
|
|
Change From Baseline in Heart Rate
Week 24,n=12,6,6,9,9,6
|
-1.4 Beats per minute
Standard Deviation 10.03
|
-0.8 Beats per minute
Standard Deviation 6.85
|
1.8 Beats per minute
Standard Deviation 7.68
|
-2.8 Beats per minute
Standard Deviation 12.04
|
3.2 Beats per minute
Standard Deviation 9.28
|
0.0 Beats per minute
Standard Deviation 4.82
|
|
Change From Baseline in Heart Rate
Week 26,n=12,6,6,9,9,6
|
-2.7 Beats per minute
Standard Deviation 10.04
|
-0.2 Beats per minute
Standard Deviation 2.56
|
-0.7 Beats per minute
Standard Deviation 6.59
|
2.0 Beats per minute
Standard Deviation 12.03
|
1.6 Beats per minute
Standard Deviation 7.09
|
1.8 Beats per minute
Standard Deviation 4.58
|
|
Change From Baseline in Heart Rate
Week 40,n=2,0,0,0,0,6
|
-2.0 Beats per minute
Standard Deviation 2.83
|
—
|
—
|
—
|
—
|
2.8 Beats per minute
Standard Deviation 10.26
|
|
Change From Baseline in Heart Rate
2 hours Day1,n=12,6,6,9,9,6
|
2.2 Beats per minute
Standard Deviation 13.62
|
-4.2 Beats per minute
Standard Deviation 5.27
|
-3.3 Beats per minute
Standard Deviation 8.64
|
0.8 Beats per minute
Standard Deviation 14.45
|
0.9 Beats per minute
Standard Deviation 10.74
|
5.2 Beats per minute
Standard Deviation 5.46
|
|
Change From Baseline in Heart Rate
8 hours Day1,n=12,6,6,9,9,6
|
-1.0 Beats per minute
Standard Deviation 7.05
|
-2.0 Beats per minute
Standard Deviation 7.27
|
-3.2 Beats per minute
Standard Deviation 3.37
|
0.3 Beats per minute
Standard Deviation 14.21
|
1.0 Beats per minute
Standard Deviation 11.62
|
4.8 Beats per minute
Standard Deviation 8.06
|
|
Change From Baseline in Heart Rate
Day 2,n=12,6,6,9,9,6
|
-1.2 Beats per minute
Standard Deviation 6.59
|
-1.5 Beats per minute
Standard Deviation 2.81
|
-1.7 Beats per minute
Standard Deviation 3.83
|
-4.0 Beats per minute
Standard Deviation 11.03
|
2.7 Beats per minute
Standard Deviation 8.14
|
-0.7 Beats per minute
Standard Deviation 3.50
|
|
Change From Baseline in Heart Rate
Day 3,n=12,6,6,9,9,6
|
-0.2 Beats per minute
Standard Deviation 4.82
|
0.2 Beats per minute
Standard Deviation 5.88
|
1.3 Beats per minute
Standard Deviation 8.41
|
0.7 Beats per minute
Standard Deviation 4.92
|
4.7 Beats per minute
Standard Deviation 3.94
|
-1.0 Beats per minute
Standard Deviation 7.40
|
|
Change From Baseline in Heart Rate
Day 4,n=12,6,6,9,9,6
|
3.8 Beats per minute
Standard Deviation 7.53
|
1.7 Beats per minute
Standard Deviation 4.84
|
4.7 Beats per minute
Standard Deviation 8.98
|
-1.2 Beats per minute
Standard Deviation 11.62
|
3.6 Beats per minute
Standard Deviation 5.27
|
1.5 Beats per minute
Standard Deviation 3.33
|
|
Change From Baseline in Heart Rate
Day 5,n=12,6,6,9,9,6
|
1.1 Beats per minute
Standard Deviation 4.91
|
2.8 Beats per minute
Standard Deviation 8.61
|
1.2 Beats per minute
Standard Deviation 7.83
|
-0.1 Beats per minute
Standard Deviation 10.30
|
0.6 Beats per minute
Standard Deviation 4.28
|
3.0 Beats per minute
Standard Deviation 4.47
|
|
Change From Baseline in Heart Rate
Week 1,n=12,6,6,9,9,6
|
-1.8 Beats per minute
Standard Deviation 6.03
|
0.0 Beats per minute
Standard Deviation 10.58
|
-1.8 Beats per minute
Standard Deviation 7.05
|
-1.1 Beats per minute
Standard Deviation 10.80
|
1.4 Beats per minute
Standard Deviation 5.98
|
5.0 Beats per minute
Standard Deviation 9.21
|
|
Change From Baseline in Heart Rate
Week 2,n=12,6,6,9,9,6
|
-4.8 Beats per minute
Standard Deviation 5.57
|
-1.3 Beats per minute
Standard Deviation 5.89
|
-5.2 Beats per minute
Standard Deviation 5.23
|
2.1 Beats per minute
Standard Deviation 12.38
|
1.0 Beats per minute
Standard Deviation 10.51
|
2.0 Beats per minute
Standard Deviation 6.00
|
|
Change From Baseline in Heart Rate
Week 8,n=12,6,6,9,9,6
|
-0.2 Beats per minute
Standard Deviation 7.12
|
-1.8 Beats per minute
Standard Deviation 7.14
|
-3.7 Beats per minute
Standard Deviation 5.79
|
-4.9 Beats per minute
Standard Deviation 15.39
|
-0.6 Beats per minute
Standard Deviation 6.52
|
-0.3 Beats per minute
Standard Deviation 4.72
|
|
Change From Baseline in Heart Rate
Week 12,n=12,6,6,9,9,6
|
-1.2 Beats per minute
Standard Deviation 10.47
|
3.3 Beats per minute
Standard Deviation 8.38
|
-2.3 Beats per minute
Standard Deviation 6.53
|
0.6 Beats per minute
Standard Deviation 16.41
|
1.0 Beats per minute
Standard Deviation 9.31
|
3.0 Beats per minute
Standard Deviation 7.38
|
|
Change From Baseline in Heart Rate
Week 32,n=6,6,6,0,0,6
|
-1.0 Beats per minute
Standard Deviation 10.55
|
-2.2 Beats per minute
Standard Deviation 5.19
|
0.7 Beats per minute
Standard Deviation 6.06
|
—
|
—
|
0.8 Beats per minute
Standard Deviation 7.28
|
|
Change From Baseline in Heart Rate
Week 36,n=6,0,0,9,9,0
|
0.5 Beats per minute
Standard Deviation 11.59
|
—
|
—
|
0.0 Beats per minute
Standard Deviation 12.50
|
2.6 Beats per minute
Standard Deviation 6.29
|
—
|
PRIMARY outcome
Timeframe: Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Respiration rate was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Respiration Rate
2 hours Day1,n=12,6,6,9,9,6
|
0.8 Breaths per minute
Standard Deviation 2.42
|
1.2 Breaths per minute
Standard Deviation 1.83
|
0.0 Breaths per minute
Standard Deviation 2.53
|
0.3 Breaths per minute
Standard Deviation 2.65
|
0.8 Breaths per minute
Standard Deviation 1.72
|
2.2 Breaths per minute
Standard Deviation 3.31
|
|
Change From Baseline in Respiration Rate
Day 3,n=12,6,6,9,9,6
|
-1.0 Breaths per minute
Standard Deviation 2.83
|
1.5 Breaths per minute
Standard Deviation 3.27
|
-0.2 Breaths per minute
Standard Deviation 2.40
|
1.1 Breaths per minute
Standard Deviation 2.80
|
1.2 Breaths per minute
Standard Deviation 2.11
|
0.7 Breaths per minute
Standard Deviation 3.50
|
|
Change From Baseline in Respiration Rate
Day 4,n=12,6,6,9,9,6
|
-0.1 Breaths per minute
Standard Deviation 3.06
|
-1.0 Breaths per minute
Standard Deviation 3.03
|
0.7 Breaths per minute
Standard Deviation 1.21
|
0.3 Breaths per minute
Standard Deviation 2.24
|
2.3 Breaths per minute
Standard Deviation 1.87
|
0.2 Breaths per minute
Standard Deviation 2.71
|
|
Change From Baseline in Respiration Rate
Week 1,n=12,6,6,9,9,6
|
-0.5 Breaths per minute
Standard Deviation 3.45
|
0.7 Breaths per minute
Standard Deviation 3.67
|
-0.2 Breaths per minute
Standard Deviation 1.33
|
-0.6 Breaths per minute
Standard Deviation 1.67
|
0.4 Breaths per minute
Standard Deviation 1.81
|
-1.8 Breaths per minute
Standard Deviation 2.71
|
|
Change From Baseline in Respiration Rate
Week 2,n=12,6,6,9,9,6
|
-0.3 Breaths per minute
Standard Deviation 2.15
|
0.7 Breaths per minute
Standard Deviation 4.08
|
0.2 Breaths per minute
Standard Deviation 2.23
|
1.1 Breaths per minute
Standard Deviation 2.76
|
0.9 Breaths per minute
Standard Deviation 2.98
|
-0.2 Breaths per minute
Standard Deviation 3.06
|
|
Change From Baseline in Respiration Rate
Week 4,n=12,6,6,9,9,6
|
0.5 Breaths per minute
Standard Deviation 3.18
|
1.5 Breaths per minute
Standard Deviation 2.59
|
1.5 Breaths per minute
Standard Deviation 1.22
|
0.4 Breaths per minute
Standard Deviation 1.88
|
1.2 Breaths per minute
Standard Deviation 2.17
|
-0.5 Breaths per minute
Standard Deviation 3.89
|
|
Change From Baseline in Respiration Rate
Week 8,n=12,6,6,9,9,6
|
-0.5 Breaths per minute
Standard Deviation 2.71
|
0.5 Breaths per minute
Standard Deviation 2.81
|
0.3 Breaths per minute
Standard Deviation 2.42
|
0.1 Breaths per minute
Standard Deviation 3.41
|
2.3 Breaths per minute
Standard Deviation 2.18
|
0.7 Breaths per minute
Standard Deviation 2.80
|
|
Change From Baseline in Respiration Rate
Week 12,n=12,6,6,9,9,6
|
0.0 Breaths per minute
Standard Deviation 3.49
|
0.7 Breaths per minute
Standard Deviation 4.63
|
0.7 Breaths per minute
Standard Deviation 2.16
|
1.2 Breaths per minute
Standard Deviation 2.86
|
0.9 Breaths per minute
Standard Deviation 1.69
|
-0.3 Breaths per minute
Standard Deviation 2.88
|
|
Change From Baseline in Respiration Rate
Week 36,n=6,0,0,9,9,0
|
0.2 Breaths per minute
Standard Deviation 1.83
|
—
|
—
|
0.2 Breaths per minute
Standard Deviation 2.64
|
1.3 Breaths per minute
Standard Deviation 1.50
|
—
|
|
Change From Baseline in Respiration Rate
Day 5,n=12,6,6,9,9,6
|
-1.1 Breaths per minute
Standard Deviation 2.39
|
0.7 Breaths per minute
Standard Deviation 3.20
|
-1.5 Breaths per minute
Standard Deviation 1.05
|
0.0 Breaths per minute
Standard Deviation 2.55
|
1.3 Breaths per minute
Standard Deviation 2.18
|
0.0 Breaths per minute
Standard Deviation 1.41
|
|
Change From Baseline in Respiration Rate
8 hours Day1,n=12,6,6,9,9,6
|
-0.1 Breaths per minute
Standard Deviation 2.19
|
0.5 Breaths per minute
Standard Deviation 3.27
|
-1.0 Breaths per minute
Standard Deviation 1.79
|
1.0 Breaths per minute
Standard Deviation 3.28
|
2.1 Breaths per minute
Standard Deviation 1.83
|
0.3 Breaths per minute
Standard Deviation 1.63
|
|
Change From Baseline in Respiration Rate
Day 2,n=12,6,6,9,9,6
|
-0.7 Breaths per minute
Standard Deviation 2.64
|
1.7 Breaths per minute
Standard Deviation 2.58
|
-1.2 Breaths per minute
Standard Deviation 1.47
|
1.9 Breaths per minute
Standard Deviation 1.96
|
1.8 Breaths per minute
Standard Deviation 1.30
|
1.5 Breaths per minute
Standard Deviation 2.07
|
|
Change From Baseline in Respiration Rate
Week 18,n=12,6,6,9,9,6
|
0.5 Breaths per minute
Standard Deviation 3.66
|
-0.2 Breaths per minute
Standard Deviation 3.06
|
-0.7 Breaths per minute
Standard Deviation 1.97
|
1.4 Breaths per minute
Standard Deviation 2.07
|
1.4 Breaths per minute
Standard Deviation 1.42
|
1.2 Breaths per minute
Standard Deviation 3.25
|
|
Change From Baseline in Respiration Rate
Week 24,n=12,6,6,9,9,6
|
-0.8 Breaths per minute
Standard Deviation 2.59
|
-0.7 Breaths per minute
Standard Deviation 4.41
|
-0.7 Breaths per minute
Standard Deviation 1.51
|
1.4 Breaths per minute
Standard Deviation 2.13
|
0.7 Breaths per minute
Standard Deviation 2.40
|
0.8 Breaths per minute
Standard Deviation 1.94
|
|
Change From Baseline in Respiration Rate
Week 26,n=12,6,6,9,9,6
|
-1.1 Breaths per minute
Standard Deviation 2.43
|
0.5 Breaths per minute
Standard Deviation 3.02
|
-0.7 Breaths per minute
Standard Deviation 1.51
|
0.6 Breaths per minute
Standard Deviation 2.01
|
1.6 Breaths per minute
Standard Deviation 2.19
|
0.3 Breaths per minute
Standard Deviation 3.01
|
|
Change From Baseline in Respiration Rate
Week 32,n=6,6,6,0,0,6
|
-1.5 Breaths per minute
Standard Deviation 1.76
|
1.3 Breaths per minute
Standard Deviation 3.01
|
0.7 Breaths per minute
Standard Deviation 2.34
|
—
|
—
|
1.0 Breaths per minute
Standard Deviation 3.10
|
|
Change From Baseline in Respiration Rate
Week 40,n=2,0,0,0,0,6
|
-2.0 Breaths per minute
Standard Deviation 1.41
|
—
|
—
|
—
|
—
|
-0.3 Breaths per minute
Standard Deviation 1.86
|
PRIMARY outcome
Timeframe: Baseline and at 2 and 8 hours on Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
12-lead ECG were performed in a supine position using an automated ECG machine that calculated the heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. ECG measurements were performed in triplicate. When multiple ECGs were performed at the same planned timepoint, the average value of each parameter was used. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
Day 2,n=12,6,6,9,9,6
|
0.4 Beats per minute
Standard Deviation 4.68
|
-0.4 Beats per minute
Standard Deviation 5.67
|
0.8 Beats per minute
Standard Deviation 5.29
|
-1.4 Beats per minute
Standard Deviation 6.32
|
-0.3 Beats per minute
Standard Deviation 7.34
|
0.3 Beats per minute
Standard Deviation 1.06
|
|
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
Day 4,n=12,6,6,9,9,6
|
3.5 Beats per minute
Standard Deviation 5.11
|
1.5 Beats per minute
Standard Deviation 8.64
|
5.5 Beats per minute
Standard Deviation 9.13
|
3.1 Beats per minute
Standard Deviation 11.04
|
2.6 Beats per minute
Standard Deviation 4.60
|
3.2 Beats per minute
Standard Deviation 3.97
|
|
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
Day 5,n=12,6,6,9,9,6
|
1.8 Beats per minute
Standard Deviation 4.78
|
1.5 Beats per minute
Standard Deviation 9.63
|
0.8 Beats per minute
Standard Deviation 5.24
|
2.5 Beats per minute
Standard Deviation 5.29
|
-0.4 Beats per minute
Standard Deviation 5.97
|
2.6 Beats per minute
Standard Deviation 4.75
|
|
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
Week 2,n=12,6,6,9,9,6
|
-4.2 Beats per minute
Standard Deviation 5.32
|
-2.3 Beats per minute
Standard Deviation 5.02
|
-5.9 Beats per minute
Standard Deviation 5.91
|
1.8 Beats per minute
Standard Deviation 10.26
|
1.7 Beats per minute
Standard Deviation 13.56
|
1.7 Beats per minute
Standard Deviation 7.11
|
|
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
Week 4,n=12,6,6,9,9,6
|
-3.8 Beats per minute
Standard Deviation 7.01
|
-1.6 Beats per minute
Standard Deviation 3.75
|
-1.2 Beats per minute
Standard Deviation 3.45
|
-1.6 Beats per minute
Standard Deviation 7.53
|
-0.3 Beats per minute
Standard Deviation 14.55
|
-0.9 Beats per minute
Standard Deviation 6.25
|
|
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
Week 18,n=12,6,6,9,9,6
|
-3.4 Beats per minute
Standard Deviation 9.05
|
-0.4 Beats per minute
Standard Deviation 6.59
|
-3.3 Beats per minute
Standard Deviation 5.20
|
1.6 Beats per minute
Standard Deviation 6.92
|
0.6 Beats per minute
Standard Deviation 8.78
|
2.2 Beats per minute
Standard Deviation 4.65
|
|
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
Week 24,n=12,6,6,9,9,6
|
-2.7 Beats per minute
Standard Deviation 7.95
|
-0.2 Beats per minute
Standard Deviation 8.28
|
2.5 Beats per minute
Standard Deviation 8.00
|
-0.3 Beats per minute
Standard Deviation 9.13
|
1.7 Beats per minute
Standard Deviation 11.03
|
1.2 Beats per minute
Standard Deviation 6.47
|
|
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
Week 26,n=12,6,6,9,9,6
|
-2.0 Beats per minute
Standard Deviation 9.35
|
-0.3 Beats per minute
Standard Deviation 5.16
|
-1.5 Beats per minute
Standard Deviation 7.18
|
2.5 Beats per minute
Standard Deviation 11.97
|
2.0 Beats per minute
Standard Deviation 8.22
|
0.3 Beats per minute
Standard Deviation 7.66
|
|
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
Week 32,n=6,6,6,0,0,6
|
-2.7 Beats per minute
Standard Deviation 9.21
|
-4.6 Beats per minute
Standard Deviation 7.34
|
0.7 Beats per minute
Standard Deviation 5.84
|
—
|
—
|
2.3 Beats per minute
Standard Deviation 6.46
|
|
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
Week 36,n=6,0,0,9,9,0
|
1.5 Beats per minute
Standard Deviation 7.13
|
—
|
—
|
-0.2 Beats per minute
Standard Deviation 10.26
|
1.3 Beats per minute
Standard Deviation 5.74
|
—
|
|
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
Week 40,n=2,0,0,0,0,6
|
-4.3 Beats per minute
Standard Deviation 0.47
|
—
|
—
|
—
|
—
|
3.6 Beats per minute
Standard Deviation 9.08
|
|
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
2 hours Day1,n=12,6,5,9,8,6
|
1.4 Beats per minute
Standard Deviation 11.13
|
-4.3 Beats per minute
Standard Deviation 7.81
|
-4.6 Beats per minute
Standard Deviation 4.56
|
0.2 Beats per minute
Standard Deviation 11.06
|
0.3 Beats per minute
Standard Deviation 11.85
|
6.8 Beats per minute
Standard Deviation 7.01
|
|
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
8 hours Day1,n=12,6,6,9,9,6
|
0.1 Beats per minute
Standard Deviation 6.34
|
-0.8 Beats per minute
Standard Deviation 8.93
|
-6.3 Beats per minute
Standard Deviation 6.10
|
-1.3 Beats per minute
Standard Deviation 6.23
|
0.0 Beats per minute
Standard Deviation 14.05
|
4.1 Beats per minute
Standard Deviation 6.20
|
|
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
Day 3,n=12,6,6,9,9,6
|
1.5 Beats per minute
Standard Deviation 5.93
|
0.3 Beats per minute
Standard Deviation 4.15
|
0.4 Beats per minute
Standard Deviation 7.36
|
1.5 Beats per minute
Standard Deviation 7.03
|
3.1 Beats per minute
Standard Deviation 3.48
|
1.9 Beats per minute
Standard Deviation 3.69
|
|
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
Week 1,n=12,6,6,9,9,6
|
-2.8 Beats per minute
Standard Deviation 5.74
|
1.6 Beats per minute
Standard Deviation 5.76
|
-2.4 Beats per minute
Standard Deviation 5.53
|
2.4 Beats per minute
Standard Deviation 9.66
|
2.0 Beats per minute
Standard Deviation 4.76
|
4.9 Beats per minute
Standard Deviation 7.60
|
|
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
Week 8,n=12,6,6,9,9,6
|
-0.8 Beats per minute
Standard Deviation 5.91
|
-0.6 Beats per minute
Standard Deviation 6.22
|
-2.0 Beats per minute
Standard Deviation 6.02
|
-2.9 Beats per minute
Standard Deviation 7.50
|
-0.7 Beats per minute
Standard Deviation 9.14
|
0.6 Beats per minute
Standard Deviation 4.97
|
|
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
Week 12,n=12,6,6,9,9,6
|
0.3 Beats per minute
Standard Deviation 11.83
|
-1.3 Beats per minute
Standard Deviation 6.24
|
-3.3 Beats per minute
Standard Deviation 6.35
|
1.8 Beats per minute
Standard Deviation 15.28
|
0.4 Beats per minute
Standard Deviation 11.55
|
1.3 Beats per minute
Standard Deviation 6.44
|
PRIMARY outcome
Timeframe: Baseline and at 2 and 8 hours on Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
12-lead ECG were performed in a supine position using an automated ECG machine that calculated PR interval, QRS interval, QT interval and QTcF interval. ECG measurements were performed in triplicate. When multiple ECGs were performed at the same planned timepoint, the average value of each parameter was used. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QRS Interval,Day 4,n=12,6,6,9,9,6
|
0.4 Milliseconds
Standard Deviation 3.78
|
1.9 Milliseconds
Standard Deviation 3.72
|
-7.8 Milliseconds
Standard Deviation 5.52
|
1.1 Milliseconds
Standard Deviation 5.28
|
-0.7 Milliseconds
Standard Deviation 5.24
|
-2.2 Milliseconds
Standard Deviation 3.38
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
PR Interval,2 hours Day1,n=12,6,5,9,8,6
|
-4.5 Milliseconds
Standard Deviation 9.46
|
3.9 Milliseconds
Standard Deviation 2.85
|
3.5 Milliseconds
Standard Deviation 8.47
|
-4.3 Milliseconds
Standard Deviation 9.10
|
3.7 Milliseconds
Standard Deviation 1.075
|
-7.5 Milliseconds
Standard Deviation 12.23
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
PR Interval,8 hours Day1,n=12,6,6,9,9,6
|
-4.1 Milliseconds
Standard Deviation 8.49
|
3.1 Milliseconds
Standard Deviation 6.02
|
-1.8 Milliseconds
Standard Deviation 3.72
|
-4.5 Milliseconds
Standard Deviation 11.76
|
1.9 Milliseconds
Standard Deviation 11.39
|
-3.3 Milliseconds
Standard Deviation 10.88
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
PR Interval,Day 4,n=12,6,6,9,9,6
|
-0.6 Milliseconds
Standard Deviation 6.80
|
8.1 Milliseconds
Standard Deviation 5.21
|
-2.5 Milliseconds
Standard Deviation 6.12
|
-2.3 Milliseconds
Standard Deviation 8.88
|
8.6 Milliseconds
Standard Deviation 10.17
|
-4.3 Milliseconds
Standard Deviation 7.54
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
PR Interval,Week 1,n=12,6,6,9,9,6
|
-0.3 Milliseconds
Standard Deviation 8.12
|
0.8 Milliseconds
Standard Deviation 5.58
|
2.2 Milliseconds
Standard Deviation 5.69
|
-3.2 Milliseconds
Standard Deviation 12.26
|
7.0 Milliseconds
Standard Deviation 6.62
|
4.5 Milliseconds
Standard Deviation 6.73
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
PR Interval,Week 2,n=12,6,6,9,9,6
|
-1.0 Milliseconds
Standard Deviation 8.62
|
5.3 Milliseconds
Standard Deviation 6.60
|
5.5 Milliseconds
Standard Deviation 10.34
|
1.8 Milliseconds
Standard Deviation 12.19
|
2.0 Milliseconds
Standard Deviation 12.64
|
1.0 Milliseconds
Standard Deviation 2.97
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
PR Interval,Week 4,n=12,6,6,8,9,6
|
1.7 Milliseconds
Standard Deviation 10.27
|
5.2 Milliseconds
Standard Deviation 3.37
|
1.8 Milliseconds
Standard Deviation 12.71
|
-1.8 Milliseconds
Standard Deviation 15.25
|
3.9 Milliseconds
Standard Deviation 11.28
|
-4.0 Milliseconds
Standard Deviation 17.49
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
PR Interval,Week 8,n=12,6,6,9,9,6
|
-3.1 Milliseconds
Standard Deviation 8.27
|
3.2 Milliseconds
Standard Deviation 9.65
|
-2.6 Milliseconds
Standard Deviation 10.27
|
-3.6 Milliseconds
Standard Deviation 10.33
|
3.4 Milliseconds
Standard Deviation 8.10
|
-1.9 Milliseconds
Standard Deviation 9.55
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
PR Interval,Week 12,n=12,6,6,9,9,6
|
-2.4 Milliseconds
Standard Deviation 7.87
|
3.9 Milliseconds
Standard Deviation 10.53
|
-4.4 Milliseconds
Standard Deviation 12.18
|
-3.8 Milliseconds
Standard Deviation 13.26
|
9.4 Milliseconds
Standard Deviation 8.33
|
-2.1 Milliseconds
Standard Deviation 10.04
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
PR Interval,Week 24,n=12,6,6,9,9,6
|
2.3 Milliseconds
Standard Deviation 7.98
|
1.4 Milliseconds
Standard Deviation 3.91
|
3.7 Milliseconds
Standard Deviation 7.25
|
-7.4 Milliseconds
Standard Deviation 11.56
|
5.5 Milliseconds
Standard Deviation 12.45
|
-5.6 Milliseconds
Standard Deviation 7.87
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
PR Interval,Week 26,n=12,6,6,9,9,6
|
1.1 Milliseconds
Standard Deviation 6.20
|
3.0 Milliseconds
Standard Deviation 4.67
|
3.7 Milliseconds
Standard Deviation 11.62
|
-3.2 Milliseconds
Standard Deviation 13.01
|
6.9 Milliseconds
Standard Deviation 11.36
|
-4.8 Milliseconds
Standard Deviation 11.69
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
PR Interval,Week 32,n=6,6,6,0,0,6
|
-4.3 Milliseconds
Standard Deviation 8.16
|
5.4 Milliseconds
Standard Deviation 7.23
|
0.0 Milliseconds
Standard Deviation 7.99
|
—
|
—
|
-3.3 Milliseconds
Standard Deviation 11.91
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
PR Interval,Week 36,n=6,0,0,9,9,0
|
-0.5 Milliseconds
Standard Deviation 8.26
|
—
|
—
|
-3.7 Milliseconds
Standard Deviation 8.49
|
2.9 Milliseconds
Standard Deviation 12.08
|
—
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QRS Interval,Day 2,n=12,6,6,9,9,6
|
1.8 Milliseconds
Standard Deviation 4.64
|
0.5 Milliseconds
Standard Deviation 4.63
|
-4.9 Milliseconds
Standard Deviation 4.60
|
-2.7 Milliseconds
Standard Deviation 5.28
|
-3.0 Milliseconds
Standard Deviation 6.27
|
-3.7 Milliseconds
Standard Deviation 4.62
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QRS Interval,Week 2,n=12,6,6,9,9,6
|
2.1 Milliseconds
Standard Deviation 3.76
|
2.1 Milliseconds
Standard Deviation 4.82
|
-3.9 Milliseconds
Standard Deviation 4.76
|
0.9 Milliseconds
Standard Deviation 2.86
|
-3.0 Milliseconds
Standard Deviation 5.47
|
-1.4 Milliseconds
Standard Deviation 3.11
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QRS Interval,Week 4,n=12,6,6,8,9,6
|
2.0 Milliseconds
Standard Deviation 6.49
|
1.8 Milliseconds
Standard Deviation 7.34
|
-6.5 Milliseconds
Standard Deviation 7.76
|
1.9 Milliseconds
Standard Deviation 4.79
|
-2.6 Milliseconds
Standard Deviation 4.98
|
-3.3 Milliseconds
Standard Deviation 3.39
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QRS Interval,Week 12,n=12,6,6,9,9,6
|
1.6 Milliseconds
Standard Deviation 4.20
|
3.1 Milliseconds
Standard Deviation 3.28
|
-4.4 Milliseconds
Standard Deviation 6.04
|
-0.1 Milliseconds
Standard Deviation 5.23
|
-2.5 Milliseconds
Standard Deviation 3.11
|
-1.1 Milliseconds
Standard Deviation 3.21
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QRS Interval,Week 18,n=12,6,6,9,9,6
|
0.6 Milliseconds
Standard Deviation 3.90
|
1.8 Milliseconds
Standard Deviation 2.79
|
-5.0 Milliseconds
Standard Deviation 5.43
|
0.4 Milliseconds
Standard Deviation 3.16
|
-2.9 Milliseconds
Standard Deviation 4.53
|
-1.6 Milliseconds
Standard Deviation 4.17
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QRS Interval,Week 24,n=12,6,6,9,9,6
|
0.6 Milliseconds
Standard Deviation 5.94
|
1.8 Milliseconds
Standard Deviation 6.53
|
-6.5 Milliseconds
Standard Deviation 5.56
|
-1.1 Milliseconds
Standard Deviation 3.76
|
-3.1 Milliseconds
Standard Deviation 2.01
|
-1.8 Milliseconds
Standard Deviation 5.12
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QT Interval,8 hours Day1,n=12,6,6,9,9,6
|
-7.5 Milliseconds
Standard Deviation 16.46
|
6.7 Milliseconds
Standard Deviation 16.22
|
12.6 Milliseconds
Standard Deviation 18.53
|
1.5 Milliseconds
Standard Deviation 14.29
|
-0.7 Milliseconds
Standard Deviation 29.93
|
-7.6 Milliseconds
Standard Deviation 22.43
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QT Interval,Week 24,n=12,6,6,9,9,6
|
7.1 Milliseconds
Standard Deviation 23.22
|
4.2 Milliseconds
Standard Deviation 18.11
|
-9.9 Milliseconds
Standard Deviation 27.45
|
0.7 Milliseconds
Standard Deviation 19.24
|
-8.6 Milliseconds
Standard Deviation 19.00
|
7.9 Milliseconds
Standard Deviation 23.80
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QTcF Interval,Week 1,n=12,6,6,9,9,6
|
-0.2 Milliseconds
Standard Deviation 10.95
|
10.3 Milliseconds
Standard Deviation 7.33
|
-6.7 Milliseconds
Standard Deviation 12.72
|
-5.4 Milliseconds
Standard Deviation 8.38
|
2.8 Milliseconds
Standard Deviation 12.12
|
5.5 Milliseconds
Standard Deviation 13.80
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QTcF Interval,Week 2,n=12,6,6,9,9,6
|
0.9 Milliseconds
Standard Deviation 16.40
|
6.3 Milliseconds
Standard Deviation 6.98
|
-8.3 Milliseconds
Standard Deviation 8.21
|
3.7 Milliseconds
Standard Deviation 19.35
|
-2.3 Milliseconds
Standard Deviation 12.64
|
11.5 Milliseconds
Standard Deviation 12.63
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QTcF Interval,Week 18,n=12,6,6,9,9,6
|
-0.5 Milliseconds
Standard Deviation 11.73
|
4.8 Milliseconds
Standard Deviation 6.79
|
-10.4 Milliseconds
Standard Deviation 9.42
|
-0.6 Milliseconds
Standard Deviation 12.29
|
-5.2 Milliseconds
Standard Deviation 12.81
|
5.9 Milliseconds
Standard Deviation 11.16
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QTcF Interval,Week 26,n=12,6,6,9,9,6
|
-1.9 Milliseconds
Standard Deviation 16.58
|
9.6 Milliseconds
Standard Deviation 9.37
|
-3.9 Milliseconds
Standard Deviation 14.54
|
-1.7 Milliseconds
Standard Deviation 10.65
|
-4.4 Milliseconds
Standard Deviation 12.21
|
12.8 Milliseconds
Standard Deviation 8.59
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QT Interval,Day 2,n=12,6,6,9,9,6
|
-4.9 Milliseconds
Standard Deviation 19.32
|
4.3 Milliseconds
Standard Deviation 14.01
|
-14.1 Milliseconds
Standard Deviation 16.26
|
-3.0 Milliseconds
Standard Deviation 18.80
|
-6.1 Milliseconds
Standard Deviation 15.86
|
-0.6 Milliseconds
Standard Deviation 11.09
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
PR Interval,Day 2,n=12,6,6,9,9,6
|
-2.7 Milliseconds
Standard Deviation 11.51
|
2.0 Milliseconds
Standard Deviation 4.11
|
1.4 Milliseconds
Standard Deviation 3.95
|
-4.4 Milliseconds
Standard Deviation 9.86
|
6.2 Milliseconds
Standard Deviation 11.05
|
-4.1 Milliseconds
Standard Deviation 11.25
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
PR Interval, Day 3,n=12,6,6,9,9,6
|
2.3 Milliseconds
Standard Deviation 6.68
|
5.2 Milliseconds
Standard Deviation 4.29
|
0.5 Milliseconds
Standard Deviation 5.62
|
-3.6 Milliseconds
Standard Deviation 11.96
|
6.0 Milliseconds
Standard Deviation 7.60
|
-1.4 Milliseconds
Standard Deviation 8.82
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
PR Interval,Day 5,n=12,6,6,9,9,6
|
1.3 Milliseconds
Standard Deviation 6.22
|
8.3 Milliseconds
Standard Deviation 8.22
|
3.5 Milliseconds
Standard Deviation 10.05
|
-0.2 Milliseconds
Standard Deviation 4.54
|
10.0 Milliseconds
Standard Deviation 8.44
|
-1.2 Milliseconds
Standard Deviation 4.91
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
PR Interval,Week 18,n=12,6,6,9,9,6
|
1.5 Milliseconds
Standard Deviation 10.74
|
1.5 Milliseconds
Standard Deviation 3.99
|
0.1 Milliseconds
Standard Deviation 7.74
|
-5.6 Milliseconds
Standard Deviation 11.87
|
7.3 Milliseconds
Standard Deviation 13.34
|
-2.0 Milliseconds
Standard Deviation 9.72
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
PR Interval,Week 40,n=2,0,0,0,0,6
|
-13.7 Milliseconds
Standard Deviation 6.60
|
—
|
—
|
—
|
—
|
-3.6 Milliseconds
Standard Deviation 8.56
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QRS Interval,2 hours Day1,n=12,6,5,9,8,6
|
1.1 Milliseconds
Standard Deviation 4.87
|
0.2 Milliseconds
Standard Deviation 4.63
|
-7.2 Milliseconds
Standard Deviation 4.97
|
0.0 Milliseconds
Standard Deviation 4.43
|
-1.5 Milliseconds
Standard Deviation 6.14
|
-1.2 Milliseconds
Standard Deviation 3.62
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QRS Interval,8 hours Day1,n=12,6,6,9,9,6
|
-0.3 Milliseconds
Standard Deviation 6.83
|
-0.2 Milliseconds
Standard Deviation 6.81
|
-4.0 Milliseconds
Standard Deviation 6.18
|
-1.1 Milliseconds
Standard Deviation 3.18
|
-2.8 Milliseconds
Standard Deviation 5.03
|
-3.1 Milliseconds
Standard Deviation 4.42
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QRS Interval, Day 3,n=12,6,6,9,9,6
|
1.4 Milliseconds
Standard Deviation 3.44
|
1.4 Milliseconds
Standard Deviation 4.18
|
-1.3 Milliseconds
Standard Deviation 3.14
|
-0.6 Milliseconds
Standard Deviation 4.03
|
-2.6 Milliseconds
Standard Deviation 5.15
|
-2.6 Milliseconds
Standard Deviation 1.54
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QRS Interval,Day 5,n=12,6,6,9,9,6
|
-0.5 Milliseconds
Standard Deviation 4.05
|
0.2 Milliseconds
Standard Deviation 5.85
|
-7.3 Milliseconds
Standard Deviation 4.79
|
-0.2 Milliseconds
Standard Deviation 5.40
|
0.7 Milliseconds
Standard Deviation 5.09
|
-2.9 Milliseconds
Standard Deviation 2.35
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QRS Interval,Week 1,n=12,6,6,9,9,6
|
2.3 Milliseconds
Standard Deviation 5.05
|
0.6 Milliseconds
Standard Deviation 5.85
|
-3.7 Milliseconds
Standard Deviation 6.18
|
0.6 Milliseconds
Standard Deviation 4.90
|
-2.4 Milliseconds
Standard Deviation 5.61
|
-2.8 Milliseconds
Standard Deviation 4.20
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QRS Interval,Week 8,n=12,6,6,9,9,6
|
1.9 Milliseconds
Standard Deviation 7.27
|
-1.0 Milliseconds
Standard Deviation 4.35
|
-3.6 Milliseconds
Standard Deviation 5.23
|
0.9 Milliseconds
Standard Deviation 4.12
|
0.5 Milliseconds
Standard Deviation 5.71
|
-1.9 Milliseconds
Standard Deviation 1.83
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QRS Interval,Week 26,n=12,6,6,9,9,6
|
0.0 Milliseconds
Standard Deviation 4.61
|
2.1 Milliseconds
Standard Deviation 4.64
|
-5.5 Milliseconds
Standard Deviation 5.75
|
0.4 Milliseconds
Standard Deviation 5.55
|
-2.7 Milliseconds
Standard Deviation 6.57
|
0.4 Milliseconds
Standard Deviation 3.40
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QRS Interval,Week 32,n=6,6,6,0,0,6
|
2.9 Milliseconds
Standard Deviation 5.78
|
2.0 Milliseconds
Standard Deviation 5.17
|
-6.1 Milliseconds
Standard Deviation 4.50
|
—
|
—
|
-1.3 Milliseconds
Standard Deviation 2.56
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QRS Interval,Week 36,n=6,0,0,9,9,0
|
-3.7 Milliseconds
Standard Deviation 6.19
|
—
|
—
|
0.7 Milliseconds
Standard Deviation 5.14
|
-3.9 Milliseconds
Standard Deviation 4.84
|
—
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QRS Interval,Week 40,n=2,0,0,0,0,6
|
0.0 Milliseconds
Standard Deviation 0.47
|
—
|
—
|
—
|
—
|
-3.0 Milliseconds
Standard Deviation 3.47
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QT Interval,2 hours Day1,n=12,6,5,9,8,6
|
-2.6 Milliseconds
Standard Deviation 22.55
|
14.8 Milliseconds
Standard Deviation 16.65
|
6.0 Milliseconds
Standard Deviation 11.28
|
-2.9 Milliseconds
Standard Deviation 20.19
|
-3.7 Milliseconds
Standard Deviation 23.95
|
-9.2 Milliseconds
Standard Deviation 18.68
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QT Interval, Day 3,n=12,6,6,9,9,6
|
-10.1 Milliseconds
Standard Deviation 19.82
|
-0.9 Milliseconds
Standard Deviation 10.33
|
-6.9 Milliseconds
Standard Deviation 14.95
|
-7.6 Milliseconds
Standard Deviation 18.49
|
-13.2 Milliseconds
Standard Deviation 15.20
|
-2.4 Milliseconds
Standard Deviation 9.29
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QT Interval,Day 4,n=12,6,6,9,9,6
|
-12.3 Milliseconds
Standard Deviation 17.15
|
-2.2 Milliseconds
Standard Deviation 14.32
|
-15.9 Milliseconds
Standard Deviation 21.55
|
-11.6 Milliseconds
Standard Deviation 25.81
|
-10.9 Milliseconds
Standard Deviation 11.99
|
-3.2 Milliseconds
Standard Deviation 17.05
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QT Interval,Day 5,n=12,6,6,9,9,6
|
-5.9 Milliseconds
Standard Deviation 14.18
|
-2.2 Milliseconds
Standard Deviation 21.88
|
-14.3 Milliseconds
Standard Deviation 13.83
|
-9.5 Milliseconds
Standard Deviation 14.97
|
-4.1 Milliseconds
Standard Deviation 18.72
|
-1.3 Milliseconds
Standard Deviation 11.57
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QT Interval,Week 1,n=12,6,6,9,9,6
|
5.3 Milliseconds
Standard Deviation 17.30
|
8.7 Milliseconds
Standard Deviation 14.19
|
0.0 Milliseconds
Standard Deviation 21.14
|
-9.4 Milliseconds
Standard Deviation 19.82
|
-1.0 Milliseconds
Standard Deviation 22.22
|
-5.6 Milliseconds
Standard Deviation 23.13
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QT Interval,Week 2,n=12,6,6,9,9,6
|
9.4 Milliseconds
Standard Deviation 16.23
|
12.9 Milliseconds
Standard Deviation 8.14
|
7.8 Milliseconds
Standard Deviation 17.65
|
1.0 Milliseconds
Standard Deviation 22.66
|
-6.1 Milliseconds
Standard Deviation 17.10
|
8.3 Milliseconds
Standard Deviation 20.06
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QT Interval,Week 4,n=12,6,6,8,9,6
|
9.4 Milliseconds
Standard Deviation 20.43
|
11.0 Milliseconds
Standard Deviation 4.78
|
-3.6 Milliseconds
Standard Deviation 24.50
|
3.3 Milliseconds
Standard Deviation 17.80
|
1.7 Milliseconds
Standard Deviation 34.52
|
14.0 Milliseconds
Standard Deviation 18.29
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QT Interval,Week 8,n=12,6,6,9,9,6
|
-0.6 Milliseconds
Standard Deviation 20.74
|
6.9 Milliseconds
Standard Deviation 9.28
|
1.0 Milliseconds
Standard Deviation 23.62
|
4.6 Milliseconds
Standard Deviation 19.06
|
-2.0 Milliseconds
Standard Deviation 20.79
|
6.0 Milliseconds
Standard Deviation 15.76
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QT Interval,Week 12,n=12,6,6,9,9,6
|
-6.8 Milliseconds
Standard Deviation 20.64
|
8.1 Milliseconds
Standard Deviation 16.21
|
4.2 Milliseconds
Standard Deviation 22.53
|
-6.5 Milliseconds
Standard Deviation 28.72
|
-2.1 Milliseconds
Standard Deviation 26.69
|
1.1 Milliseconds
Standard Deviation 14.24
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QT Interval,Week 18,n=12,6,6,9,9,6
|
7.3 Milliseconds
Standard Deviation 22.44
|
6.3 Milliseconds
Standard Deviation 15.00
|
-2.8 Milliseconds
Standard Deviation 15.12
|
-4.5 Milliseconds
Standard Deviation 19.10
|
-6.7 Milliseconds
Standard Deviation 23.77
|
0.5 Milliseconds
Standard Deviation 12.14
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QT Interval,Week 26,n=12,6,6,9,9,6
|
2.3 Milliseconds
Standard Deviation 27.36
|
10.2 Milliseconds
Standard Deviation 12.92
|
0.9 Milliseconds
Standard Deviation 29.72
|
-6.1 Milliseconds
Standard Deviation 22.91
|
-9.8 Milliseconds
Standard Deviation 18.29
|
13.2 Milliseconds
Standard Deviation 20.96
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QT Interval,Week 32,n=6,6,6,0,0,6
|
5.7 Milliseconds
Standard Deviation 20.32
|
12.9 Milliseconds
Standard Deviation 12.12
|
-14.4 Milliseconds
Standard Deviation 17.64
|
—
|
—
|
5.3 Milliseconds
Standard Deviation 14.64
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QT Interval,Week 36,n=6,0,0,9,9,0
|
-6.4 Milliseconds
Standard Deviation 41.25
|
—
|
—
|
-3.4 Milliseconds
Standard Deviation 29.83
|
-9.3 Milliseconds
Standard Deviation 16.00
|
—
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QT Interval,Week 40,n=2,0,0,0,0,6
|
23.5 Milliseconds
Standard Deviation 17.68
|
—
|
—
|
—
|
—
|
-0.9 Milliseconds
Standard Deviation 24.13
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QTcF Interval,2 hours Day1,n=12,6,5,9,8,6
|
-0.6 Milliseconds
Standard Deviation 9.11
|
4.1 Milliseconds
Standard Deviation 8.67
|
-5.5 Milliseconds
Standard Deviation 8.11
|
-3.4 Milliseconds
Standard Deviation 6.40
|
-2.3 Milliseconds
Standard Deviation 5.38
|
6.4 Milliseconds
Standard Deviation 5.17
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QTcF Interval,8 hours Day1,n=12,6,6,9,9,6
|
-6.8 Milliseconds
Standard Deviation 12.97
|
4.3 Milliseconds
Standard Deviation 7.93
|
-3.6 Milliseconds
Standard Deviation 12.32
|
-1.4 Milliseconds
Standard Deviation 9.87
|
-0.4 Milliseconds
Standard Deviation 8.32
|
2.1 Milliseconds
Standard Deviation 13.97
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QTcF Interval,Day 2,n=12,6,6,9,9,6
|
-4.0 Milliseconds
Standard Deviation 11.78
|
2.6 Milliseconds
Standard Deviation 8.43
|
-12.8 Milliseconds
Standard Deviation 10.87
|
-6.9 Milliseconds
Standard Deviation 9.34
|
-5.9 Milliseconds
Standard Deviation 5.70
|
-0.2 Milliseconds
Standard Deviation 10.66
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QTcF Interval, Day 3,n=12,6,6,9,9,6
|
-6.8 Milliseconds
Standard Deviation 14.99
|
0.4 Milliseconds
Standard Deviation 5.82
|
-6.5 Milliseconds
Standard Deviation 9.14
|
-5.3 Milliseconds
Standard Deviation 9.95
|
-6.3 Milliseconds
Standard Deviation 10.71
|
1.9 Milliseconds
Standard Deviation 14.28
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QTcF Interval,Day 4,n=12,6,6,9,9,6
|
-4.9 Milliseconds
Standard Deviation 14.08
|
0.7 Milliseconds
Standard Deviation 7.62
|
-6.1 Milliseconds
Standard Deviation 7.10
|
-7.7 Milliseconds
Standard Deviation 12.56
|
-4.8 Milliseconds
Standard Deviation 10.75
|
3.5 Milliseconds
Standard Deviation 17.05
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QTcF Interval,Day 5,n=12,6,6,9,9,6
|
-1.7 Milliseconds
Standard Deviation 11.97
|
1.5 Milliseconds
Standard Deviation 14.24
|
-13.6 Milliseconds
Standard Deviation 11.17
|
-4.7 Milliseconds
Standard Deviation 9.86
|
-4.4 Milliseconds
Standard Deviation 14.31
|
3.9 Milliseconds
Standard Deviation 16.06
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QTcF Interval,Week 4,n=12,6,6,8,9,6
|
-0.6 Milliseconds
Standard Deviation 11.22
|
7.3 Milliseconds
Standard Deviation 7.10
|
-6.6 Milliseconds
Standard Deviation 20.63
|
0.5 Milliseconds
Standard Deviation 10.86
|
-0.7 Milliseconds
Standard Deviation 10.97
|
11.4 Milliseconds
Standard Deviation 6.33
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QTcF Interval,Week 8,n=12,6,6,9,9,6
|
-2.8 Milliseconds
Standard Deviation 13.76
|
5.2 Milliseconds
Standard Deviation 9.28
|
-4.8 Milliseconds
Standard Deviation 14.70
|
-1.7 Milliseconds
Standard Deviation 11.96
|
-2.9 Milliseconds
Standard Deviation 14.10
|
8.1 Milliseconds
Standard Deviation 20.96
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QTcF Interval,Week 12,n=12,6,6,9,9,6
|
-6.4 Milliseconds
Standard Deviation 14.39
|
5.9 Milliseconds
Standard Deviation 13.50
|
-5.3 Milliseconds
Standard Deviation 10.66
|
-5.9 Milliseconds
Standard Deviation 10.93
|
-1.1 Milliseconds
Standard Deviation 11.91
|
4.7 Milliseconds
Standard Deviation 10.23
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QTcF Interval,Week 24,n=12,6,6,9,9,6
|
1.4 Milliseconds
Standard Deviation 15.42
|
3.0 Milliseconds
Standard Deviation 10.83
|
-7.2 Milliseconds
Standard Deviation 12.14
|
0.4 Milliseconds
Standard Deviation 7.96
|
-3.9 Milliseconds
Standard Deviation 12.69
|
10.1 Milliseconds
Standard Deviation 15.15
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QTcF Interval,Week 32,n=6,6,6,0,0,6
|
0.4 Milliseconds
Standard Deviation 10.98
|
1.3 Milliseconds
Standard Deviation 7.93
|
-13.8 Milliseconds
Standard Deviation 8.76
|
—
|
—
|
11.7 Milliseconds
Standard Deviation 13.74
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QTcF Interval,Week 36,n=6,0,0,9,9,0
|
-3.7 Milliseconds
Standard Deviation 24.89
|
—
|
—
|
-4.3 Milliseconds
Standard Deviation 13.45
|
-5.5 Milliseconds
Standard Deviation 14.23
|
—
|
|
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
QTcF Interval,Week 40,n=2,0,0,0,0,6
|
12.0 Milliseconds
Standard Deviation 17.44
|
—
|
—
|
—
|
—
|
7.5 Milliseconds
Standard Deviation 14.62
|
PRIMARY outcome
Timeframe: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Blood samples were collected at indicated time-points for analysis of clinical parameters like ALP, AST and ALT. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Day 2,n=12,6,5,9,9,6
|
-3.5 International units per Liter
Standard Deviation 3.55
|
-1.2 International units per Liter
Standard Deviation 2.48
|
-0.8 International units per Liter
Standard Deviation 7.19
|
-2.6 International units per Liter
Standard Deviation 4.28
|
-3.9 International units per Liter
Standard Deviation 5.42
|
-3.7 International units per Liter
Standard Deviation 3.88
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Day 3,n=12,6,6,9,9,6
|
-3.8 International units per Liter
Standard Deviation 4.86
|
-0.8 International units per Liter
Standard Deviation 4.62
|
-1.2 International units per Liter
Standard Deviation 7.22
|
-1.8 International units per Liter
Standard Deviation 3.80
|
-5.6 International units per Liter
Standard Deviation 6.58
|
-3.2 International units per Liter
Standard Deviation 4.79
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Day 3,n=12,6,6,9,9,6
|
0.3 International units per Liter
Standard Deviation 5.96
|
2.5 International units per Liter
Standard Deviation 8.17
|
5.3 International units per Liter
Standard Deviation 17.94
|
-0.6 International units per Liter
Standard Deviation 2.51
|
-1.0 International units per Liter
Standard Deviation 3.20
|
1.2 International units per Liter
Standard Deviation 4.96
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Week 24,n=12,6,6,9,9,6
|
1.2 International units per Liter
Standard Deviation 18.52
|
1.3 International units per Liter
Standard Deviation 2.73
|
0.8 International units per Liter
Standard Deviation 5.42
|
-1.1 International units per Liter
Standard Deviation 5.64
|
-2.8 International units per Liter
Standard Deviation 8.76
|
-1.8 International units per Liter
Standard Deviation 3.06
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Week 26,n=12,6,6,9,9,6
|
-2.7 International units per Liter
Standard Deviation 4.08
|
1.8 International units per Liter
Standard Deviation 1.60
|
0.2 International units per Liter
Standard Deviation 3.37
|
0.0 International units per Liter
Standard Deviation 7.00
|
0.1 International units per Liter
Standard Deviation 9.21
|
0.2 International units per Liter
Standard Deviation 3.97
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALP, Week 18,n=12,6,6,9,9,6
|
3.1 International units per Liter
Standard Deviation 6.82
|
-2.0 International units per Liter
Standard Deviation 6.48
|
-1.7 International units per Liter
Standard Deviation 4.84
|
1.9 International units per Liter
Standard Deviation 6.79
|
3.8 International units per Liter
Standard Deviation 8.27
|
-3.5 International units per Liter
Standard Deviation 6.80
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALP, Week 24,n=12,6,6,9,9,6
|
3.8 International units per Liter
Standard Deviation 12.21
|
-1.2 International units per Liter
Standard Deviation 7.94
|
-1.0 International units per Liter
Standard Deviation 4.73
|
1.2 International units per Liter
Standard Deviation 10.51
|
5.8 International units per Liter
Standard Deviation 8.39
|
-0.7 International units per Liter
Standard Deviation 6.74
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALP, Week 26,n=12,6,6,9,9,6
|
3.2 International units per Liter
Standard Deviation 8.64
|
-6.2 International units per Liter
Standard Deviation 8.30
|
-2.2 International units per Liter
Standard Deviation 4.02
|
0.4 International units per Liter
Standard Deviation 10.75
|
4.8 International units per Liter
Standard Deviation 8.24
|
-1.7 International units per Liter
Standard Deviation 6.02
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Day 2,n=12,6,5,9,9,6
|
-0.3 International units per Liter
Standard Deviation 5.12
|
0.3 International units per Liter
Standard Deviation 3.56
|
4.0 International units per Liter
Standard Deviation 14.20
|
-1.6 International units per Liter
Standard Deviation 2.07
|
-0.1 International units per Liter
Standard Deviation 3.26
|
-0.7 International units per Liter
Standard Deviation 2.73
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Day 4,n=12,6,6,9,9,6
|
1.0 International units per Liter
Standard Deviation 5.85
|
3.3 International units per Liter
Standard Deviation 11.08
|
4.2 International units per Liter
Standard Deviation 13.83
|
-1.2 International units per Liter
Standard Deviation 1.86
|
-0.1 International units per Liter
Standard Deviation 2.71
|
1.2 International units per Liter
Standard Deviation 3.43
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Day 5,n=12,6,6,9,9,6
|
1.7 International units per Liter
Standard Deviation 7.96
|
2.0 International units per Liter
Standard Deviation 9.74
|
2.3 International units per Liter
Standard Deviation 8.91
|
-0.6 International units per Liter
Standard Deviation 3.64
|
0.2 International units per Liter
Standard Deviation 3.42
|
4.5 International units per Liter
Standard Deviation 5.32
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Week 1,n=12,6,6,9,9,5
|
1.2 International units per Liter
Standard Deviation 7.76
|
1.3 International units per Liter
Standard Deviation 5.92
|
2.8 International units per Liter
Standard Deviation 7.36
|
0.7 International units per Liter
Standard Deviation 3.61
|
0.6 International units per Liter
Standard Deviation 4.98
|
1.2 International units per Liter
Standard Deviation 5.54
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Week 2,n=12,6,6,9,9,6
|
-0.2 International units per Liter
Standard Deviation 5.57
|
-5.3 International units per Liter
Standard Deviation 7.97
|
-1.3 International units per Liter
Standard Deviation 4.32
|
0.3 International units per Liter
Standard Deviation 4.85
|
-2.3 International units per Liter
Standard Deviation 4.97
|
3.0 International units per Liter
Standard Deviation 2.53
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Week 4,n=12,6,6,9,9,6
|
-0.3 International units per Liter
Standard Deviation 6.43
|
-4.3 International units per Liter
Standard Deviation 7.63
|
0.7 International units per Liter
Standard Deviation 4.23
|
1.4 International units per Liter
Standard Deviation 9.41
|
-2.6 International units per Liter
Standard Deviation 2.55
|
-2.8 International units per Liter
Standard Deviation 4.36
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Week 8,n=12,6,6,9,9,6
|
0.3 International units per Liter
Standard Deviation 7.25
|
-3.3 International units per Liter
Standard Deviation 10.39
|
2.5 International units per Liter
Standard Deviation 6.53
|
-1.6 International units per Liter
Standard Deviation 3.40
|
1.8 International units per Liter
Standard Deviation 9.56
|
-3.0 International units per Liter
Standard Deviation 4.77
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Week 12,n=12,6,6,9,9,6
|
-0.9 International units per Liter
Standard Deviation 6.07
|
-1.7 International units per Liter
Standard Deviation 4.18
|
0.5 International units per Liter
Standard Deviation 3.94
|
-0.4 International units per Liter
Standard Deviation 1.94
|
3.0 International units per Liter
Standard Deviation 5.12
|
-0.7 International units per Liter
Standard Deviation 2.66
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Week 18,n=12,6,6,9,9,6
|
-0.1 International units per Liter
Standard Deviation 6.13
|
-3.5 International units per Liter
Standard Deviation 7.56
|
1.0 International units per Liter
Standard Deviation 10.30
|
1.9 International units per Liter
Standard Deviation 8.81
|
4.4 International units per Liter
Standard Deviation 6.93
|
-0.7 International units per Liter
Standard Deviation 5.20
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Week 24,n=12,6,6,9,9,6
|
0.3 International units per Liter
Standard Deviation 12.11
|
-3.5 International units per Liter
Standard Deviation 7.64
|
5.2 International units per Liter
Standard Deviation 14.18
|
2.2 International units per Liter
Standard Deviation 10.76
|
7.3 International units per Liter
Standard Deviation 12.97
|
0.8 International units per Liter
Standard Deviation 5.34
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Week 26,n=12,6,6,9,9,6
|
-2.1 International units per Liter
Standard Deviation 6.13
|
-0.8 International units per Liter
Standard Deviation 6.79
|
-0.5 International units per Liter
Standard Deviation 6.47
|
5.1 International units per Liter
Standard Deviation 19.63
|
6.2 International units per Liter
Standard Deviation 13.08
|
2.5 International units per Liter
Standard Deviation 7.87
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Week 32,n=6,6,6,0,0,6
|
1.5 International units per Liter
Standard Deviation 8.04
|
-1.7 International units per Liter
Standard Deviation 9.89
|
-1.0 International units per Liter
Standard Deviation 3.29
|
—
|
—
|
-3.0 International units per Liter
Standard Deviation 4.60
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Week 36,n=6,0,0,9,9,0
|
0.3 International units per Liter
Standard Deviation 8.29
|
—
|
—
|
1.3 International units per Liter
Standard Deviation 6.86
|
5.0 International units per Liter
Standard Deviation 7.84
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Week 40,n=2,0,0,0,0,6
|
-3.5 International units per Liter
Standard Deviation 7.78
|
—
|
—
|
—
|
—
|
1.2 International units per Liter
Standard Deviation 8.08
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Day 4,n=12,6,6,9,9,6
|
-4.3 International units per Liter
Standard Deviation 4.27
|
-0.8 International units per Liter
Standard Deviation 5.08
|
-2.0 International units per Liter
Standard Deviation 4.34
|
-2.9 International units per Liter
Standard Deviation 2.93
|
-4.9 International units per Liter
Standard Deviation 6.33
|
-3.3 International units per Liter
Standard Deviation 4.93
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Day 5,n=12,6,6,9,9,6
|
-2.6 International units per Liter
Standard Deviation 4.10
|
-0.5 International units per Liter
Standard Deviation 5.28
|
-1.7 International units per Liter
Standard Deviation 3.67
|
-3.2 International units per Liter
Standard Deviation 3.31
|
-3.7 International units per Liter
Standard Deviation 7.57
|
-2.0 International units per Liter
Standard Deviation 5.83
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Week 1,n=12,6,6,9,9,5
|
-2.8 International units per Liter
Standard Deviation 4.12
|
0.0 International units per Liter
Standard Deviation 3.74
|
-0.2 International units per Liter
Standard Deviation 2.32
|
-1.9 International units per Liter
Standard Deviation 2.85
|
-3.3 International units per Liter
Standard Deviation 4.53
|
-4.6 International units per Liter
Standard Deviation 4.39
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Week 2,n=12,6,6,9,9,6
|
-1.5 International units per Liter
Standard Deviation 4.66
|
-0.3 International units per Liter
Standard Deviation 4.55
|
-2.5 International units per Liter
Standard Deviation 2.88
|
1.0 International units per Liter
Standard Deviation 9.19
|
-3.8 International units per Liter
Standard Deviation 6.44
|
-0.7 International units per Liter
Standard Deviation 4.80
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Week 4,n=12,6,6,9,9,6
|
-1.5 International units per Liter
Standard Deviation 3.97
|
-2.3 International units per Liter
Standard Deviation 3.83
|
0.0 International units per Liter
Standard Deviation 6.03
|
0.0 International units per Liter
Standard Deviation 4.90
|
-4.3 International units per Liter
Standard Deviation 6.87
|
-4.2 International units per Liter
Standard Deviation 5.91
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Week 8,n=12,6,6,9,9,6
|
-0.9 International units per Liter
Standard Deviation 7.45
|
-1.8 International units per Liter
Standard Deviation 3.66
|
0.5 International units per Liter
Standard Deviation 3.02
|
-0.2 International units per Liter
Standard Deviation 3.77
|
-1.0 International units per Liter
Standard Deviation 10.58
|
-4.7 International units per Liter
Standard Deviation 4.50
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Week 12,n=12,6,6,9,9,6
|
-2.8 International units per Liter
Standard Deviation 2.79
|
-1.2 International units per Liter
Standard Deviation 1.94
|
1.2 International units per Liter
Standard Deviation 3.71
|
-1.2 International units per Liter
Standard Deviation 2.17
|
-1.4 International units per Liter
Standard Deviation 6.98
|
-2.0 International units per Liter
Standard Deviation 5.83
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Week 18,n=12,6,6,9,9,6
|
-1.8 International units per Liter
Standard Deviation 4.14
|
-1.2 International units per Liter
Standard Deviation 2.86
|
1.3 International units per Liter
Standard Deviation 10.09
|
-0.7 International units per Liter
Standard Deviation 3.64
|
-1.8 International units per Liter
Standard Deviation 5.56
|
-3.3 International units per Liter
Standard Deviation 5.61
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Week 32,n=6,6,6,0,0,6
|
-2.7 International units per Liter
Standard Deviation 3.39
|
0.5 International units per Liter
Standard Deviation 3.33
|
-2.5 International units per Liter
Standard Deviation 1.52
|
—
|
—
|
-3.5 International units per Liter
Standard Deviation 5.47
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Week 36,n=6,0,0,9,9,0
|
-1.0 International units per Liter
Standard Deviation 4.69
|
—
|
—
|
-2.0 International units per Liter
Standard Deviation 4.36
|
-3.2 International units per Liter
Standard Deviation 6.70
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Week 40,n=2,0,0,0,0,6
|
-7.5 International units per Liter
Standard Deviation 6.36
|
—
|
—
|
—
|
—
|
3.0 International units per Liter
Standard Deviation 13.24
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALP, Day 2,n=12,6,5,9,9,6
|
-1.8 International units per Liter
Standard Deviation 4.84
|
-3.3 International units per Liter
Standard Deviation 1.37
|
1.0 International units per Liter
Standard Deviation 4.18
|
-4.9 International units per Liter
Standard Deviation 2.80
|
1.3 International units per Liter
Standard Deviation 7.28
|
-1.5 International units per Liter
Standard Deviation 7.77
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALP, Day 3,n=12,6,6,9,9,6
|
-1.8 International units per Liter
Standard Deviation 5.66
|
-2.7 International units per Liter
Standard Deviation 2.94
|
0.3 International units per Liter
Standard Deviation 8.52
|
-1.8 International units per Liter
Standard Deviation 3.99
|
-0.6 International units per Liter
Standard Deviation 5.32
|
0.2 International units per Liter
Standard Deviation 5.88
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALP, Day 4,n=12,6,6,9,9,6
|
-1.7 International units per Liter
Standard Deviation 5.30
|
-1.3 International units per Liter
Standard Deviation 3.20
|
0.0 International units per Liter
Standard Deviation 9.17
|
-1.9 International units per Liter
Standard Deviation 3.62
|
-0.2 International units per Liter
Standard Deviation 6.34
|
-1.3 International units per Liter
Standard Deviation 6.09
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALP, Day 5,n=12,6,6,9,9,6
|
0.1 International units per Liter
Standard Deviation 5.74
|
-2.0 International units per Liter
Standard Deviation 3.52
|
0.3 International units per Liter
Standard Deviation 4.76
|
-1.4 International units per Liter
Standard Deviation 5.25
|
1.9 International units per Liter
Standard Deviation 9.44
|
-1.2 International units per Liter
Standard Deviation 5.12
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALP, Week 1,n=12,6,6,9,9,5
|
0.2 International units per Liter
Standard Deviation 5.86
|
-2.2 International units per Liter
Standard Deviation 5.56
|
-2.5 International units per Liter
Standard Deviation 6.06
|
-0.7 International units per Liter
Standard Deviation 6.18
|
-1.1 International units per Liter
Standard Deviation 4.62
|
-1.2 International units per Liter
Standard Deviation 7.53
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALP, Week 2,n=12,6,6,9,9,6
|
1.0 International units per Liter
Standard Deviation 3.44
|
-8.2 International units per Liter
Standard Deviation 6.52
|
-4.2 International units per Liter
Standard Deviation 3.54
|
-0.6 International units per Liter
Standard Deviation 3.91
|
3.1 International units per Liter
Standard Deviation 5.25
|
-1.0 International units per Liter
Standard Deviation 8.32
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALP, Week 4,n=12,6,6,9,9,6
|
1.4 International units per Liter
Standard Deviation 4.81
|
-8.2 International units per Liter
Standard Deviation 8.30
|
-1.2 International units per Liter
Standard Deviation 3.97
|
-3.2 International units per Liter
Standard Deviation 4.32
|
2.6 International units per Liter
Standard Deviation 5.50
|
-2.2 International units per Liter
Standard Deviation 7.81
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALP, Week 8,n=12,6,6,9,9,6
|
1.9 International units per Liter
Standard Deviation 6.88
|
-2.0 International units per Liter
Standard Deviation 4.82
|
1.0 International units per Liter
Standard Deviation 10.06
|
-4.4 International units per Liter
Standard Deviation 4.03
|
3.7 International units per Liter
Standard Deviation 3.61
|
-0.8 International units per Liter
Standard Deviation 8.30
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALP, Week 12,n=12,6,6,9,9,6
|
-0.6 International units per Liter
Standard Deviation 6.43
|
-4.3 International units per Liter
Standard Deviation 7.09
|
7.2 International units per Liter
Standard Deviation 10.46
|
-2.8 International units per Liter
Standard Deviation 2.82
|
3.1 International units per Liter
Standard Deviation 11.58
|
-0.3 International units per Liter
Standard Deviation 5.09
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALP, Week 32,n=6,6,6,0,0,6
|
-2.0 International units per Liter
Standard Deviation 8.51
|
-3.3 International units per Liter
Standard Deviation 8.50
|
0.2 International units per Liter
Standard Deviation 5.31
|
—
|
—
|
-1.0 International units per Liter
Standard Deviation 7.72
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALP, Week 36,n=6,0,0,9,9,0
|
9.0 International units per Liter
Standard Deviation 15.57
|
—
|
—
|
-0.6 International units per Liter
Standard Deviation 11.19
|
7.2 International units per Liter
Standard Deviation 8.39
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALP, Week 40,n=2,0,0,0,0,6
|
-5.5 International units per Liter
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
-3.7 International units per Liter
Standard Deviation 9.48
|
PRIMARY outcome
Timeframe: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Blood samples were collected at indicated time-points for analysis of clinical parameters like glucose, calcium, potassium, sodium, BUN, and magnesium. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Glucose, Week 12,n=12,6,6,9,9,6
|
0.32 Millimoles per liter
Standard Deviation 0.606
|
-0.15 Millimoles per liter
Standard Deviation 0.428
|
0.13 Millimoles per liter
Standard Deviation 1.093
|
0.08 Millimoles per liter
Standard Deviation 0.905
|
-0.66 Millimoles per liter
Standard Deviation 0.760
|
0.23 Millimoles per liter
Standard Deviation 0.432
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Glucose, Week 1,n=11,6,6,9,9,5
|
0.00 Millimoles per liter
Standard Deviation 0.656
|
-0.35 Millimoles per liter
Standard Deviation 0.394
|
-0.18 Millimoles per liter
Standard Deviation 1.280
|
-0.20 Millimoles per liter
Standard Deviation 0.624
|
-0.23 Millimoles per liter
Standard Deviation 1.015
|
0.50 Millimoles per liter
Standard Deviation 1.345
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Glucose, Week 4,n=12,6,6,9,9,6
|
0.19 Millimoles per liter
Standard Deviation 0.783
|
-0.33 Millimoles per liter
Standard Deviation 0.543
|
0.03 Millimoles per liter
Standard Deviation 0.582
|
-0.28 Millimoles per liter
Standard Deviation 0.678
|
-0.08 Millimoles per liter
Standard Deviation 0.919
|
0.33 Millimoles per liter
Standard Deviation 0.476
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Glucose, Week 18,n=12,6,6,9,9,6
|
0.03 Millimoles per liter
Standard Deviation 0.548
|
-0.02 Millimoles per liter
Standard Deviation 0.331
|
0.42 Millimoles per liter
Standard Deviation 1.017
|
-0.17 Millimoles per liter
Standard Deviation 0.541
|
-0.23 Millimoles per liter
Standard Deviation 0.825
|
0.15 Millimoles per liter
Standard Deviation 0.288
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Glucose, Week 24,n=12,6,6,9,9,6
|
0.38 Millimoles per liter
Standard Deviation 1.131
|
-0.13 Millimoles per liter
Standard Deviation 0.333
|
0.02 Millimoles per liter
Standard Deviation 0.773
|
-0.27 Millimoles per liter
Standard Deviation 0.654
|
-0.26 Millimoles per liter
Standard Deviation 0.928
|
0.50 Millimoles per liter
Standard Deviation 0.590
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Glucose, Week 26,n=12,6,6,9,9,6
|
0.18 Millimoles per liter
Standard Deviation 0.506
|
-0.10 Millimoles per liter
Standard Deviation 0.346
|
0.62 Millimoles per liter
Standard Deviation 1.144
|
-0.09 Millimoles per liter
Standard Deviation 0.362
|
-0.22 Millimoles per liter
Standard Deviation 0.758
|
0.38 Millimoles per liter
Standard Deviation 0.445
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Glucose, Week 36,n=6,0,0,9,9,0
|
0.17 Millimoles per liter
Standard Deviation 0.493
|
—
|
—
|
-0.26 Millimoles per liter
Standard Deviation 0.436
|
-0.07 Millimoles per liter
Standard Deviation 0.996
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Calcium, Week 4,n=12,6,6,9,9,6
|
-0.040 Millimoles per liter
Standard Deviation 0.0615
|
-0.027 Millimoles per liter
Standard Deviation 0.0766
|
-0.013 Millimoles per liter
Standard Deviation 0.1198
|
-0.031 Millimoles per liter
Standard Deviation 0.0729
|
0.022 Millimoles per liter
Standard Deviation 0.0977
|
0.033 Millimoles per liter
Standard Deviation 0.0301
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Calcium, Week 8,n=12,6,6,9,9,6
|
0.000 Millimoles per liter
Standard Deviation 0.0621
|
-0.007 Millimoles per liter
Standard Deviation 0.1171
|
-0.003 Millimoles per liter
Standard Deviation 0.0898
|
-0.024 Millimoles per liter
Standard Deviation 0.0767
|
0.031 Millimoles per liter
Standard Deviation 0.0906
|
-0.003 Millimoles per liter
Standard Deviation 0.0612
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Calcium, Week 18,n=12,6,6,9,9,6
|
0.003 Millimoles per liter
Standard Deviation 0.0918
|
-0.013 Millimoles per liter
Standard Deviation 0.0826
|
-0.033 Millimoles per liter
Standard Deviation 0.0845
|
0.007 Millimoles per liter
Standard Deviation 0.0860
|
0.031 Millimoles per liter
Standard Deviation 0.0801
|
0.010 Millimoles per liter
Standard Deviation 0.0690
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Potassium, Week 2,n=12,6,6,9,9,6
|
0.00 Millimoles per liter
Standard Deviation 0.316
|
0.05 Millimoles per liter
Standard Deviation 0.315
|
0.20 Millimoles per liter
Standard Deviation 0.341
|
-0.04 Millimoles per liter
Standard Deviation 0.201
|
0.09 Millimoles per liter
Standard Deviation 0.352
|
0.02 Millimoles per liter
Standard Deviation 0.299
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Potassium, Week 26,n=12,6,6,9,9,6
|
-0.13 Millimoles per liter
Standard Deviation 0.360
|
-0.03 Millimoles per liter
Standard Deviation 0.480
|
0.00 Millimoles per liter
Standard Deviation 0.179
|
-0.01 Millimoles per liter
Standard Deviation 0.280
|
0.07 Millimoles per liter
Standard Deviation 0.235
|
0.07 Millimoles per liter
Standard Deviation 0.327
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Potassium, Week 32,n=6,6,6,0,0,6
|
-0.15 Millimoles per liter
Standard Deviation 0.476
|
0.03 Millimoles per liter
Standard Deviation 0.242
|
0.12 Millimoles per liter
Standard Deviation 0.223
|
—
|
—
|
0.12 Millimoles per liter
Standard Deviation 0.147
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Potassium, Week 36,n=6,0,0,9,9,0
|
0.07 Millimoles per liter
Standard Deviation 0.121
|
—
|
—
|
0.08 Millimoles per liter
Standard Deviation 0.311
|
0.09 Millimoles per liter
Standard Deviation 0.215
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Sodium, Day 3,n=12,6,6,9,9,6
|
1.2 Millimoles per liter
Standard Deviation 1.75
|
0.0 Millimoles per liter
Standard Deviation 0.89
|
0.3 Millimoles per liter
Standard Deviation 1.21
|
0.4 Millimoles per liter
Standard Deviation 1.33
|
0.9 Millimoles per liter
Standard Deviation 1.96
|
2.0 Millimoles per liter
Standard Deviation 1.55
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Sodium, Day 4,n=12,6,6,9,9,6
|
1.1 Millimoles per liter
Standard Deviation 1.93
|
0.2 Millimoles per liter
Standard Deviation 1.60
|
0.0 Millimoles per liter
Standard Deviation 2.19
|
-0.8 Millimoles per liter
Standard Deviation 2.11
|
0.3 Millimoles per liter
Standard Deviation 1.32
|
1.3 Millimoles per liter
Standard Deviation 1.86
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Sodium, Day 5,n=12,6,6,9,9,6
|
1.3 Millimoles per liter
Standard Deviation 1.66
|
1.7 Millimoles per liter
Standard Deviation 1.51
|
-1.3 Millimoles per liter
Standard Deviation 1.86
|
-0.2 Millimoles per liter
Standard Deviation 2.22
|
0.8 Millimoles per liter
Standard Deviation 2.05
|
1.7 Millimoles per liter
Standard Deviation 1.75
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Sodium, Week 2,n=12,6,6,9,9,6
|
0.1 Millimoles per liter
Standard Deviation 1.51
|
1.0 Millimoles per liter
Standard Deviation 1.26
|
-0.7 Millimoles per liter
Standard Deviation 1.51
|
0.0 Millimoles per liter
Standard Deviation 1.32
|
-0.3 Millimoles per liter
Standard Deviation 1.66
|
1.0 Millimoles per liter
Standard Deviation 2.28
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Sodium, Week 4,n=12,6,6,9,9,6
|
0.0 Millimoles per liter
Standard Deviation 2.04
|
1.0 Millimoles per liter
Standard Deviation 1.41
|
-1.2 Millimoles per liter
Standard Deviation 0.98
|
-1.2 Millimoles per liter
Standard Deviation 1.30
|
-0.6 Millimoles per liter
Standard Deviation 1.67
|
1.0 Millimoles per liter
Standard Deviation 1.41
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Sodium, Week 8,n=12,6,6,9,9,6
|
0.1 Millimoles per liter
Standard Deviation 1.93
|
0.0 Millimoles per liter
Standard Deviation 2.53
|
-0.5 Millimoles per liter
Standard Deviation 1.52
|
-0.7 Millimoles per liter
Standard Deviation 1.94
|
-1.1 Millimoles per liter
Standard Deviation 1.05
|
1.5 Millimoles per liter
Standard Deviation 3.45
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Sodium, Week 18,n=12,6,6,9,9,6
|
0.1 Millimoles per liter
Standard Deviation 1.51
|
-0.7 Millimoles per liter
Standard Deviation 2.25
|
-1.0 Millimoles per liter
Standard Deviation 1.10
|
-0.7 Millimoles per liter
Standard Deviation 1.22
|
0.0 Millimoles per liter
Standard Deviation 1.66
|
0.8 Millimoles per liter
Standard Deviation 1.60
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Sodium, Week 24,n=12,6,6,9,9,6
|
0.3 Millimoles per liter
Standard Deviation 2.02
|
-0.2 Millimoles per liter
Standard Deviation 1.60
|
-1.5 Millimoles per liter
Standard Deviation 1.22
|
-0.9 Millimoles per liter
Standard Deviation 2.37
|
0.2 Millimoles per liter
Standard Deviation 1.64
|
1.2 Millimoles per liter
Standard Deviation 1.72
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Sodium, Week 26,n=12,6,6,9,9,6
|
0.2 Millimoles per liter
Standard Deviation 1.40
|
0.0 Millimoles per liter
Standard Deviation 1.90
|
-0.7 Millimoles per liter
Standard Deviation 2.88
|
-1.1 Millimoles per liter
Standard Deviation 2.15
|
-1.1 Millimoles per liter
Standard Deviation 1.54
|
1.7 Millimoles per liter
Standard Deviation 1.97
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Sodium, Week 32,n=6,6,6,0,0,6
|
0.3 Millimoles per liter
Standard Deviation 2.25
|
0.5 Millimoles per liter
Standard Deviation 3.56
|
-1.8 Millimoles per liter
Standard Deviation 1.17
|
—
|
—
|
0.7 Millimoles per liter
Standard Deviation 2.07
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Sodium, Week 36,n=6,0,0,9,9,0
|
-0.3 Millimoles per liter
Standard Deviation 2.66
|
—
|
—
|
-0.9 Millimoles per liter
Standard Deviation 1.90
|
-1.3 Millimoles per liter
Standard Deviation 1.00
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Magnesium, Day 2,n=12,6,5,9,9,6
|
-0.020 Millimoles per liter
Standard Deviation 0.0467
|
-0.037 Millimoles per liter
Standard Deviation 0.0585
|
0.008 Millimoles per liter
Standard Deviation 0.0642
|
0.000 Millimoles per liter
Standard Deviation 0.0361
|
-0.036 Millimoles per liter
Standard Deviation 0.0623
|
-0.020 Millimoles per liter
Standard Deviation 0.0310
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Magnesium, Day 3,n=12,6,6,9,9,6
|
-0.012 Millimoles per liter
Standard Deviation 0.0542
|
-0.043 Millimoles per liter
Standard Deviation 0.0388
|
-0.003 Millimoles per liter
Standard Deviation 0.0709
|
0.007 Millimoles per liter
Standard Deviation 0.0283
|
-0.064 Millimoles per liter
Standard Deviation 0.0564
|
-0.037 Millimoles per liter
Standard Deviation 0.0427
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Magnesium, Day 4,n=12,6,6,9,9,6
|
-0.013 Millimoles per liter
Standard Deviation 0.0750
|
-0.020 Millimoles per liter
Standard Deviation 0.0310
|
-0.007 Millimoles per liter
Standard Deviation 0.0575
|
-0.007 Millimoles per liter
Standard Deviation 0.0283
|
-0.060 Millimoles per liter
Standard Deviation 0.0490
|
-0.047 Millimoles per liter
Standard Deviation 0.0628
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
BUN, Week 4,n=12,6,6,9,9,6
|
-0.25 Millimoles per liter
Standard Deviation 1.098
|
-0.75 Millimoles per liter
Standard Deviation 0.524
|
0.75 Millimoles per liter
Standard Deviation 0.822
|
0.22 Millimoles per liter
Standard Deviation 0.972
|
0.17 Millimoles per liter
Standard Deviation 1.225
|
-0.08 Millimoles per liter
Standard Deviation 1.114
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
BUN, Week 8,n=12,6,6,9,9,6
|
-0.75 Millimoles per liter
Standard Deviation 0.989
|
-0.17 Millimoles per liter
Standard Deviation 1.033
|
1.17 Millimoles per liter
Standard Deviation 1.252
|
0.06 Millimoles per liter
Standard Deviation 1.074
|
0.28 Millimoles per liter
Standard Deviation 1.093
|
-0.58 Millimoles per liter
Standard Deviation 1.158
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
BUN, Week 12,n=12,6,6,9,9,6
|
-0.75 Millimoles per liter
Standard Deviation 1.323
|
0.17 Millimoles per liter
Standard Deviation 0.983
|
0.17 Millimoles per liter
Standard Deviation 0.816
|
-0.06 Millimoles per liter
Standard Deviation 0.527
|
0.06 Millimoles per liter
Standard Deviation 0.682
|
0.25 Millimoles per liter
Standard Deviation 1.037
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
BUN, Week 18,n=12,6,6,9,9,6
|
-1.08 Millimoles per liter
Standard Deviation 1.505
|
0.50 Millimoles per liter
Standard Deviation 1.414
|
0.58 Millimoles per liter
Standard Deviation 1.068
|
0.39 Millimoles per liter
Standard Deviation 1.516
|
0.00 Millimoles per liter
Standard Deviation 0.866
|
-0.33 Millimoles per liter
Standard Deviation 0.983
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Glucose, Day 2,n=12,6,5,9,9,6
|
0.06 Millimoles per liter
Standard Deviation 0.912
|
-0.13 Millimoles per liter
Standard Deviation 0.418
|
0.14 Millimoles per liter
Standard Deviation 0.439
|
-0.11 Millimoles per liter
Standard Deviation 0.533
|
-0.72 Millimoles per liter
Standard Deviation 0.948
|
0.20 Millimoles per liter
Standard Deviation 0.352
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Sodium, Week 12,n=12,6,6,9,9,6
|
0.0 Millimoles per liter
Standard Deviation 2.00
|
1.0 Millimoles per liter
Standard Deviation 1.26
|
-0.8 Millimoles per liter
Standard Deviation 1.47
|
-0.2 Millimoles per liter
Standard Deviation 1.56
|
-0.3 Millimoles per liter
Standard Deviation 1.22
|
1.3 Millimoles per liter
Standard Deviation 2.25
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Sodium, Week 40,n=2,0,0,0,0,6
|
0.5 Millimoles per liter
Standard Deviation 2.12
|
—
|
—
|
—
|
—
|
0.0 Millimoles per liter
Standard Deviation 1.90
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Glucose, Day 4,n=12,6,6,9,9,6
|
-0.11 Millimoles per liter
Standard Deviation 0.712
|
0.12 Millimoles per liter
Standard Deviation 0.987
|
-0.33 Millimoles per liter
Standard Deviation 0.857
|
0.26 Millimoles per liter
Standard Deviation 0.940
|
-0.34 Millimoles per liter
Standard Deviation 1.364
|
0.50 Millimoles per liter
Standard Deviation 1.103
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Glucose, Day 5,n=12,6,6,9,9,6
|
-0.06 Millimoles per liter
Standard Deviation 0.647
|
-0.07 Millimoles per liter
Standard Deviation 0.612
|
0.28 Millimoles per liter
Standard Deviation 0.958
|
0.01 Millimoles per liter
Standard Deviation 0.775
|
-0.17 Millimoles per liter
Standard Deviation 0.728
|
0.05 Millimoles per liter
Standard Deviation 0.539
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Glucose, Week 2,n=12,6,6,9,9,6
|
0.03 Millimoles per liter
Standard Deviation 0.396
|
-0.05 Millimoles per liter
Standard Deviation 0.295
|
0.00 Millimoles per liter
Standard Deviation 0.525
|
-0.02 Millimoles per liter
Standard Deviation 1.027
|
-0.18 Millimoles per liter
Standard Deviation 0.902
|
-0.10 Millimoles per liter
Standard Deviation 0.155
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Glucose, Week 8,n=12,6,6,9,9,6
|
0.06 Millimoles per liter
Standard Deviation 0.444
|
-0.42 Millimoles per liter
Standard Deviation 0.585
|
0.27 Millimoles per liter
Standard Deviation 0.824
|
0.04 Millimoles per liter
Standard Deviation 0.430
|
-0.36 Millimoles per liter
Standard Deviation 1.193
|
0.42 Millimoles per liter
Standard Deviation 0.722
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Calcium, Week 26,n=12,6,6,9,9,6
|
-0.018 Millimoles per liter
Standard Deviation 0.0731
|
-0.067 Millimoles per liter
Standard Deviation 0.0532
|
-0.017 Millimoles per liter
Standard Deviation 0.1255
|
-0.056 Millimoles per liter
Standard Deviation 0.0260
|
0.013 Millimoles per liter
Standard Deviation 0.0529
|
-0.010 Millimoles per liter
Standard Deviation 0.0767
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Glucose, Week 32,n=6,6,6,0,0,6
|
0.40 Millimoles per liter
Standard Deviation 1.233
|
0.02 Millimoles per liter
Standard Deviation 0.194
|
-0.28 Millimoles per liter
Standard Deviation 0.703
|
—
|
—
|
0.32 Millimoles per liter
Standard Deviation 0.354
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Glucose, Week 40,n=2,0,0,0,0,6
|
0.40 Millimoles per liter
Standard Deviation 0.566
|
—
|
—
|
—
|
—
|
0.23 Millimoles per liter
Standard Deviation 0.769
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Calcium, Day 2,n=12,6,5,9,9,6
|
-0.025 Millimoles per liter
Standard Deviation 0.0645
|
-0.027 Millimoles per liter
Standard Deviation 0.0615
|
-0.004 Millimoles per liter
Standard Deviation 0.0865
|
-0.049 Millimoles per liter
Standard Deviation 0.0736
|
0.016 Millimoles per liter
Standard Deviation 0.1207
|
0.043 Millimoles per liter
Standard Deviation 0.0480
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Calcium, Day 3,n=12,6,6,9,9,6
|
0.008 Millimoles per liter
Standard Deviation 0.0833
|
-0.033 Millimoles per liter
Standard Deviation 0.1009
|
0.027 Millimoles per liter
Standard Deviation 0.1041
|
-0.011 Millimoles per liter
Standard Deviation 0.0756
|
-0.022 Millimoles per liter
Standard Deviation 0.1012
|
0.070 Millimoles per liter
Standard Deviation 0.0415
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Calcium, Day 4,n=12,6,6,9,9,6
|
0.012 Millimoles per liter
Standard Deviation 0.0658
|
-0.017 Millimoles per liter
Standard Deviation 0.0612
|
0.017 Millimoles per liter
Standard Deviation 0.0794
|
-0.033 Millimoles per liter
Standard Deviation 0.0762
|
-0.007 Millimoles per liter
Standard Deviation 0.0714
|
0.073 Millimoles per liter
Standard Deviation 0.0301
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Calcium, Day 5,n=12,6,6,9,9,6
|
-0.023 Millimoles per liter
Standard Deviation 0.0738
|
-0.050 Millimoles per liter
Standard Deviation 0.0846
|
0.003 Millimoles per liter
Standard Deviation 0.0942
|
-0.040 Millimoles per liter
Standard Deviation 0.0640
|
-0.031 Millimoles per liter
Standard Deviation 0.0933
|
0.043 Millimoles per liter
Standard Deviation 0.0843
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Calcium, Week 1,n=11,6,6,9,9,5
|
-0.009 Millimoles per liter
Standard Deviation 0.0745
|
-0.047 Millimoles per liter
Standard Deviation 0.0723
|
0.017 Millimoles per liter
Standard Deviation 0.0916
|
-0.044 Millimoles per liter
Standard Deviation 0.0847
|
-0.029 Millimoles per liter
Standard Deviation 0.0657
|
-0.040 Millimoles per liter
Standard Deviation 0.0663
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Calcium, Week 2,n=12,6,6,9,9,6
|
-0.007 Millimoles per liter
Standard Deviation 0.0634
|
-0.013 Millimoles per liter
Standard Deviation 0.0547
|
-0.033 Millimoles per liter
Standard Deviation 0.0855
|
-0.002 Millimoles per liter
Standard Deviation 0.0863
|
0.062 Millimoles per liter
Standard Deviation 0.0771
|
0.013 Millimoles per liter
Standard Deviation 0.0163
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Calcium, Week 12,n=12,6,6,9,9,6
|
-0.017 Millimoles per liter
Standard Deviation 0.0489
|
-0.060 Millimoles per liter
Standard Deviation 0.0657
|
-0.003 Millimoles per liter
Standard Deviation 0.1274
|
-0.020 Millimoles per liter
Standard Deviation 0.0755
|
0.036 Millimoles per liter
Standard Deviation 0.0581
|
-0.003 Millimoles per liter
Standard Deviation 0.0794
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Potassium, Week 1,n=11,6,6,9,9,5
|
-0.02 Millimoles per liter
Standard Deviation 0.340
|
0.05 Millimoles per liter
Standard Deviation 0.451
|
0.18 Millimoles per liter
Standard Deviation 0.194
|
0.22 Millimoles per liter
Standard Deviation 0.342
|
0.07 Millimoles per liter
Standard Deviation 0.300
|
0.00 Millimoles per liter
Standard Deviation 0.200
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Calcium, Week 24,n=12,6,6,9,9,6
|
-0.035 Millimoles per liter
Standard Deviation 0.0452
|
-0.053 Millimoles per liter
Standard Deviation 0.0677
|
0.007 Millimoles per liter
Standard Deviation 0.0864
|
-0.016 Millimoles per liter
Standard Deviation 0.0942
|
0.022 Millimoles per liter
Standard Deviation 0.1218
|
0.027 Millimoles per liter
Standard Deviation 0.0797
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Potassium, Week 4,n=12,6,6,9,9,6
|
0.00 Millimoles per liter
Standard Deviation 0.276
|
-0.07 Millimoles per liter
Standard Deviation 0.372
|
0.27 Millimoles per liter
Standard Deviation 0.344
|
-0.04 Millimoles per liter
Standard Deviation 0.283
|
0.11 Millimoles per liter
Standard Deviation 0.196
|
0.00 Millimoles per liter
Standard Deviation 0.276
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Potassium, Week 8,n=12,6,6,9,9,6
|
0.18 Millimoles per liter
Standard Deviation 0.234
|
0.00 Millimoles per liter
Standard Deviation 0.352
|
0.12 Millimoles per liter
Standard Deviation 0.117
|
0.00 Millimoles per liter
Standard Deviation 0.269
|
0.14 Millimoles per liter
Standard Deviation 0.207
|
-0.05 Millimoles per liter
Standard Deviation 0.207
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Potassium, Week 12,n=12,6,6,9,9,6
|
-0.02 Millimoles per liter
Standard Deviation 0.383
|
-0.02 Millimoles per liter
Standard Deviation 0.387
|
0.12 Millimoles per liter
Standard Deviation 0.331
|
0.00 Millimoles per liter
Standard Deviation 0.278
|
0.04 Millimoles per liter
Standard Deviation 0.213
|
0.03 Millimoles per liter
Standard Deviation 0.273
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Potassium, Week 18,n=12,6,6,9,9,6
|
-0.02 Millimoles per liter
Standard Deviation 0.343
|
0.00 Millimoles per liter
Standard Deviation 0.329
|
0.07 Millimoles per liter
Standard Deviation 0.234
|
0.03 Millimoles per liter
Standard Deviation 0.287
|
0.13 Millimoles per liter
Standard Deviation 0.308
|
0.02 Millimoles per liter
Standard Deviation 0.293
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Potassium, Week 24,n=12,6,6,9,9,6
|
-0.03 Millimoles per liter
Standard Deviation 0.458
|
-0.02 Millimoles per liter
Standard Deviation 0.397
|
0.03 Millimoles per liter
Standard Deviation 0.234
|
0.12 Millimoles per liter
Standard Deviation 0.291
|
-0.04 Millimoles per liter
Standard Deviation 0.260
|
0.07 Millimoles per liter
Standard Deviation 0.288
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Calcium, Week 32,n=6,6,6,0,0,6
|
-0.020 Millimoles per liter
Standard Deviation 0.1020
|
0.027 Millimoles per liter
Standard Deviation 0.0776
|
0.020 Millimoles per liter
Standard Deviation 0.0867
|
—
|
—
|
0.010 Millimoles per liter
Standard Deviation 0.0724
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Calcium, Week 36,n=6,0,0,9,9,0
|
0.000 Millimoles per liter
Standard Deviation 0.0607
|
—
|
—
|
-0.013 Millimoles per liter
Standard Deviation 0.0624
|
0.029 Millimoles per liter
Standard Deviation 0.0813
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Calcium, Week 40,n=2,0,0,0,0,6
|
0.000 Millimoles per liter
Standard Deviation 0.1131
|
—
|
—
|
—
|
—
|
0.043 Millimoles per liter
Standard Deviation 0.0774
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Potassium, Day 2,n=12,6,5,9,9,6
|
-0.03 Millimoles per liter
Standard Deviation 0.230
|
0.02 Millimoles per liter
Standard Deviation 0.179
|
0.44 Millimoles per liter
Standard Deviation 0.365
|
0.06 Millimoles per liter
Standard Deviation 0.397
|
0.18 Millimoles per liter
Standard Deviation 0.307
|
0.17 Millimoles per liter
Standard Deviation 0.234
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Potassium, Day 3,n=12,6,6,9,9,6
|
-0.07 Millimoles per liter
Standard Deviation 0.290
|
0.03 Millimoles per liter
Standard Deviation 0.258
|
0.02 Millimoles per liter
Standard Deviation 0.204
|
0.14 Millimoles per liter
Standard Deviation 0.332
|
0.01 Millimoles per liter
Standard Deviation 0.136
|
0.12 Millimoles per liter
Standard Deviation 0.194
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Potassium, Day 4,n=12,6,6,9,9,6
|
0.13 Millimoles per liter
Standard Deviation 0.196
|
0.05 Millimoles per liter
Standard Deviation 0.472
|
0.08 Millimoles per liter
Standard Deviation 0.232
|
0.03 Millimoles per liter
Standard Deviation 0.218
|
0.06 Millimoles per liter
Standard Deviation 0.246
|
0.27 Millimoles per liter
Standard Deviation 0.163
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Potassium Week 40,n=2,0,0,0,0,6
|
-0.35 Millimoles per liter
Standard Deviation 0.495
|
—
|
—
|
—
|
—
|
0.13 Millimoles per liter
Standard Deviation 0.356
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Sodium, Day 2,n=12,6,5,9,9,6
|
0.8 Millimoles per liter
Standard Deviation 2.14
|
0.0 Millimoles per liter
Standard Deviation 1.90
|
0.0 Millimoles per liter
Standard Deviation 1.58
|
-0.3 Millimoles per liter
Standard Deviation 1.94
|
0.9 Millimoles per liter
Standard Deviation 1.76
|
1.8 Millimoles per liter
Standard Deviation 1.72
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Potassium, Day 5,n=12,6,6,9,9,6
|
0.11 Millimoles per liter
Standard Deviation 0.303
|
0.10 Millimoles per liter
Standard Deviation 0.276
|
0.00 Millimoles per liter
Standard Deviation 0.126
|
0.11 Millimoles per liter
Standard Deviation 0.267
|
0.04 Millimoles per liter
Standard Deviation 0.207
|
0.15 Millimoles per liter
Standard Deviation 0.217
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Sodium, Week 1,n=11,6,6,9,9,5
|
0.8 Millimoles per liter
Standard Deviation 2.14
|
0.8 Millimoles per liter
Standard Deviation 2.32
|
-1.7 Millimoles per liter
Standard Deviation 1.03
|
0.1 Millimoles per liter
Standard Deviation 1.45
|
-0.1 Millimoles per liter
Standard Deviation 1.69
|
0.4 Millimoles per liter
Standard Deviation 2.19
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Magnesium, Week 26,n=12,6,6,9,9,6
|
0.002 Millimoles per liter
Standard Deviation 0.0542
|
-0.057 Millimoles per liter
Standard Deviation 0.0320
|
-0.017 Millimoles per liter
Standard Deviation 0.0463
|
0.000 Millimoles per liter
Standard Deviation 0.0469
|
-0.036 Millimoles per liter
Standard Deviation 0.0477
|
-0.027 Millimoles per liter
Standard Deviation 0.0432
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Magnesium, Day 5,n=12,6,6,9,9,6
|
-0.017 Millimoles per liter
Standard Deviation 0.0545
|
-0.047 Millimoles per liter
Standard Deviation 0.0745
|
-0.033 Millimoles per liter
Standard Deviation 0.0413
|
0.007 Millimoles per liter
Standard Deviation 0.0283
|
-0.036 Millimoles per liter
Standard Deviation 0.0536
|
-0.020 Millimoles per liter
Standard Deviation 0.0632
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Magnesium, Week 1,n=11,6,6,9,9,5
|
-0.004 Millimoles per liter
Standard Deviation 0.0427
|
-0.003 Millimoles per liter
Standard Deviation 0.0638
|
0.017 Millimoles per liter
Standard Deviation 0.0480
|
-0.007 Millimoles per liter
Standard Deviation 0.0520
|
-0.040 Millimoles per liter
Standard Deviation 0.0346
|
-0.032 Millimoles per liter
Standard Deviation 0.0460
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
BUN, Week 24,n=12,6,6,9,9,6
|
-0.79 Millimoles per liter
Standard Deviation 1.389
|
-0.17 Millimoles per liter
Standard Deviation 0.876
|
1.42 Millimoles per liter
Standard Deviation 1.594
|
0.11 Millimoles per liter
Standard Deviation 1.453
|
0.33 Millimoles per liter
Standard Deviation 1.146
|
0.17 Millimoles per liter
Standard Deviation 0.683
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Magnesium, Week 32,n=6,6,6,0,0,6
|
-0.010 Millimoles per liter
Standard Deviation 0.0245
|
-0.023 Millimoles per liter
Standard Deviation 0.0497
|
0.017 Millimoles per liter
Standard Deviation 0.0480
|
—
|
—
|
-0.027 Millimoles per liter
Standard Deviation 0.0301
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Magnesium, Week 2,n=12,6,6,9,9,6
|
0.005 Millimoles per liter
Standard Deviation 0.0410
|
-0.003 Millimoles per liter
Standard Deviation 0.0513
|
0.033 Millimoles per liter
Standard Deviation 0.0484
|
0.018 Millimoles per liter
Standard Deviation 0.0570
|
-0.036 Millimoles per liter
Standard Deviation 0.0445
|
-0.027 Millimoles per liter
Standard Deviation 0.0501
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Magnesium Week 36,n=6,0,0,9,9,0
|
-0.013 Millimoles per liter
Standard Deviation 0.0532
|
—
|
—
|
0.004 Millimoles per liter
Standard Deviation 0.0133
|
-0.013 Millimoles per liter
Standard Deviation 0.0447
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Magnesium, Week 40,n=2,0,0,0,0,6
|
0.030 Millimoles per liter
Standard Deviation 0.0424
|
—
|
—
|
—
|
—
|
-0.030 Millimoles per liter
Standard Deviation 0.0329
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
BUN, Day 2,n=12,6,5,9,9,6
|
-0.83 Millimoles per liter
Standard Deviation 1.135
|
-0.17 Millimoles per liter
Standard Deviation 0.408
|
0.20 Millimoles per liter
Standard Deviation 1.304
|
-0.67 Millimoles per liter
Standard Deviation 0.791
|
-0.28 Millimoles per liter
Standard Deviation 0.833
|
-1.25 Millimoles per liter
Standard Deviation 1.084
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
BUN, Day 3,n=12,6,6,9,9,6
|
-0.79 Millimoles per liter
Standard Deviation 1.373
|
0.00 Millimoles per liter
Standard Deviation 0.316
|
-0.17 Millimoles per liter
Standard Deviation 0.931
|
-0.72 Millimoles per liter
Standard Deviation 0.833
|
-0.28 Millimoles per liter
Standard Deviation 0.755
|
-1.17 Millimoles per liter
Standard Deviation 1.402
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
BUN, Day 4,n=12,6,6,9,9,6
|
-0.75 Millimoles per liter
Standard Deviation 1.357
|
-0.25 Millimoles per liter
Standard Deviation 0.274
|
-0.33 Millimoles per liter
Standard Deviation 1.169
|
-0.61 Millimoles per liter
Standard Deviation 0.928
|
0.00 Millimoles per liter
Standard Deviation 0.707
|
-0.50 Millimoles per liter
Standard Deviation 1.673
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
BUN, Day 5,n=12,6,6,9,9,6
|
-0.71 Millimoles per liter
Standard Deviation 1.339
|
-0.33 Millimoles per liter
Standard Deviation 0.816
|
0.67 Millimoles per liter
Standard Deviation 1.169
|
-0.61 Millimoles per liter
Standard Deviation 0.961
|
-0.17 Millimoles per liter
Standard Deviation 0.968
|
-0.67 Millimoles per liter
Standard Deviation 1.602
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
BUN, Week 1,n=11,6,6,9,9,5
|
-0.45 Millimoles per liter
Standard Deviation 1.150
|
-0.50 Millimoles per liter
Standard Deviation 1.183
|
0.50 Millimoles per liter
Standard Deviation 1.581
|
-0.44 Millimoles per liter
Standard Deviation 1.014
|
0.11 Millimoles per liter
Standard Deviation 0.782
|
-1.10 Millimoles per liter
Standard Deviation 1.084
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
BUN, Week 2,n=12,6,6,9,9,6
|
-0.33 Millimoles per liter
Standard Deviation 1.267
|
-0.75 Millimoles per liter
Standard Deviation 1.037
|
0.33 Millimoles per liter
Standard Deviation 1.780
|
0.06 Millimoles per liter
Standard Deviation 0.726
|
-0.17 Millimoles per liter
Standard Deviation 0.612
|
-0.33 Millimoles per liter
Standard Deviation 1.080
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
BUN, Week 26,n=12,6,6,9,9,6
|
-0.38 Millimoles per liter
Standard Deviation 1.069
|
-0.33 Millimoles per liter
Standard Deviation 0.983
|
0.83 Millimoles per liter
Standard Deviation 1.366
|
-0.17 Millimoles per liter
Standard Deviation 1.000
|
0.22 Millimoles per liter
Standard Deviation 0.755
|
0.08 Millimoles per liter
Standard Deviation 1.068
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
BUN, Week 32,n=6,6,6,0,0,6
|
-1.00 Millimoles per liter
Standard Deviation 0.949
|
-0.33 Millimoles per liter
Standard Deviation 0.683
|
0.75 Millimoles per liter
Standard Deviation 1.405
|
—
|
—
|
-0.08 Millimoles per liter
Standard Deviation 0.801
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
BUN, Week 36,n=6,0,0,9,9,0
|
-0.58 Millimoles per liter
Standard Deviation 1.855
|
—
|
—
|
-0.72 Millimoles per liter
Standard Deviation 1.034
|
0.28 Millimoles per liter
Standard Deviation 1.228
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
BUN, Week 40,n=2,0,0,0,0,6
|
-1.00 Millimoles per liter
Standard Deviation 0.000
|
—
|
—
|
—
|
—
|
-0.42 Millimoles per liter
Standard Deviation 1.201
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Magnesium, Week 4,n=12,6,6,9,9,6
|
0.007 Millimoles per liter
Standard Deviation 0.0345
|
-0.033 Millimoles per liter
Standard Deviation 0.0589
|
0.000 Millimoles per liter
Standard Deviation 0.0456
|
0.007 Millimoles per liter
Standard Deviation 0.0346
|
-0.027 Millimoles per liter
Standard Deviation 0.0529
|
-0.017 Millimoles per liter
Standard Deviation 0.0408
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Magnesium, Week 8,n=12,6,6,9,9,6
|
-0.003 Millimoles per liter
Standard Deviation 0.0608
|
-0.027 Millimoles per liter
Standard Deviation 0.0501
|
-0.007 Millimoles per liter
Standard Deviation 0.0484
|
0.016 Millimoles per liter
Standard Deviation 0.0240
|
-0.018 Millimoles per liter
Standard Deviation 0.0338
|
-0.003 Millimoles per liter
Standard Deviation 0.0585
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Magnesium, Week 12,n=12,6,6,9,9,6
|
-0.013 Millimoles per liter
Standard Deviation 0.0492
|
-0.043 Millimoles per liter
Standard Deviation 0.0686
|
0.000 Millimoles per liter
Standard Deviation 0.0551
|
0.011 Millimoles per liter
Standard Deviation 0.0448
|
-0.011 Millimoles per liter
Standard Deviation 0.0501
|
0.000 Millimoles per liter
Standard Deviation 0.0456
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Magnesium, Week 18,n=12,6,6,9,9,6
|
0.017 Millimoles per liter
Standard Deviation 0.0525
|
-0.030 Millimoles per liter
Standard Deviation 0.0576
|
0.000 Millimoles per liter
Standard Deviation 0.0456
|
0.000 Millimoles per liter
Standard Deviation 0.0566
|
-0.036 Millimoles per liter
Standard Deviation 0.0773
|
0.000 Millimoles per liter
Standard Deviation 0.0551
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Magnesium, Week 24,n=12,6,6,9,9,6
|
0.008 Millimoles per liter
Standard Deviation 0.0422
|
-0.023 Millimoles per liter
Standard Deviation 0.0585
|
-0.017 Millimoles per liter
Standard Deviation 0.0686
|
0.000 Millimoles per liter
Standard Deviation 0.0424
|
-0.047 Millimoles per liter
Standard Deviation 0.0557
|
-0.003 Millimoles per liter
Standard Deviation 0.0320
|
|
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Glucose, Day 3,n=12,6,6,9,9,6
|
-0.28 Millimoles per liter
Standard Deviation 0.673
|
-0.10 Millimoles per liter
Standard Deviation 1.215
|
-0.93 Millimoles per liter
Standard Deviation 1.117
|
-0.18 Millimoles per liter
Standard Deviation 0.455
|
-0.21 Millimoles per liter
Standard Deviation 0.647
|
0.15 Millimoles per liter
Standard Deviation 0.521
|
PRIMARY outcome
Timeframe: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Urine samples were collected to analyze presence of ketones, occult blood, glucose, and protein in urine. In this dipstick test, the level of occult blood, glucose, ketones and urine protein in urine samples were recorded as negative, trace, 1+ and 2+ indicating proportional concentrations in urine. Only categories with abnormal significant values have been presented.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein
Urine Ketone, Trace, Week 18,n=2,1,0,1,0,0
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein
Urine Ketone, Trace, Week 24,n=1,1,0,4,0,0
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein
Occult blood, Trace,Week 4,n=2,1,1,5,0,1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein
Urine Ketone, Trace,Day 2,n=1,2,0,2,0,0
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein
Urine Ketone, Trace, Day 4,n=0,0,1,1,0,0
|
—
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein
Urine Ketone, Trace, Day 5,n=2,0,0,2,1,0
|
1 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein
Urine Ketone, Trace, Week 1,n=2,1,1,3,0,0
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein
Urine Ketone, Trace, Week 2,n=1,0,0,3,1,0
|
1 Participants
|
—
|
—
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein
Urine Ketone, Trace, Week 4,n=2,1,1,5,0,0
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein
Urine Ketone, Trace, Week 26,n=0,0,0,2,0,0
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
|
Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein
Urine Ketone, Trace,Week 32,n=1,0,0,0,0,0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein
Urine Ketone, 1+, Week 40,n=0,0,0,0,0,1
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein
Urine Protein, 2+, Week 4,n=2,1,1,5,0,1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein
Urine Protein, Trace, Week 8,n=1,0,0,2,0,0
|
1 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein
Urine Protein, Trace, Week 18,n=2,1,0,1,0,0
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Urinary pH measurement is a routine part of urinalysis. 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=1 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=1 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=5 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=1 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=1 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
Day 2,n=1,1,0,2,0,0
|
5.00 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
7.00 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
6.50 pH
Standard Deviation 1.414
|
—
|
—
|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
Week 1,n=2,1,1,3,0,0
|
5.50 pH
Standard Deviation 0.000
|
7.00 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
6.00 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
5.50 pH
Standard Deviation 0.500
|
—
|
—
|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
Week 4,n=3,1,1,5,0,1
|
6.50 pH
Standard Deviation 0.866
|
8.00 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
5.50 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
6.00 pH
Standard Deviation 0.707
|
—
|
5.00 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
Day 3,n=3,0,0,1,0,0
|
6.00 pH
Standard Deviation 0.500
|
—
|
—
|
5.00 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
—
|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
Day 4,n=0,0,1,1,0,0
|
—
|
—
|
6.50 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
5.00 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
—
|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
Day 5,n=2,0,0,2,1,0
|
5.50 pH
Standard Deviation 0.707
|
—
|
—
|
5.75 pH
Standard Deviation 1.061
|
5.50 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
Week 2,n=1,0,0,4,1,0
|
5.50 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
—
|
5.63 pH
Standard Deviation 0.479
|
8.50 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
Week 8,n=1,0,0,2,0,0
|
5.50 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
—
|
5.50 pH
Standard Deviation 0.000
|
—
|
—
|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
Week 12,n=0,1,0,1,0,0
|
—
|
6.50 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
5.00 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
—
|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
Week 18,n=3,1,0,1,0,0
|
5.67 pH
Standard Deviation 0.577
|
7.00 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
5.00 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
—
|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
Week 24,n=1,1,0,4,0,0
|
6.00 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
6.50 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
5.38 pH
Standard Deviation 0.479
|
—
|
—
|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
Week 26,n=0,0,0,2,0,0
|
—
|
—
|
—
|
5.50 pH
Standard Deviation 0.000
|
—
|
—
|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
Week 32,n=1,0,0,0,0,0
|
7.50 pH
Standard Deviation NA
NA indicates that standard deviation could not be calculated for a single data point.
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and at Days 2, 3, 4 and 5; Weeks 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40Population: Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).
Blood samples were collected at indicated timepoints for analysis for complement (C3 and C4). Baseline was defined as latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Absolute Values of Complement (C)3 and C4
C3, Day 2,n=12,6,6,9,9,6
|
1.13 Grams per liter
Interval 1.042 to 1.225
|
1.27 Grams per liter
Interval 1.051 to 1.535
|
1.16 Grams per liter
Interval 0.94 to 1.433
|
1.114 Grams per liter
Interval 1.018 to 1.219
|
1.188 Grams per liter
Interval 1.053 to 1.341
|
1.286 Grams per liter
Interval 1.182 to 1.4
|
|
Absolute Values of Complement (C)3 and C4
C3, Day 3,n=12,6,6,9,9,6
|
1.187 Grams per liter
Interval 1.063 to 1.325
|
1.244 Grams per liter
Interval 1.029 to 1.503
|
1.236 Grams per liter
Interval 1.011 to 1.511
|
1.142 Grams per liter
Interval 1.037 to 1.258
|
1.157 Grams per liter
Interval 1.038 to 1.29
|
1.322 Grams per liter
Interval 1.197 to 1.46
|
|
Absolute Values of Complement (C)3 and C4
C3, Week 2,n=12,6,6,9,9,6
|
1.136 Grams per liter
Interval 1.062 to 1.215
|
1.147 Grams per liter
Interval 0.986 to 1.333
|
1.02 Grams per liter
Interval 0.841 to 1.238
|
1.139 Grams per liter
Interval 1.045 to 1.241
|
1.174 Grams per liter
Interval 1.039 to 1.327
|
1.28 Grams per liter
Interval 1.136 to 1.442
|
|
Absolute Values of Complement (C)3 and C4
C3, Week 4,n=12,6,6,9,9,6
|
1.114 Grams per liter
Interval 1.043 to 1.191
|
1.05 Grams per liter
Interval 0.873 to 1.262
|
1.111 Grams per liter
Interval 0.9 to 1.37
|
1.07 Grams per liter
Interval 0.957 to 1.197
|
1.148 Grams per liter
Interval 1.019 to 1.293
|
1.22 Grams per liter
Interval 1.085 to 1.372
|
|
Absolute Values of Complement (C)3 and C4
C3, Week 12,n=12,6,6,9,9,6
|
1.117 Grams per liter
Interval 1.011 to 1.234
|
1.033 Grams per liter
Interval 0.935 to 1.141
|
1.124 Grams per liter
Interval 0.947 to 1.334
|
1.147 Grams per liter
Interval 1.05 to 1.254
|
1.211 Grams per liter
Interval 1.065 to 1.377
|
1.28 Grams per liter
Interval 1.117 to 1.465
|
|
Absolute Values of Complement (C)3 and C4
C3, Week 26,n=12,6,6,9,9,6
|
1.204 Grams per liter
Interval 1.106 to 1.311
|
0.927 Grams per liter
Interval 0.45 to 1.91
|
1.142 Grams per liter
Interval 0.963 to 1.355
|
1.156 Grams per liter
Interval 1.07 to 1.249
|
1.222 Grams per liter
Interval 1.081 to 1.381
|
1.298 Grams per liter
Interval 1.123 to 1.501
|
|
Absolute Values of Complement (C)3 and C4
C3, Week 32,n=6,6,6,0,0,6
|
1.173 Grams per liter
Interval 0.985 to 1.398
|
1.243 Grams per liter
Interval 1.137 to 1.358
|
1.231 Grams per liter
Interval 1.016 to 1.491
|
—
|
—
|
1.204 Grams per liter
Interval 1.116 to 1.299
|
|
Absolute Values of Complement (C)3 and C4
C3, Week 36,n=6,0,0,9,9,0
|
1.243 Grams per liter
Interval 1.107 to 1.397
|
—
|
—
|
1.188 Grams per liter
Interval 1.085 to 1.301
|
1.236 Grams per liter
Interval 1.106 to 1.382
|
—
|
|
Absolute Values of Complement (C)3 and C4
C4, Baseline,n=12,6,6,9,9,6
|
0.2576 Grams per liter
Interval 0.2108 to 0.3147
|
0.2061 Grams per liter
Interval 0.1653 to 0.257
|
0.1919 Grams per liter
Interval 0.1337 to 0.2755
|
0.2144 Grams per liter
Interval 0.1727 to 0.2663
|
0.1939 Grams per liter
Interval 0.1496 to 0.2512
|
0.215 Grams per liter
Interval 0.1859 to 0.2488
|
|
Absolute Values of Complement (C)3 and C4
C4, Week 4,n=12,6,6,9,9,6
|
0.2602 Grams per liter
Interval 0.2078 to 0.3258
|
0.1928 Grams per liter
Interval 0.1623 to 0.229
|
0.189 Grams per liter
Interval 0.1292 to 0.2766
|
0.2063 Grams per liter
Interval 0.1636 to 0.2602
|
0.1872 Grams per liter
Interval 0.1419 to 0.2468
|
0.1929 Grams per liter
Interval 0.1733 to 0.2146
|
|
Absolute Values of Complement (C)3 and C4
C4, Week 8,n=12,6,6,9,9,6
|
0.2738 Grams per liter
Interval 0.2186 to 0.3431
|
0.2547 Grams per liter
Interval 0.201 to 0.3226
|
0.2045 Grams per liter
Interval 0.1315 to 0.318
|
0.2009 Grams per liter
Interval 0.1654 to 0.2441
|
0.1901 Grams per liter
Interval 0.1542 to 0.2343
|
0.2231 Grams per liter
Interval 0.1778 to 0.28
|
|
Absolute Values of Complement (C)3 and C4
C4, Week 18,n=12,6,6,9,9,6
|
0.261 Grams per liter
Interval 0.1992 to 0.342
|
0.2266 Grams per liter
Interval 0.1873 to 0.2742
|
0.2025 Grams per liter
Interval 0.1322 to 0.3102
|
0.226 Grams per liter
Interval 0.192 to 0.266
|
0.1678 Grams per liter
Interval 0.1255 to 0.2245
|
0.216 Grams per liter
Interval 0.174 to 0.2681
|
|
Absolute Values of Complement (C)3 and C4
C4, Week 24,n=12,6,6,8,9,6
|
0.2474 Grams per liter
Interval 0.1894 to 0.3232
|
0.2244 Grams per liter
Interval 0.1742 to 0.289
|
0.197 Grams per liter
Interval 0.1324 to 0.2932
|
0.206 Grams per liter
Interval 0.1801 to 0.2357
|
0.1909 Grams per liter
Interval 0.15 to 0.243
|
0.2114 Grams per liter
Interval 0.1682 to 0.2658
|
|
Absolute Values of Complement (C)3 and C4
C4, Week 36,n=6,0,0,9,9,0
|
0.2844 Grams per liter
Interval 0.211 to 0.3834
|
—
|
—
|
0.2025 Grams per liter
Interval 0.1637 to 0.2504
|
0.206 Grams per liter
Interval 0.1626 to 0.2611
|
—
|
|
Absolute Values of Complement (C)3 and C4
C4, Week 40,n=2,0,0,0,0,6
|
0.1699 Grams per liter
NA indicates not available as 95% Confidence Interval (CI) was only available when at least 3 participants contribute to the statistics
|
—
|
—
|
—
|
—
|
0.2134 Grams per liter
Interval 0.1766 to 0.258
|
|
Absolute Values of Complement (C)3 and C4
C3, Baseline,n=12,6,6,9,9,6
|
1.149 Grams per liter
Interval 1.061 to 1.243
|
1.182 Grams per liter
Interval 0.995 to 1.404
|
1.086 Grams per liter
Interval 0.941 to 1.254
|
1.074 Grams per liter
Interval 0.982 to 1.175
|
1.137 Grams per liter
Interval 1.013 to 1.277
|
1.254 Grams per liter
Interval 1.122 to 1.402
|
|
Absolute Values of Complement (C)3 and C4
C3, Day 4,n=12,6,6,9,9,6
|
1.17 Grams per liter
Interval 1.051 to 1.302
|
1.284 Grams per liter
Interval 1.023 to 1.611
|
1.181 Grams per liter
Interval 1.016 to 1.374
|
1.144 Grams per liter
Interval 1.051 to 1.245
|
1.165 Grams per liter
Interval 1.038 to 1.307
|
1.316 Grams per liter
Interval 1.189 to 1.458
|
|
Absolute Values of Complement (C)3 and C4
C3, Day 5,n=12,6,6,9,9,6
|
1.136 Grams per liter
Interval 1.011 to 1.277
|
1.122 Grams per liter
Interval 0.993 to 1.268
|
1.092 Grams per liter
Interval 0.909 to 1.311
|
1.113 Grams per liter
Interval 1.011 to 1.226
|
1.165 Grams per liter
Interval 1.026 to 1.323
|
1.305 Grams per liter
Interval 1.159 to 1.469
|
|
Absolute Values of Complement (C)3 and C4
C3, Week 8,n=12,6,6,9,9,6
|
1.224 Grams per liter
Interval 1.15 to 1.303
|
1.226 Grams per liter
Interval 1.115 to 1.347
|
1.097 Grams per liter
Interval 0.875 to 1.376
|
1.117 Grams per liter
Interval 0.993 to 1.257
|
1.167 Grams per liter
Interval 1.085 to 1.254
|
1.34 Grams per liter
Interval 1.191 to 1.506
|
|
Absolute Values of Complement (C)3 and C4
C3, Week 18,n=12,6,6,9,9,6
|
1.173 Grams per liter
Interval 1.065 to 1.291
|
1.215 Grams per liter
Interval 0.984 to 1.5
|
1.124 Grams per liter
Interval 0.922 to 1.37
|
1.184 Grams per liter
Interval 1.045 to 1.342
|
1.231 Grams per liter
Interval 1.119 to 1.353
|
1.283 Grams per liter
Interval 1.158 to 1.422
|
|
Absolute Values of Complement (C)3 and C4
C3, Week 24,n=12,6,6,8,9,6
|
1.15 Grams per liter
Interval 1.067 to 1.238
|
1.136 Grams per liter
Interval 1.031 to 1.252
|
1.171 Grams per liter
Interval 1.029 to 1.332
|
1.157 Grams per liter
Interval 1.019 to 1.312
|
1.243 Grams per liter
Interval 1.107 to 1.395
|
1.222 Grams per liter
Interval 1.1 to 1.356
|
|
Absolute Values of Complement (C)3 and C4
C3, Week 40,n=2,0,0,0,0,6
|
1.181 Grams per liter
NA indicates not available as 95% Confidence Interval (CI) was only available when at least 3 participants contribute to the statistics
|
—
|
—
|
—
|
—
|
1.231 Grams per liter
Interval 1.069 to 1.417
|
|
Absolute Values of Complement (C)3 and C4
C4, Day 2,n=12,6,6,9,9,6
|
0.2525 Grams per liter
Interval 0.2037 to 0.313
|
0.2161 Grams per liter
Interval 0.1832 to 0.2549
|
0.2061 Grams per liter
Interval 0.1469 to 0.2891
|
0.2133 Grams per liter
Interval 0.1784 to 0.2549
|
0.203 Grams per liter
Interval 0.1597 to 0.2581
|
0.22 Grams per liter
Interval 0.1832 to 0.2643
|
|
Absolute Values of Complement (C)3 and C4
C4, Day 3,n=12,6,6,9,9,6
|
0.2647 Grams per liter
Interval 0.2068 to 0.3389
|
0.2038 Grams per liter
Interval 0.1685 to 0.2464
|
0.2212 Grams per liter
Interval 0.1464 to 0.3342
|
0.2142 Grams per liter
Interval 0.1759 to 0.2609
|
0.1962 Grams per liter
Interval 0.1514 to 0.2544
|
0.223 Grams per liter
Interval 0.1921 to 0.2589
|
|
Absolute Values of Complement (C)3 and C4
C4, Day 4,n=12,6,6,9,9,6
|
0.253 Grams per liter
Interval 0.2013 to 0.3179
|
0.2303 Grams per liter
Interval 0.1918 to 0.2767
|
0.2006 Grams per liter
Interval 0.1416 to 0.2842
|
0.2128 Grams per liter
Interval 0.1766 to 0.2564
|
0.1935 Grams per liter
Interval 0.1472 to 0.2543
|
0.2188 Grams per liter
Interval 0.1867 to 0.2564
|
|
Absolute Values of Complement (C)3 and C4
C4, Day 5,n=12,6,6,9,9,6
|
0.2497 Grams per liter
Interval 0.1929 to 0.3232
|
0.1892 Grams per liter
Interval 0.1572 to 0.2277
|
0.1866 Grams per liter
Interval 0.1327 to 0.268
|
0.2073 Grams per liter
Interval 0.1685 to 0.2551
|
0.1943 Grams per liter
Interval 0.1492 to 0.2531
|
0.2163 Grams per liter
Interval 0.1869 to 0.2503
|
|
Absolute Values of Complement (C)3 and C4
C4, Week 2,n=12,6,6,9,9,6
|
0.2555 Grams per liter
Interval 0.2028 to 0.322
|
0.2108 Grams per liter
Interval 0.1768 to 0.2514
|
0.1781 Grams per liter
Interval 0.1172 to 0.2706
|
0.221 Grams per liter
Interval 0.1813 to 0.2695
|
0.2018 Grams per liter
Interval 0.1497 to 0.272
|
0.2169 Grams per liter
Interval 0.1765 to 0.2664
|
|
Absolute Values of Complement (C)3 and C4
C4, Week 12,n=12,6,6,9,9,6
|
0.2413 Grams per liter
Interval 0.1901 to 0.3063
|
0.1862 Grams per liter
Interval 0.1567 to 0.2213
|
0.2034 Grams per liter
Interval 0.1307 to 0.3167
|
0.2114 Grams per liter
Interval 0.1723 to 0.2594
|
0.196 Grams per liter
Interval 0.1494 to 0.2572
|
0.2074 Grams per liter
Interval 0.1792 to 0.24
|
|
Absolute Values of Complement (C)3 and C4
C4, Week 26,n=12,6,6,9,9,6
|
0.2517 Grams per liter
Interval 0.1926 to 0.3291
|
0.202 Grams per liter
Interval 0.1319 to 0.3095
|
0.1939 Grams per liter
Interval 0.1291 to 0.2912
|
0.2115 Grams per liter
Interval 0.1704 to 0.2627
|
0.163 Grams per liter
Interval 0.125 to 0.2126
|
0.226 Grams per liter
Interval 0.1887 to 0.2627
|
|
Absolute Values of Complement (C)3 and C4
C4, Week 32,n=6,6,6,0,0,6
|
0.2772 Grams per liter
Interval 0.1617 to 0.4754
|
0.2401 Grams per liter
Interval 0.2003 to 0.2877
|
0.2007 Grams per liter
Interval 0.1297 to 0.3105
|
—
|
—
|
0.2051 Grams per liter
Interval 0.1808 to 0.2326
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dosePopulation: Pharmacokinetic Population.
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Pharmacokinetic parameters were calculated by standard non compartmental analysis. Pharmacokinetic Population included participants in the Safety population for whom a pharmcokinetic sample was obtained and analyzed.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK3511294 2 mg and 10 mg
|
24.795 Day*microgram per milliliter
Geometric Coefficient of Variation 51.6
|
68.904 Day*microgram per milliliter
Geometric Coefficient of Variation 23.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dosePopulation: Pharmacokinetic Population.
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Pharmacokinetic parameters were calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
AUC(0-inf) of GSK3511294 30 mg and 100 mg
|
208.308 Day*microgram per milliliter
Geometric Coefficient of Variation 39.6
|
846.686 Day*microgram per milliliter
Geometric Coefficient of Variation 7.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dosePopulation: Pharmacokinetic Population.
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Pharmacokinetic parameters were calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
AUC(0-inf) of GSK3511294 300 mg
|
1873.657 Day*microgram per milliliter
Geometric Coefficient of Variation 25.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dosePopulation: Pharmacokinetic Population.
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). Pharmacokinetic parameters were calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK3511294 2 mg and 10 mg
|
18.369 Day*microgram per milliliter
Geometric Coefficient of Variation 59.2
|
62.101 Day*microgram per milliliter
Geometric Coefficient of Variation 28.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). Pharmacokinetic parameters were calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
AUC(0-t) of GSK3511294 30 mg and 100 mg
|
201.434 Day*microgram per milliliter
Geometric Coefficient of Variation 41.1
|
830.245 Day*microgram per milliliter
Geometric Coefficient of Variation 7.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
AUC(0-t) of GSK3511294 300 mg
|
1855.619 Day*microgram per milliliter
Geometric Coefficient of Variation 25.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, and 4 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-Week 4). Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Week 4 (AUC[0-Week 4]) of GSK3511294
|
6.856 Day*microgram per milliliter
Geometric Coefficient of Variation 22.0
|
19.685 Day*microgram per milliliter
Geometric Coefficient of Variation 14.0
|
62.994 Day*microgram per milliliter
Geometric Coefficient of Variation 40.6
|
292.698 Day*microgram per milliliter
Geometric Coefficient of Variation 11.0
|
676.055 Day*microgram per milliliter
Geometric Coefficient of Variation 22.7
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8 and 12 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-Week 12). Pharmacokinetic parameters were calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Week 12 (AUC[0-Week 12]) of GSK3511294
|
16.102 Day*microgram per milliliter
Geometric Coefficient of Variation 37.1
|
48.389 Day*microgram per milliliter
Geometric Coefficient of Variation 22.7
|
148.798 Day*microgram per milliliter
Geometric Coefficient of Variation 37.8
|
663.984 Day*microgram per milliliter
Geometric Coefficient of Variation 8.1
|
1445.726 Day*microgram per milliliter
Geometric Coefficient of Variation 23.8
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-Week 26). Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Week 26 (AUC [0-Week 26]) of GSK3511294
|
21.829 Day*microgram per milliliter
Geometric Coefficient of Variation 42.7
|
64.453 Day*microgram per milliliter
Geometric Coefficient of Variation 24.3
|
199.893 Day*microgram per milliliter
Geometric Coefficient of Variation 39.9
|
805.359 Day*microgram per milliliter
Geometric Coefficient of Variation 7.7
|
1789.451 Day*microgram per milliliter
Geometric Coefficient of Variation 26.3
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for %AUCex. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Percentage of AUC (0-inf) Obtained by Extrapolation (%AUCex) of GSK3511294 2 mg and 10 mg
|
24.3560 Percentage of AUCex
Geometric Coefficient of Variation 35.8
|
7.7705 Percentage of AUCex
Geometric Coefficient of Variation 81.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for %AUCex. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
%AUCex of GSK3511294 30 mg and 100 mg
|
2.9636 Percentage of AUCex
Geometric Coefficient of Variation 55.6
|
1.4162 Percentage of AUCex
Geometric Coefficient of Variation 88.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for %AUCex. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
%AUCex of GSK3511294 300 mg
|
0.9096 Percentage of AUCex
Geometric Coefficient of Variation 35.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for Cmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of GSK3511294 2 mg and 10 mg
|
0.3400 Microgram per milliliter
Geometric Coefficient of Variation 25.3
|
0.8759 Microgram per milliliter
Geometric Coefficient of Variation 18.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for Cmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Cmax of GSK3511294 30 mg and 100 mg
|
2.8101 Microgram per milliliter
Geometric Coefficient of Variation 41.1
|
12.2471 Microgram per milliliter
Geometric Coefficient of Variation 15.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for Cmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Cmax of GSK3511294 300 mg
|
28.5987 Microgram per milliliter
Geometric Coefficient of Variation 23.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for Tmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Time of Occurrence of Cmax (Tmax) of GSK3511294 2 mg and 10 mg
|
10.966 Days
Interval 6.99 to 27.98
|
7.956 Days
Interval 7.0 to 28.91
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for Tmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Tmax of GSK3511294 30 mg and 100 mg
|
13.943 Days
Interval 4.0 to 28.02
|
13.970 Days
Interval 3.97 to 16.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for Tmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Tmax of GSK3511294 300 mg
|
13.909 Days
Interval 2.0 to 15.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for Tlast. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Time of Last Quantifiable Concentration (Tlast) of GSK3511294 2 mg and 10 mg
|
84.47 Days
Interval 84.0 to 182.0
|
176.46 Days
Interval 126.0 to 185.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dosePopulation: Pharmacokinetic Population.
Blood samples were collected from participants at indicated time points and analyzed for Tlast. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Tlast of GSK3511294 30 mg and 100 mg
|
182.01 Days
Interval 182.0 to 254.8
|
252.00 Days
Interval 250.0 to 255.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for Tlast. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Tlast of GSK3511294 300 mg
|
279.99 Days
Interval 278.0 to 283.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for CL/F. CL/F was calculated as dose divided by AUC(0-inf). Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Apparent Clearance Following Subcutaneous Dosing (CL/F) of GSK3511294 2 mg and 10 mg
|
0.08066 Liters per day
Geometric Coefficient of Variation 51.6
|
0.14513 Liters per day
Geometric Coefficient of Variation 23.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for CL/F. CL/F was calculated as dose divided by AUC(0-inf). Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
CL/F of GSK3511294 30 mg and 100 mg
|
0.14402 Liters per day
Geometric Coefficient of Variation 39.6
|
0.11811 Liters per day
Geometric Coefficient of Variation 7.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for CL/F. CL/F was calculated as dose divided by AUC(0-inf). Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
CL/F of GSK3511294 300 mg
|
0.16011 Liters per day
Geometric Coefficient of Variation 25.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for Vd/F. Vd/F was calculated as dose divided by terminal elimination rate constant (lambda\_z) \*AUC(0-inf). Pharmacokinetic parameters were calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution After Subcutaneous Administration (Vd/F) of GSK3511294 2 mg and 10 mg
|
6.113 Liters
Geometric Coefficient of Variation 37.6
|
9.193 Liters
Geometric Coefficient of Variation 34.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for Vd/F. Vd/F was calculated as dose divided by \[lambda\_z \*AUC(0-inf)\]. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Vd/F of GSK3511294 30 mg and 100 mg
|
7.812 Liters
Geometric Coefficient of Variation 40.4
|
6.630 Liters
Geometric Coefficient of Variation 12.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for Vd/F. Vd/F was calculated as dose divided by \[lambda\_z \*AUC(0-inf)\]. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Vd/F of GSK3511294 300 mg
|
9.337 Liters
Geometric Coefficient of Variation 30.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for lambda\_z. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Terminal Phase Elimination Rate Constant (Lambda_z) of GSK3511294 2 mg and 10 mg
|
0.013195 Day^-1
Geometric Coefficient of Variation 37.3
|
0.015787 Day^-1
Geometric Coefficient of Variation 16.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for lambda\_z. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Lambda_z of GSK3511294 30 mg and 100 mg
|
0.018435 Day^-1
Geometric Coefficient of Variation 10.7
|
0.017813 Day^-1
Geometric Coefficient of Variation 11.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for lambda\_z. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Lambda_z of GSK3511294 300 mg
|
0.017148 Day^-1
Geometric Coefficient of Variation 6.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for t1/2. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Terminal Phase Half-life (t1/2) of GSK3511294 2 mg and 10 mg
|
52.531 Days
Geometric Coefficient of Variation 37.3
|
43.907 Days
Geometric Coefficient of Variation 16.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for t1/2. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
T1/2 of GSK3511294 30 mg and 100 mg
|
37.599 Days
Geometric Coefficient of Variation 10.7
|
38.913 Days
Geometric Coefficient of Variation 11.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dosePopulation: Pharmacokinetic Population
Blood samples were collected from participants at indicated time points and analyzed for t1/2. Pharmacokinetic parameters was calculated by standard non compartmental analysis.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
T1/2 of GSK3511294 300 mg
|
40.422 Days
Geometric Coefficient of Variation 6.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 2, 3, 4, 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36, and 40Population: Pharmacodynamic Population. Only those participants with planned assessments at that particular time point has been presented (represented by n=X in category titles)
Blood samples were collected at indicated time-points. Analysis was performed using a mixed model repeated measures analysis (MMRM) model on log-transformed data with fixed categorical effects of treatment, planned timepoint and treatment-by-planned timepoint interaction and fixed continuous covariates of log Baseline blood eosinophil count and log Baseline blood eosinophil count-by-planned timepoint interaction. Baseline is defined as the latest predose non-missing blood eosinophil count. Ratio to Baseline is defined as post-dose visit value divided by Baseline value. Pharmacodynamic Population included participants in the 'Safety' population for whom a post-dose pharmacodynamic (ie blood eosinophil) sample was obtained and analyzed.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Ratio to Baseline in Absolute Blood Eosinophil Count
Day 2, n=12, 6, 6, 8, 9, 6
|
1.083 Ratio of eosinophils in blood
Interval 0.828 to 1.418
|
0.562 Ratio of eosinophils in blood
Interval 0.382 to 0.827
|
0.522 Ratio of eosinophils in blood
Interval 0.356 to 0.765
|
0.434 Ratio of eosinophils in blood
Interval 0.313 to 0.601
|
0.496 Ratio of eosinophils in blood
Interval 0.364 to 0.677
|
0.466 Ratio of eosinophils in blood
Interval 0.317 to 0.683
|
|
Ratio to Baseline in Absolute Blood Eosinophil Count
Day 5, n=11, 6, 6, 9, 9, 6
|
0.927 Ratio of eosinophils in blood
Interval 0.705 to 1.22
|
0.300 Ratio of eosinophils in blood
Interval 0.204 to 0.442
|
0.267 Ratio of eosinophils in blood
Interval 0.182 to 0.391
|
0.219 Ratio of eosinophils in blood
Interval 0.159 to 0.3
|
0.280 Ratio of eosinophils in blood
Interval 0.205 to 0.382
|
0.299 Ratio of eosinophils in blood
Interval 0.204 to 0.438
|
|
Ratio to Baseline in Absolute Blood Eosinophil Count
Week 12, n=12, 5, 6, 9, 9, 5
|
1.031 Ratio of eosinophils in blood
Interval 0.788 to 1.35
|
0.373 Ratio of eosinophils in blood
Interval 0.25 to 0.557
|
0.171 Ratio of eosinophils in blood
Interval 0.116 to 0.25
|
0.123 Ratio of eosinophils in blood
Interval 0.089 to 0.168
|
0.161 Ratio of eosinophils in blood
Interval 0.118 to 0.22
|
0.164 Ratio of eosinophils in blood
Interval 0.11 to 0.244
|
|
Ratio to Baseline in Absolute Blood Eosinophil Count
Week 26, n=12, 6, 6, 9, 9, 6
|
1.119 Ratio of eosinophils in blood
Interval 0.855 to 1.464
|
0.776 Ratio of eosinophils in blood
Interval 0.527 to 1.141
|
0.663 Ratio of eosinophils in blood
Interval 0.452 to 0.972
|
0.317 Ratio of eosinophils in blood
Interval 0.231 to 0.435
|
0.199 Ratio of eosinophils in blood
Interval 0.146 to 0.271
|
0.186 Ratio of eosinophils in blood
Interval 0.127 to 0.273
|
|
Ratio to Baseline in Absolute Blood Eosinophil Count
Week 18, n=12, 6, 6, 9, 9, 6
|
1.079 Ratio of eosinophils in blood
Interval 0.824 to 1.412
|
0.466 Ratio of eosinophils in blood
Interval 0.317 to 0.685
|
0.314 Ratio of eosinophils in blood
Interval 0.214 to 0.46
|
0.152 Ratio of eosinophils in blood
Interval 0.111 to 0.208
|
0.139 Ratio of eosinophils in blood
Interval 0.102 to 0.19
|
0.179 Ratio of eosinophils in blood
Interval 0.122 to 0.262
|
|
Ratio to Baseline in Absolute Blood Eosinophil Count
Week 24, n=11, 6, 6, 9, 9, 6
|
1.005 Ratio of eosinophils in blood
Interval 0.763 to 1.322
|
0.661 Ratio of eosinophils in blood
Interval 0.449 to 0.972
|
0.563 Ratio of eosinophils in blood
Interval 0.384 to 0.825
|
0.285 Ratio of eosinophils in blood
Interval 0.208 to 0.391
|
0.149 Ratio of eosinophils in blood
Interval 0.109 to 0.203
|
0.202 Ratio of eosinophils in blood
Interval 0.137 to 0.296
|
|
Ratio to Baseline in Absolute Blood Eosinophil Count
Day 3, n=12, 6, 6, 9, 9, 6
|
0.977 Ratio of eosinophils in blood
Interval 0.747 to 1.279
|
0.431 Ratio of eosinophils in blood
Interval 0.293 to 0.633
|
0.350 Ratio of eosinophils in blood
Interval 0.238 to 0.512
|
0.281 Ratio of eosinophils in blood
Interval 0.205 to 0.386
|
0.262 Ratio of eosinophils in blood
Interval 0.192 to 0.357
|
0.403 Ratio of eosinophils in blood
Interval 0.275 to 0.591
|
|
Ratio to Baseline in Absolute Blood Eosinophil Count
Day 4, n=12, 6, 6, 8, 8, 6
|
1.008 Ratio of eosinophils in blood
Interval 0.77 to 1.319
|
0.400 Ratio of eosinophils in blood
Interval 0.272 to 0.589
|
0.340 Ratio of eosinophils in blood
Interval 0.232 to 0.499
|
0.215 Ratio of eosinophils in blood
Interval 0.155 to 0.298
|
0.250 Ratio of eosinophils in blood
Interval 0.182 to 0.344
|
0.360 Ratio of eosinophils in blood
Interval 0.246 to 0.528
|
|
Ratio to Baseline in Absolute Blood Eosinophil Count
Week 1, n=12, 6, 6, 9, 9, 5
|
1.136 Ratio of eosinophils in blood
Interval 0.868 to 1.487
|
0.304 Ratio of eosinophils in blood
Interval 0.206 to 0.447
|
0.223 Ratio of eosinophils in blood
Interval 0.152 to 0.326
|
0.226 Ratio of eosinophils in blood
Interval 0.165 to 0.311
|
0.237 Ratio of eosinophils in blood
Interval 0.173 to 0.323
|
0.250 Ratio of eosinophils in blood
Interval 0.167 to 0.373
|
|
Ratio to Baseline in Absolute Blood Eosinophil Count
Week 2, n=12, 6, 5, 9, 9, 6
|
1.174 Ratio of eosinophils in blood
Interval 0.897 to 1.536
|
0.274 Ratio of eosinophils in blood
Interval 0.186 to 0.403
|
0.225 Ratio of eosinophils in blood
Interval 0.151 to 0.336
|
0.170 Ratio of eosinophils in blood
Interval 0.124 to 0.233
|
0.214 Ratio of eosinophils in blood
Interval 0.157 to 0.292
|
0.265 Ratio of eosinophils in blood
Interval 0.18 to 0.388
|
|
Ratio to Baseline in Absolute Blood Eosinophil Count
Week 4,n=12, 6, 5, 9, 9, 6
|
1.062 Ratio of eosinophils in blood
Interval 0.812 to 1.39
|
0.198 Ratio of eosinophils in blood
Interval 0.134 to 0.291
|
0.195 Ratio of eosinophils in blood
Interval 0.131 to 0.29
|
0.131 Ratio of eosinophils in blood
Interval 0.095 to 0.179
|
0.185 Ratio of eosinophils in blood
Interval 0.135 to 0.252
|
0.180 Ratio of eosinophils in blood
Interval 0.123 to 0.264
|
|
Ratio to Baseline in Absolute Blood Eosinophil Count
Week 8, n=12, 6, 6, 9, 9, 6
|
1.095 Ratio of eosinophils in blood
Interval 0.837 to 1.434
|
0.201 Ratio of eosinophils in blood
Interval 0.137 to 0.296
|
0.129 Ratio of eosinophils in blood
Interval 0.088 to 0.189
|
0.102 Ratio of eosinophils in blood
Interval 0.075 to 0.14
|
0.126 Ratio of eosinophils in blood
Interval 0.092 to 0.172
|
0.178 Ratio of eosinophils in blood
Interval 0.121 to 0.261
|
|
Ratio to Baseline in Absolute Blood Eosinophil Count
Week 32, n=6, 6, 6, 0, 0, 6
|
0.912 Ratio of eosinophils in blood
Interval 0.656 to 1.268
|
0.968 Ratio of eosinophils in blood
Interval 0.655 to 1.43
|
0.837 Ratio of eosinophils in blood
Interval 0.569 to 1.229
|
—
|
—
|
0.210 Ratio of eosinophils in blood
Interval 0.142 to 0.308
|
|
Ratio to Baseline in Absolute Blood Eosinophil Count
Week 36, n=6, 0, 0, 9, 9, 0
|
0.975 Ratio of eosinophils in blood
Interval 0.691 to 1.376
|
—
|
—
|
0.858 Ratio of eosinophils in blood
Interval 0.624 to 1.18
|
0.374 Ratio of eosinophils in blood
Interval 0.274 to 0.511
|
—
|
|
Ratio to Baseline in Absolute Blood Eosinophil Count
Week 40, n=2, 0, 0, 0, 0, 6
|
1.210 Ratio of eosinophils in blood
Interval 0.604 to 2.422
|
—
|
—
|
—
|
—
|
0.258 Ratio of eosinophils in blood
Interval 0.172 to 0.387
|
SECONDARY outcome
Timeframe: Up to Week 40Population: Safety Population.
Serum samples were collected to determine the presence of anti-GSK3511294 binding antibodies using a validated bioanalytical method. Data for any time post-Baseline is reported. The results were categorized as negative, transient positive (defined as a single confirmatory positive immunogenic response that does not occur at the final study assessment) and persistent positive (defined as a confirmatory positive immunogenic response for at least 2 consecutive assessments or a single result at the final study assessment).
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Number of Participants With Anti-drug Antibody (ADA) Binding to GSK3511294
Transient positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibody (ADA) Binding to GSK3511294
Negative
|
12 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Anti-drug Antibody (ADA) Binding to GSK3511294
Persistent positive
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 40Population: Safety Population. Only participants with positive results for ADA were analyzed.
Serum samples were collected to determine the presence of anti-GSK3511294 binding antibodies using a validated bioanalytical method. Data for any time post-Baseline is reported. Titer was only measured when a positive result was found.
Outcome measures
| Measure |
Placebo
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=1 Participants
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=5 Participants
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=2 Participants
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=1 Participants
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Titers of Binding ADA to GSK3511294
|
—
|
—
|
80.0 Titer
Interval 80.0 to 80.0
|
160.0 Titer
Interval 80.0 to 320.0
|
80.0 Titer
Interval 80.0 to 80.0
|
80.0 Titer
Interval 80.0 to 320.0
|
Adverse Events
Placebo
GSK3511294 2mg
GSK3511294 10mg
GSK3511294 30mg
GSK3511294 100mg
GSK3511294 300mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=12 participants at risk
Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
|
GSK3511294 2mg
n=6 participants at risk
Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
|
GSK3511294 10mg
n=6 participants at risk
Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
|
GSK3511294 30mg
n=9 participants at risk
Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
|
GSK3511294 100mg
n=9 participants at risk
Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
|
GSK3511294 300mg
n=6 participants at risk
Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
16.7%
2/12 • Number of events 3 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
33.3%
2/6 • Number of events 4 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
33.3%
3/9 • Number of events 3 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
55.6%
5/9 • Number of events 5 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
33.3%
2/6 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Infections and infestations
Rhinitis
|
25.0%
3/12 • Number of events 3 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
22.2%
2/9 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
22.2%
2/9 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Infections and infestations
Root canal infection
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Infections and infestations
Viral upper respiratory tract infection
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
22.2%
2/9 • Number of events 4 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
33.3%
3/9 • Number of events 4 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
33.3%
2/6 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Nervous system disorders
Lethargy
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Nervous system disorders
Sciatica
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
22.2%
2/9 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
33.3%
2/6 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Injury, poisoning and procedural complications
Back injury
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Injury, poisoning and procedural complications
Muscle strain
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Injury, poisoning and procedural complications
Splinter
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
33.3%
2/6 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Gastrointestinal disorders
Dental pulp disorder
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Gastrointestinal disorders
Food poisoning
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Gastrointestinal disorders
Mouth ulceration
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Gastrointestinal disorders
Tongue discomfort
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Gastrointestinal disorders
Toothache
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Immune system disorders
Seasonal allergy
|
16.7%
2/12 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
33.3%
2/6 • Number of events 3 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
22.2%
2/9 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 4 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
22.2%
2/9 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
3/12 • Number of events 3 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
22.2%
2/9 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
22.2%
2/9 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Investigations
Peak expiratory flow rate decreased
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 3 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 4 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Eye disorders
Dry eye
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Surgical and medical procedures
Dental care
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
Vascular disorders
Haematoma
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
General disorders
Medical device site reaction
|
16.7%
2/12 • Number of events 2 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
General disorders
Injection site haematoma
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
General disorders
Chest discomfort
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
11.1%
1/9 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
General disorders
Cyst
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
General disorders
Hernia pain
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
|
General disorders
Injection site swelling
|
0.00%
0/12 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/6 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
0.00%
0/9 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose groups
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.
Non-SAEs and SAEs were reported for the Safety Population. Within each cohort participants were assigned to active or placebo in a 3:1 ratio. A pooled placebo group was to be used as comparison group. An identical proportion of participants in pooled placebo group had same total duration of study as participants in each of the active dose 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