Trial Outcomes & Findings for Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers (NCT NCT04114656)
NCT ID: NCT04114656
Last Updated: 2024-03-18
Results Overview
Thermal pain tests performed first on normal skin contralateral to site of UVB irradiation then on UVB irradiated skin.A 30\*30 millimeter(mm)thermode was placed on participant's back. Initial temperature of thermode was 32 degree Celsius(C)and increased by 0.5 degree C/second until participant indicated painful stimulus(pain detection threshold indicated by pushing a button on hand-held feedback control or when temperature of 50 degree C reached).AUC ratio to Baseline derived from log change from Baseline in temperature versus(vs)time of study period calculated via trapezoidal method \&normalized \& back transformed(exponential)to get ratio to Baseline. Baseline was mean value of 2 assessments taken before each dosing(Day 1).Posterior Median Ratio to Baseline derived from Bayesian analysis updating prior(non-informative)with information collected from study(likelihood).Data reported as 'Median' refers to 'Posterior Median' and '95% Confidence Interval' refers to '95% Credible Interval'.
TERMINATED
PHASE1
21 participants
Baseline (Day 1) and up to Day 8
2024-03-18
Participant Flow
This study evaluated the effects of GSK3858279 on a battery of evoked pain tests in healthy male participants. This study was terminated due to meeting protocol defined futility.
A total of 21 healthy male participants were enrolled.
Participant milestones
| Measure |
Placebo/GSK3858279 3 mg/kg IV/GSK3858279 3 mg/kg IV
Participants received a single dose of Placebo (normal saline i.e.\[0.9 percent {%} sodium chloride\]) administered intravenously (IV) in treatment period 1 followed by GSK3858279 3 milligrams per kilogram (mg/kg) administered IV in treatment period 2 followed by GSK3858279 3 mg/kg administered IV in treatment period 3. There was a washout of at least 4 weeks between dosing (i.e. Day 1) in each of the study periods.
|
GSK3858279 3 mg/kg IV/Placebo/Placebo
Participants received a single dose of GSK3858279 3 mg/kg administered IV in treatment period 1 followed by Placebo (normal saline \[0.9%\] sodium chloride) administered IV in treatment period 2 followed by Placebo (normal saline \[0.9%\] sodium chloride) administered IV in treatment period 3. There was a washout of at least 4 weeks between dosing (i.e. Day 1) in each of the study periods.
|
|---|---|---|
|
Treatment Period1+Washout(Up to 28 Days)
STARTED
|
11
|
10
|
|
Treatment Period1+Washout(Up to 28 Days)
COMPLETED
|
9
|
7
|
|
Treatment Period1+Washout(Up to 28 Days)
NOT COMPLETED
|
2
|
3
|
|
Treatment Period2+Washout(Up to 28 Days)
STARTED
|
9
|
7
|
|
Treatment Period2+Washout(Up to 28 Days)
COMPLETED
|
9
|
6
|
|
Treatment Period2+Washout(Up to 28 Days)
NOT COMPLETED
|
0
|
1
|
|
Treatment Period 3 (Up to 28 Days)
STARTED
|
9
|
6
|
|
Treatment Period 3 (Up to 28 Days)
COMPLETED
|
9
|
6
|
|
Treatment Period 3 (Up to 28 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo/GSK3858279 3 mg/kg IV/GSK3858279 3 mg/kg IV
Participants received a single dose of Placebo (normal saline i.e.\[0.9 percent {%} sodium chloride\]) administered intravenously (IV) in treatment period 1 followed by GSK3858279 3 milligrams per kilogram (mg/kg) administered IV in treatment period 2 followed by GSK3858279 3 mg/kg administered IV in treatment period 3. There was a washout of at least 4 weeks between dosing (i.e. Day 1) in each of the study periods.
|
GSK3858279 3 mg/kg IV/Placebo/Placebo
Participants received a single dose of GSK3858279 3 mg/kg administered IV in treatment period 1 followed by Placebo (normal saline \[0.9%\] sodium chloride) administered IV in treatment period 2 followed by Placebo (normal saline \[0.9%\] sodium chloride) administered IV in treatment period 3. There was a washout of at least 4 weeks between dosing (i.e. Day 1) in each of the study periods.
|
|---|---|---|
|
Treatment Period1+Washout(Up to 28 Days)
Withdrawal by Subject
|
0
|
1
|
|
Treatment Period1+Washout(Up to 28 Days)
Study closed/terminated
|
0
|
2
|
|
Treatment Period1+Washout(Up to 28 Days)
Participant reached protocol defined stopping criteria
|
1
|
0
|
|
Treatment Period1+Washout(Up to 28 Days)
Protocol Violation
|
1
|
0
|
|
Treatment Period2+Washout(Up to 28 Days)
Participant reached protocol defined stopping criteria
|
0
|
1
|
Baseline Characteristics
Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Placebo/GSK3858279 3 mg/kg IV/GSK3858279 3 mg/kg IV
n=11 Participants
Participants received a single dose of Placebo (normal saline i.e.\[0.9 percent {%} sodium chloride\]) administered intravenously (IV) in treatment period 1 followed by GSK3858279 3 milligrams per kilogram (mg/kg) administered IV in treatment period 2 followed by GSK3858279 3 mg/kg administered IV in treatment period 3. There was a washout of at least 4 weeks between dosing (i.e. Day 1) in each of the study periods.
|
GSK3858279 3 mg/kg IV/Placebo/Placebo
n=10 Participants
Participants received a single dose of GSK3858279 3 mg/kg administered IV in treatment period 1 followed by Placebo (normal saline \[0.9%\] sodium chloride) administered IV in treatment period 2 followed by Placebo (normal saline \[0.9%\] sodium chloride) administered IV in treatment period 3. There was a washout of at least 4 weeks between dosing (i.e. Day 1) in each of the study periods.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.3 Years
STANDARD_DEVIATION 7.93 • n=5 Participants
|
31.1 Years
STANDARD_DEVIATION 7.71 • n=7 Participants
|
30.1 Years
STANDARD_DEVIATION 7.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European heritage
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to Day 8Population: UVB modified intent to treat (MITT) Population comprised of participants in the MITT Population who also performed at least one UVB Heat Pain detection PainCart assessment on irradiated skin in at least two study periods. Only those participants with data available at specified time points were analyzed.
Thermal pain tests performed first on normal skin contralateral to site of UVB irradiation then on UVB irradiated skin.A 30\*30 millimeter(mm)thermode was placed on participant's back. Initial temperature of thermode was 32 degree Celsius(C)and increased by 0.5 degree C/second until participant indicated painful stimulus(pain detection threshold indicated by pushing a button on hand-held feedback control or when temperature of 50 degree C reached).AUC ratio to Baseline derived from log change from Baseline in temperature versus(vs)time of study period calculated via trapezoidal method \&normalized \& back transformed(exponential)to get ratio to Baseline. Baseline was mean value of 2 assessments taken before each dosing(Day 1).Posterior Median Ratio to Baseline derived from Bayesian analysis updating prior(non-informative)with information collected from study(likelihood).Data reported as 'Median' refers to 'Posterior Median' and '95% Confidence Interval' refers to '95% Credible Interval'.
Outcome measures
| Measure |
Placebo
n=12 Participants
All participants who received at least a single IV dose of Placebo on Day 1 in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
GSK3858279 3 mg/kg IV
n=12 Participants
All participants who received at least a single IV dose of GSK3858279 3 mg/kg on Day 1 in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|---|
|
Posterior Median Ratio to Baseline of Area Under the Curve (AUC 1-8 Days) in Ultraviolet B (UVB) Heat Pain Detection
|
1.005 Ratio
Interval 0.98 to 1.03
|
0.998 Ratio
Interval 0.976 to 1.021
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to Day 15Population: MITT Population comprised of all randomized participants who received at least one dose of study treatment and completed at least one PainCart assessment in at least two study periods. Only those participants with data available at specified time points were analyzed. Data reported as 'Median' refers to 'Posterior Median'\& data reported as '95% Confidence Interval' refers to'95% Credible Interval'.
Participants put non-dominant hand in water bath at 35+/-0.5 degree C.Blood pressure cuff on upper arm inflated to 20mm of Mercury below resting diastolic pressure. Participants then removed hand \& directly placed in similar-size bath(1.0+/-0.5 degree C).Participants indicated increase in pain intensity by moving electronic Visual Analogue scale(eVAS) slider when pain detection threshold was reached(first change in sensation from cold non-painful to painful).When pain tolerance was reached, participants removed their hand\& blood pressure cuff was deflated.AUC ratio to Baseline derived from log change from Baseline in time to intolerable pain vs time of study period calculated via trapezoidal method \&normalized and back transformed(exponential) to get ratio to Baseline.Baseline was mean value of 2 assessments taken before each dosing(Day 1).Posterior Median Ratio to Baseline derived from Bayesian analysis updating prior(non-informative)with information collected from study(likelihood).
Outcome measures
| Measure |
Placebo
n=15 Participants
All participants who received at least a single IV dose of Placebo on Day 1 in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
GSK3858279 3 mg/kg IV
n=15 Participants
All participants who received at least a single IV dose of GSK3858279 3 mg/kg on Day 1 in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|---|
|
Posterior Median Ratio to Baseline of AUC (1-15 Days) in Cold Pressor Time to Intolerable Pain Threshold
|
1.05 Ratio
Interval 0.96 to 1.15
|
1.05 Ratio
Interval 0.97 to 1.14
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to Day 15Population: MITT Population. Only those participants with data available at specified time points were analyzed.
Two electrodes were placed on clean (scrubbed) skin overlying left tibial bone 100mm distal from caudal end of patella to detect cutaneous electrical pain. Each stimulus(10-Hertz \[Hz\] tetanic pulse with duration of 0.2 milliseconds) was controlled by a computer-controlled constant current stimulator.Pain intensity after each stimulation was measured using eVAS,until pain tolerance level was reached,or maximum of 50 milliamper(mA) was reached. AUC ratio to Baseline derived from log change from Baseline in mA versus time of study period calculated via trapezoidal method and normalized and back transformed(exponential)to get ratio to Baseline. Baseline was mean value of 2 assessments taken before dosing(Day 1).Posterior Median Ratio to Baseline derived from Bayesian analysis updating prior (non-informative) with information collected from study(likelihood).Data reported as 'Median' refers to'Posterior Median'and data reported as'95% Confidence Interval' refers to '95% Credible Interval'.
Outcome measures
| Measure |
Placebo
n=15 Participants
All participants who received at least a single IV dose of Placebo on Day 1 in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
GSK3858279 3 mg/kg IV
n=15 Participants
All participants who received at least a single IV dose of GSK3858279 3 mg/kg on Day 1 in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|---|
|
Posterior Median Ratio to Baseline of AUC (1-15 Days) in Electrical Pain Tolerance Threshold (Single Stimulus)
|
1.09 Ratio
Interval 1.01 to 1.17
|
1.07 Ratio
Interval 1.0 to 1.14
|
Adverse Events
Placebo
GSK3858279 3 mg/kg IV
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=18 participants at risk
All participants who received at least a single IV dose of Placebo on Day 1 in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
GSK3858279 3 mg/kg IV
n=19 participants at risk
All participants who received at least a single IV dose of GSK3858279 3 mg/kg on Day 1 in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 2 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
General disorders
Fatigue
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
10.5%
2/19 • Number of events 3 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
General disorders
Vaccination site pain
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
General disorders
Application site erythema
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
General disorders
Application site warmth
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
General disorders
Catheter site bruise
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
General disorders
Chills
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
General disorders
Malaise
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
15.8%
3/19 • Number of events 3 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Nervous system disorders
Presyncope
|
5.6%
1/18 • Number of events 2 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
21.1%
4/19 • Number of events 4 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Rhinitis
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Investigations
Hepatic enzyme increased
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Investigations
Urine output increased
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
10.5%
2/19 • Number of events 2 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Blister
|
11.1%
2/18 • Number of events 2 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Psychiatric disorders
Abnormal dreams
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Cardiac disorders
Bradycardia
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Eye disorders
Chalazion
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
1/18 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
0.00%
0/19 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/18 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, serious adverse events (SAEs), and non-serious adverse events (non-SAEs) were collected up to 302 days
All-cause mortality, SAEs and non-SAEs were collected for the Safety Population that comprised of all randomized participants who received at least one dose of study treatment. Adverse events were presented treatment-wise.
|
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