Trial Outcomes & Findings for A First Time in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Healthy Subjects and Stable Heart Failure Patients (NCT NCT02119260)
NCT ID: NCT02119260
Last Updated: 2018-09-27
Results Overview
Vital signs included seated supine systolic blood pressure (SBP) and diastolic blood pressure (DBP), heart rate (HR), and respiratory rate (RR). Vital signs criteria of potential clinical concern were SBP: \<100 and \>170 millimeters of mercury (mmHg); DBP: \<50 and \>110 mmHg and HR: \<50 and \>120 beats per minute (bpm). Only those parameters for which at least one value of potential clinical concern was reported are summarized. All Subjects Population includes any participant enrolled into the study who received at least one dose of study medication within a cohort
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Up to 17 Weeks
Results posted on
2018-09-27
Participant Flow
This study is a placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single dose (SD) and repeat, ascending doses (RD) of GSK2798745 in healthy participants (par.) and stable heart failure par. This study was conducted at two centers in the United Kingdom
Sixty one par. entered this 5-cohort study where Cohorts 1-3 were healthy par. and Cohorts 4 and 5 were par. with stable heart failure. Of those,1 par. was withdrawn pre-dose due to issues with ECG values. In Cohort 1 and 2, par. were randomized to sequence and in Cohorts 3, 4 and 5 par. were randomized to drug or placebo
Participant milestones
| Measure |
Cohort 1
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 4 (GSK2798745 2.4 mg SD and RD)
Participants with heart failure received single oral and subsequent 7-days repeat-dose evaluation of GSK2798745 2.4 mg . GSK2798745 was administered in capsule formulation
|
Cohort 4 (Placebo RD)
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Cohort 5 (GSK2798745 2.4 mg RD)
Participants with heart failure received repeat-doses of GSK2798745 2.4 mg. GSK2798745 was administered in capsule formulation
|
Cohort 5 (Placebo RD)
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
12
|
8
|
10
|
13
|
6
|
2
|
|
Overall Study
COMPLETED
|
8
|
11
|
7
|
10
|
13
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 4 (GSK2798745 2.4 mg SD and RD)
Participants with heart failure received single oral and subsequent 7-days repeat-dose evaluation of GSK2798745 2.4 mg . GSK2798745 was administered in capsule formulation
|
Cohort 4 (Placebo RD)
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Cohort 5 (GSK2798745 2.4 mg RD)
Participants with heart failure received repeat-doses of GSK2798745 2.4 mg. GSK2798745 was administered in capsule formulation
|
Cohort 5 (Placebo RD)
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrew consent
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A First Time in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Healthy Subjects and Stable Heart Failure Patients
Baseline characteristics by cohort
| Measure |
Cohort 1
n=9 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=12 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
n=8 Participants
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 4 (GSK2798745 2.4 mg SD and RD)
n=10 Participants
Participants with heart failure received single oral and subsequent 7-days repeat-dose evaluation of GSK2798745 2.4 mg . GSK2798745 was administered in capsule formulation
|
Cohort 4 (Placebo RD)
n=13 Participants
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Cohort 5 (GSK2798745 2.4 mg RD)
n=6 Participants
Participants with heart failure received repeat-doses of GSK2798745 2.4 mg. GSK2798745 was administered in capsule formulation
|
Cohort 5 (Placebo RD)
n=2 Participants
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.3 Years
STANDARD_DEVIATION 6.40 • n=5 Participants
|
42.8 Years
STANDARD_DEVIATION 10.50 • n=7 Participants
|
43.0 Years
STANDARD_DEVIATION 10.43 • n=5 Participants
|
71.0 Years
STANDARD_DEVIATION 7.18 • n=4 Participants
|
64.1 Years
STANDARD_DEVIATION 7.87 • n=21 Participants
|
70.7 Years
STANDARD_DEVIATION 6.92 • n=8 Participants
|
54.0 Years
STANDARD_DEVIATION 9.90 • n=8 Participants
|
55.3 Years
STANDARD_DEVIATION 8.5 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
53 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
1 Count of Participants
n=5 Participants
|
0 Count of Participants
n=7 Participants
|
0 Count of Participants
n=5 Participants
|
0 Count of Participants
n=4 Participants
|
1 Count of Participants
n=21 Participants
|
0 Count of Participants
n=8 Participants
|
0 Count of Participants
n=8 Participants
|
2 Count of Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
|
8 Count of Participants
n=5 Participants
|
12 Count of Participants
n=7 Participants
|
6 Count of Participants
n=5 Participants
|
10 Count of Participants
n=4 Participants
|
11 Count of Participants
n=21 Participants
|
6 Count of Participants
n=8 Participants
|
2 Count of Participants
n=8 Participants
|
55 Count of Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage & White
|
0 Count of Participants
n=5 Participants
|
0 Count of Participants
n=7 Participants
|
1 Count of Participants
n=5 Participants
|
0 Count of Participants
n=4 Participants
|
1 Count of Participants
n=21 Participants
|
0 Count of Participants
n=8 Participants
|
0 Count of Participants
n=8 Participants
|
2 Count of Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian & White
|
0 Count of Participants
n=5 Participants
|
0 Count of Participants
n=7 Participants
|
1 Count of Participants
n=5 Participants
|
0 Count of Participants
n=4 Participants
|
0 Count of Participants
n=21 Participants
|
0 Count of Participants
n=8 Participants
|
0 Count of Participants
n=8 Participants
|
1 Count of Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Up to 17 WeeksPopulation: All Subjects Population
Vital signs included seated supine systolic blood pressure (SBP) and diastolic blood pressure (DBP), heart rate (HR), and respiratory rate (RR). Vital signs criteria of potential clinical concern were SBP: \<100 and \>170 millimeters of mercury (mmHg); DBP: \<50 and \>110 mmHg and HR: \<50 and \>120 beats per minute (bpm). Only those parameters for which at least one value of potential clinical concern was reported are summarized. All Subjects Population includes any participant enrolled into the study who received at least one dose of study medication within a cohort
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=12 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
n=8 Participants
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 5 (Placebo RD)
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Co 2 (GSK2798745 Fasted Suspension)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fasted Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fed Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 3 (GSK2798745 Day 1-5mg)
Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Co 3 (GSK2798745 Day 14-5mg)
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Values of Potential Clinical Concern in Healthy Participants
SBP
|
0 Participants
|
0 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Sign Values of Potential Clinical Concern in Healthy Participants
DBP
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Sign Values of Potential Clinical Concern in Healthy Participants
HR
|
0 Participants
|
0 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 17 weeksPopulation: All Subjects Population
Vital signs included seated supine systolic blood pressure (SBP) and diastolic blood pressure (DBP), heart rate (HR), and respiratory rate (RR). Vital signs criteria of potential clinical concern were SBP: \<100 and \>170 millimeters of mercury (mmHg); DBP: \<50 and \>110 mmHg and HR: \<50 and \>120 beats per minute (bpm). Only those parameters for which at least one value of potential clinical concern was reported are summarized. All Subjects Population includes any participant enrolled into the study who received at least one dose of study medication within a cohort
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=13 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
n=6 Participants
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 5 (Placebo RD)
n=2 Participants
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Co 2 (GSK2798745 Fasted Suspension)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fasted Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fed Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 3 (GSK2798745 Day 1-5mg)
Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Co 3 (GSK2798745 Day 14-5mg)
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Values of Potential Clinical Concern in Stable Heart Failure Participants
SBP
|
7 Participants
|
6 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Sign Values of Potential Clinical Concern in Stable Heart Failure Participants
DBP
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Sign Values of Potential Clinical Concern in Stable Heart Failure Participants
HR
|
4 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 17 weeksPopulation: All Subjects Population
ECGs will be obtained in the semi-supine position after at least 5 minutes. The potential clinical concern range for ECG parameters are: QRS interval: \>200 milliseconds (msec); time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Bazett's formula (QTcB):\>500msec; time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): \>500 msec; PR interval:\>300msec. The number of participants with ECG values of potential clinical concern have been presented.
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=12 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
n=8 Participants
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 5 (Placebo RD)
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Co 2 (GSK2798745 Fasted Suspension)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fasted Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fed Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 3 (GSK2798745 Day 1-5mg)
Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Co 3 (GSK2798745 Day 14-5mg)
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern in Healthy Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 17 weeksPopulation: All Subjects Population
ECGs will be obtained in the semi-supine position after at least 5 minutes. The potential clinical concern range for ECG parameters are: QRS interval: \>200 milliseconds (msec); time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Bazett's formula (QTcB):\>500msec; time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): \>500 msec; PR interval:\>300msec. The number of participants with ECG values of potential clinical concern have been presented.
Outcome measures
| Measure |
Cohort 1
n=23 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=8 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 5 (Placebo RD)
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Co 2 (GSK2798745 Fasted Suspension)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fasted Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fed Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 3 (GSK2798745 Day 1-5mg)
Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Co 3 (GSK2798745 Day 14-5mg)
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern in Stable Heart Failure Participants
|
10 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 17 weeksPopulation: All Subjects Population
Blood samples were collected from participants to evaluate clinical parameters of potential clinical concern. Clinical parameters included blood urea nitrogen, potassium, total and direct bilirubin, creatinine chloride, alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase, alkaline phosphatase, uric acid, glucose, fasting troponin, albumin, sodium calcium total protein, and creatine phosphokinase. The number of participants with clinical chemistry values of potential clinical concern have been presented.
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=12 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
n=8 Participants
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 5 (Placebo RD)
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Co 2 (GSK2798745 Fasted Suspension)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fasted Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fed Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 3 (GSK2798745 Day 1-5mg)
Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Co 3 (GSK2798745 Day 14-5mg)
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Chemistry Laboratory Values of Potential Clinical Concern in Healthy Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 17 weeksPopulation: All Subjects Population
Blood samples were collected from participants to evaluate clinical parameters of potential clinical concern. Clinical parameters included blood urea nitrogen, potassium, total and direct bilirubin, creatinine chloride, alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase, alkaline phosphatase, uric acid, glucose, fasting troponin, albumin, sodium calcium total protein, and creatine phosphokinase. The number of participants with clinical chemistry values of potential clinical concern have been presented.
Outcome measures
| Measure |
Cohort 1
n=23 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=8 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 5 (Placebo RD)
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Co 2 (GSK2798745 Fasted Suspension)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fasted Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fed Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 3 (GSK2798745 Day 1-5mg)
Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Co 3 (GSK2798745 Day 14-5mg)
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Chemistry Laboratory Values of Potential Clinical Concern in Stable Heart Failure Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 17 weeksPopulation: All subjects population
Blood samples were collected from participants to evaluate hematology parameters of potential clinical concern. Hematology parameters included platelet count, red blood cells count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, neutrophils, white blood cells count, lymphocytes, reticulocyte count, monocytes, hemoglobin, eosinophil, hematocrit, and basophiles. The number of participants with hematology values of potential clinical concern have been presented.
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=12 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
n=8 Participants
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 5 (Placebo RD)
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Co 2 (GSK2798745 Fasted Suspension)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fasted Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fed Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 3 (GSK2798745 Day 1-5mg)
Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Co 3 (GSK2798745 Day 14-5mg)
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Hematology Parameter Laboratory Values of Potential Clinical Concern in Healthy Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 17 weeksPopulation: All Subjects Population
Blood samples were collected from participants to evaluate hematology parameters of potential clinical concern. Hematology parameters included platelet count, red blood cells count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, neutrophils, white blood cells count, lymphocytes, reticulocyte count, monocytes, hemoglobin, eosinophil, hematocrit, and basophiles. The number of participants with hematology values of potential clinical concern have been presented.
Outcome measures
| Measure |
Cohort 1
n=23 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=8 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 5 (Placebo RD)
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Co 2 (GSK2798745 Fasted Suspension)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fasted Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fed Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 3 (GSK2798745 Day 1-5mg)
Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Co 3 (GSK2798745 Day 14-5mg)
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Hematology Parameter Laboratory Values of Potential Clinical Concern in Stable Heart Failure Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 17 weeksPopulation: All Subjects Population
Urine samples were collected to analyze specific gravity, determining potential of hydrogen (pH), glucose, protein, blood, and ketones by dipstick method, and microscopic examination (if blood or protein is abnormal). The number of participants with abnormal urinalysis data have been presented.
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=12 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
n=8 Participants
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 5 (Placebo RD)
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Co 2 (GSK2798745 Fasted Suspension)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fasted Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fed Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 3 (GSK2798745 Day 1-5mg)
Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Co 3 (GSK2798745 Day 14-5mg)
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Routine Urinalysis in Healthy Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 17 weeksPopulation: All Subjects Population
Urine samples were collected to analyze specific gravity, determining potential of hydrogen (pH), glucose, protein, blood, and ketones by dipstick method, and microscopic examination (if blood or protein is abnormal). The number of participants with abnormal urinalysis data have been presented.
Outcome measures
| Measure |
Cohort 1
n=23 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=8 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 5 (Placebo RD)
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Co 2 (GSK2798745 Fasted Suspension)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fasted Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fed Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 3 (GSK2798745 Day 1-5mg)
Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Co 3 (GSK2798745 Day 14-5mg)
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Routine Urinalysis in Stable Heart Failure Participants
|
14 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 17 weeksPopulation: All Subjects Population
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect, any other situation according to medical or scientific judgment, or is associated with liver injury and impaired liver function will be categorized as SAE.
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=12 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
n=8 Participants
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 5 (Placebo RD)
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Co 2 (GSK2798745 Fasted Suspension)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fasted Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fed Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 3 (GSK2798745 Day 1-5mg)
Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Co 3 (GSK2798745 Day 14-5mg)
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Healthy Participants
Any AE
|
5 Participants
|
7 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Healthy Participants
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 17 weeksPopulation: All Subjects Population
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect, any other situation according to medical or scientific judgment, or is associated with liver injury and impaired liver function will be categorized as SAE.
Outcome measures
| Measure |
Cohort 1
n=23 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=8 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 5 (Placebo RD)
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Co 2 (GSK2798745 Fasted Suspension)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fasted Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fed Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 3 (GSK2798745 Day 1-5mg)
Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Co 3 (GSK2798745 Day 14-5mg)
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Stable Heart Failure Participants
Any AE
|
22 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Stable Heart Failure Participants
Any SAE
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Pharmacokinetic Population
Blood samples for Pharmacokinetic (PK) analysis were obtained at Day 1 of each treatment period for analysis of AUC\[0-inf\]. Log untransformed values for AUC\[0-inf\] has been presented. The 'PK Population' includes 'All Subjects' population for whom a pharmacokinetic sample was obtained and analyzed.
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=6 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
n=6 Participants
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 5 (Placebo RD)
n=6 Participants
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Co 2 (GSK2798745 Fasted Suspension)
n=12 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fasted Capsule)
n=11 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fed Capsule)
n=11 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 3 (GSK2798745 Day 1-5mg)
n=6 Participants
Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Co 3 (GSK2798745 Day 14-5mg)
n=3 Participants
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC[0-inf]) Following Single and Repeat Doses of GSK2798745 in Healthy Subjects
|
9.6 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 3.7
|
62.2 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 26.6
|
347.0 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 122.8
|
686.1 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 275.0
|
287.7 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 101.2
|
312.1 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 71.0
|
361.8 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 99.4
|
223.2 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 31.0
|
318.7 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 39.6
|
SECONDARY outcome
Timeframe: Day 1 (Cohort 1,2,3) and Day 14 (Cohort 3)Population: Pharmacokinetic Population
Blood samples for PK analysis were obtained at Day 1 and Day 14 of each treatment period for analysis of Cmax. Log transformed values for Cmax has been presented.
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=6 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
n=6 Participants
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 5 (Placebo RD)
n=6 Participants
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Co 2 (GSK2798745 Fasted Suspension)
n=12 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fasted Capsule)
n=11 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fed Capsule)
n=11 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 3 (GSK2798745 Day 1-5mg)
n=6 Participants
Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Co 3 (GSK2798745 Day 14-5mg)
n=3 Participants
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of GSK2798745 in Healthy Participants
|
1.1 ng/mL
Standard Deviation 0.4
|
4.2 ng/mL
Standard Deviation 1.9
|
22.9 ng/mL
Standard Deviation 2.4
|
47.9 ng/mL
Standard Deviation 12.1
|
22.2 ng/mL
Standard Deviation 5.7
|
23.1 ng/mL
Standard Deviation 4.3
|
25.7 ng/mL
Standard Deviation 7.9
|
23.9 ng/mL
Standard Deviation 5.6
|
29.9 ng/mL
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Day 1 (Cohort 1,2,3) and Day 14 (Cohort 3)Population: Pharmacokinetic Population
Blood samples for PK analysis were obtained at Day 1 of each treatment period and Day 14 of Cohort 3 for analysis of tmax. Log untransformed values for tmax has been presented.
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=6 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
n=6 Participants
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 5 (Placebo RD)
n=6 Participants
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Co 2 (GSK2798745 Fasted Suspension)
n=12 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fasted Capsule)
n=11 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fed Capsule)
n=11 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 3 (GSK2798745 Day 1-5mg)
n=6 Participants
Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Co 3 (GSK2798745 Day 14-5mg)
n=3 Participants
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Occurrence of Cmax (Tmax) Following Single and Repeat Doses of GSK2798745 in Healthy Participants
|
1.3 hours
Interval 1.0 to 2.0
|
1.6 hours
Interval 1.0 to 3.0
|
2.3 hours
Interval 2.0 to 3.0
|
2.5 hours
Interval 2.0 to 3.0
|
2.0 hours
Interval 1.0 to 3.0
|
1.5 hours
Interval 1.0 to 4.0
|
1.5 hours
Interval 1.0 to 3.0
|
1.8 hours
Interval 1.8 to 3.0
|
2.0 hours
Interval 2.0 to 2.0
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: Pharmacokinetic Population
Blood samples for PK analysis were obtained at Day 1 and Day 7 of each treatment period for analysis of Cmax. Log untransformed values for Cmax has been presented.
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=8 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 5 (Placebo RD)
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Co 2 (GSK2798745 Fasted Suspension)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fasted Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fed Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 3 (GSK2798745 Day 1-5mg)
Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Co 3 (GSK2798745 Day 14-5mg)
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of GSK2798745 in Stable Heart Failure Participants
Day 1
|
13.7 ng/mL
Standard Deviation 1.9
|
13.4 ng/mL
Standard Deviation 4.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of GSK2798745 in Stable Heart Failure Participants
Day 7
|
17.1 ng/mL
Standard Deviation 7.3
|
16.2 ng/mL
Standard Deviation 3.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: Pharmacokinetic Population
Blood samples for PK analysis were obtained at Day 1 and Day 7 of each treatment period for analysis of AUC (0-24). Log untransformed values for Cmax has been presented.
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=8 Participants
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 5 (Placebo RD)
Participants with heart failure received placebo. Placebo was administered in capsule formulation
|
Co 2 (GSK2798745 Fasted Suspension)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a liquid suspension to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fasted Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 2 (GSK2798745 Fed Capsule)
Healthy participants received three single oral doses of GSK2798745 5 mg following a standard meal. GSK2798745 was administered in a capsule formulation to evaluate food effect and relative bioavailability.
|
Co 3 (GSK2798745 Day 1-5mg)
Healthy participants received oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Co 3 (GSK2798745 Day 14-5mg)
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Pre-dose to 24 Hours Post-dose (AUC [0-24]) Following Single and Repeat Doses of GSK2798745 in Stable Heart Failure Participants
Day 1
|
133.6 hour*ng/mL
Standard Deviation 57.9
|
131.4 hour*ng/mL
Standard Deviation 11.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration-time Curve From Pre-dose to 24 Hours Post-dose (AUC [0-24]) Following Single and Repeat Doses of GSK2798745 in Stable Heart Failure Participants
Day 7
|
208.5 hour*ng/mL
Standard Deviation 115.2
|
207.6 hour*ng/mL
Standard Deviation 36.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Cohort 5
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=9 participants at risk
Healthy participants received single oral doses of GSK2798745 0.25 milligram (mg), 1 mg, 5 mg, 12.5 mg and one dose of GSK2798745 matching placebo in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid form (suspension) in this single dose escalation cohort.
|
Cohort 2
n=12 participants at risk
Healthy participants received three single oral doses of GSK2798745 5 mg in fasted state and following a standard meal. GSK2798745 was administered in a liquid suspension and capsule formulation to evaluate food effect and relative bioavailability.
|
Cohort 3
n=8 participants at risk
Healthy participants received repeat oral doses of GSK2798745 5 mg or matching placebo (ratio 3:1) in fasted state. Participants fasted from midnight to four hours post-dose. GSK2798745 was administered in a liquid formulation (suspension)
|
Cohort 4
n=23 participants at risk
Participants with heart failure received single oral and subsequent 7-days repeat-dose evaluation of GSK2798745 2.4 mg or placebo in capsule formulation
|
Cohort 5
n=8 participants at risk
Participants with heart failure received repeat-doses of GSK2798745 2.4 mg or placebo in capsule formulation
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
16.7%
2/12 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.7%
2/23 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Nervous system disorders
Migraine with aura
|
11.1%
1/9 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Nervous system disorders
Syncope
|
11.1%
1/9 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Infections and infestations
Nasopharyngitis
|
22.2%
2/9 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
4.3%
1/23 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Immune system disorders
Seasonal allergy
|
11.1%
1/9 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
11.1%
1/9 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Skin and subcutaneous tissue disorders
Scab
|
11.1%
1/9 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
16.7%
2/12 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
21.7%
5/23 • Number of events 7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
25.0%
2/8 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.3%
1/12 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
4.3%
1/23 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
16.7%
2/12 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
4.3%
1/23 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.3%
1/12 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.3%
1/12 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.3%
1/12 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.3%
1/12 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
General disorders
Catheter site bruise
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.3%
1/12 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.7%
2/23 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
General disorders
Fatigue
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.3%
1/12 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
General disorders
Pain
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.3%
1/12 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.3%
1/12 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.3%
1/12 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
4.3%
1/23 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.3%
1/12 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
4.3%
1/23 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.3%
1/12 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.3%
1/12 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.3%
1/12 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Eye disorders
Blepharospasm
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.3%
1/12 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
25.0%
2/8 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
4.3%
1/23 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
47.8%
11/23 • Number of events 18 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
General disorders
Feeling abnormal
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Psychiatric disorders
Agitation
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
4.3%
1/23 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
13.0%
3/23 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
37.5%
3/8 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.7%
2/23 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
4.3%
1/23 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.7%
2/23 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
General disorders
Feeling hot
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
13.0%
3/23 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Investigations
Audiogram abnormal
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
13.0%
3/23 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.7%
2/23 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
4.3%
1/23 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
4.3%
1/23 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
8.7%
2/23 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
25.0%
2/8 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
|
Vascular disorders
Hyperaemia
|
0.00%
0/9 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/12 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
0.00%
0/23 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
12.5%
1/8 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the Follow up (Up to 17 weeks)
AEs and SAEs were collected in All Subjects Population which comprised all the participants enrolled into the study and received at least one dose of study medication within a cohort
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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