Trial Outcomes & Findings for Concentration-QT Study of Paroxetine in Healthy Adults (NCT NCT06065735)
NCT ID: NCT06065735
Last Updated: 2024-12-16
Results Overview
A standard 12-lead electrocardiogram (ECG) were recorded in a participant using an ECG machine after 10 minutes rest in the supine position. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
Baseline (Day -1); 0.25 Hours Pre-dose on Day 1; 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12 Hours Post-dose on Day 1
Results posted on
2024-12-16
Participant Flow
This study investigated the cardiac effects, safety, and tolerability of paroxetine in healthy adult participants.
A total of 38 participants were enrolled in the study to receive 20 milligrams (mg), 40 mg and 60 mg doses of paroxetine.
Participant milestones
| Measure |
Participants Who Received Paroxetine 20 mg
Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.
|
Participants Who Received Paroxetine 40 mg
Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.
|
Participants Who Received Paroxetine 60 mg
Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.
|
|---|---|---|---|
|
Paroxetine 20 mg (Days 1 to 7)
STARTED
|
38
|
0
|
0
|
|
Paroxetine 20 mg (Days 1 to 7)
COMPLETED
|
33
|
0
|
0
|
|
Paroxetine 20 mg (Days 1 to 7)
NOT COMPLETED
|
5
|
0
|
0
|
|
Paroxetine 40 mg (Days 8 to 14)
STARTED
|
0
|
33
|
0
|
|
Paroxetine 40 mg (Days 8 to 14)
COMPLETED
|
0
|
32
|
0
|
|
Paroxetine 40 mg (Days 8 to 14)
NOT COMPLETED
|
0
|
1
|
0
|
|
Paroxetine 60 mg (Days 15 to 21)
STARTED
|
0
|
0
|
32
|
|
Paroxetine 60 mg (Days 15 to 21)
COMPLETED
|
0
|
0
|
31
|
|
Paroxetine 60 mg (Days 15 to 21)
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Participants Who Received Paroxetine 20 mg
Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.
|
Participants Who Received Paroxetine 40 mg
Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.
|
Participants Who Received Paroxetine 60 mg
Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.
|
|---|---|---|---|
|
Paroxetine 20 mg (Days 1 to 7)
Adverse Event
|
2
|
0
|
0
|
|
Paroxetine 20 mg (Days 1 to 7)
Physician Decision
|
2
|
0
|
0
|
|
Paroxetine 20 mg (Days 1 to 7)
Withdrawal by Subject
|
1
|
0
|
0
|
|
Paroxetine 40 mg (Days 8 to 14)
Adverse Event
|
0
|
1
|
0
|
|
Paroxetine 60 mg (Days 15 to 21)
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
Concentration-QT Study of Paroxetine in Healthy Adults
Baseline characteristics by cohort
| Measure |
All Study Participants Receiving Paroxetine
n=38 Participants
Participants received paroxetine tablets titrated to a dose of 60 mg once daily at increments of 20 mg per week. Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7 followed by paroxetine 40 mg tablets, orally once daily from Days 8 to 14 and then paroxetine 60 mg tablets orally once daily from Days 15 to 21. Participants were followed-up for up-to Day 48.
|
|---|---|
|
Age, Continuous
|
37.3 Years
STANDARD_DEVIATION 11.48 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
23 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
De-identified
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -1); 0.25 Hours Pre-dose on Day 1; 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12 Hours Post-dose on Day 1Population: Pharmacodynamic Population included all participants in the Safety Population who had at least 1 non-missing ECG assessment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
A standard 12-lead electrocardiogram (ECG) were recorded in a participant using an ECG machine after 10 minutes rest in the supine position. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value.
Outcome measures
| Measure |
Participants Who Received Paroxetine 20 mg
n=33 Participants
Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.
|
Participants Who Received Paroxetine 40 mg
n=32 Participants
Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.
|
Participants Who Received Paroxetine 60 mg
n=31 Participants
Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.
|
|---|---|---|---|
|
Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)
0.25 Hours Pre-dose on Day 1
|
1.9 Milliseconds
Standard Deviation 7.37
|
1.0 Milliseconds
Standard Deviation 10.82
|
0.9 Milliseconds
Standard Deviation 9.88
|
|
Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)
1 Hour Post-dose on Day 1
|
2.2 Milliseconds
Standard Deviation 10.68
|
2.9 Milliseconds
Standard Deviation 12.60
|
0.6 Milliseconds
Standard Deviation 13.35
|
|
Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)
2 Hours Post-dose on Day 1
|
-3.0 Milliseconds
Standard Deviation 9.54
|
-2.9 Milliseconds
Standard Deviation 10.83
|
-4.2 Milliseconds
Standard Deviation 11.05
|
|
Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)
3 Hours Post-dose on Day 1
|
-7.1 Milliseconds
Standard Deviation 8.48
|
-5.4 Milliseconds
Standard Deviation 10.10
|
-6.9 Milliseconds
Standard Deviation 8.92
|
|
Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)
4 Hours Post-dose on Day 1
|
-4.4 Milliseconds
Standard Deviation 9.68
|
-4.2 Milliseconds
Standard Deviation 10.48
|
-4.6 Milliseconds
Standard Deviation 10.70
|
|
Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)
4.5 Hours Post-dose on Day 1
|
-2.5 Milliseconds
Standard Deviation 8.26
|
-1.2 Milliseconds
Standard Deviation 11.85
|
-1.5 Milliseconds
Standard Deviation 11.15
|
|
Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)
5 Hours Post-dose on Day 1
|
-0.3 Milliseconds
Standard Deviation 10.08
|
0.9 Milliseconds
Standard Deviation 12.53
|
-0.7 Milliseconds
Standard Deviation 10.37
|
|
Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)
5.5 Hours Post-dose on Day 1
|
4.0 Milliseconds
Standard Deviation 8.49
|
3.6 Milliseconds
Standard Deviation 11.91
|
3.2 Milliseconds
Standard Deviation 10.57
|
|
Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)
6 Hours Post-dose on Day 1
|
4.2 Milliseconds
Standard Deviation 9.15
|
4.0 Milliseconds
Standard Deviation 11.35
|
4.7 Milliseconds
Standard Deviation 8.51
|
|
Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)
8 Hours Post-dose on Day 1
|
1.6 Milliseconds
Standard Deviation 12.34
|
-0.2 Milliseconds
Standard Deviation 13.35
|
-0.1 Milliseconds
Standard Deviation 11.76
|
|
Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)
10 Hours Post-dose on Day 1
|
-5.0 Milliseconds
Standard Deviation 9.62
|
-5.2 Milliseconds
Standard Deviation 10.22
|
-5.0 Milliseconds
Standard Deviation 12.51
|
|
Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)
12 Hours Post-dose on Day 1
|
-0.5 Milliseconds
Standard Deviation 10.41
|
-4.0 Milliseconds
Standard Deviation 10.61
|
-4.2 Milliseconds
Standard Deviation 12.06
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 48Population: Safety Population included all participants who received at least one dose of study intervention. As all participants received 20, 40 and 60 mg of paroxetine and as there was no intent of comparison of vital signs across these doses, the results were planned to be presented as a single overall arm.
SBP and DBP were measured in the supine position using a semi-automatic blood pressure recording device with an appropriate cuff size after at least 5 minutes of rest. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and standard deviation (SD) values of vital sign assessments at Day 48 are reported.
Outcome measures
| Measure |
Participants Who Received Paroxetine 20 mg
n=38 Participants
Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.
|
Participants Who Received Paroxetine 40 mg
Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.
|
Participants Who Received Paroxetine 60 mg
Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.
|
|---|---|---|---|
|
Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Systolic Blood Pressure
|
6.474 Millimeters of mercury (mmHg)
Standard Deviation 5.8713
|
—
|
—
|
|
Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Diastolic Blood Pressure
|
4.763 Millimeters of mercury (mmHg)
Standard Deviation 5.9340
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 48Population: Safety Population included all participants who received at least one dose of study intervention. As all participants received 20, 40 and 60 mg of paroxetine and as there was no intent of comparison of vital signs across these doses, the results were planned to be presented as a single overall arm.
Pulse rate was measured in the supine position using a semi-automatic recording device with an appropriate cuff size after at least 5 minutes of rest. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and SD values of vital sign assessments at Day 48 are reported.
Outcome measures
| Measure |
Participants Who Received Paroxetine 20 mg
n=38 Participants
Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.
|
Participants Who Received Paroxetine 40 mg
Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.
|
Participants Who Received Paroxetine 60 mg
Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.
|
|---|---|---|---|
|
Change From Baseline in Vital Sign: Pulse Rate
|
1.842 Beats per minute (bpm)
Standard Deviation 5.0325
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 48Population: Safety Population included all participants who received at least one dose of study intervention. As all participants received 20, 40 and 60 mg of paroxetine and as there was no intent of comparison of vital signs across these doses, the results were planned to be presented as a single overall arm.
Body temperature measurements were performed in participants. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and SD values of vital sign assessments at Day 48 are reported.
Outcome measures
| Measure |
Participants Who Received Paroxetine 20 mg
n=38 Participants
Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.
|
Participants Who Received Paroxetine 40 mg
Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.
|
Participants Who Received Paroxetine 60 mg
Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.
|
|---|---|---|---|
|
Change From Baseline in Vital Sign: Body Temperature
|
0.047 Degrees Celsius
Standard Deviation 0.1109
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 48Population: Safety Population included all participants who received at least one dose of study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or any other situation as determined per medical and scientific judgment.
Outcome measures
| Measure |
Participants Who Received Paroxetine 20 mg
n=38 Participants
Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.
|
Participants Who Received Paroxetine 40 mg
n=33 Participants
Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.
|
Participants Who Received Paroxetine 60 mg
n=32 Participants
Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
23 Participants
|
19 Participants
|
9 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 48Population: Safety Population included all participants who received at least one dose of study intervention.
The laboratory measurements included hematology, clinical chemistry and coagulation parameters. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets, Reticulocytes, Alanine Aminotransferase, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Potassium, Sodium, Creatinine kinase, Prothrombin time (PT), activated partial thromboplastin time (aPTT), international normalized ration (INR). Clinical significance was determined by the investigator. Number of participants with clinically significant findings in hematology, clinical chemistry and coagulation were reported.
Outcome measures
| Measure |
Participants Who Received Paroxetine 20 mg
n=38 Participants
Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.
|
Participants Who Received Paroxetine 40 mg
n=33 Participants
Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.
|
Participants Who Received Paroxetine 60 mg
n=32 Participants
Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters
Hematology
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters
Clinical chemistry
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters
Coagulation
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 48Population: Safety Population included all participants who received at least one dose of study intervention.
Vital signs included systolic and diastolic blood pressure, pulse rate and body temperature. Blood pressure and pulse rate were measured with the participant in supine position after at least 5 minutes rest. Clinical significance was determined by the investigator. Number of participants with clinically significant findings in vital signs were reported.
Outcome measures
| Measure |
Participants Who Received Paroxetine 20 mg
n=38 Participants
Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.
|
Participants Who Received Paroxetine 40 mg
n=33 Participants
Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.
|
Participants Who Received Paroxetine 60 mg
n=32 Participants
Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Findings for Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 48Population: Safety Population included all participants who received at least one dose of study intervention.
Physical examinations included assessment of skin, lungs, cardiovascular system, and abdomen (liver and spleen). Clinical significance was determined by the investigator. Number of Participants with clinically significant findings for physical examinations were reported.
Outcome measures
| Measure |
Participants Who Received Paroxetine 20 mg
n=38 Participants
Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.
|
Participants Who Received Paroxetine 40 mg
n=33 Participants
Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.
|
Participants Who Received Paroxetine 60 mg
n=32 Participants
Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Findings for Physical Examinations
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Participants Who Received Paroxetine 20 mg
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Participants Who Received Paroxetine 40 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Participants Who Received Paroxetine 60 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants Who Received Paroxetine 20 mg
n=38 participants at risk
Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.
|
Participants Who Received Paroxetine 40 mg
n=33 participants at risk
Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.
|
Participants Who Received Paroxetine 60 mg
n=32 participants at risk
Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.
|
|---|---|---|---|
|
Nervous system disorders
Dyskinesia
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
Other adverse events
| Measure |
Participants Who Received Paroxetine 20 mg
n=38 participants at risk
Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7.
|
Participants Who Received Paroxetine 40 mg
n=33 participants at risk
Participants received paroxetine 40 mg tablets, orally once daily from Days 8 to 14.
|
Participants Who Received Paroxetine 60 mg
n=32 participants at risk
Participants received paroxetine 60 mg tablets, orally once daily from Days 15 to 21.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
15.8%
6/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
15.2%
5/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
6.2%
2/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Nervous system disorders
Somnolence
|
10.5%
4/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
12.1%
4/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Nervous system disorders
Dizziness
|
10.5%
4/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.0%
1/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Nervous system disorders
Disturbance in attention
|
7.9%
3/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Nervous system disorders
Lethargy
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.0%
1/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Nervous system disorders
Tremor
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
6.1%
2/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Nervous system disorders
Paraesthesia
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Nervous system disorders
Parosmia
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Nervous system disorders
Presyncope
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Nervous system disorders
Restless legs syndrome
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Nervous system disorders
Taste disorder
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Gastrointestinal disorders
Nausea
|
15.8%
6/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
9.1%
3/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.0%
1/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.0%
1/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
General disorders
Fatigue
|
13.2%
5/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
9.1%
3/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
General disorders
Catheter site bruise
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
6.1%
2/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
General disorders
Catheter site pain
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.0%
1/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
General disorders
Feeling abnormal
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
General disorders
Thirst
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Psychiatric disorders
Insomnia
|
10.5%
4/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.0%
1/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
6.2%
2/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.0%
1/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Psychiatric disorders
Euphoric mood
|
5.3%
2/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.0%
1/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Psychiatric disorders
Bruxism
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Psychiatric disorders
Confusional state
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Psychiatric disorders
Dissociation
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Psychiatric disorders
Emotional poverty
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.0%
1/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Psychiatric disorders
Libido decreased
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.5%
4/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.0%
1/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.3%
2/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
6.1%
2/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
9.4%
3/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
10.5%
4/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.0%
1/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.0%
1/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Eye disorders
Vision blurred
|
5.3%
2/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Eye disorders
Dry eye
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Eye disorders
Visual impairment
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.0%
1/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.0%
1/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.0%
1/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Infections and infestations
COVID-19
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.0%
1/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
General disorders
Feeling hot
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Psychiatric disorders
Abnormal dreams
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
3.0%
1/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.6%
1/38 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/33 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48
Safety Population included all participants who received at least one dose of study intervention. AEs were reported Treatment-wise.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER