Trial Outcomes & Findings for A Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult Participants (NCT NCT06058390)
NCT ID: NCT06058390
Last Updated: 2025-07-18
Results Overview
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. Pharmacokinetic (PK) Parameter Population included all participants in the PK concentration Population for whom valid and evaluable plasma PK parameters were derived.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
160 participants
Primary outcome timeframe
Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)
Results posted on
2025-07-18
Participant Flow
A total of 160 participants were enrolled in the study which were randomized in 4 groups. (Enrolled Population: All participants who entered the study \[who were randomized or received study intervention or underwent a post-screening procedure\]).
Participant milestones
| Measure |
Bepirovirsen 300 mg Vial by HCP
Participants received a single dose of Bepirovirsen (GSK3228836) 300 milligrams (mg) (2\*150 mg) subcutaneous (SC) injection packaged in a vial, administered by Healthcare Professionals (HCP).
|
Bepirovirsen 300 mg PFS SSD by HCP
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a prefilled syringe (PFS) fitted with a safety syringe device (SSD), administered by HCP.
|
Bepirovirsen 300 mg PFS SSD Self-administered Post-training
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with training from HCP. Participants were monitored by HCP during self-administration.
|
Bepirovirsen 300 mg PFS SSD Self-administered Without Training
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with no training from HCP. Participants were monitored by HCP during self-administration.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
49
|
32
|
33
|
|
Overall Study
Safety Population
|
46
|
49
|
32
|
32
|
|
Overall Study
COMPLETED
|
46
|
49
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
3
|
Reasons for withdrawal
| Measure |
Bepirovirsen 300 mg Vial by HCP
Participants received a single dose of Bepirovirsen (GSK3228836) 300 milligrams (mg) (2\*150 mg) subcutaneous (SC) injection packaged in a vial, administered by Healthcare Professionals (HCP).
|
Bepirovirsen 300 mg PFS SSD by HCP
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a prefilled syringe (PFS) fitted with a safety syringe device (SSD), administered by HCP.
|
Bepirovirsen 300 mg PFS SSD Self-administered Post-training
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with training from HCP. Participants were monitored by HCP during self-administration.
|
Bepirovirsen 300 mg PFS SSD Self-administered Without Training
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with no training from HCP. Participants were monitored by HCP during self-administration.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Participants did not receive any study intervention
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
Bepirovirsen 300 mg Vial by HCP
n=46 Participants
Participants received a single dose of Bepirovirsen (GSK3228836) 300 milligrams (mg) (2\*150 mg) subcutaneous (SC) injection packaged in a vial, administered by Healthcare Professionals (HCP).
|
Bepirovirsen 300 mg PFS SSD by HCP
n=49 Participants
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a prefilled syringe (PFS) fitted with a safety syringe device (SSD), administered by HCP.
|
Bepirovirsen 300 mg PFS SSD Self-administered Post-training
n=32 Participants
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with training from HCP. Participants were monitored by HCP during self-administration.
|
Bepirovirsen 300 mg PFS SSD Self-administered Without Training
n=32 Participants
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with no training from HCP. Participants were monitored by HCP during self-administration.
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.7 YEARS
STANDARD_DEVIATION 9.09 • n=99 Participants
|
36.5 YEARS
STANDARD_DEVIATION 9.57 • n=107 Participants
|
36.6 YEARS
STANDARD_DEVIATION 9.35 • n=206 Participants
|
37.5 YEARS
STANDARD_DEVIATION 9.74 • n=7 Participants
|
36.5 YEARS
STANDARD_DEVIATION 9.35 • n=31 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
82 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
77 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
25 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
76 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
All Other Races
|
21 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
83 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)Population: PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD by HCP and reference group is Bepirovirsen 300 mg Vial by HCP for this outcome measure. Based on the test and reference, data was analyzed and Cmax values were modelled as described in measure description which vary across different outcome measures.
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. Pharmacokinetic (PK) Parameter Population included all participants in the PK concentration Population for whom valid and evaluable plasma PK parameters were derived.
Outcome measures
| Measure |
Bepirovirsen 300 mg Vial by HCP
n=46 Participants
Participants received a single dose of Bepirovirsen (GSK3228836) 300 milligrams (mg) (2\*150 mg) subcutaneous (SC) injection packaged in a vial, administered by Healthcare Professionals (HCP).
|
Bepirovirsen 300 mg PFS SSD by HCP
n=49 Participants
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a prefilled syringe (PFS) fitted with a safety syringe device (SSD), administered by HCP.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using Vial and PFS by HCP
|
9954.89 Nanograms per milliliters (ng/mL)
Standard Error 0.049
|
10163.74 Nanograms per milliliters (ng/mL)
Standard Error 0.048
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)Population: PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD by HCP and reference group is Bepirovirsen 300 mg Vial by HCP for this outcome measure. Based on the test and reference, data was analyzed and AUC(0-inf) values were modelled as described in measure description which vary across different outcome measures.
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation.
Outcome measures
| Measure |
Bepirovirsen 300 mg Vial by HCP
n=46 Participants
Participants received a single dose of Bepirovirsen (GSK3228836) 300 milligrams (mg) (2\*150 mg) subcutaneous (SC) injection packaged in a vial, administered by Healthcare Professionals (HCP).
|
Bepirovirsen 300 mg PFS SSD by HCP
n=49 Participants
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a prefilled syringe (PFS) fitted with a safety syringe device (SSD), administered by HCP.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC [0-Inf]) Following Administration of Bepirovirsen Using Vial and PFS by HCP
|
112495.66 Hours*nanogram per milliliter (h*ng/mL)
Standard Error 0.039
|
118622.59 Hours*nanogram per milliliter (h*ng/mL)
Standard Error 0.038
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)Population: PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD self-administered post-training and reference group is Bepirovirsen 300 mg PFS SSD by HCP for this outcome measure. Based on the test and reference, data was analyzed and Cmax values were modelled as described in measure description which vary across different outcome measures.
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation.
Outcome measures
| Measure |
Bepirovirsen 300 mg Vial by HCP
n=49 Participants
Participants received a single dose of Bepirovirsen (GSK3228836) 300 milligrams (mg) (2\*150 mg) subcutaneous (SC) injection packaged in a vial, administered by Healthcare Professionals (HCP).
|
Bepirovirsen 300 mg PFS SSD by HCP
n=29 Participants
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a prefilled syringe (PFS) fitted with a safety syringe device (SSD), administered by HCP.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training
|
10225.39 Nanograms per milliliters
Standard Error 0.050
|
10421.21 Nanograms per milliliters
Standard Error 0.067
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)Population: PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD self-administered post-training and reference group is Bepirovirsen 300 mg PFS SSD by HCP for this outcome measure. Based on the test and reference, data was analyzed and AUC(0-inf) values were modelled as described in measure description which vary across different outcome measures.
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation.
Outcome measures
| Measure |
Bepirovirsen 300 mg Vial by HCP
n=49 Participants
Participants received a single dose of Bepirovirsen (GSK3228836) 300 milligrams (mg) (2\*150 mg) subcutaneous (SC) injection packaged in a vial, administered by Healthcare Professionals (HCP).
|
Bepirovirsen 300 mg PFS SSD by HCP
n=29 Participants
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a prefilled syringe (PFS) fitted with a safety syringe device (SSD), administered by HCP.
|
|---|---|---|
|
AUC(0-inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training
|
120034.02 Hours*nanograms per milliliters
Standard Error 0.038
|
117805.29 Hours*nanograms per milliliters
Standard Error 0.050
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)Population: PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD self-administered without training and reference group is Bepirovirsen 300 mg PFS SSD by HCP for this outcome measure. Based on the test and reference, data was analyzed and Cmax values were modelled as described in measure description which vary across different outcome measures.
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation.
Outcome measures
| Measure |
Bepirovirsen 300 mg Vial by HCP
n=49 Participants
Participants received a single dose of Bepirovirsen (GSK3228836) 300 milligrams (mg) (2\*150 mg) subcutaneous (SC) injection packaged in a vial, administered by Healthcare Professionals (HCP).
|
Bepirovirsen 300 mg PFS SSD by HCP
n=29 Participants
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a prefilled syringe (PFS) fitted with a safety syringe device (SSD), administered by HCP.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training
|
10007.69 Nanograms per milliliters
Standard Error 0.046
|
9896.63 Nanograms per milliliters
Standard Error 0.061
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours)Population: PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD self-administered without training and reference group is Bepirovirsen 300 mg PFS SSD by HCP for this outcome measure. Based on the test and reference, data was analyzed and AUC(0-inf) values were modelled as described in measure description which vary across different outcome measures.
Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation.
Outcome measures
| Measure |
Bepirovirsen 300 mg Vial by HCP
n=49 Participants
Participants received a single dose of Bepirovirsen (GSK3228836) 300 milligrams (mg) (2\*150 mg) subcutaneous (SC) injection packaged in a vial, administered by Healthcare Professionals (HCP).
|
Bepirovirsen 300 mg PFS SSD by HCP
n=29 Participants
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a prefilled syringe (PFS) fitted with a safety syringe device (SSD), administered by HCP.
|
|---|---|---|
|
AUC(0-Inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training
|
117938.68 Hours*nanograms per milliliters
Standard Error 0.037
|
114492.19 Hours*nanograms per milliliters
Standard Error 0.049
|
Adverse Events
Bepirovirsen 300 mg Vial by HCP
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Bepirovirsen 300 mg PFS SSD by HCP
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Bepirovirsen 300 mg PFS SSD Self-administered Post-training
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Bepirovirsen 300 mg PFS SSD Self-administered Without Training
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bepirovirsen 300 mg Vial by HCP
n=46 participants at risk
Participants received a single dose of Bepirovirsen (GSK3228836) 300 milligrams (mg) (2\*150 mg) subcutaneous (SC) injection packaged in a vial, administered by Healthcare Professionals (HCP).
|
Bepirovirsen 300 mg PFS SSD by HCP
n=49 participants at risk
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a prefilled syringe (PFS) fitted with a safety syringe device (SSD), administered by HCP.
|
Bepirovirsen 300 mg PFS SSD Self-administered Post-training
n=32 participants at risk
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with training from HCP. Participants were monitored by HCP during self-administration.
|
Bepirovirsen 300 mg PFS SSD Self-administered Without Training
n=32 participants at risk
Participants received a single dose of Bepirovirsen 300 mg (2\*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with no training from HCP. Participants were monitored by HCP during self-administration.
|
|---|---|---|---|---|
|
General disorders
Injection site erythema
|
76.1%
35/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
75.5%
37/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
93.8%
30/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
93.8%
30/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Injection site swelling
|
45.7%
21/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
49.0%
24/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
43.8%
14/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
59.4%
19/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Injection site pain
|
50.0%
23/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
44.9%
22/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
31.2%
10/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
37.5%
12/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Injection site pruritus
|
17.4%
8/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
22.4%
11/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
28.1%
9/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
40.6%
13/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Injection site discolouration
|
15.2%
7/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
10.2%
5/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
18.8%
6/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
15.6%
5/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Injection site pallor
|
13.0%
6/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
6.1%
3/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
15.6%
5/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
9.4%
3/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Injection site haemorrhage
|
10.9%
5/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
4.1%
2/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
9.4%
3/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Injection site bruising
|
4.3%
2/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
6.1%
3/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
12.5%
4/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Injection site warmth
|
6.5%
3/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
4.1%
2/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
6.2%
2/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Pyrexia
|
6.5%
3/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
4.1%
2/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Chills
|
4.3%
2/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
6.2%
2/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Injection site inflammation
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
6.2%
2/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Injection site nodule
|
4.3%
2/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Fatigue
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Medical device site dermatitis
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Influenza like illness
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Injection site dermatitis
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Injection site discomfort
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Injection site exfoliation
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Injection site paraesthesia
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Injection site scab
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Malaise
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Nervous system disorders
Headache
|
26.1%
12/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
10.2%
5/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
15.6%
5/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
21.9%
7/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
4.1%
2/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Nervous system disorders
Presyncope
|
4.3%
2/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Nervous system disorders
Syncope
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Gastrointestinal disorders
Nausea
|
6.5%
3/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
6.1%
3/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
6.2%
2/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
6.2%
2/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
2/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Infections and infestations
Viral infection
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Infections and infestations
Bacterial vaginosis
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Infections and infestations
Impetigo
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Infections and infestations
Influenza
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Infections and infestations
Paronychia
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.9%
5/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
3/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Injury, poisoning and procedural complications
Contusion
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
4.1%
2/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Investigations
C-reactive protein increased
|
4.3%
2/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Investigations
Neutrophil percentage increased
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Investigations
Weight increased
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
6.2%
2/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Immune system disorders
Drug hypersensitivity
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Immune system disorders
Allergy to arthropod sting
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
6.2%
2/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Renal and urinary disorders
Urinary tract discomfort
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
2.0%
1/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Eye disorders
Conjunctival hyperaemia
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Eye disorders
Vision blurred
|
2.2%
1/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Vascular disorders
Flushing
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/46 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/49 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
3.1%
1/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
0.00%
0/32 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
|
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