Trial Outcomes & Findings for VH4524184 Proof-of-Concept in Treatment-Naïve Adults Living With HIV-1 (NCT NCT06214052)
NCT ID: NCT06214052
Last Updated: 2025-06-29
Results Overview
Plasma samples were collected for the quantitative analysis of plasma HIV-1 RNA. The maximum change from baseline was calculated by determining the largest change from baseline value across all assessment timepoints during the monotherapy period. This is identified by subtracting the lowest post-dose visit value up to Day 10 (inclusive) from the baseline value. The baseline was defined as the most recent pre-dose assessment with a valid, non-missing value, including measurements from any unscheduled visits.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
At Day 10
Results posted on
2025-06-29
Participant Flow
Part 2 of the study was optional and was not selected for enrollment following interim analysis of part 1 based on Pharmacokinetic/Pharmacodynamic modelling and preliminary clinical data.
Participant milestones
| Measure |
VH4524184 Dose 1
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|
|
Monotherapy Period (Day 1 to Day 10)
STARTED
|
6
|
6
|
7
|
3
|
|
Monotherapy Period (Day 1 to Day 10)
COMPLETED
|
6
|
6
|
7
|
3
|
|
Monotherapy Period (Day 1 to Day 10)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Follow-Up Period(Day 11 to Day 38)
STARTED
|
6
|
6
|
7
|
3
|
|
Follow-Up Period(Day 11 to Day 38)
COMPLETED
|
6
|
6
|
7
|
3
|
|
Follow-Up Period(Day 11 to Day 38)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VH4524184 Proof-of-Concept in Treatment-Naïve Adults Living With HIV-1
Baseline characteristics by cohort
| Measure |
VH4524184 Dose 1
n=6 Participants
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
n=6 Participants
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
n=7 Participants
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
n=3 Participants
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.2 YEARS
STANDARD_DEVIATION 10.61 • n=5 Participants
|
36.7 YEARS
STANDARD_DEVIATION 16.18 • n=7 Participants
|
33.9 YEARS
STANDARD_DEVIATION 12.52 • n=5 Participants
|
29.3 YEARS
STANDARD_DEVIATION 3.79 • n=4 Participants
|
34.1 YEARS
STANDARD_DEVIATION 11.85 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
All Other Races
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At Day 10Population: Analysis was performed on Full Analysis Set (FAS), which included all randomized participants who received at least 1 full dose of study intervention.
Plasma samples were collected for the quantitative analysis of plasma HIV-1 RNA. The maximum change from baseline was calculated by determining the largest change from baseline value across all assessment timepoints during the monotherapy period. This is identified by subtracting the lowest post-dose visit value up to Day 10 (inclusive) from the baseline value. The baseline was defined as the most recent pre-dose assessment with a valid, non-missing value, including measurements from any unscheduled visits.
Outcome measures
| Measure |
VH4524184 Dose 1
n=6 Participants
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
n=6 Participants
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
n=7 Participants
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
n=3 Participants
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|
|
Monotherapy: Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA)
|
-1.17 Copies per milliliter (copies/mL)
Standard Deviation 0.460
|
-2.15 Copies per milliliter (copies/mL)
Standard Deviation 0.254
|
-2.31 Copies per milliliter (copies/mL)
Standard Deviation 0.463
|
-0.28 Copies per milliliter (copies/mL)
Standard Deviation 0.370
|
SECONDARY outcome
Timeframe: Day 1 to Day 38Population: Analysis was performed on the Safety Set, which included all randomized participants who received at least one partial or full dose of the study intervention. As pre-specified in the protocol, the outcome measure data are reported for monotherapy and FU periods combined that includes all participants and all doses administered during the specified duration. Each participant is counted once across both the periods, reflecting the total number of participants affected by any adverse event.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Any AEs = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
VH4524184 Dose 1
n=6 Participants
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
n=6 Participants
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
n=7 Participants
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
n=3 Participants
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|
|
Monotherapy and Follow-up: Number of Participants With Any Adverse Event (AE)
|
4 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 38Population: Analysis was performed on Safety Set. As pre-specified in the protocol, the outcome measure data are reported for monotherapy and FU periods combined that includes all participants and all doses administered during the specified duration. Each participant is counted once across both the periods, reflecting the total number of participants affected by any adverse event.
The severity was assessed using The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.1 where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening and Grade 5 = Death.
Outcome measures
| Measure |
VH4524184 Dose 1
n=6 Participants
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
n=6 Participants
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
n=7 Participants
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
n=3 Participants
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|
|
Monotherapy and Follow-up: Number of Participants With AEs by Severity
Grade 1
|
3 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Monotherapy and Follow-up: Number of Participants With AEs by Severity
Grade 2
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Monotherapy and Follow-up: Number of Participants With AEs by Severity
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With AEs by Severity
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With AEs by Severity
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Population: Analysis was performed on Safety Set.
Outcome measures
| Measure |
VH4524184 Dose 1
n=6 Participants
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
n=6 Participants
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
n=7 Participants
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
n=3 Participants
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|
|
Monotherapy: Number of Participants With AEs Leading to Study Treatment Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Baseline (Day 1), Day 2, Day 4, Day 7, Day 10, Day 17, Day 24, Day 31 and Day 38Population: Analysis was performed on Safety Set. As pre-specified in the protocol, the outcome measure data are reported for monotherapy and FU periods combined that includes all participants and all doses administered during the specified timepoints.
Blood samples were collected at the indicated timepoints.
Outcome measures
| Measure |
VH4524184 Dose 1
n=6 Participants
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
n=6 Participants
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
n=7 Participants
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
n=3 Participants
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALP, Day 10
|
4.2 International units per liter (IU/L)
Standard Deviation 3.92
|
-1.7 International units per liter (IU/L)
Standard Deviation 6.53
|
2.1 International units per liter (IU/L)
Standard Deviation 3.89
|
5.7 International units per liter (IU/L)
Standard Deviation 13.65
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALP, Day 17
|
4.5 International units per liter (IU/L)
Standard Deviation 5.09
|
0.0 International units per liter (IU/L)
Standard Deviation 3.74
|
0.9 International units per liter (IU/L)
Standard Deviation 6.72
|
8.3 International units per liter (IU/L)
Standard Deviation 4.93
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALT, Baseline (Day 1)
|
25.5 International units per liter (IU/L)
Standard Deviation 15.35
|
26.0 International units per liter (IU/L)
Standard Deviation 9.27
|
30.4 International units per liter (IU/L)
Standard Deviation 20.82
|
21.0 International units per liter (IU/L)
Standard Deviation 7.21
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALT, Day 2
|
0.0 International units per liter (IU/L)
Standard Deviation 4.20
|
1.3 International units per liter (IU/L)
Standard Deviation 2.50
|
4.3 International units per liter (IU/L)
Standard Deviation 11.70
|
0.0 International units per liter (IU/L)
Standard Deviation 4.00
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALT, Day 4
|
2.2 International units per liter (IU/L)
Standard Deviation 4.54
|
0.5 International units per liter (IU/L)
Standard Deviation 4.42
|
0.0 International units per liter (IU/L)
Standard Deviation 12.41
|
-1.0 International units per liter (IU/L)
Standard Deviation 1.00
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALT, Day 7
|
0.2 International units per liter (IU/L)
Standard Deviation 3.25
|
-3.5 International units per liter (IU/L)
Standard Deviation 5.36
|
-6.4 International units per liter (IU/L)
Standard Deviation 14.39
|
-1.3 International units per liter (IU/L)
Standard Deviation 5.86
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALT, Day 10
|
4.5 International units per liter (IU/L)
Standard Deviation 5.79
|
-5.5 International units per liter (IU/L)
Standard Deviation 5.82
|
-6.1 International units per liter (IU/L)
Standard Deviation 16.95
|
8.3 International units per liter (IU/L)
Standard Deviation 16.50
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALT, Day 17
|
6.7 International units per liter (IU/L)
Standard Deviation 15.10
|
-7.0 International units per liter (IU/L)
Standard Deviation 6.24
|
-8.0 International units per liter (IU/L)
Standard Deviation 13.99
|
-3.0 International units per liter (IU/L)
Standard Deviation 8.72
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALT, Day 24
|
-1.7 International units per liter (IU/L)
Standard Deviation 6.15
|
1.2 International units per liter (IU/L)
Standard Deviation 12.22
|
-8.6 International units per liter (IU/L)
Standard Deviation 14.41
|
-4.3 International units per liter (IU/L)
Standard Deviation 4.51
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALT, Day 31
|
-2.8 International units per liter (IU/L)
Standard Deviation 10.31
|
0.2 International units per liter (IU/L)
Standard Deviation 7.31
|
-10.4 International units per liter (IU/L)
Standard Deviation 11.84
|
-5.0 International units per liter (IU/L)
Standard Deviation 4.58
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALT, Day 38
|
-2.8 International units per liter (IU/L)
Standard Deviation 8.26
|
-2.5 International units per liter (IU/L)
Standard Deviation 9.16
|
-13.0 International units per liter (IU/L)
Standard Deviation 16.67
|
-3.0 International units per liter (IU/L)
Standard Deviation 5.57
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
AST, Baseline (Day 1)
|
29.7 International units per liter (IU/L)
Standard Deviation 24.64
|
26.5 International units per liter (IU/L)
Standard Deviation 11.45
|
25.9 International units per liter (IU/L)
Standard Deviation 8.76
|
22.3 International units per liter (IU/L)
Standard Deviation 11.68
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
AST, Day 2
|
-1.3 International units per liter (IU/L)
Standard Deviation 6.65
|
-1.2 International units per liter (IU/L)
Standard Deviation 4.96
|
2.6 International units per liter (IU/L)
Standard Deviation 10.06
|
0.0 International units per liter (IU/L)
Standard Deviation 3.46
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
AST, Day 4
|
2.2 International units per liter (IU/L)
Standard Deviation 3.06
|
-3.2 International units per liter (IU/L)
Standard Deviation 9.02
|
-2.9 International units per liter (IU/L)
Standard Deviation 6.12
|
1.3 International units per liter (IU/L)
Standard Deviation 3.06
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
AST, Day 7
|
-0.3 International units per liter (IU/L)
Standard Deviation 3.67
|
-4.8 International units per liter (IU/L)
Standard Deviation 6.97
|
-4.9 International units per liter (IU/L)
Standard Deviation 6.57
|
-0.7 International units per liter (IU/L)
Standard Deviation 4.73
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
AST, Day 10
|
9.7 International units per liter (IU/L)
Standard Deviation 17.82
|
-6.2 International units per liter (IU/L)
Standard Deviation 8.47
|
-4.7 International units per liter (IU/L)
Standard Deviation 7.45
|
2.0 International units per liter (IU/L)
Standard Deviation 11.79
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
AST, Day 17
|
22.0 International units per liter (IU/L)
Standard Deviation 47.41
|
-9.0 International units per liter (IU/L)
Standard Deviation 5.83
|
-5.1 International units per liter (IU/L)
Standard Deviation 7.36
|
-1.3 International units per liter (IU/L)
Standard Deviation 8.74
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
AST, Day 24
|
1.2 International units per liter (IU/L)
Standard Deviation 8.01
|
-4.3 International units per liter (IU/L)
Standard Deviation 6.59
|
-3.3 International units per liter (IU/L)
Standard Deviation 6.73
|
-4.0 International units per liter (IU/L)
Standard Deviation 7.00
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
AST, Day 31
|
-0.8 International units per liter (IU/L)
Standard Deviation 6.30
|
-3.0 International units per liter (IU/L)
Standard Deviation 4.20
|
-2.4 International units per liter (IU/L)
Standard Deviation 6.45
|
-3.0 International units per liter (IU/L)
Standard Deviation 5.20
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
AST, Day 38
|
-4.7 International units per liter (IU/L)
Standard Deviation 14.05
|
-4.7 International units per liter (IU/L)
Standard Deviation 5.54
|
-6.0 International units per liter (IU/L)
Standard Deviation 9.36
|
0.3 International units per liter (IU/L)
Standard Deviation 8.02
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALP, Baseline (Day 1)
|
81.3 International units per liter (IU/L)
Standard Deviation 32.51
|
70.3 International units per liter (IU/L)
Standard Deviation 15.76
|
72.9 International units per liter (IU/L)
Standard Deviation 10.06
|
103.7 International units per liter (IU/L)
Standard Deviation 56.00
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALP, Day 2
|
3.3 International units per liter (IU/L)
Standard Deviation 9.14
|
2.5 International units per liter (IU/L)
Standard Deviation 6.69
|
0.6 International units per liter (IU/L)
Standard Deviation 3.26
|
7.3 International units per liter (IU/L)
Standard Deviation 13.58
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALP, Day 4
|
2.5 International units per liter (IU/L)
Standard Deviation 9.18
|
-0.2 International units per liter (IU/L)
Standard Deviation 3.13
|
2.9 International units per liter (IU/L)
Standard Deviation 5.84
|
13.3 International units per liter (IU/L)
Standard Deviation 18.01
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALP, Day 7
|
3.7 International units per liter (IU/L)
Standard Deviation 6.50
|
-4.0 International units per liter (IU/L)
Standard Deviation 3.63
|
-2.6 International units per liter (IU/L)
Standard Deviation 4.72
|
2.7 International units per liter (IU/L)
Standard Deviation 15.82
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALP, Day 24
|
3.2 International units per liter (IU/L)
Standard Deviation 2.86
|
-0.2 International units per liter (IU/L)
Standard Deviation 5.19
|
-0.7 International units per liter (IU/L)
Standard Deviation 6.80
|
-1.3 International units per liter (IU/L)
Standard Deviation 17.01
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALP, Day 31
|
5.2 International units per liter (IU/L)
Standard Deviation 3.90
|
0.3 International units per liter (IU/L)
Standard Deviation 12.60
|
0.1 International units per liter (IU/L)
Standard Deviation 9.01
|
20.3 International units per liter (IU/L)
Standard Deviation 14.36
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
ALP, Day 38
|
4.5 International units per liter (IU/L)
Standard Deviation 3.51
|
0.2 International units per liter (IU/L)
Standard Deviation 14.33
|
-0.6 International units per liter (IU/L)
Standard Deviation 5.83
|
-3.0 International units per liter (IU/L)
Standard Deviation 21.17
|
SECONDARY outcome
Timeframe: At Baseline (Day 1), Day 2, Day 4, Day 7, Day 10, Day 17, Day 24, Day 31 and Day 38Population: Analysis was performed on Safety Set. As pre-specified in the protocol, the outcome measure data are reported for monotherapy and FU periods combined that includes all participants and all doses administered during the specified timepoints.
Blood samples were collected at the indicated timepoints.
Outcome measures
| Measure |
VH4524184 Dose 1
n=6 Participants
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
n=6 Participants
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
n=7 Participants
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
n=3 Participants
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Bilirubin
Day 38
|
1.7100 Micromoles per liter (μmol/L)
Standard Deviation 5.46665
|
-0.1712 Micromoles per liter (μmol/L)
Standard Deviation 3.59512
|
0.2931 Micromoles per liter (μmol/L)
Standard Deviation 1.14163
|
-3.1923 Micromoles per liter (μmol/L)
Standard Deviation 3.60425
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Bilirubin
Baseline (Day 1)
|
8.2935 Micromoles per liter (μmol/L)
Standard Deviation 5.93914
|
5.6145 Micromoles per liter (μmol/L)
Standard Deviation 3.21992
|
5.9117 Micromoles per liter (μmol/L)
Standard Deviation 3.21410
|
8.0370 Micromoles per liter (μmol/L)
Standard Deviation 5.75333
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Bilirubin
Day 2
|
1.0545 Micromoles per liter (μmol/L)
Standard Deviation 3.03093
|
0.2565 Micromoles per liter (μmol/L)
Standard Deviation 1.32787
|
1.1481 Micromoles per liter (μmol/L)
Standard Deviation 1.75421
|
-0.7410 Micromoles per liter (μmol/L)
Standard Deviation 4.86174
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Bilirubin
Day 4
|
1.4820 Micromoles per liter (μmol/L)
Standard Deviation 5.38437
|
0.8550 Micromoles per liter (μmol/L)
Standard Deviation 2.93204
|
1.6856 Micromoles per liter (μmol/L)
Standard Deviation 3.71694
|
-3.2490 Micromoles per liter (μmol/L)
Standard Deviation 5.08132
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Bilirubin
Day 7
|
-1.5105 Micromoles per liter (μmol/L)
Standard Deviation 4.25706
|
2.1660 Micromoles per liter (μmol/L)
Standard Deviation 2.20230
|
-0.8306 Micromoles per liter (μmol/L)
Standard Deviation 2.63700
|
-1.8813 Micromoles per liter (μmol/L)
Standard Deviation 5.60653
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Bilirubin
Day 10
|
2.2515 Micromoles per liter (μmol/L)
Standard Deviation 6.11541
|
0.7695 Micromoles per liter (μmol/L)
Standard Deviation 3.53892
|
0.3176 Micromoles per liter (μmol/L)
Standard Deviation 2.28020
|
-3.0210 Micromoles per liter (μmol/L)
Standard Deviation 3.16389
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Bilirubin
Day 17
|
0.7980 Micromoles per liter (μmol/L)
Standard Deviation 7.47774
|
0.1368 Micromoles per liter (μmol/L)
Standard Deviation 3.23863
|
0.4641 Micromoles per liter (μmol/L)
Standard Deviation 3.39097
|
1.7670 Micromoles per liter (μmol/L)
Standard Deviation 4.44052
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Bilirubin
Day 24
|
1.7100 Micromoles per liter (μmol/L)
Standard Deviation 6.10927
|
0.2280 Micromoles per liter (μmol/L)
Standard Deviation 3.65583
|
1.3436 Micromoles per liter (μmol/L)
Standard Deviation 3.54789
|
-0.5130 Micromoles per liter (μmol/L)
Standard Deviation 2.68748
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Bilirubin
Day 31
|
-0.2052 Micromoles per liter (μmol/L)
Standard Deviation 7.41576
|
0.0285 Micromoles per liter (μmol/L)
Standard Deviation 1.40768
|
0.3909 Micromoles per liter (μmol/L)
Standard Deviation 2.62828
|
0.8550 Micromoles per liter (μmol/L)
Standard Deviation 4.42292
|
SECONDARY outcome
Timeframe: At Baseline (Day 1), Day 2, Day 4, Day 7, Day 10, Day 17, Day 24, Day 31 and Day 38Population: Analysis was performed on Safety Set. As pre-specified in the protocol, the outcome measure data are reported for monotherapy and FU periods combined that includes all participants and all doses administered during the specified timepoints.
Blood samples were collected at the indicated timepoints.
Outcome measures
| Measure |
VH4524184 Dose 1
n=6 Participants
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
n=6 Participants
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
n=7 Participants
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
n=3 Participants
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Protein
Baseline (Day 1)
|
76.5 Grams per liter
Standard Deviation 4.55
|
75.5 Grams per liter
Standard Deviation 3.39
|
77.1 Grams per liter
Standard Deviation 5.49
|
70.0 Grams per liter
Standard Deviation 5.57
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Protein
Day 38
|
0.5 Grams per liter
Standard Deviation 2.26
|
-1.3 Grams per liter
Standard Deviation 4.68
|
-1.4 Grams per liter
Standard Deviation 4.35
|
2.0 Grams per liter
Standard Deviation 4.58
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Protein
Day 2
|
2.8 Grams per liter
Standard Deviation 3.60
|
2.2 Grams per liter
Standard Deviation 3.31
|
0.7 Grams per liter
Standard Deviation 3.30
|
5.7 Grams per liter
Standard Deviation 1.53
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Protein
Day 4
|
4.3 Grams per liter
Standard Deviation 4.37
|
1.5 Grams per liter
Standard Deviation 2.66
|
2.1 Grams per liter
Standard Deviation 2.97
|
2.0 Grams per liter
Standard Deviation 1.00
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Protein
Day 7
|
2.0 Grams per liter
Standard Deviation 3.63
|
-1.3 Grams per liter
Standard Deviation 2.34
|
-1.9 Grams per liter
Standard Deviation 3.89
|
-1.0 Grams per liter
Standard Deviation 1.00
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Protein
Day 10
|
2.2 Grams per liter
Standard Deviation 2.40
|
-0.7 Grams per liter
Standard Deviation 3.14
|
1.6 Grams per liter
Standard Deviation 2.64
|
0.3 Grams per liter
Standard Deviation 2.08
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Protein
Day 17
|
1.2 Grams per liter
Standard Deviation 3.25
|
0.4 Grams per liter
Standard Deviation 2.30
|
0.1 Grams per liter
Standard Deviation 5.21
|
7.3 Grams per liter
Standard Deviation 4.16
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Protein
Day 24
|
0.8 Grams per liter
Standard Deviation 3.06
|
0.3 Grams per liter
Standard Deviation 4.46
|
0.6 Grams per liter
Standard Deviation 4.43
|
2.0 Grams per liter
Standard Deviation 3.00
|
|
Monotherapy and Follow-up: Change From Baseline for Liver Panel Laboratory Parameter: Protein
Day 31
|
0.4 Grams per liter
Standard Deviation 4.56
|
-0.2 Grams per liter
Standard Deviation 5.23
|
-0.9 Grams per liter
Standard Deviation 3.80
|
8.3 Grams per liter
Standard Deviation 4.51
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) and up to Day 38Population: Analysis was performed on Safety Set. As pre-specified in the protocol, the outcome measure data are reported for monotherapy and FU periods combined that includes all participants and all doses administered during the specified duration.
Liver panel parameters assessed were: ALT, AST, ALP, bilirubin. The parameters were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase is defined as an increase in grade relative to baseline grade.
Outcome measures
| Measure |
VH4524184 Dose 1
n=6 Participants
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
n=6 Participants
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
n=7 Participants
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
n=3 Participants
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
ALT, Increase to Grade 1
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
ALT, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
ALT, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
ALT, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
AST, Increase to Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
AST, Increase to Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
AST, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
AST, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
ALP, Increase to Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
ALP, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
ALP, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
ALP, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
Bilirubin, Increase to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
Bilirubin, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
Bilirubin, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: ALT, AST, ALP, Bilirubin
Bilirubin, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) and up to Day 38Population: Analysis was performed on Safety Set. As pre-specified in the protocol, the outcome measure data are reported for monotherapy and FU periods combined that includes all participants and all doses administered during the specified duration.
Participants are categorized based on changes in their liver panel laboratory parameters (protein) to 'Low,' 'Normal,' or 'High,' unless there is no change in their initial category. Participants whose lab values remain unchanged (e.g., 'High' to 'High') or whose values return to normal are recorded in the 'To Normal or No Change' category. Participants may be counted in both the 'To Low' and 'To High' categories if their values fluctuate between these states. As a result, the percentages may exceed 100% due to dual categorization. Participants with a missing baseline value are assumed to have a normal baseline value.
Outcome measures
| Measure |
VH4524184 Dose 1
n=6 Participants
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
n=6 Participants
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
n=7 Participants
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
n=3 Participants
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: Protein
To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: Protein
To Normal or No Change
|
4 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
|
Monotherapy and Follow-up: Number of Participants With Maximum Toxicity Grade Increase Relative to Baseline in Liver Panel Laboratory Parameters: Protein
To High
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Day 1 and Day 7Population: Analysis was performed on PK Set, which included All participants in the Safety analysis set who had at least 1 non-missing PK assessment. Only participants with data available at the specified timepoints were included in this analysis.
Blood samples were collected at indicated time points for Pharmacokinetic (PK) analysis of VH4524184.
Outcome measures
| Measure |
VH4524184 Dose 1
n=6 Participants
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
n=6 Participants
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
n=7 Participants
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|
|
Monotherapy: Maximum Observed Plasma Drug Concentration (Cmax) of VH4524184
Day 1
|
1332.57 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 16.78
|
6173.61 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 30.71
|
23589.70 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 32.39
|
—
|
|
Monotherapy: Maximum Observed Plasma Drug Concentration (Cmax) of VH4524184
Day 7
|
1488.59 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 32.06
|
7112.60 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 16.59
|
23069.92 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 45.77
|
—
|
SECONDARY outcome
Timeframe: At Day 1 and Day 7Population: Analysis was performed on PK Set. Only participants with data available at the specified timepoints were included in this analysis.
Blood samples were collected at indicated time points for PK analysis of VH4524184.
Outcome measures
| Measure |
VH4524184 Dose 1
n=6 Participants
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
n=6 Participants
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
n=7 Participants
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|
|
Monotherapy: Time to Maximum Observed Plasma Drug Concentration (Tmax) of VH4524184
Day 1
|
3.13 hours
Interval 1.0 to 5.0
|
4.00 hours
Interval 2.0 to 5.0
|
2.00 hours
Interval 1.0 to 5.0
|
—
|
|
Monotherapy: Time to Maximum Observed Plasma Drug Concentration (Tmax) of VH4524184
Day 7
|
4.00 hours
Interval 0.5 to 5.1
|
4.49 hours
Interval 1.0 to 6.0
|
2.13 hours
Interval 1.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: At Day 10Population: Analysis was performed on PK Set. Only participants with data available at the specified timepoint were included in this analysis.
Blood samples was collected at indicated time point for PK analysis of VH4524184.
Outcome measures
| Measure |
VH4524184 Dose 1
n=6 Participants
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
n=6 Participants
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
n=7 Participants
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|
|
Monotherapy: Plasma Concentration of VH4524184 at Day 10
|
127.5 ng/mL
Standard Deviation 75.59
|
523.5 ng/mL
Standard Deviation 324.50
|
1328.3 ng/mL
Standard Deviation 486.99
|
—
|
SECONDARY outcome
Timeframe: From Day 1 to Day 10Population: Analysis was performed on PK Set. Only participants with data available at the specified duration were included in this analysis.
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value. Change from baseline is defined as post-dose visit value minus baseline value. Statistical analysis for relationship between PK parameter (Cmax) and PD measure (change from baseline in logarithm to base 10 (log10) values for maximum plasma HIV-1 RNA) were explored using an Emax non-linear mixed-effects model. The model parameters estimated were maximum response (Emax) which is defined as the maximum change (at infinite exposure) and EC50 which defines the PK parameter value that attains 50 percent (%) of the maximal effect
Outcome measures
| Measure |
VH4524184 Dose 1
n=6 Participants
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
n=6 Participants
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
n=7 Participants
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|
|
Monotherapy: Correlation of VH4524184 Cmax With Maximum Plasma HIV-1 RNA Log 10 Change From Baseline Through Day 10
|
-1.17 Log10 copies/mL
Standard Deviation 0.460
|
-2.15 Log10 copies/mL
Standard Deviation 0.254
|
-2.31 Log10 copies/mL
Standard Deviation 0.463
|
—
|
SECONDARY outcome
Timeframe: At Baseline (Day 1) and Day 10Population: Analysis was performed on FAS.
Plasma samples were collected to assess treatment emergent Genotypic Resistance.
Outcome measures
| Measure |
VH4524184 Dose 1
n=6 Participants
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
n=6 Participants
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
n=7 Participants
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|
|
Monotherapy: Number of Participants With Treatment-emergent Genotypic Resistance
Day 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Monotherapy: Number of Participants With Treatment-emergent Genotypic Resistance
Day 10
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At Baseline (Day 1) and Day 10Population: Analysis was performed on FAS.
Plasma samples were collected to assess treatment emergent Phenotypic Resistance.
Outcome measures
| Measure |
VH4524184 Dose 1
n=6 Participants
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
n=6 Participants
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
n=7 Participants
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|
|
Monotherapy: Number of Participants With Treatment-emergent Phenotypic Resistance
Day 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Monotherapy: Number of Participants With Treatment-emergent Phenotypic Resistance
Day 10
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At Day 10 compared to Baseline (Day 1)Population: Analysis was performed on Safety Set. Only participants with data available at the specified timepoints were included in this analysis.
Blood samples were collected for assessment of T-cells subsets (CD4+ T-cells count) by flow cytometry at Day 10 compared to Baseline.
Outcome measures
| Measure |
VH4524184 Dose 1
n=6 Participants
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2
n=6 Participants
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3
n=7 Participants
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo
n=3 Participants
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|
|
Monotherapy: Change From Baseline in Cluster of Differentiation 4 (CD4+) T-cell Counts at Day 10
|
131.333 CD4+ million cells per Liter (10^6/L)
Standard Deviation 98.4473
|
68.667 CD4+ million cells per Liter (10^6/L)
Standard Deviation 122.1191
|
47.000 CD4+ million cells per Liter (10^6/L)
Standard Deviation 45.9093
|
63.667 CD4+ million cells per Liter (10^6/L)
Standard Deviation 216.1512
|
Adverse Events
VH4524184 Dose 1_Monotherapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
VH4524184 Dose 2_Monotherapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
VH4524184 Dose 3_Monotherapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo_Monotherapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
VH4524184 Dose 1_Follow-up
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
VH4524184 Dose 2_Follow-up
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
VH4524184 Dose 3_Follow-up
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo_Follow-up
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VH4524184 Dose 1_Monotherapy
n=6 participants at risk
Participants received VH4524184 Dose 1 (low dose) on Day 1, Day 4, and Day 7.
|
VH4524184 Dose 2_Monotherapy
n=6 participants at risk
Participants received VH4524184 Dose 2 (medium dose) on Day 1, Day 4, and Day 7.
|
VH4524184 Dose 3_Monotherapy
n=7 participants at risk
Participants received VH4524184 Dose 3 (high) on Day 1, Day 4, and Day 7.
|
Placebo_Monotherapy
n=3 participants at risk
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7.
|
VH4524184 Dose 1_Follow-up
n=6 participants at risk
Participants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 2_Follow-up
n=6 participants at risk
Participants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
VH4524184 Dose 3_Follow-up
n=7 participants at risk
Participants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
Placebo_Follow-up
n=3 participants at risk
Participants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
14.3%
1/7 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
33.3%
1/3 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
33.3%
1/3 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
14.3%
1/7 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
14.3%
1/7 • Number of events 2 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
33.3%
1/3 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
14.3%
1/7 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
14.3%
1/7 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
14.3%
1/7 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
14.3%
1/7 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
14.3%
1/7 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
33.3%
1/3 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Investigations
Amylase increased
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Investigations
Blood pressure increased
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
33.3%
1/3 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
14.3%
1/7 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
14.3%
1/7 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
14.3%
1/7 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
66.7%
2/3 • Number of events 2 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
14.3%
1/7 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
33.3%
1/3 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
14.3%
1/7 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
14.3%
1/7 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/6 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
16.7%
1/6 • Number of events 1 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/7 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
0.00%
0/3 • Serious AEs (SAEs) and Non-serious AEs were assessed from Day 1 until the final visit in the Follow-up Period (at Day 38)
Adverse events are reported individually for the Monotherapy and Follow-Up period from the Safety Set. Participants are counted in each period based on the occurrence and frequency of events.
|
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