Trial Outcomes & Findings for Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults (NCT NCT06039579)
NCT ID: NCT06039579
Last Updated: 2025-09-30
Results Overview
Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum change from baseline was calculated by subtracting the baseline value from the post-dose visit value when the plasma HIV-1 RNA reached its minimum level up to Day 11 (inclusive). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. The results were expressed as log10 copies per milliliter (log10 c/mL).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
From Baseline (Day 1) and up to Day 11
Results posted on
2025-09-30
Participant Flow
All participants that were enrolled started the study.
Participant milestones
| Measure |
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy (Day 1-Day 11)
STARTED
|
6
|
6
|
6
|
3
|
7
|
6
|
7
|
3
|
|
Monotherapy (Day 1-Day 11)
COMPLETED
|
6
|
6
|
6
|
3
|
7
|
6
|
7
|
3
|
|
Monotherapy (Day 1-Day 11)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Follow-Up (Day 11-Day 39)
STARTED
|
6
|
6
|
6
|
3
|
7
|
6
|
7
|
3
|
|
Follow-Up (Day 11-Day 39)
COMPLETED
|
6
|
6
|
6
|
3
|
7
|
6
|
7
|
2
|
|
Follow-Up (Day 11-Day 39)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Follow-Up (Day 11-Day 39)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults
Baseline characteristics by cohort
| Measure |
Part 1a: VH4004280 Dose Level 1
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=6 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
n=3 Participants
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
n=7 Participants
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
n=6 Participants
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
n=7 Participants
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
n=3 Participants
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.3 YEARS
STANDARD_DEVIATION 12.82 • n=5 Participants
|
42.8 YEARS
STANDARD_DEVIATION 10.3 • n=7 Participants
|
31.5 YEARS
STANDARD_DEVIATION 9.75 • n=5 Participants
|
28.7 YEARS
STANDARD_DEVIATION 9.29 • n=4 Participants
|
31.6 YEARS
STANDARD_DEVIATION 9.29 • n=21 Participants
|
49.3 YEARS
STANDARD_DEVIATION 7.45 • n=8 Participants
|
28.6 YEARS
STANDARD_DEVIATION 9.93 • n=8 Participants
|
26 YEARS
STANDARD_DEVIATION 2.65 • n=24 Participants
|
34.8 YEARS
STANDARD_DEVIATION 11.6 • n=42 Participants
|
|
Sex/Gender, Customized
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
37 Participants
n=42 Participants
|
|
Sex/Gender, Customized
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
31 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) and up to Day 11Population: Analysis was performed on Full Analysis Set (FAS) population, which included all randomized participants who received at least one full dose of study treatment. Only participants that received VH4004280 intervention or matching placebo for VH4004280 and had data available at the specified timepoints were included in this analysis.
Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum change from baseline was calculated by subtracting the baseline value from the post-dose visit value when the plasma HIV-1 RNA reached its minimum level up to Day 11 (inclusive). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. The results were expressed as log10 copies per milliliter (log10 c/mL).
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=6 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
n=3 Participants
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10
Baseline (Day 1)
|
5.004 log10 c/mL
Standard Deviation 0.4592
|
4.923 log10 c/mL
Standard Deviation 0.5428
|
4.866 log10 c/mL
Standard Deviation 0.7696
|
4.636 log10 c/mL
Standard Deviation 0.6641
|
—
|
—
|
—
|
—
|
|
Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10
Maximum change compared to Baseline (Day 1)
|
-1.056 log10 c/mL
Standard Deviation 0.4567
|
-1.391 log10 c/mL
Standard Deviation 0.6986
|
-1.983 log10 c/mL
Standard Deviation 0.2171
|
-0.070 log10 c/mL
Standard Deviation 0.0574
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) and up to Day 11Population: Analysis was performed on FAS population. Only participants that received VH4011499 intervention or matching placebo for VH4011499 and had data available at the specified timepoints were included in this analysis.
Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum change from baseline was calculated by subtracting the baseline value from the post-dose visit value when the plasma HIV-1 RNA reached its minimum level up to Day 11 (inclusive). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=7 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=7 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
n=3 Participants
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy, VH4011499: Maximum Change From Baseline (Day 1) in Plasma HIV-1 RNA log10
Baseline (Day 1)
|
5.001 log10 c/mL
Standard Deviation 0.7304
|
4.339 log10 c/mL
Standard Deviation 0.6185
|
4.960 log10 c/mL
Standard Deviation 0.7288
|
4.714 log10 c/mL
Standard Deviation 0.7736
|
—
|
—
|
—
|
—
|
|
Monotherapy, VH4011499: Maximum Change From Baseline (Day 1) in Plasma HIV-1 RNA log10
Maximum change compared to Baseline (Day 1)
|
-1.834 log10 c/mL
Standard Deviation 0.5141
|
-1.797 log10 c/mL
Standard Deviation 0.4544
|
-2.165 log10 c/mL
Standard Deviation 0.4310
|
-0.176 log10 c/mL
Standard Deviation 0.1969
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) and up to Day 11Population: Analysis was performed on Safety Population, which included all randomized participants who received at least 1 dose of study treatment and had safety data available.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any = occurrence of the event regardless of intensity grade or relation to the study intervention.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=6 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
n=3 Participants
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
n=7 Participants
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
n=6 Participants
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
n=7 Participants
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
n=3 Participants
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy: Number of Participants With Any Adverse Events (AEs)
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 11 and up to Day 39Population: Analysis was performed on Safety Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any = occurrence of the event regardless of intensity grade or relation to the study intervention.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=6 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
n=3 Participants
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
n=7 Participants
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
n=6 Participants
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
n=7 Participants
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
n=3 Participants
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Follow-up: Number of Participants With Any AEs
|
1 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) and up to Day 11Population: Analysis was performed on Safety Population.
Severity was rated according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=6 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
n=3 Participants
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
n=7 Participants
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
n=6 Participants
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
n=7 Participants
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
n=3 Participants
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy: Number of Participants With AEs by Severity
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy: Number of Participants With AEs by Severity
Grade 1
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Monotherapy: Number of Participants With AEs by Severity
Grade 2
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy: Number of Participants With AEs by Severity
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Monotherapy: Number of Participants With AEs by Severity
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 11 and up to Day 39Population: Analysis was performed on Safety Population.
Severity was rated according to the DAIDS grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=6 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
n=3 Participants
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
n=7 Participants
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
n=6 Participants
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
n=7 Participants
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
n=3 Participants
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Follow-up: Number of Participants With AEs by Severity
Grade 1
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Follow-up: Number of Participants With AEs by Severity
Grade 2
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Follow-up: Number of Participants With AEs by Severity
Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Follow-up: Number of Participants With AEs by Severity
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Follow-up: Number of Participants With AEs by Severity
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) and up to Day 11Population: Analysis was performed on Safety Population, which included all participants that received at least one study intervention. Discontinuation of treatment was not possible for participants that received VH4004280 or matching placebo for VH4004280, since these participants received only one dose intervention at Day 1 (all planned interventions as per protocol schedule).
'Discontinuation' of study intervention refers to any participant who has not received all planned doses of study intervention.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
n=7 Participants
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
n=6 Participants
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
n=7 Participants
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
n=3 Participants
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
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) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39Population: Analysis was performed on Safety Population. Only participants that received VH4004280 intervention or matching placebo for VH4004280 and had data available at the specified timepoints were included in the analysis.
Change from Baseline values for liver panel laboratory parameters total bilirubin and direct bilirubin were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.Standard deviation (SD) = 0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=6 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
n=3 Participants
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Baseline (Day 1)
|
6.641 Micromole per liter (µmol/L)
Standard Deviation 1.5157
|
8.408 Micromole per liter (µmol/L)
Standard Deviation 5.5383
|
6.926 Micromole per liter (µmol/L)
Standard Deviation 4.6300
|
6.783 Micromole per liter (µmol/L)
Standard Deviation 1.2370
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 2
|
-0.143 Micromole per liter (µmol/L)
Standard Deviation 1.7719
|
-0.513 Micromole per liter (µmol/L)
Standard Deviation 2.9697
|
0.239 Micromole per liter (µmol/L)
Standard Deviation 4.4814
|
1.995 Micromole per liter (µmol/L)
Standard Deviation 3.5100
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 4
|
0.547 Micromole per liter (µmol/L)
Standard Deviation 1.0073
|
-2.081 Micromole per liter (µmol/L)
Standard Deviation 3.5614
|
1.984 Micromole per liter (µmol/L)
Standard Deviation 3.1078
|
-1.767 Micromole per liter (µmol/L)
Standard Deviation 1.5516
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 6
|
-0.171 Micromole per liter (µmol/L)
Standard Deviation 3.5771
|
0.485 Micromole per liter (µmol/L)
Standard Deviation 3.6055
|
2.366 Micromole per liter (µmol/L)
Standard Deviation 5.2755
|
2.565 Micromole per liter (µmol/L)
Standard Deviation 2.8460
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 7
|
1.539 Micromole per liter (µmol/L)
Standard Deviation 1.4307
|
0.941 Micromole per liter (µmol/L)
Standard Deviation 3.3295
|
0.599 Micromole per liter (µmol/L)
Standard Deviation 2.4774
|
1.767 Micromole per liter (µmol/L)
Standard Deviation 3.2189
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 9
|
1.060 Micromole per liter (µmol/L)
Standard Deviation 2.5230
|
0.656 Micromole per liter (µmol/L)
Standard Deviation 4.2584
|
1.055 Micromole per liter (µmol/L)
Standard Deviation 1.7752
|
0.969 Micromole per liter (µmol/L)
Standard Deviation 3.7672
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 11
|
1.154 Micromole per liter (µmol/L)
Standard Deviation 1.5758
|
1.539 Micromole per liter (µmol/L)
Standard Deviation 1.8670
|
0.085 Micromole per liter (µmol/L)
Standard Deviation 1.2649
|
-0.171 Micromole per liter (µmol/L)
Standard Deviation 2.7360
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 18
|
0.684 Micromole per liter (µmol/L)
Standard Deviation 2.6513
|
0.399 Micromole per liter (µmol/L)
Standard Deviation 2.4005
|
-1.340 Micromole per liter (µmol/L)
Standard Deviation 3.2199
|
-0.342 Micromole per liter (µmol/L)
Standard Deviation 1.8016
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 25
|
0.570 Micromole per liter (µmol/L)
Standard Deviation 1.1731
|
0.513 Micromole per liter (µmol/L)
Standard Deviation 3.0049
|
-2.195 Micromole per liter (µmol/L)
Standard Deviation 3.5417
|
-0.741 Micromole per liter (µmol/L)
Standard Deviation 2.2771
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 32
|
0.770 Micromole per liter (µmol/L)
Standard Deviation 2.1596
|
-0.542 Micromole per liter (µmol/L)
Standard Deviation 2.5557
|
-1.881 Micromole per liter (µmol/L)
Standard Deviation 3.4709
|
1.026 Micromole per liter (µmol/L)
Standard Deviation 3.6194
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 39
|
0.923 Micromole per liter (µmol/L)
Standard Deviation 1.3712
|
-1.197 Micromole per liter (µmol/L)
Standard Deviation 3.2910
|
-0.513 Micromole per liter (µmol/L)
Standard Deviation 3.2332
|
0.456 Micromole per liter (µmol/L)
Standard Deviation 2.8682
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Baseline (Day 1)
|
3.410 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
3.410 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
3.410 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
3.410 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 2
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.002 Micromole per liter (µmol/L)
Standard Deviation 0.0041
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 4
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.002 Micromole per liter (µmol/L)
Standard Deviation 0.0041
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 6
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.030 Micromole per liter (µmol/L)
Standard Deviation 0.0739
|
0.030 Micromole per liter (µmol/L)
Standard Deviation 0.0739
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 7
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.059 Micromole per liter (µmol/L)
Standard Deviation 0.1437
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 9
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 11
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.002 Micromole per liter (µmol/L)
Standard Deviation 0.0041
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 18
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.174 Micromole per liter (µmol/L)
Standard Deviation 0.4221
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 25
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.030 Micromole per liter (µmol/L)
Standard Deviation 0.0739
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 32
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 39
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
0.000 Micromole per liter (µmol/L)
Standard Deviation 0.0000
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39Population: Analysis was performed on Safety Population. Only participants that received VH4011499 intervention or matching placebo for VH4011499 and had data available at the specified timepoints were included in the analysis.
Change from Baseline values for liver panel laboratory parameters total bilirubin and direct bilirubin were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. SD = 0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=7 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=7 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
n=3 Participants
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 39
|
0.239 µmol/L
Standard Deviation 1.3927
|
-0.599 µmol/L
Standard Deviation 1.7861
|
0.489 µmol/L
Standard Deviation 2.2630
|
-0.855 µmol/L
Standard Deviation 0.2418
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 32
|
-0.057 µmol/L
Standard Deviation 0.2395
|
0.230 µmol/L
Standard Deviation 0.5626
|
-0.295 µmol/L
Standard Deviation 0.7794
|
0.114 µmol/L
Standard Deviation 0.1975
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 32
|
0.599 µmol/L
Standard Deviation 2.9175
|
0.513 µmol/L
Standard Deviation 3.3017
|
1.075 µmol/L
Standard Deviation 2.2398
|
0.627 µmol/L
Standard Deviation 4.9452
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Baseline (Day 1)
|
5.643 µmol/L
Standard Deviation 2.4898
|
7.524 µmol/L
Standard Deviation 2.6579
|
4.544 µmol/L
Standard Deviation 1.7576
|
7.011 µmol/L
Standard Deviation 2.2361
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 2
|
-0.928 µmol/L
Standard Deviation 0.9095
|
0.114 µmol/L
Standard Deviation 0.9951
|
0.611 µmol/L
Standard Deviation 1.6008
|
-0.855 µmol/L
Standard Deviation 0.6165
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 4
|
0.122 µmol/L
Standard Deviation 2.3975
|
-0.656 µmol/L
Standard Deviation 0.9937
|
1.808 µmol/L
Standard Deviation 2.3463
|
-0.570 µmol/L
Standard Deviation 1.5516
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 6
|
-0.171 µmol/L
Standard Deviation 2.4741
|
-1.967 µmol/L
Standard Deviation 2.6286
|
0.440 µmol/L
Standard Deviation 1.4370
|
-2.109 µmol/L
Standard Deviation 3.6529
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 7
|
0.366 µmol/L
Standard Deviation 3.4476
|
-0.200 µmol/L
Standard Deviation 2.7111
|
0.367 µmol/L
Standard Deviation 1.4081
|
-1.995 µmol/L
Standard Deviation 3.6569
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 9
|
-0.440 µmol/L
Standard Deviation 2.3774
|
-0.228 µmol/L
Standard Deviation 1.4004
|
1.099 µmol/L
Standard Deviation 1.4804
|
0.912 µmol/L
Standard Deviation 3.5924
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 11
|
1.050 µmol/L
Standard Deviation 2.0766
|
-0.884 µmol/L
Standard Deviation 1.3439
|
0.709 µmol/L
Standard Deviation 2.3036
|
-2.964 µmol/L
Standard Deviation 1.2370
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 18
|
-0.366 µmol/L
Standard Deviation 2.7081
|
-0.057 µmol/L
Standard Deviation 1.7989
|
0.586 µmol/L
Standard Deviation 1.7739
|
1.083 µmol/L
Standard Deviation 3.4427
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Day 25
|
0.366 µmol/L
Standard Deviation 3.9024
|
0.798 µmol/L
Standard Deviation 3.2258
|
1.295 µmol/L
Standard Deviation 2.1332
|
-1.026 µmol/L
Standard Deviation 3.0059
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Baseline (Day 1)
|
3.485 µmol/L
Standard Deviation 0.1977
|
3.410 µmol/L
Standard Deviation 0.0000
|
3.705 µmol/L
Standard Deviation 0.7794
|
3.527 µmol/L
Standard Deviation 0.2032
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 2
|
-0.075 µmol/L
Standard Deviation 0.1977
|
0.000 µmol/L
Standard Deviation 0.0000
|
-0.295 µmol/L
Standard Deviation 0.7794
|
-0.117 µmol/L
Standard Deviation 0.2032
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 4
|
-0.057 µmol/L
Standard Deviation 0.1396
|
0.000 µmol/L
Standard Deviation 0.0000
|
-0.295 µmol/L
Standard Deviation 0.7794
|
-0.114 µmol/L
Standard Deviation 0.1975
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 6
|
-0.073 µmol/L
Standard Deviation 0.1939
|
0.000 µmol/L
Standard Deviation 0.0000
|
-0.295 µmol/L
Standard Deviation 0.7794
|
-0.117 µmol/L
Standard Deviation 0.2032
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 7
|
-0.049 µmol/L
Standard Deviation 0.2197
|
0.000 µmol/L
Standard Deviation 0.0000
|
-0.295 µmol/L
Standard Deviation 0.7794
|
1.140 µmol/L
Standard Deviation 2.2862
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 9
|
-0.075 µmol/L
Standard Deviation 0.1977
|
0.002 µmol/L
Standard Deviation 0.0041
|
-0.295 µmol/L
Standard Deviation 0.7794
|
-0.057 µmol/L
Standard Deviation 0.0987
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 11
|
-0.073 µmol/L
Standard Deviation 0.1983
|
0.000 µmol/L
Standard Deviation 0.0000
|
-0.295 µmol/L
Standard Deviation 0.7794
|
-0.117 µmol/L
Standard Deviation 0.2032
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 18
|
-0.075 µmol/L
Standard Deviation 0.1977
|
0.000 µmol/L
Standard Deviation 0.0000
|
-0.295 µmol/L
Standard Deviation 0.7794
|
0.057 µmol/L
Standard Deviation 0.0987
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 25
|
0.027 µmol/L
Standard Deviation 0.1571
|
0.030 µmol/L
Standard Deviation 0.0739
|
-0.295 µmol/L
Standard Deviation 0.7794
|
-0.114 µmol/L
Standard Deviation 0.1975
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Day 39
|
-0.087 µmol/L
Standard Deviation 0.2135
|
0.000 µmol/L
Standard Deviation 0.0000
|
-0.295 µmol/L
Standard Deviation 0.7794
|
-0.171 µmol/L
Standard Deviation 0.2418
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39Population: Analysis was performed on Safety Population. Only participants that received VH4004280 intervention or matching placebo for VH4004280 and had data available at the specified timepoints were included in the analysis.
Change from Baseline values for liver panel laboratory parameters ALT, ALP and AST were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=6 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
n=3 Participants
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Baseline (Day 1)
|
31.3 International units per liter (IU/L)
Standard Deviation 13.59
|
21.7 International units per liter (IU/L)
Standard Deviation 7.17
|
33.2 International units per liter (IU/L)
Standard Deviation 13.23
|
52.7 International units per liter (IU/L)
Standard Deviation 55.82
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 4
|
-3.8 International units per liter (IU/L)
Standard Deviation 4.09
|
-2.3 International units per liter (IU/L)
Standard Deviation 2.80
|
0.2 International units per liter (IU/L)
Standard Deviation 6.10
|
4.7 International units per liter (IU/L)
Standard Deviation 9.29
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 18
|
-4.7 International units per liter (IU/L)
Standard Deviation 6.44
|
0.0 International units per liter (IU/L)
Standard Deviation 6.51
|
4.2 International units per liter (IU/L)
Standard Deviation 16.46
|
-1.0 International units per liter (IU/L)
Standard Deviation 3.61
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 11
|
-6.3 International units per liter (IU/L)
Standard Deviation 6.34
|
-2.0 International units per liter (IU/L)
Standard Deviation 4.60
|
7.0 International units per liter (IU/L)
Standard Deviation 22.52
|
-6.7 International units per liter (IU/L)
Standard Deviation 5.03
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 2
|
-2.8 International units per liter (IU/L)
Standard Deviation 3.25
|
-1.8 International units per liter (IU/L)
Standard Deviation 3.25
|
-0.2 International units per liter (IU/L)
Standard Deviation 3.56
|
15.0 International units per liter (IU/L)
Standard Deviation 29.46
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 6
|
-7.8 International units per liter (IU/L)
Standard Deviation 9.33
|
-1.3 International units per liter (IU/L)
Standard Deviation 1.51
|
2.2 International units per liter (IU/L)
Standard Deviation 8.13
|
-13.7 International units per liter (IU/L)
Standard Deviation 27.14
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 7
|
-6.7 International units per liter (IU/L)
Standard Deviation 9.77
|
-2.0 International units per liter (IU/L)
Standard Deviation 3.03
|
0.2 International units per liter (IU/L)
Standard Deviation 7.39
|
-19.3 International units per liter (IU/L)
Standard Deviation 32.62
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 9
|
-6.0 International units per liter (IU/L)
Standard Deviation 13.69
|
-0.7 International units per liter (IU/L)
Standard Deviation 9.63
|
1.5 International units per liter (IU/L)
Standard Deviation 12.10
|
-20.7 International units per liter (IU/L)
Standard Deviation 35.81
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 11
|
-8.8 International units per liter (IU/L)
Standard Deviation 15.78
|
-2.0 International units per liter (IU/L)
Standard Deviation 6.26
|
-0.2 International units per liter (IU/L)
Standard Deviation 11.99
|
-16.7 International units per liter (IU/L)
Standard Deviation 29.74
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 18
|
-6.2 International units per liter (IU/L)
Standard Deviation 14.16
|
-0.2 International units per liter (IU/L)
Standard Deviation 4.45
|
8.3 International units per liter (IU/L)
Standard Deviation 27.46
|
-15.7 International units per liter (IU/L)
Standard Deviation 31.18
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 25
|
-6.8 International units per liter (IU/L)
Standard Deviation 15.48
|
-0.5 International units per liter (IU/L)
Standard Deviation 2.17
|
1.7 International units per liter (IU/L)
Standard Deviation 14.54
|
-27.7 International units per liter (IU/L)
Standard Deviation 44.50
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 32
|
-9.2 International units per liter (IU/L)
Standard Deviation 11.97
|
-0.3 International units per liter (IU/L)
Standard Deviation 4.23
|
0.3 International units per liter (IU/L)
Standard Deviation 12.32
|
-33.0 International units per liter (IU/L)
Standard Deviation 56.40
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 39
|
-9.8 International units per liter (IU/L)
Standard Deviation 11.12
|
-0.3 International units per liter (IU/L)
Standard Deviation 3.50
|
-4.0 International units per liter (IU/L)
Standard Deviation 8.72
|
-33.0 International units per liter (IU/L)
Standard Deviation 54.62
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Baseline (Day 1)
|
79.2 International units per liter (IU/L)
Standard Deviation 14.40
|
74.3 International units per liter (IU/L)
Standard Deviation 15.74
|
71.7 International units per liter (IU/L)
Standard Deviation 19.39
|
64.3 International units per liter (IU/L)
Standard Deviation 16.80
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 2
|
-1.3 International units per liter (IU/L)
Standard Deviation 7.87
|
-2.7 International units per liter (IU/L)
Standard Deviation 10.03
|
-1.0 International units per liter (IU/L)
Standard Deviation 3.16
|
-3.0 International units per liter (IU/L)
Standard Deviation 3.00
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 4
|
0.6 International units per liter (IU/L)
Standard Deviation 5.41
|
-5.0 International units per liter (IU/L)
Standard Deviation 5.90
|
-2.6 International units per liter (IU/L)
Standard Deviation 2.51
|
-1.0 International units per liter (IU/L)
Standard Deviation 3.61
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 6
|
1.5 International units per liter (IU/L)
Standard Deviation 6.75
|
-4.5 International units per liter (IU/L)
Standard Deviation 6.35
|
0.7 International units per liter (IU/L)
Standard Deviation 5.35
|
-2.3 International units per liter (IU/L)
Standard Deviation 1.15
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 7
|
-0.2 International units per liter (IU/L)
Standard Deviation 6.24
|
-6.2 International units per liter (IU/L)
Standard Deviation 2.71
|
-2.0 International units per liter (IU/L)
Standard Deviation 4.52
|
-6.0 International units per liter (IU/L)
Standard Deviation 4.36
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 9
|
-0.2 International units per liter (IU/L)
Standard Deviation 2.95
|
-4.3 International units per liter (IU/L)
Standard Deviation 6.09
|
-3.5 International units per liter (IU/L)
Standard Deviation 5.82
|
-6.3 International units per liter (IU/L)
Standard Deviation 6.66
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 11
|
-5.0 International units per liter (IU/L)
Standard Deviation 2.94
|
-4.8 International units per liter (IU/L)
Standard Deviation 6.05
|
-5.8 International units per liter (IU/L)
Standard Deviation 8.28
|
-6.3 International units per liter (IU/L)
Standard Deviation 4.93
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 18
|
-0.5 International units per liter (IU/L)
Standard Deviation 3.33
|
-7.0 International units per liter (IU/L)
Standard Deviation 5.40
|
-2.7 International units per liter (IU/L)
Standard Deviation 8.50
|
-4.3 International units per liter (IU/L)
Standard Deviation 4.51
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 25
|
1.0 International units per liter (IU/L)
Standard Deviation 11.17
|
-5.0 International units per liter (IU/L)
Standard Deviation 4.69
|
-1.3 International units per liter (IU/L)
Standard Deviation 8.71
|
-5.0 International units per liter (IU/L)
Standard Deviation 4.36
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 32
|
3.2 International units per liter (IU/L)
Standard Deviation 21.10
|
-2.7 International units per liter (IU/L)
Standard Deviation 10.84
|
-3.8 International units per liter (IU/L)
Standard Deviation 8.47
|
-5.3 International units per liter (IU/L)
Standard Deviation 5.77
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 39
|
0.6 International units per liter (IU/L)
Standard Deviation 4.16
|
-5.5 International units per liter (IU/L)
Standard Deviation 7.82
|
-2.2 International units per liter (IU/L)
Standard Deviation 4.15
|
0.3 International units per liter (IU/L)
Standard Deviation 3.51
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Baseline (Day 1)
|
26.0 International units per liter (IU/L)
Standard Deviation 4.94
|
21.5 International units per liter (IU/L)
Standard Deviation 4.23
|
27.2 International units per liter (IU/L)
Standard Deviation 3.49
|
29.7 International units per liter (IU/L)
Standard Deviation 11.72
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 2
|
-3.5 International units per liter (IU/L)
Standard Deviation 3.62
|
-0.8 International units per liter (IU/L)
Standard Deviation 2.71
|
-0.2 International units per liter (IU/L)
Standard Deviation 4.09
|
11.0 International units per liter (IU/L)
Standard Deviation 26.00
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 4
|
-3.6 International units per liter (IU/L)
Standard Deviation 3.21
|
-0.8 International units per liter (IU/L)
Standard Deviation 0.75
|
0.8 International units per liter (IU/L)
Standard Deviation 3.96
|
-1.0 International units per liter (IU/L)
Standard Deviation 5.29
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 6
|
-4.8 International units per liter (IU/L)
Standard Deviation 4.36
|
-2.0 International units per liter (IU/L)
Standard Deviation 1.26
|
0.7 International units per liter (IU/L)
Standard Deviation 5.54
|
-8.3 International units per liter (IU/L)
Standard Deviation 11.06
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 7
|
-4.8 International units per liter (IU/L)
Standard Deviation 4.54
|
-2.2 International units per liter (IU/L)
Standard Deviation 2.23
|
-1.2 International units per liter (IU/L)
Standard Deviation 4.88
|
-9.0 International units per liter (IU/L)
Standard Deviation 9.85
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 9
|
-5.0 International units per liter (IU/L)
Standard Deviation 6.00
|
-1.5 International units per liter (IU/L)
Standard Deviation 4.72
|
2.5 International units per liter (IU/L)
Standard Deviation 8.53
|
-9.3 International units per liter (IU/L)
Standard Deviation 10.69
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 25
|
-4.7 International units per liter (IU/L)
Standard Deviation 9.35
|
-0.3 International units per liter (IU/L)
Standard Deviation 3.56
|
1.5 International units per liter (IU/L)
Standard Deviation 7.40
|
-11.3 International units per liter (IU/L)
Standard Deviation 11.93
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 32
|
-5.0 International units per liter (IU/L)
Standard Deviation 6.81
|
-1.3 International units per liter (IU/L)
Standard Deviation 3.08
|
0.7 International units per liter (IU/L)
Standard Deviation 4.72
|
-9.0 International units per liter (IU/L)
Standard Deviation 14.80
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 39
|
-6.6 International units per liter (IU/L)
Standard Deviation 5.50
|
0.5 International units per liter (IU/L)
Standard Deviation 3.39
|
-2.4 International units per liter (IU/L)
Standard Deviation 3.13
|
-10.3 International units per liter (IU/L)
Standard Deviation 13.65
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39Population: Analysis was performed on Safety Population. Only participants that received VH4011499 intervention or matching placebo for VH4011499 and had data available at the specified timepoints were included in the analysis.
Change from Baseline values for liver panel laboratory parameters ALT, ALP and AST were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=7 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=7 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
n=3 Participants
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Day 25
|
1.6 IU/L
Standard Deviation 5.86
|
-0.5 IU/L
Standard Deviation 4.32
|
-2.6 IU/L
Standard Deviation 4.86
|
-3.7 IU/L
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Baseline (Day 1)
|
14.9 IU/L
Standard Deviation 4.41
|
19.5 IU/L
Standard Deviation 9.03
|
31.7 IU/L
Standard Deviation 22.60
|
18.3 IU/L
Standard Deviation 2.08
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Day 2
|
1.7 IU/L
Standard Deviation 1.25
|
-1.2 IU/L
Standard Deviation 1.83
|
-1.6 IU/L
Standard Deviation 3.78
|
0.7 IU/L
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Day 4
|
2.4 IU/L
Standard Deviation 1.72
|
-1.0 IU/L
Standard Deviation 3.85
|
-3.6 IU/L
Standard Deviation 13.20
|
-1.0 IU/L
Standard Deviation 1.00
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Day 6
|
-0.1 IU/L
Standard Deviation 1.57
|
-1.2 IU/L
Standard Deviation 3.76
|
-5.1 IU/L
Standard Deviation 14.58
|
0.7 IU/L
Standard Deviation 1.15
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Day 7
|
0.1 IU/L
Standard Deviation 2.54
|
-1.5 IU/L
Standard Deviation 4.76
|
-7.3 IU/L
Standard Deviation 14.91
|
-0.7 IU/L
Standard Deviation 1.57
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Day 9
|
-0.3 IU/L
Standard Deviation 1.98
|
-0.2 IU/L
Standard Deviation 4.07
|
-8.0 IU/L
Standard Deviation 16.42
|
-0.3 IU/L
Standard Deviation 2.08
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Day 11
|
0.0 IU/L
Standard Deviation 3.32
|
-1.2 IU/L
Standard Deviation 3.76
|
-7.3 IU/L
Standard Deviation 11.71
|
0.0 IU/L
Standard Deviation 3.61
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Day 18
|
0.3 IU/L
Standard Deviation 5.19
|
-1.3 IU/L
Standard Deviation 4.46
|
-4.0 IU/L
Standard Deviation 17.91
|
1.7 IU/L
Standard Deviation 2.52
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Day 25
|
2.0 IU/L
Standard Deviation 9.02
|
0.0 IU/L
Standard Deviation 5.66
|
-7.4 IU/L
Standard Deviation 17.52
|
0.7 IU/L
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Day 32
|
4.0 IU/L
Standard Deviation 13.62
|
-2.7 IU/L
Standard Deviation 3.88
|
-10.3 IU/L
Standard Deviation 16.63
|
3.0 IU/L
Standard Deviation 4.36
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Day 39
|
0.0 IU/L
Standard Deviation 7.84
|
0.8 IU/L
Standard Deviation 4.49
|
-3.6 IU/L
Standard Deviation 15.87
|
28.0 IU/L
Standard Deviation 28.28
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Baseline (Day 1)
|
81.1 IU/L
Standard Deviation 14.55
|
68.2 IU/L
Standard Deviation 18.90
|
78.9 IU/L
Standard Deviation 20.69
|
89.3 IU/L
Standard Deviation 16.50
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Day 2
|
1.0 IU/L
Standard Deviation 5.60
|
-1.2 IU/L
Standard Deviation 2.48
|
0.6 IU/L
Standard Deviation 6.48
|
-0.3 IU/L
Standard Deviation 1.53
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Day 4
|
2.7 IU/L
Standard Deviation 6.97
|
-2.5 IU/L
Standard Deviation 3.33
|
-4.9 IU/L
Standard Deviation 13.38
|
-0.7 IU/L
Standard Deviation 7.51
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Day 6
|
-1.4 IU/L
Standard Deviation 7.44
|
-3.7 IU/L
Standard Deviation 5.75
|
-3.6 IU/L
Standard Deviation 4.69
|
6.3 IU/L
Standard Deviation 8.33
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Day 7
|
3.9 IU/L
Standard Deviation 5.70
|
-4.5 IU/L
Standard Deviation 3.39
|
-0.4 IU/L
Standard Deviation 8.66
|
4.0 IU/L
Standard Deviation 8.72
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Day 9
|
0.0 IU/L
Standard Deviation 9.80
|
-1.5 IU/L
Standard Deviation 1.76
|
-1.4 IU/L
Standard Deviation 9.76
|
-0.7 IU/L
Standard Deviation 8.08
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Day 11
|
2.9 IU/L
Standard Deviation 13.32
|
-1.3 IU/L
Standard Deviation 3.20
|
-1.6 IU/L
Standard Deviation 7.96
|
10.3 IU/L
Standard Deviation 14.47
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Day 18
|
-0.1 IU/L
Standard Deviation 6.01
|
-3.2 IU/L
Standard Deviation 3.92
|
-2.9 IU/L
Standard Deviation 6.49
|
2.3 IU/L
Standard Deviation 9.71
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Day 25
|
2.4 IU/L
Standard Deviation 7.59
|
-5.0 IU/L
Standard Deviation 5.76
|
-6.4 IU/L
Standard Deviation 10.97
|
-1.7 IU/L
Standard Deviation 17.21
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Day 32
|
0.3 IU/L
Standard Deviation 9.05
|
-4.5 IU/L
Standard Deviation 3.45
|
-3.7 IU/L
Standard Deviation 9.81
|
-2.3 IU/L
Standard Deviation 8.02
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Day 39
|
-2.4 IU/L
Standard Deviation 13.72
|
-2.2 IU/L
Standard Deviation 8.04
|
-1.7 IU/L
Standard Deviation 14.69
|
1.0 IU/L
Standard Deviation 11.31
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Baseline (Day 1)
|
18.6 IU/L
Standard Deviation 3.87
|
24.0 IU/L
Standard Deviation 8.07
|
24.7 IU/L
Standard Deviation 7.20
|
27.7 IU/L
Standard Deviation 5.51
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Day 2
|
-0.7 IU/L
Standard Deviation 2.43
|
-2.3 IU/L
Standard Deviation 2.80
|
-2.0 IU/L
Standard Deviation 1.29
|
-2.3 IU/L
Standard Deviation 3.21
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Day 4
|
1.1 IU/L
Standard Deviation 4.45
|
-2.7 IU/L
Standard Deviation 3.27
|
1.7 IU/L
Standard Deviation 7.50
|
-2.3 IU/L
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Day 6
|
-0.9 IU/L
Standard Deviation 4.02
|
-1.5 IU/L
Standard Deviation 5.68
|
-2.4 IU/L
Standard Deviation 3.55
|
-1.7 IU/L
Standard Deviation 3.21
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Day 7
|
-1.7 IU/L
Standard Deviation 4.07
|
-3.5 IU/L
Standard Deviation 5.75
|
-3.7 IU/L
Standard Deviation 5.12
|
-5.7 IU/L
Standard Deviation 2.31
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Day 9
|
0.0 IU/L
Standard Deviation 3.00
|
-2.7 IU/L
Standard Deviation 4.41
|
-4.3 IU/L
Standard Deviation 5.02
|
-5.0 IU/L
Standard Deviation 6.24
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Day 11
|
-1.6 IU/L
Standard Deviation 3.74
|
-2.2 IU/L
Standard Deviation 4.79
|
-2.1 IU/L
Standard Deviation 3.29
|
-4.7 IU/L
Standard Deviation 7.51
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Day 18
|
-1.3 IU/L
Standard Deviation 5.82
|
-3.2 IU/L
Standard Deviation 5.31
|
2.4 IU/L
Standard Deviation 9.55
|
-0.3 IU/L
Standard Deviation 5.51
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Day 32
|
2.8 IU/L
Standard Deviation 9.97
|
-1.4 IU/L
Standard Deviation 3.13
|
-2.9 IU/L
Standard Deviation 6.69
|
-2.3 IU/L
Standard Deviation 4.93
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Day 39
|
0.0 IU/L
Standard Deviation 5.43
|
1.3 IU/L
Standard Deviation 2.58
|
1.7 IU/L
Standard Deviation 10.64
|
23.0 IU/L
Standard Deviation 5.66
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) and up to Day 39Population: Analysis was performed on Safety Population. Only participants that received VH4004280 intervention or matching placebo for VH4004280 and had data available at the specified timepoints were included in the analysis.
Laboratory abnormalities 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.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=6 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
n=3 Participants
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Increase to Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Increase to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) and up to Day 39Population: Analysis was performed on Safety Population. Only participants that received VH4011499 intervention or matching placebo for VH4011499 and had data available at the specified timepoints were included in the analysis.
Laboratory abnormalities 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.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=7 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=7 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
n=3 Participants
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Increase to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Total Bilirubin, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Increase to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Direct Bilirubin, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) and up to Day 39Population: Analysis was performed on Safety Population. Only participants that received VH4004280 intervention or matching placebo for VH4004280 and had data available at the specified timepoints were included in the analysis.
Laboratory abnormalities 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.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=6 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
n=3 Participants
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Increase to Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Increase to Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Increase to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Increase to Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) and up to Day 39Population: Analysis was performed on Safety Population. Only participants that received VH4011499 intervention or matching placebo for VH4011499 and had data available at the specified timepoints were included in the analysis.
Laboratory abnormalities 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.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=7 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=7 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
n=3 Participants
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Increase to Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALT, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Increase to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
ALP, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Increase to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
AST, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After dose administration at Day 1Population: Analysis was performed on Pharmacokinetic (PK) population, which included all participants in the Safety analysis population who had at least 1 non-missing PK assessment. Data was reported according to the actual study treatment. Only participants that received VH4004280 intervention and had data available at the specified timepoint were included in the analysis.
Cmax is defined as the maximum concentration of the drug in plasma.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=6 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy, VH4004280: Maximum Observed Plasma Drug Concentration (Cmax)
|
131.57 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 77.68
|
364.70 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 85.21
|
473.00 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 54.23
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After dose administration at Day 1 and Day 6Population: Analysis was performed on PK population. Only participants that received VH4011499 intervention and had data available at the specified timepoints were included in the analysis.
Cmax is defined as the maximum concentration of the drug in plasma.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=7 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=7 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy, VH4011499: Cmax
Day 1
|
27.63 ng/mL
Geometric Coefficient of Variation 94.53
|
31.88 ng/mL
Geometric Coefficient of Variation 26.58
|
133.59 ng/mL
Geometric Coefficient of Variation 42.34
|
—
|
—
|
—
|
—
|
—
|
|
Monotherapy, VH4011499: Cmax
Day 6
|
35.30 ng/mL
Geometric Coefficient of Variation 81.31
|
32.31 ng/mL
Geometric Coefficient of Variation 25.97
|
141.18 ng/mL
Geometric Coefficient of Variation 47.79
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After dose administration at Day 1Population: Analysis was performed on PK population. Only participants that received VH4004280 intervention and had data available at the specified timepoint were included in the analysis.
Tmax is a measure of the time required to reach the maximum concentration of the drug.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=6 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy, VH4004280: Time to Maximum Observed Plasma Drug Concentration (Tmax)
|
7.95 Hour (h)
Interval 6.0 to 9.7
|
9.00 Hour (h)
Interval 6.0 to 11.6
|
8.04 Hour (h)
Interval 6.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After dose administration at Day 1 and Day 6Population: Analysis was performed on PK population. Only participants that received VH4011499 intervention and had data available at the specified timepoints were included in the analysis.
Tmax is a measure of the time required to reach the maximum concentration of the drug.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=7 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=7 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy, VH4011499: Tmax
Day 1
|
9.95 h
Interval 6.0 to 12.0
|
9.88 h
Interval 8.1 to 10.1
|
8.00 h
Interval 4.1 to 12.0
|
—
|
—
|
—
|
—
|
—
|
|
Monotherapy, VH4011499: Tmax
Day 6
|
10.00 h
Interval 8.0 to 26.9
|
10.04 h
Interval 8.0 to 11.6
|
11.52 h
Interval 6.0 to 24.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 11Population: Analysis was performed on PK population. Only participants that received VH4004280 intervention and had data available at the specified timepoint were included in the analysis.
C11 is defined as the concentration of the drug in plasma at Day 11.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=3 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=6 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy, VH4004280: Plasma Concentration at Day 11 (C11)
|
18.07 ng/mL
Geometric Coefficient of Variation 132.07
|
48.53 ng/mL
Geometric Coefficient of Variation 130.33
|
50.42 ng/mL
Geometric Coefficient of Variation 41.52
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 11Population: Analysis was performed on PK population. Only participants that received VH4011499 intervention and had data available at the specified timepoint were included in the analysis.
C11 is defined as the concentration of the drug in plasma at Day 11.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=4 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=7 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy, VH4011499: C11
|
11.16 ng/mL
Geometric Coefficient of Variation 50.02
|
10.56 ng/mL
Geometric Coefficient of Variation 36.61
|
27.04 ng/mL
Geometric Coefficient of Variation 50.68
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Baseline (Day 1) and Day 11Population: Analysis was performed on FAS population. Only participants that received VH4004280 intervention and had data available at the specified timepoints were included in the analysis.
Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=6 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy, VH4004280: Change in Plasma HIV-1 RNA From Baseline
Baseline (Day 1)
|
5.004 log10 c/mL
Standard Deviation 0.4592
|
4.923 log10 c/mL
Standard Deviation 0.5428
|
4.866 log10 c/mL
Standard Deviation 0.7696
|
—
|
—
|
—
|
—
|
—
|
|
Monotherapy, VH4004280: Change in Plasma HIV-1 RNA From Baseline
Day 11
|
-0.941 log10 c/mL
Standard Deviation 0.6608
|
-1.322 log10 c/mL
Standard Deviation 0.7727
|
-1.939 log10 c/mL
Standard Deviation 0.1124
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Baseline (Day 1) and Day 11Population: Analysis was performed on FAS population. Only participants that received VH4011499 intervention and had data available at the specified timepoints were included in the analysis.
Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1a: VH4004280 Dose Level 1
n=7 Participants
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 Participants
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose
n=7 Participants
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy, VH4011499: Change in Plasma HIV-1 RNA From Baseline
Baseline (Day 1)
|
5.001 log10 c/mL
Standard Deviation 0.7304
|
4.339 log10 c/mL
Standard Deviation 0.6185
|
4.960 log10 c/mL
Standard Deviation 0.7288
|
—
|
—
|
—
|
—
|
—
|
|
Monotherapy, VH4011499: Change in Plasma HIV-1 RNA From Baseline
Day 11
|
-1.801 log10 c/mL
Standard Deviation 0.5165
|
-1.750 log10 c/mL
Standard Deviation 0.4962
|
-2.165 log10 c/mL
Standard Deviation 0.4310
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1a: VH4004280 Dose Level 1 (Monotherapy)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1a: VH4004280 Dose Level 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2a: VH4004280 Pre-specified Dose (Monotherapy)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Matching Placebo for VH4004280 (Monotherapy)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1b: VH4011499 Dose Level 1 (Monotherapy)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1b: VH4011499 Dose Level 2 (Monotherapy)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2b: VH4011499 Pre-specified Dose (Monotherapy)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Matching Placebo for VH4011499 (Monotherapy)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1a: VH4004280 Dose Level 1 (Follow-up)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1a: VH4004280 Dose Level 2 (Follow-up)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2a: VH4004280 Pre-specified Dose (Follow-up)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Matching Placebo for VH4004280 (Follow-up)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1b: VH4011499 Dose Level 1 (Follow-up)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1b: VH4011499 Dose Level 2 (Follow-up)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2b: VH4011499 Pre-specified Dose (Follow-up)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Matching Placebo for VH4011499 (Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1a: VH4004280 Dose Level 1 (Monotherapy)
n=6 participants at risk
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2
n=6 participants at risk
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose (Monotherapy)
n=6 participants at risk
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280 (Monotherapy)
n=3 participants at risk
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1 (Monotherapy)
n=7 participants at risk
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2 (Monotherapy)
n=6 participants at risk
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose (Monotherapy)
n=7 participants at risk
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499 (Monotherapy)
n=3 participants at risk
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1a: VH4004280 Dose Level 1 (Follow-up)
n=6 participants at risk
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
|
Part 1a: VH4004280 Dose Level 2 (Follow-up)
n=6 participants at risk
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2a: VH4004280 Pre-specified Dose (Follow-up)
n=6 participants at risk
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4004280 (Follow-up)
n=3 participants at risk
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 1 (Follow-up)
n=7 participants at risk
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
|
Part 1b: VH4011499 Dose Level 2 (Follow-up)
n=6 participants at risk
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Part 2b: VH4011499 Pre-specified Dose (Follow-up)
n=7 participants at risk
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
Matching Placebo for VH4011499 (Follow-up)
n=3 participants at risk
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
General disorders
Asthenia
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
General disorders
Feeling cold
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Infections and infestations
Dermatophytosis
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Infections and infestations
Periodontitis
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/6 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/7 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
0.00%
0/3 • All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee ViiV Healthcare agreements may vary with individual investigators, but will not prohibit any investigator from publishing. ViiV Healthcare 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