Trial Outcomes & Findings for A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PD) of GSK3888130B in Healthy Participants (NCT NCT05131971)
NCT ID: NCT05131971
Last Updated: 2025-03-26
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
Up to 160 days
Results posted on
2025-03-26
Participant Flow
A total 54 participants were enrolled in this study. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
Participant milestones
| Measure |
Placebo
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
3
|
3
|
6
|
6
|
6
|
9
|
6
|
|
Overall Study
COMPLETED
|
15
|
3
|
3
|
6
|
6
|
6
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PD) of GSK3888130B in Healthy Participants
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
n=9 Participants
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.3 YEARS
STANDARD_DEVIATION 8.93 • n=5 Participants
|
40.0 YEARS
STANDARD_DEVIATION 7.94 • n=7 Participants
|
48.3 YEARS
STANDARD_DEVIATION 3.06 • n=5 Participants
|
38.8 YEARS
STANDARD_DEVIATION 8.75 • n=4 Participants
|
41.2 YEARS
STANDARD_DEVIATION 9.52 • n=21 Participants
|
40.8 YEARS
STANDARD_DEVIATION 7.70 • n=8 Participants
|
38.7 YEARS
STANDARD_DEVIATION 9.86 • n=8 Participants
|
41.5 YEARS
STANDARD_DEVIATION 11.57 • n=24 Participants
|
40.6 YEARS
STANDARD_DEVIATION 8.78 • n=42 Participants
|
|
Sex: Female, Male
Female
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
54 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
All Other Races
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
54 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to 160 daysPopulation: Safety Population included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
n=9 Participants
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
8 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 85 daysPopulation: Safety Population included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan.
Blood samples were collected for analysis of following hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin (Hg), Lymphocytes, Mean corpuscular Hg, Mean corpuscular volume, Monocytes, Platelet count, Red blood cell count, Reticulocytes, Total Neutrophils, and White blood cells count (WBC). Number of participants with clinically significant changes in hematology were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
n=9 Participants
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Hematology Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to 85 daysPopulation: Safety Population included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan.
Blood samples were collected for the analysis of CD4+ T Cell Counts. The CD4+ T Cell Counts were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 0: Above 0.5\*10\^9 cells/Liter (L), Grade 1: \<0.5 to 0.2\*10\^9 cells/L, Grade 2: \<0.2 to 0.05\*10\^9 cells/L, Grade 3: Below 0.05\*10\^9 cells/L. Baseline was defined as the latest pre-dose assessment. An increase was defined as an increase in grade relative to Baseline grade. Any worst-case post Baseline increase to Grade 1, Grade 2 and Grade 3 are presented.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
n=9 Participants
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst-case Cluster of Differentiation (CD) 4+ T Cell Counts Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 1
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Worst-case Cluster of Differentiation (CD) 4+ T Cell Counts Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Cluster of Differentiation (CD) 4+ T Cell Counts Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to 85 daysPopulation: Safety Population included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan.
Blood samples were collected for the analysis of Creatinine. Creatinine was graded according to the NCI-CTCAE. Grade 0: \<1.5\* Baseline, or increase from Baseline \<26 micromoles per liter (umol/L), Grade 1: 1.5 to 1.9\* Baseline, or increase from Baseline \>=26 umol/L, Grade 2: 2.0 to 2.9\* Baseline, Grade 3: \>=3.0\* Baseline, or \>=354 umol/L. Baseline was defined as the latest pre-dose assessment. An increase was defined as an increase in grade relative to Baseline grade. Any worst-case post Baseline increase to Grade 1, Grade 2 and Grade 3 are presented.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
n=9 Participants
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst-case Creatinine Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Creatinine Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Creatinine Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 85 daysPopulation: Safety Population included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan.
Blood samples were collected for analysis of following clinical chemistry parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Calcium, Total and Direct bilirubin, Glucose, Potassium, Sodium, Total protein, Lactate dehydrogenase, Haptoglobins and Urea. Number of participants with clinically significant changes in clinical chemistry were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
n=9 Participants
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Clinical Chemistry Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to 85 daysPopulation: Safety Population included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan.
Urine samples were collected for analysis of Specific gravity, potential of hydrogen (pH), glucose, protein, erythrocytes, ketones, bilirubin, urobilinogen, nitrite, and leukocyte in urine by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase means any increase to trace, 1+, 2+ or 3+ post-Baseline relative to Baseline. Baseline was defined as the latest pre-dose assessment. Number of participants with worst-case any increase in urinalysis results post-Baseline relative to Baseline has been presented.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
n=9 Participants
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
Bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
Erythrocytes
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
Glucose
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
Ketones
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
Leukocytes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
Nitrite
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
Protein
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
Specific Gravity
|
8 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
Urobilinogen
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
pH
|
12 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
8 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to 85 daysPopulation: Safety Population included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan.
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
n=9 Participants
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Sign Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 15 and Day 85Population: Safety Population included all participants who received study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. Placebo arms were combined as pre-specified in reporting and analysis plan.
VZV-Nucleic acid from blood samples were extracted using the QIASymphony SP followed by TaqMan real time polymerase chain reaction (PCR) for amplification and detection. Murine cytomegalovirus (mCMV) was used as an internal control (IC) and was introduced during the extraction process. CMV-Nucleic acid was extracted using the QIASymphony SP/AS followed by automated set up of Artus real time PCR using the Rotor-Gene Q for amplification and detection. Baseline was defined as the latest pre-dose assessment. Number of participants with Positive CMV DNA and VZV DNA has been presented.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
n=9 Participants
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) and Varicella Zoster Virus (VZV) DNA
Varicella Zoster Virus DNA, Baseline (Day 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) and Varicella Zoster Virus (VZV) DNA
Cytomegalovirus DNA, Baseline (Day 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) and Varicella Zoster Virus (VZV) DNA
Cytomegalovirus DNA, Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) and Varicella Zoster Virus (VZV) DNA
Cytomegalovirus DNA, Day 85
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) and Varicella Zoster Virus (VZV) DNA
Varicella Zoster Virus DNA, Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) and Varicella Zoster Virus (VZV) DNA
Varicella Zoster Virus DNA, Day 85
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 15 and Day 85Population: Safety Population included all participants who received study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. Placebo arms were combined as pre-specified in reporting and analysis plan.
EBV DNA was assessed and qualitative data has been presented. Data has been categorized into 'Positive \>=LLQ' and 'Positive \< LLQ'. LLQ is lower limit of quantification. Participants who had EBV DNA values \>=LLQ were categorized as 'Positive \>=LLQ'. This represents a positive result that is above the assay limit of quantification. Participants who had EBV DNA values \<LLQ were categorized as 'Positive \<LLQ'. This represents a positive result that is below the assay limit of quantification. Baseline was defined as the latest pre-dose assessment.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
n=9 Participants
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Epstein-Barr Virus (EBV) DNA
Baseline (Day 1), Positive < LLQ
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Positive Epstein-Barr Virus (EBV) DNA
Baseline (Day 1), Positive >= LLQ
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Positive Epstein-Barr Virus (EBV) DNA
Day 15, Positive < LLQ
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Positive Epstein-Barr Virus (EBV) DNA
Day 15, Positive >= LLQ
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Positive Epstein-Barr Virus (EBV) DNA
Day 85, Positive < LLQ
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Epstein-Barr Virus (EBV) DNA
Day 85, Positive >= LLQ
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 85 daysPopulation: Safety Population included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan.
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT corrected interval. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
n=9 Participants
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
CLINICALLY SIGNIFICANT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
NOT CLINICALLY SIGNIFICANT
|
12 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: PK Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for measurement of serum concentrations of GSK3888130B following intravenous administration. Pharmacokinetic (PK) Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
DAY 1 (4 Hours)
|
761.4 Nanograms per milliliter (ng/mL)
Interval 677.2 to 856.1
|
4497.0 Nanograms per milliliter (ng/mL)
Interval 2542.8 to 7953.0
|
32762.8 Nanograms per milliliter (ng/mL)
Interval 28319.4 to 37903.3
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
DAY 1 (Pre-dose)
|
NA Nanograms per milliliter (ng/mL)
Geometric mean and 95% CI could not be calculated if any values were imputed due to being non-quantifiable (NQ).
|
NA Nanograms per milliliter (ng/mL)
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
NA Nanograms per milliliter (ng/mL)
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
DAY 1 (15 Minutes)
|
363.2 Nanograms per milliliter (ng/mL)
Interval 196.7 to 670.9
|
2155.9 Nanograms per milliliter (ng/mL)
Interval 1003.0 to 4634.4
|
15901.1 Nanograms per milliliter (ng/mL)
Interval 13993.4 to 18069.0
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
DAY 1 (30 Minutes)
|
893.1 Nanograms per milliliter (ng/mL)
Interval 504.7 to 1580.5
|
4717.5 Nanograms per milliliter (ng/mL)
Interval 3173.3 to 7013.1
|
35633.0 Nanograms per milliliter (ng/mL)
Interval 30628.5 to 41455.2
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
DAY 1 (8 Hours)
|
753.5 Nanograms per milliliter (ng/mL)
Interval 483.7 to 1173.8
|
3964.2 Nanograms per milliliter (ng/mL)
Interval 1974.7 to 7958.0
|
31180.8 Nanograms per milliliter (ng/mL)
Interval 27855.3 to 34903.4
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
DAY 1 (12 Hours)
|
758.1 Nanograms per milliliter (ng/mL)
Interval 601.3 to 955.8
|
3599.9 Nanograms per milliliter (ng/mL)
Interval 2601.7 to 4981.2
|
29821.8 Nanograms per milliliter (ng/mL)
Interval 26986.2 to 32955.3
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
DAY 1 (24 Hours)
|
720.8 Nanograms per milliliter (ng/mL)
Interval 558.6 to 930.0
|
3781.5 Nanograms per milliliter (ng/mL)
Interval 2095.7 to 6823.7
|
28096.6 Nanograms per milliliter (ng/mL)
Interval 26173.0 to 30161.6
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
DAY 1 (48 Hours)
|
572.8 Nanograms per milliliter (ng/mL)
Interval 401.3 to 817.7
|
3184.0 Nanograms per milliliter (ng/mL)
Interval 2280.6 to 4445.1
|
23358.3 Nanograms per milliliter (ng/mL)
Interval 20418.2 to 26721.8
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
DAY 6
|
NA Nanograms per milliliter (ng/mL)
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
2134.0 Nanograms per milliliter (ng/mL)
Interval 1229.6 to 3703.5
|
15978.7 Nanograms per milliliter (ng/mL)
Interval 14176.6 to 18009.9
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
DAY 8
|
NA Nanograms per milliliter (ng/mL)
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
1862.5 Nanograms per milliliter (ng/mL)
Interval 883.6 to 3926.1
|
14071.9 Nanograms per milliliter (ng/mL)
Interval 13088.2 to 15129.5
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
DAY 10
|
NA Nanograms per milliliter (ng/mL)
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
1850.1 Nanograms per milliliter (ng/mL)
Interval 928.4 to 3687.1
|
12873.0 Nanograms per milliliter (ng/mL)
Interval 11718.1 to 14141.7
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
DAY 15
|
NA Nanograms per milliliter (ng/mL)
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
1539.6 Nanograms per milliliter (ng/mL)
Interval 740.1 to 3202.8
|
10293.7 Nanograms per milliliter (ng/mL)
Interval 9018.8 to 11748.8
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
DAY 21
|
NA Nanograms per milliliter (ng/mL)
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
1263.0 Nanograms per milliliter (ng/mL)
Interval 416.5 to 3829.5
|
8485.9 Nanograms per milliliter (ng/mL)
Interval 7647.8 to 9415.9
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
DAY 29
|
NA Nanograms per milliliter (ng/mL)
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
1027.3 Nanograms per milliliter (ng/mL)
Interval 404.7 to 2607.4
|
6904.9 Nanograms per milliliter (ng/mL)
Interval 5741.6 to 8304.0
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
DAY 57
|
NA Nanograms per milliliter (ng/mL)
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
625.4 Nanograms per milliliter (ng/mL)
Interval 192.9 to 2027.2
|
3545.2 Nanograms per milliliter (ng/mL)
Interval 2721.4 to 4618.4
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
DAY 85
|
NA Nanograms per milliliter (ng/mL)
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
NA Nanograms per milliliter (ng/mL)
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
1797.5 Nanograms per milliliter (ng/mL)
Interval 1152.8 to 2802.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at indicated time points for measurement of serum concentrations of GSK3888130B following subcutaneous administration.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
DAY 29
|
2266.1 ng/mL
Interval 1614.4 to 3181.0
|
21108.5 ng/mL
Interval 16241.6 to 27434.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
DAY 57
|
1288.8 ng/mL
Interval 817.0 to 2032.9
|
11567.5 ng/mL
Interval 7780.8 to 17197.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
DAY 1 (Pre-dose)
|
NA ng/mL
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
NA ng/mL
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
DAY 1 (4 Hours)
|
NA ng/mL
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
2540.4 ng/mL
Interval 1193.5 to 5407.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
DAY 1 (8 Hours)
|
NA ng/mL
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
5287.2 ng/mL
Interval 2659.9 to 10509.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
DAY 1 (12 Hours)
|
NA ng/mL
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
8236.8 ng/mL
Interval 4122.6 to 16456.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
DAY 1 (24 Hours)
|
1284.2 ng/mL
Interval 795.2 to 2073.7
|
14161.9 ng/mL
Interval 7502.7 to 26731.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
DAY 1 (48 Hours)
|
2297.0 ng/mL
Interval 1506.7 to 3501.9
|
23239.0 ng/mL
Interval 12191.4 to 44297.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
DAY 6
|
3253.7 ng/mL
Interval 2339.4 to 4525.5
|
34612.8 ng/mL
Interval 25180.0 to 47579.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
DAY 8
|
3327.1 ng/mL
Interval 2422.0 to 4570.5
|
34801.7 ng/mL
Interval 25828.6 to 46892.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
DAY 10
|
3078.4 ng/mL
Interval 2316.4 to 4091.2
|
33654.8 ng/mL
Interval 25702.9 to 44066.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
DAY 15
|
2814.4 ng/mL
Interval 2172.0 to 3646.8
|
29870.9 ng/mL
Interval 22782.2 to 39165.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
DAY 21
|
2856.1 ng/mL
Interval 2199.3 to 3709.1
|
27433.3 ng/mL
Interval 21634.8 to 34785.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
DAY 85
|
NA ng/mL
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
5780.9 ng/mL
Interval 3113.3 to 10733.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated time points for measurement of serum concentrations of GSK3888130B following intravenous administration. Pharmacokinetic (PK) Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
DAY 1 (30 Minutes)
|
201271.5 ng/mL
Interval 162241.9 to 249690.2
|
446824.2 ng/mL
Interval 396812.5 to 503139.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
DAY 8
|
148716.7 ng/mL
Interval 122678.0 to 180282.2
|
362540.8 ng/mL
Interval 282254.6 to 465664.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
DAY 1 (Pre-dose)
|
NA ng/mL
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
NA ng/mL
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
DAY 1 (1 Hour)
|
365002.7 ng/mL
Interval 300217.9 to 443767.6
|
887258.7 ng/mL
Interval 772728.3 to 1018764.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
DAY 1 (4 Hours)
|
334755.7 ng/mL
Interval 275365.5 to 406955.0
|
845654.2 ng/mL
Interval 743870.4 to 961365.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
DAY 1 (8 Hours)
|
333669.5 ng/mL
Interval 254377.8 to 437677.0
|
839439.2 ng/mL
Interval 725811.5 to 970855.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
DAY 1 (12 Hours)
|
312692.1 ng/mL
Interval 251461.1 to 388832.9
|
738220.9 ng/mL
Interval 642655.8 to 847997.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
DAY 1 (24 Hours)
|
288550.5 ng/mL
Interval 235725.2 to 353213.8
|
744312.7 ng/mL
Interval 631579.3 to 877168.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
DAY 1 (48 Hours)
|
221884.4 ng/mL
Interval 173674.6 to 283476.6
|
595269.2 ng/mL
Interval 525651.3 to 674107.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
DAY 6
|
186043.0 ng/mL
Interval 154906.8 to 223437.5
|
432475.7 ng/mL
Interval 378277.5 to 494439.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
DAY 10
|
150354.6 ng/mL
Interval 119156.0 to 189722.0
|
361427.9 ng/mL
Interval 295704.5 to 441759.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
DAY 15
|
124163.7 ng/mL
Interval 104218.9 to 147925.3
|
311912.7 ng/mL
Interval 254633.2 to 382077.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
DAY 21
|
108208.1 ng/mL
Interval 95733.2 to 122308.5
|
259786.4 ng/mL
Interval 206492.4 to 326835.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
DAY 29
|
88424.1 ng/mL
Interval 81046.3 to 96473.4
|
207998.2 ng/mL
Interval 147558.4 to 293194.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
DAY 57
|
34733.0 ng/mL
Interval 24307.2 to 49630.7
|
100288.2 ng/mL
Interval 65503.1 to 153545.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
DAY 85
|
16634.1 ng/mL
Interval 12462.7 to 22201.9
|
53029.2 ng/mL
Interval 34299.5 to 81986.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Time t (AUC[0 to t]) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
|
65.81 Hours*micrograms per milliliter(h*ug/mL)
Geometric Coefficient of Variation 75.50
|
1837.01 Hours*micrograms per milliliter(h*ug/mL)
Geometric Coefficient of Variation 48.86
|
13524.34 Hours*micrograms per milliliter(h*ug/mL)
Geometric Coefficient of Variation 16.29
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
AUC(0 to t) for Dose Levels 3 and 5 Subcutaneous Administration
|
3550.71 h*ug/mL
Geometric Coefficient of Variation 38.63
|
35669.70 h*ug/mL
Geometric Coefficient of Variation 25.35
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
AUC(0 to t) for Dose Levels 6 and 7 Intravenous Administration
|
153885.4 h*ug/mL
Geometric Coefficient of Variation 12.54
|
387454.3 h*ug/mL
Geometric Coefficient of Variation 24.96
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
|
0.9034 Micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 21.5707
|
4.8156 Micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 18.7069
|
35.6330 Micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 14.4965
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Cmax of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
|
3.4609 ug/mL
Geometric Coefficient of Variation 31.2624
|
36.3795 ug/mL
Geometric Coefficient of Variation 24.9230
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Cmax of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration
|
386.4759 ug/mL
Geometric Coefficient of Variation 29.7837
|
907.7045 ug/mL
Geometric Coefficient of Variation 11.2907
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Cmax (Tmax) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
|
0.583 Hour
Interval 0.55 to 4.0
|
0.550 Hour
Interval 0.55 to 4.0
|
0.558 Hour
Interval 0.55 to 0.58
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Tmax of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
|
168.000 Hour
Interval 120.0 to 222.12
|
143.475 Hour
Interval 120.0 to 240.95
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Tmax of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration
|
1.083 Hour
Interval 1.05 to 24.0
|
2.533 Hour
Interval 1.05 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Half-life (t1/2) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
|
123.73 Hour
Geometric Coefficient of Variation 35.44
|
633.05 Hour
Geometric Coefficient of Variation 32.53
|
627.11 Hour
Geometric Coefficient of Variation 17.66
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
t1/2 of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
|
784.05 Hour
Geometric Coefficient of Variation 13.62
|
749.02 Hour
Geometric Coefficient of Variation 31.55
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
t1/2 of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration
|
563.53 Hour
Geometric Coefficient of Variation 22.12
|
628.91 Hour
Geometric Coefficient of Variation 13.71
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Clearance (CL) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
|
21.501 Milliliter per hour (mL/h)
Geometric Coefficient of Variation 38.138
|
4.240 Milliliter per hour (mL/h)
Geometric Coefficient of Variation 52.782
|
6.542 Milliliter per hour (mL/h)
Geometric Coefficient of Variation 22.034
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Clearance Factor (CL/F) of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
|
9.149 mL/h
Geometric Coefficient of Variation 36.810
|
9.297 mL/h
Geometric Coefficient of Variation 27.211
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85Population: Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
CL of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration
|
5.920 mL/h
Geometric Coefficient of Variation 11.548
|
6.860 mL/h
Geometric Coefficient of Variation 28.592
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 15, Day 29, Day 57 and Day 85Population: Safety Population included all participants who received study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. Placebo arms were combined as pre-specified in reporting and analysis plan.
Serum samples were collected for the determination of anti-drug antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Baseline was defined as the latest pre-dose assessment.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
n=9 Participants
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-drug Antibodies Against GSK3888130B
Day 57
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies Against GSK3888130B
Day 29
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies Against GSK3888130B
Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies Against GSK3888130B
Baseline (Day 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies Against GSK3888130B
Day 85
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to 8 hoursPopulation: Pharmacodynamic (PD) Population consisted of all participants in the Safety Population who had at least one post Baseline PD result. Placebo arms were combined as pre-specified in reporting and analysis plan. Zeros reported reflect measured data derived during analysis.
Free IL-7 levels were derived from total IL-7 and total GSK3888130B concentrations (named as Derived Free IL-7) over time using a nonlinear mixed effects modelling approach. A target-mediated drug disposition model was used to fit the total IL-7 and total GSK3888130B assay concentration data to derive the free-IL-7 concentrations. Peak reduction relative to Baseline (Percent change) was calculated for each participant as; Peak reduction = (1 - minimum \[Free IL7/IL7 Baseline\])\*100. Baseline was defined as the latest pre-dose assessment.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
n=9 Participants
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Peak Reduction From Baseline in Derived Free Interleukin 7 (IL 7) in Blood
|
0.0 Percent Change
Standard Deviation 0.00
|
95.8 Percent Change
Standard Deviation 1.5383
|
99.1 Percent Change
Standard Deviation 0.2841
|
90.3 Percent Change
Standard Deviation 4.2311
|
99.9 Percent Change
Standard Deviation 0.0246
|
98.6 Percent Change
Standard Deviation 0.8138
|
100 Percent Change
Standard Deviation 0.0025
|
100 Percent Change
Standard Deviation 0.0004
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 15Population: Pharmacodynamic (PD) Population consisted of all participants in the Safety Population who had at least one post Baseline PD result. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for specified time points.
Blood samples were collected at indicated time points to measure Bcl-2 Expression in CD4+ T Cells as median fluorescence intensity (MdFI). Baseline was defined as the latest pre-dose assessment. MdFI values as a measure of Bcl-2 expression in CD4+ T cells was measured by flow cytometry. Placebo arms were combined as pre-specified in reporting and analysis plan.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=3 Participants
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
n=6 Participants
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
n=6 Participants
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
n=9 Participants
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
n=4 Participants
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Median Fluorescence Intensity (MdFI) of B-cell Lymphoma 2 (Bcl-2) Expression in CD4+ T Cells in Blood
Day 15
|
88899.0 Median fluorescence intensity
Interval 62339.0 to 128682.0
|
79882.5 Median fluorescence intensity
Interval 65395.0 to 94370.0
|
75396.0 Median fluorescence intensity
Interval 53411.0 to 77550.0
|
62436.5 Median fluorescence intensity
Interval 32520.0 to 77948.0
|
52592.0 Median fluorescence intensity
Interval 50096.0 to 67410.0
|
55938.5 Median fluorescence intensity
Interval 26200.0 to 63447.0
|
50715.0 Median fluorescence intensity
Interval 40283.0 to 65395.0
|
58098.5 Median fluorescence intensity
Interval 49364.0 to 69492.0
|
|
Median Fluorescence Intensity (MdFI) of B-cell Lymphoma 2 (Bcl-2) Expression in CD4+ T Cells in Blood
Baseline (Day 1)
|
92427.0 Median fluorescence intensity
Interval 55433.0 to 114550.0
|
64576.0 Median fluorescence intensity
Interval 47010.0 to 82059.0
|
68096.0 Median fluorescence intensity
Interval 54750.0 to 72379.0
|
92724.0 Median fluorescence intensity
Interval 64251.0 to 104760.0
|
73182.5 Median fluorescence intensity
Interval 66900.0 to 93636.0
|
93540.5 Median fluorescence intensity
Interval 79770.0 to 108965.0
|
90059.0 Median fluorescence intensity
Interval 71281.0 to 118233.0
|
101786.0 Median fluorescence intensity
Interval 101255.0 to 120759.0
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
GSK3888130B Dose Level 1 IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
GSK3888130B Dose Level 2 IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GSK3888130B Dose Level 3 SC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
GSK3888130B Dose Level 4 IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GSK3888130B Dose Level 5 SC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
GSK3888130B Dose Level 6 IV
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
GSK3888130B Dose Level 7 IV
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=15 participants at risk
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
|
GSK3888130B Dose Level 1 IV
n=3 participants at risk
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
|
GSK3888130B Dose Level 2 IV
n=3 participants at risk
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
|
GSK3888130B Dose Level 3 SC
n=6 participants at risk
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
|
GSK3888130B Dose Level 4 IV
n=6 participants at risk
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
|
GSK3888130B Dose Level 5 SC
n=6 participants at risk
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
|
GSK3888130B Dose Level 6 IV
n=9 participants at risk
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
|
GSK3888130B Dose Level 7 IV
n=6 participants at risk
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Gastrointestinal disorders
Toothache
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
General disorders
Catheter site pain
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
General disorders
Catheter site rash
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
General disorders
Influenza like illness
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
General disorders
Injection site pruritus
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
General disorders
Malaise
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
General disorders
Swelling face
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Immune system disorders
Seasonal allergy
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Infections and infestations
Acne pustular
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Infections and infestations
COVID-19
|
20.0%
3/15 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
66.7%
2/3 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Infections and infestations
Cellulitis
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Infections and infestations
Influenza
|
13.3%
2/15 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Infections and infestations
Lower respiratory tract infection
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
66.7%
2/3 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
33.3%
3/9 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Infections and infestations
Oral herpes
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Investigations
Blood pressure increased
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Nervous system disorders
Head discomfort
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Nervous system disorders
Headache
|
20.0%
3/15 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.3%
2/15 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/15 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/3 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/9 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
0.00%
0/6 • All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place