Trial Outcomes & Findings for Pharmacokinetic Study of Ravulizumab Administered Subcutaneously With Recombinant Human Hyaluronidase PH20 (rHuPH20) in Healthy Adult Volunteers (NCT NCT05396742)
NCT ID: NCT05396742
Last Updated: 2024-01-22
Results Overview
Dose-normalized area under the serum concentration versus time curve from 0 extrapolated to infinity (AUC0-inf) and body weight-adjusted AUC0-inf for the ravulizumab/rHuPH20 SC cohorts were compared with the 400 mg ravulizumab intravenous (IV) cohort to determine absolute bioavailability. Geometric mean ratios of the AUC0-inf parameter were calculated for each group. Absolute bioavailability is reported as the geometric mean ratio, which was defined as the ratio of geometric means for the dose-normalized AUC0-inf parameter (with and without body-weight adjustment) for the ravulizumab SC cohort divided by that for the ravulizumab IV cohort.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
49 participants
Primary outcome timeframe
Day 1 (after first dose) to Day 200
Results posted on
2024-01-22
Participant Flow
Eligible participants who met all inclusion and no exclusion criteria were assigned unique numbers for enrollment and randomization. Randomization was only used when cohorts were enrolled in parallel.
A total of 108 potential participants were screened (including 5 rescreened and 59 rejects \[screen fail\]). A total of 49 participants were ultimately treated in this study.
Participant milestones
| Measure |
Cohort 1
Participants received a single dose of ravulizumab 400 mg (milligrams) subcutaneously.
|
Cohort 2
Participants received a single dose of ravulizumab 500 mg/recombinant human hyaluronidase PH20 (rHuPH20) 10000 units subcutaneously.
|
Cohort 3
Participants received a single dose of ravulizumab 1000 mg/rHuPH20 20000 units subcutaneously.
|
Cohort 4
Participants received a single dose of ravulizumab 2000 mg/rHuPH20 40000 units subcutaneously.
|
Cohort 5
Participants received a single dose of ravulizumab 400 mg intravenously.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
12
|
12
|
12
|
6
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
7
|
12
|
12
|
12
|
6
|
|
Overall Study
COMPLETED
|
7
|
12
|
12
|
12
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic Study of Ravulizumab Administered Subcutaneously With Recombinant Human Hyaluronidase PH20 (rHuPH20) in Healthy Adult Volunteers
Baseline characteristics by cohort
| Measure |
Cohort 1
n=7 Participants
Participants received a single dose of ravulizumab 400 mg subcutaneously.
|
Cohort 2
n=12 Participants
Participants received a single dose of ravulizumab 500 mg/rHuPH20 10000 units subcutaneously.
|
Cohort 3
n=12 Participants
Participants received a single dose of ravulizumab 1000 mg/rHuPH20 20000 units subcutaneously.
|
Cohort 4
n=12 Participants
Participants received a single dose of ravulizumab 2000 mg/rHuPH20 40000 units subcutaneously.
|
Cohort 5
n=6 Participants
Participants received a single dose of ravulizumab 400 mg intravenously.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.6 years
STANDARD_DEVIATION 7.41 • n=93 Participants
|
27.5 years
STANDARD_DEVIATION 5.11 • n=4 Participants
|
28.9 years
STANDARD_DEVIATION 6.99 • n=27 Participants
|
29.5 years
STANDARD_DEVIATION 7.57 • n=483 Participants
|
28.8 years
STANDARD_DEVIATION 4.75 • n=36 Participants
|
28.8 years
STANDARD_DEVIATION 6.34 • n=10 Participants
|
|
Age, Customized
In utero
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 wks)
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Customized
Adults (18-64 years)
|
7 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
49 Participants
n=10 Participants
|
|
Age, Customized
From 65-84 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
16 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
33 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
47 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
36 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 1 (after first dose) to Day 200Population: The Pharmacokinetics (PK) Population included all participants who had sufficient serum concentration data to enable the calculation of PK parameters of at least area under the serum concentration versus time curve (AUC). For this outcome measure, the Number of Participants Analyzed includes the participants from both the IV group and the respective SC group.
Dose-normalized area under the serum concentration versus time curve from 0 extrapolated to infinity (AUC0-inf) and body weight-adjusted AUC0-inf for the ravulizumab/rHuPH20 SC cohorts were compared with the 400 mg ravulizumab intravenous (IV) cohort to determine absolute bioavailability. Geometric mean ratios of the AUC0-inf parameter were calculated for each group. Absolute bioavailability is reported as the geometric mean ratio, which was defined as the ratio of geometric means for the dose-normalized AUC0-inf parameter (with and without body-weight adjustment) for the ravulizumab SC cohort divided by that for the ravulizumab IV cohort.
Outcome measures
| Measure |
Cohort 1
n=12 Participants
Participants received a single dose of ravulizumab 400 mg subcutaneously.
|
Cohort 2
n=18 Participants
Participants received a single dose of ravulizumab 500 mg/rHuPH20 10000 units subcutaneously.
|
Cohort 3
n=18 Participants
Participants received a single dose of ravulizumab 1000 mg/rHuPH20 20000 units subcutaneously.
|
Cohort 4
n=18 Participants
Participants received a single dose of ravulizumab 2000 mg/rHuPH20 40000 units subcutaneously.
|
Cohort 5
Participants received a single dose of ravulizumab 400 mg intravenously.
|
|---|---|---|---|---|---|
|
Absolute Bioavailability Of Ravulizumab Subcutaneous (SC)/rHuPH20
Dose-normalized AUC0-inf
|
64 Percent bioavailability
Interval 44.0 to 92.0
|
73 Percent bioavailability
Interval 57.0 to 94.0
|
77 Percent bioavailability
Interval 57.0 to 102.0
|
84 Percent bioavailability
Interval 63.0 to 113.0
|
—
|
|
Absolute Bioavailability Of Ravulizumab Subcutaneous (SC)/rHuPH20
Body weight-adjusted and dose-normalized AUC0-inf
|
63 Percent bioavailability
Interval 46.0 to 85.0
|
69 Percent bioavailability
Interval 57.0 to 84.0
|
70 Percent bioavailability
Interval 55.0 to 90.0
|
81 Percent bioavailability
Interval 63.0 to 104.0
|
—
|
PRIMARY outcome
Timeframe: Day 1 (after first dose) up to Day 200 (including safety follow up)Population: The Safety Population included all participants who receive at least 1 dose of study drug.
An AE was reported as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AEs (SAEs) were defined as any untoward medical occurrence that, at any dose resulted in death, life threatening, required hospitalization, resulted in persistent disability or incapacity, resulted in birth defect, or other situations. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Cohort 1
n=7 Participants
Participants received a single dose of ravulizumab 400 mg subcutaneously.
|
Cohort 2
n=12 Participants
Participants received a single dose of ravulizumab 500 mg/rHuPH20 10000 units subcutaneously.
|
Cohort 3
n=12 Participants
Participants received a single dose of ravulizumab 1000 mg/rHuPH20 20000 units subcutaneously.
|
Cohort 4
n=12 Participants
Participants received a single dose of ravulizumab 2000 mg/rHuPH20 40000 units subcutaneously.
|
Cohort 5
n=6 Participants
Participants received a single dose of ravulizumab 400 mg intravenously.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
TEAEs
|
7 Participants
|
11 Participants
|
12 Participants
|
10 Participants
|
5 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
Discontinuations due to TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (after first dose) to Day 200Population: The PK Population included all participants who had sufficient serum concentration data to enable the calculation of PK parameters of at least AUC. For this outcome measure, the Number of Participants Analyzed includes the participants from both the ravulizumab/rHuPH SC cohort and the respective ravulizumab SC cohort.
Dose-normalized AUC0-inf and body weight-adjusted AUC0-inf for the ravulizumab/rHuPH20 SC cohorts were compared with the 400 mg ravulizumab SC cohort to determine relative bioavailability. Geometric mean ratios of the AUC0-inf parameter were calculated for each group. Relative bioavailability is reported as the geometric mean ratio, which was defined as the ratio of the geometric means for the dose-normalized AUC0-inf parameter (with and without body-weight adjustment) for the ravulizumab/rHuPH SC cohort divided by that for the ravulizumab SC cohort.
Outcome measures
| Measure |
Cohort 1
n=18 Participants
Participants received a single dose of ravulizumab 400 mg subcutaneously.
|
Cohort 2
n=18 Participants
Participants received a single dose of ravulizumab 500 mg/rHuPH20 10000 units subcutaneously.
|
Cohort 3
n=18 Participants
Participants received a single dose of ravulizumab 1000 mg/rHuPH20 20000 units subcutaneously.
|
Cohort 4
Participants received a single dose of ravulizumab 2000 mg/rHuPH20 40000 units subcutaneously.
|
Cohort 5
Participants received a single dose of ravulizumab 400 mg intravenously.
|
|---|---|---|---|---|---|
|
Relative Bioavailability Of Ravulizumab SC/rHuPH20 Compared With Ravulizumab SC
Dose-normalized AUC0-inf
|
115 Percent bioavailability
Interval 91.0 to 145.0
|
120 Percent bioavailability
Interval 91.0 to 158.0
|
132 Percent bioavailability
Interval 100.0 to 175.0
|
—
|
—
|
|
Relative Bioavailability Of Ravulizumab SC/rHuPH20 Compared With Ravulizumab SC
Body weight-adjusted and dose-normalized AUC0-inf
|
109 Percent bioavailability
Interval 90.0 to 134.0
|
112 Percent bioavailability
Interval 88.0 to 142.0
|
129 Percent bioavailability
Interval 101.0 to 165.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Up to Day 200Population: The Pharmacodynamics (PD) Population included all participants who had sufficient free C5 concentration data that enabled the evaluation of the PD effects.
The highest (maximum difference) mean (standard deviation \[SD\]) PCFB at up to Day 200 is reported. Baseline was defined as the last available value prior to the first drug administration. Change from Baseline was calculated as observed value minus the baseline value. PCFB was calculated as change from baseline divided by baseline multiplied by 100.
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Participants received a single dose of ravulizumab 400 mg subcutaneously.
|
Cohort 2
n=12 Participants
Participants received a single dose of ravulizumab 500 mg/rHuPH20 10000 units subcutaneously.
|
Cohort 3
n=12 Participants
Participants received a single dose of ravulizumab 1000 mg/rHuPH20 20000 units subcutaneously.
|
Cohort 4
n=12 Participants
Participants received a single dose of ravulizumab 2000 mg/rHuPH20 40000 units subcutaneously.
|
Cohort 5
n=6 Participants
Participants received a single dose of ravulizumab 400 mg intravenously.
|
|---|---|---|---|---|---|
|
Maximum Percent Change From Baseline (PCFB) In Serum Levels Of Total Complement Component 5 (C5) Concentrations
|
92.12 Percent change
Standard Deviation 58.332
|
98.68 Percent change
Standard Deviation 27.659
|
107.46 Percent change
Standard Deviation 45.769
|
133.48 Percent change
Standard Deviation 35.782
|
112.90 Percent change
Standard Deviation 27.878
|
SECONDARY outcome
Timeframe: Baseline, Day 200Population: The PD Population included all participants who had sufficient free C5 concentration data that enabled the evaluation of the PD effects.
The highest (maximum difference) mean (SD) PCFB at up to Day 200 is reported. Baseline was defined as the last available value prior to the first drug administration. Change from Baseline was calculated as observed value minus the baseline value. PCFB was calculated as change from baseline divided by baseline multiplied by 100.
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Participants received a single dose of ravulizumab 400 mg subcutaneously.
|
Cohort 2
n=12 Participants
Participants received a single dose of ravulizumab 500 mg/rHuPH20 10000 units subcutaneously.
|
Cohort 3
n=12 Participants
Participants received a single dose of ravulizumab 1000 mg/rHuPH20 20000 units subcutaneously.
|
Cohort 4
n=12 Participants
Participants received a single dose of ravulizumab 2000 mg/rHuPH20 40000 units subcutaneously.
|
Cohort 5
n=6 Participants
Participants received a single dose of ravulizumab 400 mg intravenously.
|
|---|---|---|---|---|---|
|
Maximum PCFB In Serum Levels Of Free C5 Concentrations
|
-96.83 Percent Change
Standard Deviation 4.783
|
-99.48 Percent Change
Standard Deviation 0.349
|
-99.84 Percent Change
Standard Deviation 0.116
|
-99.90 Percent Change
Standard Deviation 0.00
|
-99.90 Percent Change
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Baseline, Up to Day 200Population: The PD Population included all participants who had sufficient free C5 concentration data that enabled the evaluation of the PD effects.
The highest (maximum difference) mean (SD) PCFB at up to Day 200 is reported. Baseline was defined as the last available value prior to the first drug administration. Change from Baseline was calculated as observed value minus the baseline value. PCFB was calculated as change from baseline divided by baseline multiplied by 100.
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Participants received a single dose of ravulizumab 400 mg subcutaneously.
|
Cohort 2
n=12 Participants
Participants received a single dose of ravulizumab 500 mg/rHuPH20 10000 units subcutaneously.
|
Cohort 3
n=12 Participants
Participants received a single dose of ravulizumab 1000 mg/rHuPH20 20000 units subcutaneously.
|
Cohort 4
n=12 Participants
Participants received a single dose of ravulizumab 2000 mg/rHuPH20 40000 units subcutaneously.
|
Cohort 5
n=6 Participants
Participants received a single dose of ravulizumab 400 mg intravenously.
|
|---|---|---|---|---|---|
|
Maximum PCFB In Ex Vivo Chicken Red Blood Cell (cRBC) Hemolysis Activity
|
-58.07 Percent change
Standard Deviation 19.382
|
-77.68 Percent change
Standard Deviation 23.765
|
-80.74 Percent change
Standard Deviation 28.153
|
-99.35 Percent change
Standard Deviation 0.684
|
-98.52 Percent change
Standard Deviation 1.790
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 5
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 |
Cohort 1
n=7 participants at risk
Participants received a single dose of ravulizumab 400 mg subcutaneously
|
Cohort 2
n=12 participants at risk
Participants received a single dose of ravulizumab 500 mg/rHuPH20 10000 units subcutaneously.
|
Cohort 3
n=12 participants at risk
Participants received a single dose of ravulizumab 1000 mg/rHuPH20 20000 units subcutaneously.
|
Cohort 4
n=12 participants at risk
Participants received a single dose of ravulizumab 2000 mg/rHuPH20 40000 units subcutaneously.
|
Cohort 5
n=6 participants at risk
Participants received a single dose of ravulizumab 400 mg intravenously.
|
|---|---|---|---|---|---|
|
General disorders
Medical device site pruritus
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
14.3%
1/7 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
25.0%
3/12 • Number of events 3 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
25.0%
3/12 • Number of events 4 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
General disorders
Injection site paraesthesia
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
16.7%
2/12 • Number of events 2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
71.4%
5/7 • Number of events 5 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
50.0%
6/12 • Number of events 11 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
33.3%
4/12 • Number of events 4 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
33.3%
4/12 • Number of events 4 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
50.0%
3/6 • Number of events 4 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
28.6%
2/7 • Number of events 2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
16.7%
2/12 • Number of events 2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
25.0%
3/12 • Number of events 3 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
50.0%
1/2 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
—
0/0 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
16.7%
2/12 • Number of events 2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
41.7%
5/12 • Number of events 5 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
33.3%
2/6 • Number of events 4 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
16.7%
2/12 • Number of events 2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
16.7%
2/12 • Number of events 2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
16.7%
2/12 • Number of events 2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Number of events 2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
16.7%
2/12 • Number of events 2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
General disorders
Medical device site reaction
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
25.0%
3/12 • Number of events 3 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
General disorders
Hangover
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
16.7%
2/12 • Number of events 2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
25.0%
3/12 • Number of events 3 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
16.7%
2/12 • Number of events 2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
1/7 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
General disorders
Injection site pruritus
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
25.0%
3/12 • Number of events 3 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
50.0%
6/12 • Number of events 6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
33.3%
4/12 • Number of events 4 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Infections and infestations
Bacterial vaginosis
|
50.0%
1/2 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/3 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
—
0/0 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Infections and infestations
Laryngitis viral
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infections
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Infections and infestations
Tooth infection
|
14.3%
1/7 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Infections and infestations
Viral pharyngitis
|
14.3%
1/7 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
General disorders
Injection site discomfort
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
General disorders
Injection site reaction
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal disorder
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gingival bleeding
|
14.3%
1/7 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Tongue discomfort
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urine abnormality
|
14.3%
1/7 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal cyst
|
0.00%
0/2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/3 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
—
0/0 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/3 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
—
0/0 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/7 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Investigations
Menstruation normal
|
0.00%
0/2 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/4 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/3 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
—
0/0 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
|
Surgical and medical procedures
Tooth extraction
|
14.3%
1/7 • Number of events 1 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/12 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
0.00%
0/6 • Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
|
Additional Information
Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Phone: +1.855.752.2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER