Trial Outcomes & Findings for Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection (NCT NCT04412863)
NCT ID: NCT04412863
Last Updated: 2026-04-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
Up to 148 Weeks
Results posted on
2026-04-16
Participant Flow
Phase 1 Part1 A-C data results are posted on clinicaltrials.gov in NCT03672188.
Participant milestones
| Measure |
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
|
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
|
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
|
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
|
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
|
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
5
|
18
|
18
|
13
|
|
Overall Study
COMPLETED
|
9
|
15
|
5
|
17
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
0
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
|
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
|
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
|
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
|
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
|
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Rolled over to another study
|
6
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection
Baseline characteristics by cohort
| Measure |
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
n=15 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
|
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
n=15 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
|
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
n=5 Participants
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
|
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
n=18 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
|
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
n=18 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
|
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
n=13 Participants
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
2 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
4 Participants
n=13 Participants
|
3 Participants
n=43 Participants
|
6 Participants
n=1 Participants
|
18 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=193 Participants
|
13 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
14 Participants
n=13 Participants
|
15 Participants
n=43 Participants
|
7 Participants
n=1 Participants
|
66 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
New Zealand
|
6 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
2 Participants
n=13 Participants
|
3 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
15 Participants
n=8 Participants
|
|
Region of Enrollment
South Korea
|
7 Participants
n=193 Participants
|
6 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
10 Participants
n=13 Participants
|
4 Participants
n=43 Participants
|
9 Participants
n=1 Participants
|
40 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=8 Participants
|
|
Age, Continuous
|
50.3 Years
STANDARD_DEVIATION 8.62 • n=193 Participants
|
46.6 Years
STANDARD_DEVIATION 7.80 • n=193 Participants
|
46.2 Years
STANDARD_DEVIATION 8.14 • n=386 Participants
|
48.7 Years
STANDARD_DEVIATION 5.79 • n=13 Participants
|
45.2 Years
STANDARD_DEVIATION 9.36 • n=43 Participants
|
48.5 Years
STANDARD_DEVIATION 7.55 • n=1 Participants
|
47.7 Years
STANDARD_DEVIATION 7.89 • n=8 Participants
|
|
Region of Enrollment
Australia
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
Thailand
|
1 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
3 Participants
n=13 Participants
|
6 Participants
n=43 Participants
|
1 Participants
n=1 Participants
|
13 Participants
n=8 Participants
|
|
Region of Enrollment
Hong Kong
|
1 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
5 Participants
n=43 Participants
|
3 Participants
n=1 Participants
|
10 Participants
n=8 Participants
|
|
Region of Enrollment
Malaysia
|
0 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
3 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
5 Participants
n=8 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=193 Participants
|
15 Participants
n=193 Participants
|
5 Participants
n=386 Participants
|
18 Participants
n=13 Participants
|
17 Participants
n=43 Participants
|
13 Participants
n=1 Participants
|
83 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=193 Participants
|
15 Participants
n=193 Participants
|
5 Participants
n=386 Participants
|
18 Participants
n=13 Participants
|
18 Participants
n=43 Participants
|
13 Participants
n=1 Participants
|
84 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=193 Participants
|
13 Participants
n=193 Participants
|
5 Participants
n=386 Participants
|
16 Participants
n=13 Participants
|
18 Participants
n=43 Participants
|
13 Participants
n=1 Participants
|
77 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
1 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
1 Participants
n=13 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=8 Participants
|
|
Hepatitis B surface antigen (Log10 IU/mL)
|
3.44 Log10 IU/mL
STANDARD_DEVIATION 0.447 • n=193 Participants
|
3.20 Log10 IU/mL
STANDARD_DEVIATION 0.676 • n=193 Participants
|
3.39 Log10 IU/mL
STANDARD_DEVIATION 1.039 • n=386 Participants
|
3.28 Log10 IU/mL
STANDARD_DEVIATION 0.726 • n=13 Participants
|
2.90 Log10 IU/mL
STANDARD_DEVIATION 0.818 • n=43 Participants
|
3.35 Log10 IU/mL
STANDARD_DEVIATION 0.696 • n=1 Participants
|
3.23 Log10 IU/mL
STANDARD_DEVIATION 0.717 • n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 148 WeeksOutcome measures
| Measure |
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
n=15 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
|
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
n=15 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
|
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
n=5 Participants
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
|
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
n=18 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
|
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
n=18 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
|
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
n=13 Participants
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events as Assessed by CTCAE v5.0
|
9 Participants
|
13 Participants
|
3 Participants
|
16 Participants
|
17 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Up to 148 WeeksPopulation: All participants that received at least one dose of any study intervention were included in this analysis.
Outcome measures
| Measure |
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
n=15 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
|
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
n=15 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
|
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
n=5 Participants
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
|
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
n=18 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
|
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
n=18 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
|
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
n=13 Participants
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
ALT Grade 1
|
2 Participants
|
12 Participants
|
2 Participants
|
12 Participants
|
14 Participants
|
9 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
ALT Grade 2
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
ALT Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Alkaline phosphatase Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
AST Grade 1
|
2 Participants
|
11 Participants
|
4 Participants
|
14 Participants
|
16 Participants
|
10 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
AST Grade 2
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
AST Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Bilirubin Grade 1
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Bilirubin Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Prothrombin, Internalized Normalized Ratio (INR) Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Hemoglobin, anemia (g/DL) grade 1
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
8 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Hemoglobin, anemia (g/DL) grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Leukocytes, White blood cell decreased (10^9/L), grade 1
|
3 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Leukocytes, White blood cell decreased (10^9/L), grade 2
|
0 Participants
|
6 Participants
|
1 Participants
|
13 Participants
|
9 Participants
|
7 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Leukocytes, White blood cell decreased (10^9/L), grade 3
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Lymphocytes, Lymphocyte count decreased (10^9/L), grade 1
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Lymphocytes, Lymphocyte count decreased (10^9/L), grade 2
|
0 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
10 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Lymphocytes, Lymphocyte count decreased (10^9/L), grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Neutrophils, Neutrophil count decreased (10^9/L), grade 1
|
3 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Neutrophils, Neutrophil count decreased (10^9/L), grade 2
|
1 Participants
|
8 Participants
|
1 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Neutrophils, Neutrophil count decreased (10^9/L), grade 3
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
10 Participants
|
6 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Neutrophils, Neutrophil count decreased (10^9/L), grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Platelets, Platelet count decreased (10^9/L), grade 1
|
1 Participants
|
10 Participants
|
3 Participants
|
10 Participants
|
14 Participants
|
9 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Platelets, Platelet count decreased (10^9/L), grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Calcium, Hypocalcemia (mg/dL), grade 1
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Creatinine Clearance (mL/min), grade 1
|
6 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Creatinine Clearance (mL/min), grade 2
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Gamma Glutamyl Transferase (U/L), grade 1
|
1 Participants
|
8 Participants
|
2 Participants
|
8 Participants
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Gamma Glutamyl Transferase (U/L), grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Gamma Glutamyl Transferase (U/L), grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Glucose (mg/dL), grade 1
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Lactate Dehydrogenase (U/L), grade 1
|
0 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Potassium, Hyperkalemia (mEq/L), grade 1
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Potassium, Hypokalemia (mEq/L), grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Sodium, Hypernatremia (mEq/L), grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 148 WeeksOutcome measures
| Measure |
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
n=15 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
|
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
n=15 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
|
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
n=5 Participants
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
|
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
n=18 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
|
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
n=18 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
|
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
n=13 Participants
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
|
|---|---|---|---|---|---|---|
|
Mean Maximum Reduction of Serum HBsAg at Any Timepoint
|
-1.96 Log 10 IU/mL
Standard Deviation 0.29
|
-2.15 Log 10 IU/mL
Standard Deviation 0.61
|
-1.73 Log 10 IU/mL
Standard Deviation 0.37
|
-2.52 Log 10 IU/mL
Standard Deviation 0.82
|
-2.48 Log 10 IU/mL
Standard Deviation 1.41
|
-2.99 Log 10 IU/mL
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: Up to 148 WeeksOutcome measures
| Measure |
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
n=15 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
|
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
n=15 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
|
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
n=5 Participants
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
|
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
n=18 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
|
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
n=18 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
|
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
n=13 Participants
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
|
|---|---|---|---|---|---|---|
|
Proportion of Subjects With Serum HBsAg Loss (Undetectable HBsAg) at Any Timepoint
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 148 WeeksOutcome measures
| Measure |
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
n=15 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
|
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
n=15 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
|
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
n=5 Participants
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
|
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
n=18 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
|
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
n=18 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
|
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
n=13 Participants
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
|
|---|---|---|---|---|---|---|
|
Proportion of Subjects With Sustained Serum HBsAg Loss (Undetectable HBsAg) for Greater Than 6 Months
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 148 WeeksAnti-HBs seroconversion is defined as Anti-HBs quantitative value changed from baseline \<LLOQ (5 mIU/mL) to post-baseline\>=LLOQ.
Outcome measures
| Measure |
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
n=13 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
|
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
n=14 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
|
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
n=5 Participants
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
|
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
n=17 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
|
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
n=14 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
|
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
n=11 Participants
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
|
|---|---|---|---|---|---|---|
|
Proportion of Subjects With Anti-HBs Seroconversion at Any Timepoint
|
9 Participants
|
8 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 148 weeksPopulation: Cohort 3d: This outcome is 0 as it is only applicable to HBeAg positive participants, no HBeAg positive participants were assigned to cohort 3d.
Outcome measures
| Measure |
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
n=1 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
|
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
n=1 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
|
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
|
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
n=4 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
|
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
n=5 Participants
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
|
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
n=1 Participants
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
|
|---|---|---|---|---|---|---|
|
For HBeAg-positive Patients: Proportion of Subjects With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion at Any Timepoint
HBeAg loss at any time
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
For HBeAg-positive Patients: Proportion of Subjects With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion at Any Timepoint
HBeAg loss with anti-HBe seroconversion at any time
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
n=15 participants at risk
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
|
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
n=15 participants at risk
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
|
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
n=5 participants at risk
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
|
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
n=18 participants at risk
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
|
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
n=18 participants at risk
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
|
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
n=13 participants at risk
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Psychiatric disorders
Mania
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
Other adverse events
| Measure |
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
n=15 participants at risk
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
|
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
n=15 participants at risk
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
|
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
n=5 participants at risk
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
|
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
n=18 participants at risk
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
|
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
n=18 participants at risk
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
|
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
n=13 participants at risk
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
20.0%
3/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
22.2%
4/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
16.7%
3/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
30.8%
4/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Immune system disorders
Injection site erythema
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
13.3%
2/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
20.0%
1/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
11.1%
2/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
27.8%
5/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
15.4%
2/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Fatigue
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
33.3%
5/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
20.0%
1/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
11.1%
2/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
11.1%
2/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Pyrexia
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
20.0%
3/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
16.7%
3/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
27.8%
5/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
15.4%
2/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
20.0%
1/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
33.3%
6/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
16.7%
3/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
30.8%
4/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
13.3%
2/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
15.4%
2/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Skin and subcutaneous tissue disorders
Injection site pruritus
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
11.1%
2/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
15.4%
2/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
20.0%
1/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
22.2%
4/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
30.8%
4/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Influenza like illness
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
13.3%
2/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
11.1%
2/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
11.1%
2/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
30.8%
4/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Infections and infestations
COVID-19
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
11.1%
2/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
46.2%
6/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
3/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
23.1%
3/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
13.3%
2/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
16.7%
3/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Injection site bruising
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
11.1%
2/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
11.1%
2/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
11.1%
2/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
15.4%
2/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
13.3%
2/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
11.1%
2/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
16.7%
3/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Erythema
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
15.4%
2/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Injection site pain
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
11.1%
2/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Injection site rash
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
11.1%
2/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Vaccination site pain
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
11.1%
2/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
20.0%
1/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Malaise
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
13.3%
2/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Gastrointestinal disorders
Stomatitis
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
11.1%
2/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
20.0%
1/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
13.3%
2/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Non-cardiac chest pain
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Rash pruritic
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Eye disorders
Retinopathy
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Seborrhoeic dermatitis
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
20.0%
1/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Asthenia
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
20.0%
1/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Eye disorders
Visual impairment
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
11.1%
2/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Investigations
Weight decreased
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Eye disorders
Chalazion
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Chest discomfort
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Chest pain
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Metabolism and nutrition disorders
Increased appetite
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Injection site discolouration
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Injection site haematoma
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Injection site swelling
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Psychiatric disorders
Mania
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Infections and infestations
Orchitis
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Pain
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
General disorders
Injection site induration
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Injury, poisoning and procedural complications
Injection site irritation
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Infections and infestations
Paronychia
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Reproductive system and breast disorders
Penile blister
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Musculoskeletal and connective tissue disorders
Tendon discomfort
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
7.7%
1/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Nervous system disorders
Tremor
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
1/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/15 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/5 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
5.6%
1/18 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
0.00%
0/13 • Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The study results in their entirety have been publicly disclosed by or with the consent of the Sponsor OR study has been completed at all investigative sites for at least 18 months provision of publication up to 60 days before planned submission to allow Sponsor to remove confidential information or identify Sponsor intellectual property. Publication may be delayed as applicable, up to 120 days for Sponsor to file patent application(s).
- Publication restrictions are in place
Restriction type: OTHER