Trial Outcomes & Findings for TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM) (NCT NCT00451321)
NCT ID: NCT00451321
Last Updated: 2017-11-13
Results Overview
AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
88 participants
Primary outcome timeframe
Up to Month 24
Results posted on
2017-11-13
Participant Flow
The study was conducted at 17 centers from United States and Canada during the period 31 July 2006 to 1 December 2011.
Participants from all 7 cohorts who had received a total dose \<3.0 milligrams (mg) were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
Participant milestones
| Measure |
Otelixizumab <3.0 mg
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
15
|
18
|
19
|
7
|
9
|
6
|
6
|
|
Overall Study
COMPLETED
|
1
|
10
|
0
|
7
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
18
|
12
|
7
|
9
|
6
|
6
|
Reasons for withdrawal
| Measure |
Otelixizumab <3.0 mg
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
1
|
3
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Overall Study
Study closed/terminated
|
1
|
1
|
17
|
5
|
7
|
7
|
5
|
3
|
|
Overall Study
Sponsor decision to amend protocol
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
3
|
Baseline Characteristics
TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)
Baseline characteristics by cohort
| Measure |
Otelixizumab <3.0 mg
n=8 Participants
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=15 Participants
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
n=18 Participants
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=19 Participants
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 Participants
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 Participants
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 Participants
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=6 Participants
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.8 Years
STANDARD_DEVIATION 11.36 • n=5 Participants
|
42.3 Years
STANDARD_DEVIATION 13.25 • n=7 Participants
|
18.9 Years
STANDARD_DEVIATION 5.17 • n=5 Participants
|
34.6 Years
STANDARD_DEVIATION 9.89 • n=4 Participants
|
36.1 Years
STANDARD_DEVIATION 9.70 • n=21 Participants
|
28.9 Years
STANDARD_DEVIATION 10.74 • n=8 Participants
|
37.2 Years
STANDARD_DEVIATION 14.37 • n=8 Participants
|
28.8 Years
STANDARD_DEVIATION 6.79 • n=24 Participants
|
31.6 Years
STANDARD_DEVIATION 12.49 • n=42 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
39 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
49 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
86 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to Month 24Population: The 'All Subjects population' was defined as all participants who received at least one dose of study medication and was used in all study population and safety analyses. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group.
AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Outcome measures
| Measure |
Otelixizumab <3.0 mg
n=8 Participants
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=15 Participants
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
n=18 Participants
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=19 Participants
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 Participants
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 Participants
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 Participants
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=6 Participants
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAEs
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AEs
|
8 Participants
|
15 Participants
|
18 Participants
|
18 Participants
|
7 Participants
|
9 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to Month 24Population: All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group.
AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Cytokine release AEs were defined as occurring during dosing or within a limited time window after the last dose.
Outcome measures
| Measure |
Otelixizumab <3.0 mg
n=8 Participants
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=15 Participants
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
n=18 Participants
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=19 Participants
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 Participants
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 Participants
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 Participants
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=6 Participants
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Cytokine Release AE
|
8 Participants
|
11 Participants
|
18 Participants
|
17 Participants
|
7 Participants
|
9 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to Month 48Population: All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group.
Hematology parameters: hemoglobin, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration were assessed for abnormal PCC values. Data for abnormal parameters (high and low) is presented. Only those parameters for which at least one value of PCC was reported are summarized.
Outcome measures
| Measure |
Otelixizumab <3.0 mg
n=8 Participants
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=15 Participants
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
n=18 Participants
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=19 Participants
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 Participants
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 Participants
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 Participants
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=6 Participants
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Hematology Values of Potential Clinical Concern (PCC)
Neutrophils, low
|
1 Participants
|
2 Participants
|
11 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Hematology Values of Potential Clinical Concern (PCC)
Lymphocytes, low
|
4 Participants
|
12 Participants
|
18 Participants
|
17 Participants
|
7 Participants
|
9 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Abnormal Hematology Values of Potential Clinical Concern (PCC)
WBC, low
|
3 Participants
|
4 Participants
|
12 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Hematology Values of Potential Clinical Concern (PCC)
Hemoglobin, high
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values of Potential Clinical Concern (PCC)
Platelets, low
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values of Potential Clinical Concern (PCC)
Platelets, high
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Month 48Population: All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group.
Clinical chemistry parameters: alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, gamma-glutamyl transferase, lactate dehydrogenase, lipids, blood urea nitrogen, creatinine, uric acid, sodium, potassium, chloride, carbon dioxide, creatinine phosphokinase, albumin, calcium, magnesium, glucose, phosphate, bicarbonate and total protein were assessed for abnormal PCC values. Data for abnormal parameters (high and low) is presented. Only those parameters for which at least one value of PCC was reported are summarized.
Outcome measures
| Measure |
Otelixizumab <3.0 mg
n=8 Participants
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=15 Participants
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
n=18 Participants
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=19 Participants
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 Participants
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 Participants
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 Participants
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=6 Participants
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Clinical Chemistry Values of PCC
Fasting glucose, low
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values of PCC
ALT, high
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values of PCC
AST, high
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values of PCC
Fasting glucose, high
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values of PCC
Potassium, high
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values of PCC
Bicarbonate, high
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values of PCC
Bicarbonate, low
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values of PCC
Calcium, low
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values of PCC
Magnesium, high
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values of PCC
Alkaline phosphatase, high
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values of PCC
Total billirubin, high
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Month 48Population: All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group.
Urinalysis parameters: Occult blood, Glucose urine, Ketones, Leukocyte esterase, Nitrite, pH, Protein urine were assessed. Abnormal values for occult blood and ketones were presented as 1+, 2+ and 3+ (the plus sign increases with a higher level of parameters: 1+=slightly positive, 2+=positive, 3+=high positive). Abnormal glucose urine values were presented as 50, 100, 250 and 1000 mg/dL. Abnormal nitrite values were presented as 'positive', and abnormal urine protein values were presented as 30 and 100 mg/dL.
Outcome measures
| Measure |
Otelixizumab <3.0 mg
n=8 Participants
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=15 Participants
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
n=18 Participants
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=19 Participants
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 Participants
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 Participants
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 Participants
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=6 Participants
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult blood, Month 24, 3+
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein urine, Month 48, 30
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult blood, Month 24, 1+
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult blood, Day 8, 3+
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult blood, Month 12, 1+
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult blood, Month 12, 2+
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult blood, Month 12, 3+
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult blood, Month 36, 2+
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult blood, Month 36, 3+
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine glucose, Day 8, 500
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine glucose, Month 12, 100
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine glucose, Month 12, 1000
|
2 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine glucose, Month 12, 250
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine glucose, Month 12, 50
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine glucose, Month 24, 100
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine glucose, Month 24, 1000
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine glucose, Month 24, 250
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine glucose, Month 24, 500
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine glucose, Month 36, 1000
|
0 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine glucose, Month 36, 250
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine glucose, Month 36, 500
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine glucose, Month 48, 100
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine glucose, Month 48, 1000
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine glucose, Month 48, 250
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine ketones, Month 12, 1+
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine ketones, Month 12, 2+
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine ketones, Month 12, 3+
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine ketones, Month 24, 1+
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine ketones, Month 24, 2+
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine ketones, Month 24, 3+
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine ketones, Month 36, 1+
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine ketones, Month 36, 2+
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Urine ketones, Month 48, 1+
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Leukocyte esterase, Month 12, 1+
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Leukocyte esterase, Month 12, 2+
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Leukocyte esterase, Month 24, 1+
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Leukocyte esterase, Month 24, 3+
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Leukocyte esterase, Month 36, 1+
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Nitrite, Month 12, positive
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Nitrite, Month 24, positive
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Nitrite, Month 36, positive
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein urine, Month 12, 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein urine, Month 24, 100
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 8Population: All subjects Population. Only those participants available for analysis for the particular parameter are presented. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group.
Levels of cytokines: interferon (IFN)-gamma, interleukin (IL)-10, IL-6 and tumor necrosis factor (TNF)-alpha were assessed. One sample was collected at Baseline, on dose Day 1 at 1, 2, 3, and 8 hours post-end of infusion (EOI) and on all other dosing days at pre-dose, and 1, 2, 3, and 8 hour post-EOI. After the completion of dosing, on Day 21 and Week 8, only the IL-10 level was assessed in the cytokine blood sample.
Outcome measures
| Measure |
Otelixizumab <3.0 mg
n=8 Participants
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=15 Participants
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
n=18 Participants
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=19 Participants
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 Participants
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 Participants
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 Participants
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=6 Participants
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Overall Maximum Cytokines Level
IFN-Gamma
|
55.180 Picograms per milliliter (pg/mL)
Standard Deviation NA
Only one participant was analyzed, hence no data.
|
20.170 Picograms per milliliter (pg/mL)
Standard Deviation NA
Only one participant was analyzed, hence no data.
|
25.878 Picograms per milliliter (pg/mL)
Standard Deviation 19.0272
|
20.410 Picograms per milliliter (pg/mL)
Standard Deviation 15.6070
|
40.860 Picograms per milliliter (pg/mL)
Standard Deviation NA
Only one participant was analyzed, hence no data.
|
9.730 Picograms per milliliter (pg/mL)
Standard Deviation NA
Only one participant was analyzed, hence no data.
|
23.210 Picograms per milliliter (pg/mL)
Standard Deviation 12.7279
|
30.463 Picograms per milliliter (pg/mL)
Standard Deviation 23.4652
|
|
Mean Overall Maximum Cytokines Level
IL-10
|
146.084 Picograms per milliliter (pg/mL)
Standard Deviation 337.2007
|
44.609 Picograms per milliliter (pg/mL)
Standard Deviation 48.1712
|
58.743 Picograms per milliliter (pg/mL)
Standard Deviation 59.6380
|
75.879 Picograms per milliliter (pg/mL)
Standard Deviation 66.3559
|
80.267 Picograms per milliliter (pg/mL)
Standard Deviation 51.6266
|
82.786 Picograms per milliliter (pg/mL)
Standard Deviation 68.4322
|
193.065 Picograms per milliliter (pg/mL)
Standard Deviation 225.7715
|
82.547 Picograms per milliliter (pg/mL)
Standard Deviation 55.4185
|
|
Mean Overall Maximum Cytokines Level
IL-6
|
101.161 Picograms per milliliter (pg/mL)
Standard Deviation 193.9999
|
71.748 Picograms per milliliter (pg/mL)
Standard Deviation 78.0909
|
75.954 Picograms per milliliter (pg/mL)
Standard Deviation 63.2599
|
83.739 Picograms per milliliter (pg/mL)
Standard Deviation 65.1953
|
111.567 Picograms per milliliter (pg/mL)
Standard Deviation 115.1136
|
121.862 Picograms per milliliter (pg/mL)
Standard Deviation 99.0309
|
358.890 Picograms per milliliter (pg/mL)
Standard Deviation 544.0678
|
186.593 Picograms per milliliter (pg/mL)
Standard Deviation 200.7019
|
|
Mean Overall Maximum Cytokines Level
TNF-Alpha
|
18.079 Picograms per milliliter (pg/mL)
Standard Deviation 10.2902
|
23.071 Picograms per milliliter (pg/mL)
Standard Deviation 29.9426
|
34.814 Picograms per milliliter (pg/mL)
Standard Deviation 40.1511
|
27.225 Picograms per milliliter (pg/mL)
Standard Deviation 37.5837
|
51.503 Picograms per milliliter (pg/mL)
Standard Deviation 36.9749
|
69.678 Picograms per milliliter (pg/mL)
Standard Deviation 145.2403
|
50.877 Picograms per milliliter (pg/mL)
Standard Deviation 74.6931
|
44.232 Picograms per milliliter (pg/mL)
Standard Deviation 51.2616
|
PRIMARY outcome
Timeframe: Up to Month 18Population: All subjects Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group.
EBV load was measured using quantitative polymerase chain reaction (PCR) method. If a participant had an EBV viral load of \>100,000 copies/10\^6 peripheral blood mononuclear cells (c/10\^6 PBMC) lymphocytes at any time post-dose, the test was repeated immediately. Data for participants with abnormal viral load is presented.
Outcome measures
| Measure |
Otelixizumab <3.0 mg
n=8 Participants
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=15 Participants
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
n=18 Participants
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=19 Participants
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 Participants
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 Participants
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 Participants
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=6 Participants
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load
Screening, 1-10000
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load
Day 14, 1-10000
|
1 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load
Day 21, 1-10000
|
0 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load
Day 21, >10000
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load
Day 28, 1-10000
|
2 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load
Week 6, 1-10000
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load
Week 12, 1-10000
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load
Month 6, 1-10000
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load
Month 18, 1-10000
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load
Month 12, 1-10000
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-start of infusion (SOI). On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.Population: PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented.
Pharmacokinetic (PK) samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 micrograms per milliliter (µg/mL). The 'PK summary Population' was defined as participants in the 'All Subjects' Population for whom a pharmacokinetic sample was obtained and analyzed, and who received the full scheduled dose, as specified in the protocol. Only those participants available at the specified time points were analyzed.
Outcome measures
| Measure |
Otelixizumab <3.0 mg
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=14 Participants
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=15 Participants
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 Participants
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 Participants
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 Participants
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=3 Participants
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUClast) of Otelixizumab
Day 7
|
—
|
0.01789 Hour*micrograms per milliliter
Geometric Coefficient of Variation 66.5077
|
—
|
0.08946 Hour*micrograms per milliliter
Geometric Coefficient of Variation 161.9423
|
0.15744 Hour*micrograms per milliliter
Geometric Coefficient of Variation 1108.625
|
0.02332 Hour*micrograms per milliliter
Geometric Coefficient of Variation 27.3059
|
0.19563 Hour*micrograms per milliliter
Geometric Coefficient of Variation 665.7708
|
0.20039 Hour*micrograms per milliliter
Geometric Coefficient of Variation 80.3599
|
|
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUClast) of Otelixizumab
Day 1
|
—
|
—
|
—
|
0.03961 Hour*micrograms per milliliter
Geometric Coefficient of Variation 139.9399
|
0.89984 Hour*micrograms per milliliter
Geometric Coefficient of Variation NA
Only one participant was analyzed.
|
—
|
—
|
—
|
|
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUClast) of Otelixizumab
Day 4
|
—
|
0.01791 Hour*micrograms per milliliter
Geometric Coefficient of Variation 48.7376
|
—
|
0.02752 Hour*micrograms per milliliter
Geometric Coefficient of Variation 78.0203
|
0.06047 Hour*micrograms per milliliter
Geometric Coefficient of Variation 809.8761
|
0.02595 Hour*micrograms per milliliter
Geometric Coefficient of Variation NA
Only one participant was analyzed.
|
0.01701 Hour*micrograms per milliliter
Geometric Coefficient of Variation 47.9050
|
0.01370 Hour*micrograms per milliliter
Geometric Coefficient of Variation 3.6149
|
|
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUClast) of Otelixizumab
Day 8
|
—
|
0.01848 Hour*micrograms per milliliter
Geometric Coefficient of Variation 73.4326
|
—
|
0.14250 Hour*micrograms per milliliter
Geometric Coefficient of Variation 93.2214
|
0.08367 Hour*micrograms per milliliter
Geometric Coefficient of Variation 280.2741
|
0.06685 Hour*micrograms per milliliter
Geometric Coefficient of Variation 188.0044
|
0.62938 Hour*micrograms per milliliter
Geometric Coefficient of Variation 256.4433
|
1.34488 Hour*micrograms per milliliter
Geometric Coefficient of Variation 567.3411
|
SECONDARY outcome
Timeframe: At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.Population: PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented.
PK samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 µg/mL. Only those participants available at the specified time points were analyzed.
Outcome measures
| Measure |
Otelixizumab <3.0 mg
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=14 Participants
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=15 Participants
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 Participants
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 Participants
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 Participants
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=3 Participants
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Drug Concentration (Cmax) of Otelixizumab
Day 1
|
—
|
—
|
—
|
0.04399 µg/mL
Geometric Coefficient of Variation 124.5265
|
0.06370 µg/mL
Geometric Coefficient of Variation NA
Only one participant was analyzed.
|
—
|
—
|
—
|
|
Maximum Plasma Drug Concentration (Cmax) of Otelixizumab
Day 4
|
—
|
0.03050 µg/mL
Geometric Coefficient of Variation 42.9529
|
—
|
0.03862 µg/mL
Geometric Coefficient of Variation 41.1649
|
0.03041 µg/mL
Geometric Coefficient of Variation 30.4698
|
0.03460 µg/mL
Geometric Coefficient of Variation NA
Only one participant was analyzed.
|
0.03160 µg/mL
Geometric Coefficient of Variation 39.9688
|
0.02739 µg/mL
Geometric Coefficient of Variation 3.6149
|
|
Maximum Plasma Drug Concentration (Cmax) of Otelixizumab
Day 7
|
—
|
0.02660 µg/mL
Geometric Coefficient of Variation 37.1463
|
—
|
0.06715 µg/mL
Geometric Coefficient of Variation 41.7413
|
0.05054 µg/mL
Geometric Coefficient of Variation 41.4392
|
0.03075 µg/mL
Geometric Coefficient of Variation 26.2309
|
0.12211 µg/mL
Geometric Coefficient of Variation 118.6807
|
0.12601 µg/mL
Geometric Coefficient of Variation 68.8972
|
|
Maximum Plasma Drug Concentration (Cmax) of Otelixizumab
Day 8
|
—
|
0.02988 µg/mL
Geometric Coefficient of Variation 41.3271
|
—
|
0.06455 µg/mL
Geometric Coefficient of Variation 45.7850
|
0.05519 µg/mL
Geometric Coefficient of Variation 77.5056
|
0.03773 µg/mL
Geometric Coefficient of Variation 41.5855
|
0.15106 µg/mL
Geometric Coefficient of Variation 122.2439
|
0.23138 µg/mL
Geometric Coefficient of Variation 254.9093
|
SECONDARY outcome
Timeframe: At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.Population: PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented.
PK samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 µg/mL. Only those participants available at the specified time points were analyzed.
Outcome measures
| Measure |
Otelixizumab <3.0 mg
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=14 Participants
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=15 Participants
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 Participants
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 Participants
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 Participants
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=3 Participants
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Time of Last Quantifiable Drug Concentration (Tlast) and Time of Occurrence of Maximum Plasma Drug Concentration (Tmax) of Otelixizumab
tlast, Day 1
|
—
|
—
|
—
|
2.150 hour
Interval 2.08 to 4.05
|
22.250 hour
Interval 22.25 to 22.25
|
—
|
—
|
—
|
|
Time of Last Quantifiable Drug Concentration (Tlast) and Time of Occurrence of Maximum Plasma Drug Concentration (Tmax) of Otelixizumab
tlast, Day 4
|
—
|
2.175 hour
Interval 2.13 to 2.22
|
—
|
2.133 hour
Interval 2.03 to 4.58
|
2.250 hour
Interval 2.25 to 23.58
|
2.500 hour
Interval 2.5 to 2.5
|
2.075 hour
Interval 2.0 to 2.17
|
2.000 hour
Interval 2.0 to 2.0
|
|
Time of Last Quantifiable Drug Concentration (Tlast) and Time of Occurrence of Maximum Plasma Drug Concentration (Tmax) of Otelixizumab
tlast, Day 7
|
—
|
2.217 hour
Interval 2.0 to 4.0
|
—
|
4.000 hour
Interval 2.0 to 23.67
|
12.375 hour
Interval 2.25 to 23.47
|
2.517 hour
Interval 2.5 to 2.53
|
4.000 hour
Interval 2.0 to 20.7
|
4.000 hour
Interval 4.0 to 4.0
|
|
Time of Last Quantifiable Drug Concentration (Tlast) and Time of Occurrence of Maximum Plasma Drug Concentration (Tmax) of Otelixizumab
tlast, Day 8
|
—
|
2.075 hour
Interval 2.0 to 4.0
|
—
|
5.033 hour
Interval 2.0 to 10.0
|
3.250 hour
Interval 1.75 to 8.32
|
3.500 hour
Interval 2.0 to 8.53
|
10.000 hour
Interval 4.03 to 10.17
|
12.000 hour
Interval 6.0 to 12.03
|
|
Time of Last Quantifiable Drug Concentration (Tlast) and Time of Occurrence of Maximum Plasma Drug Concentration (Tmax) of Otelixizumab
tmax, Day 1
|
—
|
—
|
—
|
2.083 hour
Interval 2.0 to 2.15
|
2.42 hour
Interval 2.42 to 2.42
|
—
|
—
|
—
|
|
Time of Last Quantifiable Drug Concentration (Tlast) and Time of Occurrence of Maximum Plasma Drug Concentration (Tmax) of Otelixizumab
tmax, Day 4
|
—
|
2.175 hour
Interval 2.13 to 2.22
|
—
|
2.108 hour
Interval 1.92 to 2.53
|
2.250 hour
Interval 2.25 to 2.3
|
2.500 hour
Interval 2.5 to 2.5
|
2.075 hour
Interval 2.0 to 2.17
|
2.000 hour
Interval 2.0 to 2.0
|
|
Time of Last Quantifiable Drug Concentration (Tlast) and Time of Occurrence of Maximum Plasma Drug Concentration (Tmax) of Otelixizumab
tmax, Day 7
|
—
|
2.100 hour
Interval 2.0 to 2.33
|
—
|
2.083 hour
Interval 2.0 to 2.2
|
2.308 hour
Interval 2.25 to 22.47
|
2.517 hour
Interval 2.5 to 2.53
|
2.033 hour
Interval 2.0 to 2.33
|
3.042 hour
Interval 2.08 to 4.0
|
|
Time of Last Quantifiable Drug Concentration (Tlast) and Time of Occurrence of Maximum Plasma Drug Concentration (Tmax) of Otelixizumab
tmax, Day 8
|
—
|
2.075 hour
Interval 2.0 to 2.27
|
—
|
2.167 hour
Interval 2.0 to 2.75
|
2.000 hour
Interval 1.75 to 3.28
|
2.000 hour
Interval 2.0 to 2.5
|
3.500 hour
Interval 2.0 to 4.12
|
4.000 hour
Interval 4.0 to 4.03
|
SECONDARY outcome
Timeframe: Day 8 and 28Population: Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.
One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. To obtain absolute counts for each lymphocyte subset (CD19+ B cells, CD4+CD25hiFoxP3+ T cells, CD8+CD25+FoxP3+ T cells) the proportion of total lymphocytes constituting that subset was multiplied by the total count for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented. The 'Pharmacodynamic (PD) summary population' was defined as participants in the 'All Subjects' Population for whom a PD sample was obtained and analyzed and who received the full scheduled dose, as specified in the protocol.
Outcome measures
| Measure |
Otelixizumab <3.0 mg
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=14 Participants
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=18 Participants
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 Participants
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 Participants
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 Participants
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=4 Participants
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD19+ B Cells, Baseline
|
—
|
0.187 Cells per microliter
Standard Deviation 0.1360
|
—
|
0.247 Cells per microliter
Standard Deviation 0.1029
|
0.288 Cells per microliter
Standard Deviation 0.1173
|
0.393 Cells per microliter
Standard Deviation 0.2125
|
0.200 Cells per microliter
Standard Deviation 0.0873
|
0.220 Cells per microliter
Standard Deviation 0.0922
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD19+ B Cells, Day 8, pre-dose
|
—
|
0.182 Cells per microliter
Standard Deviation 0.1697
|
—
|
0.180 Cells per microliter
Standard Deviation 0.0627
|
0.146 Cells per microliter
Standard Deviation 0.0305
|
0.203 Cells per microliter
Standard Deviation 0.1019
|
0.099 Cells per microliter
Standard Deviation 0.0468
|
0.151 Cells per microliter
Standard Deviation 0.0906
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD19+ B Cells, Day 8, 15 minutes
|
—
|
—
|
—
|
—
|
0.170 Cells per microliter
Standard Deviation 0.0446
|
—
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD19+ B Cells, Day 8, 30 minutes
|
—
|
—
|
—
|
—
|
—
|
0.204 Cells per microliter
Standard Deviation 0.1094
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD19+ B Cells, Day 8, 2 hours
|
—
|
0.177 Cells per microliter
Standard Deviation 0.1528
|
—
|
0.162 Cells per microliter
Standard Deviation 0.0570
|
—
|
—
|
0.087 Cells per microliter
Standard Deviation 0.0604
|
0.099 Cells per microliter
Standard Deviation 0.0869
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD19+ B Cells, Day 8, 2.25 hours
|
—
|
—
|
—
|
—
|
0.156 Cells per microliter
Standard Deviation 0.0602
|
—
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD19+ B Cells, Day 8, 2.5 hours
|
—
|
—
|
—
|
—
|
—
|
0.161 Cells per microliter
Standard Deviation 0.0737
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD19+ B Cells, Day 8, 4 hours
|
—
|
0.186 Cells per microliter
Standard Deviation 0.1314
|
—
|
0.167 Cells per microliter
Standard Deviation 0.0699
|
—
|
—
|
0.084 Cells per microliter
Standard Deviation 0.0523
|
0.083 Cells per microliter
Standard Deviation 0.0465
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD19+ B Cells, Day 28
|
—
|
0.198 Cells per microliter
Standard Deviation 0.1978
|
—
|
0.210 Cells per microliter
Standard Deviation 0.0634
|
0.156 Cells per microliter
Standard Deviation 0.0553
|
0.279 Cells per microliter
Standard Deviation 0.1558
|
0.167 Cells per microliter
Standard Deviation 0.0470
|
0.153 Cells per microliter
Standard Deviation 0.0783
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD4+CD25hiFoxP3+T cells, Baseline
|
—
|
0.0138 Cells per microliter
Standard Deviation 0.01010
|
—
|
0.0099 Cells per microliter
Standard Deviation 0.01142
|
0.0180 Cells per microliter
Standard Deviation 0.00865
|
0.0165 Cells per microliter
Standard Deviation 0.01262
|
0.0089 Cells per microliter
Standard Deviation 0.00948
|
0.0379 Cells per microliter
Standard Deviation 0.02839
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD4+CD25hiFoxP3+T cells, Day 8, pre-dose
|
—
|
0.0062 Cells per microliter
Standard Deviation 0.00497
|
—
|
0.0039 Cells per microliter
Standard Deviation 0.00425
|
0.0056 Cells per microliter
Standard Deviation 0.00488
|
0.0105 Cells per microliter
Standard Deviation 0.00693
|
0.0028 Cells per microliter
Standard Deviation 0.00180
|
0.0237 Cells per microliter
Standard Deviation 0.01067
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD4+CD25hiFoxP3+T cells, Day 8, 15 minutes
|
—
|
—
|
—
|
—
|
0.0039 Cells per microliter
Standard Deviation 0.00549
|
—
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD4+CD25hiFoxP3+T cells, Day 8, 30 minutes
|
—
|
—
|
—
|
—
|
—
|
0.0033 Cells per microliter
Standard Deviation 0.00283
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD4+CD25hiFoxP3+T cells, Day 8, 2 hours
|
—
|
0.0035 Cells per microliter
Standard Deviation 0.00336
|
—
|
0.0015 Cells per microliter
Standard Deviation 0.00265
|
—
|
—
|
0.0013 Cells per microliter
Standard Deviation 0.00178
|
0.0055 Cells per microliter
Standard Deviation 0.00466
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD4+CD25hiFoxP3+T cells, Day 8, 2.25 hours
|
—
|
—
|
—
|
—
|
0.0034 Cells per microliter
Standard Deviation 0.00409
|
—
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD4+CD25hiFoxP3+T cells, Day 8, 2.5 hours
|
—
|
—
|
—
|
—
|
—
|
0.0027 Cells per microliter
Standard Deviation 0.00293
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD4+CD25hiFoxP3+T cells, Day 8, 4 hours
|
—
|
0.0038 Cells per microliter
Standard Deviation 0.00380
|
—
|
0.0017 Cells per microliter
Standard Deviation 0.00285
|
—
|
—
|
0.0012 Cells per microliter
Standard Deviation 0.00125
|
0.0047 Cells per microliter
Standard Deviation 0.00379
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD4+CD25hiFoxP3+T cells, Day 28
|
—
|
0.0132 Cells per microliter
Standard Deviation 0.01176
|
—
|
0.0096 Cells per microliter
Standard Deviation 0.01231
|
0.0163 Cells per microliter
Standard Deviation 0.00740
|
0.0200 Cells per microliter
Standard Deviation 0.01421
|
0.0163 Cells per microliter
Standard Deviation 0.00635
|
0.0253 Cells per microliter
Standard Deviation 0.01205
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD8+CD25+FoxP3+T cells, Baseline
|
—
|
0.0001 Cells per microliter
Standard Deviation 0.00264
|
—
|
0.0032 Cells per microliter
Standard Deviation 0.00699
|
0.0230 Cells per microliter
Standard Deviation 0.03795
|
-0.0086 Cells per microliter
Standard Deviation 0.02386
|
0.0020 Cells per microliter
Standard Deviation 0.00153
|
0.0027 Cells per microliter
Standard Deviation 0.00825
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD8+CD25+FoxP3+T cells, Day 8, pre-dose
|
—
|
0.0006 Cells per microliter
Standard Deviation 0.00211
|
—
|
0.0011 Cells per microliter
Standard Deviation 0.00302
|
0.0048 Cells per microliter
Standard Deviation 0.01791
|
0.0054 Cells per microliter
Standard Deviation 0.00563
|
0.0000 Cells per microliter
Standard Deviation 0.00213
|
-0.0006 Cells per microliter
Standard Deviation 0.00360
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD8+CD25+FoxP3+T cells, Day 8, 15 minutes
|
—
|
—
|
—
|
—
|
0.0096 Cells per microliter
Standard Deviation 0.01322
|
—
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD8+CD25+FoxP3+T cells, Day 8, 30 minutes
|
—
|
—
|
—
|
—
|
—
|
0.0138 Cells per microliter
Standard Deviation 0.03663
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD8+CD25+FoxP3+T cells, Day 8, 2 hours
|
—
|
0.0020 Cells per microliter
Standard Deviation 0.00241
|
—
|
0.0005 Cells per microliter
Standard Deviation 0.00291
|
—
|
—
|
-0.0001 Cells per microliter
Standard Deviation 0.00187
|
0.0036 Cells per microliter
Standard Deviation 0.00420
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD8+CD25+FoxP3+T cells, Day 8, 2.25 hours
|
—
|
—
|
—
|
—
|
-0.0057 Cells per microliter
Standard Deviation 0.01376
|
—
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD8+CD25+FoxP3+T cells, Day 8, 2.5 hours
|
—
|
—
|
—
|
—
|
—
|
0.0045 Cells per microliter
Standard Deviation 0.01405
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD8+CD25+FoxP3+T cells, Day 8, 4 hours
|
—
|
0.0052 Cells per microliter
Standard Deviation 0.01082
|
—
|
-0.0006 Cells per microliter
Standard Deviation 0.00443
|
—
|
—
|
0.0007 Cells per microliter
Standard Deviation 0.00085
|
0.0008 Cells per microliter
Standard Deviation 0.00459
|
|
Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
CD8+CD25+FoxP3+T cells, Day 28
|
—
|
0.0036 Cells per microliter
Standard Deviation 0.00443
|
—
|
-0.0045 Cells per microliter
Standard Deviation 0.01304
|
0.0037 Cells per microliter
Standard Deviation 0.01012
|
0.0005 Cells per microliter
Standard Deviation 0.01527
|
0.0004 Cells per microliter
Standard Deviation 0.00382
|
0.0105 Cells per microliter
Standard Deviation 0.01099
|
SECONDARY outcome
Timeframe: Day 8 and 28Population: PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.
One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. To obtain absolute counts for each lymphocyte subset (CD4+ T cells, CD8+ T cells) the proportion of total lymphocytes constituting that subset was multiplied by the total count for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.
Outcome measures
| Measure |
Otelixizumab <3.0 mg
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=14 Participants
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
n=17 Participants
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=18 Participants
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 Participants
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 Participants
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 Participants
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=4 Participants
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD4+ T cells, Baseline
|
—
|
0.943 Cells per microliter
Standard Deviation 0.2982
|
0.841 Cells per microliter
Standard Deviation 0.2111
|
0.959 Cells per microliter
Standard Deviation 0.2726
|
0.802 Cells per microliter
Standard Deviation 0.1535
|
0.929 Cells per microliter
Standard Deviation 0.1879
|
0.961 Cells per microliter
Standard Deviation 0.5173
|
1.007 Cells per microliter
Standard Deviation 0.2653
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD4+ T cells, Day 8
|
—
|
—
|
0.636 Cells per microliter
Standard Deviation 0.1741
|
—
|
—
|
—
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD4+ T cells, Day 8, pre-dose
|
—
|
0.463 Cells per microliter
Standard Deviation 0.1928
|
—
|
0.416 Cells per microliter
Standard Deviation 0.1511
|
0.327 Cells per microliter
Standard Deviation 0.1175
|
0.329 Cells per microliter
Standard Deviation 0.1348
|
0.188 Cells per microliter
Standard Deviation 0.0867
|
0.386 Cells per microliter
Standard Deviation 0.1154
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD4+ T cells, Day 8, 15 minutes
|
—
|
—
|
—
|
—
|
0.233 Cells per microliter
Standard Deviation 0.1504
|
—
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD4+ T cells, Day 8, 30 minutes
|
—
|
—
|
—
|
—
|
—
|
0.113 Cells per microliter
Standard Deviation 0.0779
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD4+ T cells, Day 8, 2 hours
|
—
|
0.296 Cells per microliter
Standard Deviation 0.1341
|
—
|
0.210 Cells per microliter
Standard Deviation 0.1781
|
—
|
—
|
0.108 Cells per microliter
Standard Deviation 0.1202
|
0.099 Cells per microliter
Standard Deviation 0.0553
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD4+ T cells, Day 8, 2.25 hours
|
—
|
—
|
—
|
—
|
0.218 Cells per microliter
Standard Deviation 0.1569
|
—
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD4+ T cells, Day 8, 2.5 hours
|
—
|
—
|
—
|
—
|
—
|
0.117 Cells per microliter
Standard Deviation 0.0502
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD4+ T cells, Day 8, 4 hours
|
—
|
0.397 Cells per microliter
Standard Deviation 0.1779
|
—
|
0.267 Cells per microliter
Standard Deviation 0.1799
|
—
|
—
|
0.126 Cells per microliter
Standard Deviation 0.0962
|
0.112 Cells per microliter
Standard Deviation 0.0469
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD4+ T cells, Day 28
|
—
|
0.835 Cells per microliter
Standard Deviation 0.2971
|
0.812 Cells per microliter
Standard Deviation 0.2211
|
0.978 Cells per microliter
Standard Deviation 0.3193
|
0.743 Cells per microliter
Standard Deviation 0.1846
|
0.797 Cells per microliter
Standard Deviation 0.1824
|
0.927 Cells per microliter
Standard Deviation 0.2153
|
0.689 Cells per microliter
Standard Deviation 0.2199
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD8+ T cells, Baseline
|
—
|
0.586 Cells per microliter
Standard Deviation 0.2370
|
0.442 Cells per microliter
Standard Deviation 0.1404
|
0.425 Cells per microliter
Standard Deviation 0.1213
|
0.466 Cells per microliter
Standard Deviation 0.1720
|
0.519 Cells per microliter
Standard Deviation 0.2813
|
0.437 Cells per microliter
Standard Deviation 0.1761
|
0.638 Cells per microliter
Standard Deviation 0.1711
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD8+ T cells, Day 8
|
—
|
—
|
0.324 Cells per microliter
Standard Deviation 0.1370
|
—
|
—
|
—
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD8+ T cells, Day 8, pre-dose
|
—
|
0.242 Cells per microliter
Standard Deviation 0.1133
|
—
|
0.192 Cells per microliter
Standard Deviation 0.0873
|
0.149 Cells per microliter
Standard Deviation 0.0297
|
0.161 Cells per microliter
Standard Deviation 0.0815
|
0.143 Cells per microliter
Standard Deviation 0.1248
|
0.298 Cells per microliter
Standard Deviation 0.1108
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD8+ T cells, Day 8, 15 minutes
|
—
|
—
|
—
|
—
|
0.124 Cells per microliter
Standard Deviation 0.0577
|
—
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD8+ T cells, Day 8, 30 minutes
|
—
|
—
|
—
|
—
|
—
|
0.093 Cells per microliter
Standard Deviation 0.0558
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD2+ T cells, Day 8, 2 hours
|
—
|
0.183 Cells per microliter
Standard Deviation 0.1143
|
—
|
0.134 Cells per microliter
Standard Deviation 0.0981
|
—
|
—
|
0.072 Cells per microliter
Standard Deviation 0.0776
|
0.121 Cells per microliter
Standard Deviation 0.0731
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD8+ T cells, Day 8, 2.25 hours
|
—
|
—
|
—
|
—
|
0.120 Cells per microliter
Standard Deviation 0.0563
|
—
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD8+ T cells, Day 8, 2.5 hours
|
—
|
—
|
—
|
—
|
—
|
0.076 Cells per microliter
Standard Deviation 0.0323
|
—
|
—
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD8+ T cells, Day 8, 4 hours
|
—
|
0.211 Cells per microliter
Standard Deviation 0.1255
|
—
|
0.150 Cells per microliter
Standard Deviation 0.1013
|
—
|
—
|
0.095 Cells per microliter
Standard Deviation 0.0857
|
0.138 Cells per microliter
Standard Deviation 0.0313
|
|
Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
CD8+ T cells, Day 28
|
—
|
0.533 Cells per microliter
Standard Deviation 0.1924
|
0.460 Cells per microliter
Standard Deviation 0.1578
|
0.510 Cells per microliter
Standard Deviation 0.2168
|
0.378 Cells per microliter
Standard Deviation 0.0906
|
0.444 Cells per microliter
Standard Deviation 0.1838
|
0.779 Cells per microliter
Standard Deviation 0.3551
|
0.507 Cells per microliter
Standard Deviation 0.1596
|
SECONDARY outcome
Timeframe: Day 8 and 28Population: PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.
One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. CD4+/CD8+ ratio was determined by dividing the absolute count of CD4+ T cells by the absolute count of CD8+ T cells for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.
Outcome measures
| Measure |
Otelixizumab <3.0 mg
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=14 Participants
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
n=17 Participants
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=18 Participants
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 Participants
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 Participants
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 Participants
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=4 Participants
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Mean CD4+/CD8+ Ratio
Day 8
|
—
|
—
|
2.12 Ratio
Standard Deviation 0.531
|
—
|
—
|
—
|
—
|
—
|
|
Mean CD4+/CD8+ Ratio
Day 8, pre-dose
|
—
|
2.15 Ratio
Standard Deviation 0.965
|
—
|
2.36 Ratio
Standard Deviation 0.958
|
2.15 Ratio
Standard Deviation 0.467
|
2.12 Ratio
Standard Deviation 0.564
|
1.80 Ratio
Standard Deviation 0.932
|
1.34 Ratio
Standard Deviation 0.276
|
|
Mean CD4+/CD8+ Ratio
Day 28
|
—
|
1.69 Ratio
Standard Deviation 0.684
|
1.87 Ratio
Standard Deviation 0.339
|
2.08 Ratio
Standard Deviation 0.838
|
2.00 Ratio
Standard Deviation 0.357
|
2.02 Ratio
Standard Deviation 0.829
|
1.61 Ratio
Standard Deviation 1.263
|
1.38 Ratio
Standard Deviation 0.319
|
|
Mean CD4+/CD8+ Ratio
Baseline
|
—
|
1.95 Ratio
Standard Deviation 0.952
|
2.00 Ratio
Standard Deviation 0.551
|
2.35 Ratio
Standard Deviation 0.783
|
1.81 Ratio
Standard Deviation 0.339
|
2.14 Ratio
Standard Deviation 0.846
|
2.38 Ratio
Standard Deviation 1.099
|
1.64 Ratio
Standard Deviation 0.465
|
|
Mean CD4+/CD8+ Ratio
Day 8, 15 minutes
|
—
|
—
|
—
|
—
|
1.72 Ratio
Standard Deviation 0.684
|
—
|
—
|
—
|
|
Mean CD4+/CD8+ Ratio
Day 8, 30 minutes
|
—
|
—
|
—
|
—
|
—
|
1.17 Ratio
Standard Deviation 0.547
|
—
|
—
|
|
Mean CD4+/CD8+ Ratio
Day 8, 2 hours
|
—
|
1.82 Ratio
Standard Deviation 0.740
|
—
|
1.51 Ratio
Standard Deviation 0.728
|
—
|
—
|
1.62 Ratio
Standard Deviation 1.163
|
0.85 Ratio
Standard Deviation 0.255
|
|
Mean CD4+/CD8+ Ratio
Day 8, 2.25 hours
|
—
|
—
|
—
|
—
|
1.72 Ratio
Standard Deviation 0.731
|
—
|
—
|
—
|
|
Mean CD4+/CD8+ Ratio
Day 8, 2.5 hours
|
—
|
—
|
—
|
—
|
—
|
1.56 Ratio
Standard Deviation 0.441
|
—
|
—
|
|
Mean CD4+/CD8+ Ratio
Day 8, 4 hours
|
—
|
2.11 Ratio
Standard Deviation 0.906
|
—
|
1.86 Ratio
Standard Deviation 0.873
|
—
|
—
|
1.72 Ratio
Standard Deviation 1.079
|
0.80 Ratio
Standard Deviation 0.239
|
|
Mean CD4+/CD8+ Ratio
Day 8, 10 hours
|
—
|
1.36 Ratio
Standard Deviation NA
Only one participant was analyzed, hence no data.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8 and 28Population: PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.
One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.
Outcome measures
| Measure |
Otelixizumab <3.0 mg
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
n=17 Participants
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Lymphocytes Subsets (CD25+CD8+Tregs) Count
Baseline
|
—
|
—
|
20.71 Percentage of lymphocytes
Standard Deviation 25.324
|
—
|
—
|
—
|
—
|
—
|
|
Percent Lymphocytes Subsets (CD25+CD8+Tregs) Count
Day 8
|
—
|
—
|
22.08 Percentage of lymphocytes
Standard Deviation 23.486
|
—
|
—
|
—
|
—
|
—
|
|
Percent Lymphocytes Subsets (CD25+CD8+Tregs) Count
Day 28
|
—
|
—
|
35.62 Percentage of lymphocytes
Standard Deviation 28.538
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At the screening visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.Population: PD summary Population. Data was not collected for this endpoint.
Samples were planned to analyze at the screening visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the screening visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.Population: PD summary Population. Data was not collected for this endpoint.
Samples were planned to analyze at the screening visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the Screen visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.Population: PD summary Population. Data was not collected for this endpoint.
Samples were planned to analyze at the Screen visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Month 48Population: All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. Immunogenicity data was not collected for Cohort 5 (5 day dosing) participants.
Anti-otelixizumab antibody levels were determined by ELISA. Immunogenicity data was not collected for Cohort 5 (5 day dosing) participants.
Outcome measures
| Measure |
Otelixizumab <3.0 mg
n=8 Participants
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=15 Participants
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=19 Participants
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 Participants
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 Participants
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 Participants
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=6 Participants
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Detectable Anti-otelixizumab Antiglobulin Response
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 8Population: All subjects Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group.
Ibuprofen (analgesic) was given orally as follows: 400-800 mg 2 hour before SOI, 400-800 mg 2 hour after SOI, 400-800 mg 6 hour after SOI, and 400-800 mg at bedtime. If ibuprofen was contraindicated, acetaminophen was used in place of ibuprofen. Acetaminophen doses were adjusted so as it did not exceed 1000 mg per 6 hour or 4000 mg per day. A non-sedating antihistamine (cetirizine) was administered approximately 1 hour prior to each infusion of study drug. The recommended initial dose of cetirizine was 5 mg or 10 mg per day in adults and children aged 12 years and older. Normal saline solution was administered IV as needed to maintain hydration.
Outcome measures
| Measure |
Otelixizumab <3.0 mg
n=8 Participants
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=15 Participants
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
n=18 Participants
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=19 Participants
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 Participants
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 Participants
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 Participants
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=6 Participants
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 6, IV Saline
|
0 Participants
|
13 Participants
|
—
|
17 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 7, Analgesics
|
—
|
11 Participants
|
—
|
19 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 7, Antihistamines
|
—
|
11 Participants
|
—
|
19 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 7, IV Saline
|
—
|
14 Participants
|
—
|
18 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 8, Analgesics
|
—
|
12 Participants
|
—
|
18 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 8, Antihistamines
|
—
|
12 Participants
|
—
|
19 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 2, Analgesics
|
8 Participants
|
11 Participants
|
17 Participants
|
19 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 2, IV Saline
|
7 Participants
|
13 Participants
|
14 Participants
|
18 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 3, Analgesics
|
7 Participants
|
11 Participants
|
18 Participants
|
19 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 3, Antihistamines
|
7 Participants
|
11 Participants
|
18 Participants
|
19 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 3, IV Saline
|
6 Participants
|
13 Participants
|
14 Participants
|
17 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 5, Analgesics
|
2 Participants
|
11 Participants
|
17 Participants
|
19 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 5, Antihistamines
|
2 Participants
|
11 Participants
|
17 Participants
|
18 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 5, IV Saline
|
2 Participants
|
13 Participants
|
14 Participants
|
17 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 6, Antihistamines
|
1 Participants
|
11 Participants
|
—
|
19 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 8, IV Saline
|
—
|
14 Participants
|
—
|
18 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 1, Analgesics
|
8 Participants
|
11 Participants
|
18 Participants
|
19 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 1, Antihistamines
|
8 Participants
|
11 Participants
|
18 Participants
|
19 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 1, IV Saline
|
6 Participants
|
13 Participants
|
13 Participants
|
16 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 2, Antihistamines
|
8 Participants
|
11 Participants
|
18 Participants
|
19 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 4, Analgesics
|
5 Participants
|
11 Participants
|
18 Participants
|
19 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 4, Antihistamines
|
5 Participants
|
11 Participants
|
18 Participants
|
19 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 4, IV Saline
|
5 Participants
|
13 Participants
|
14 Participants
|
17 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Day 6, Analgesics
|
1 Participants
|
15 Participants
|
—
|
19 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to Month 48Population: PD summary Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. Data for only quantifiable concentration is presented.
Participants were seen weekly during the first 4 weeks post-dose and then every other week through Week 12. After Week 12, visits occurred every 1 to 3 months through Month 18, which completes the Core Study up to Month 48 (follow up). Day 1 pre-dose value was considered as Baseline value. Change from Baseline was post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Otelixizumab <3.0 mg
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=14 Participants
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
n=17 Participants
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=18 Participants
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 Participants
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 Participants
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 Participants
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=4 Participants
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Day 28
|
—
|
-0.58 Percentage of glycosylated hemoglobin
Standard Deviation 0.656
|
-0.44 Percentage of glycosylated hemoglobin
Standard Deviation 0.788
|
-0.41 Percentage of glycosylated hemoglobin
Standard Deviation 0.404
|
-0.44 Percentage of glycosylated hemoglobin
Standard Deviation 0.416
|
-0.60 Percentage of glycosylated hemoglobin
Standard Deviation 0.624
|
-0.88 Percentage of glycosylated hemoglobin
Standard Deviation 0.578
|
-0.53 Percentage of glycosylated hemoglobin
Standard Deviation 0.737
|
|
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Month 9
|
—
|
-0.43 Percentage of glycosylated hemoglobin
Standard Deviation 0.878
|
1.03 Percentage of glycosylated hemoglobin
Standard Deviation 1.589
|
0.26 Percentage of glycosylated hemoglobin
Standard Deviation 1.118
|
0.10 Percentage of glycosylated hemoglobin
Standard Deviation 1.307
|
0.19 Percentage of glycosylated hemoglobin
Standard Deviation 1.558
|
-0.64 Percentage of glycosylated hemoglobin
Standard Deviation 1.076
|
-0.00 Percentage of glycosylated hemoglobin
Standard Deviation 2.304
|
|
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Week 8
|
—
|
-0.69 Percentage of glycosylated hemoglobin
Standard Deviation 0.825
|
-0.48 Percentage of glycosylated hemoglobin
Standard Deviation 1.187
|
-0.19 Percentage of glycosylated hemoglobin
Standard Deviation 0.749
|
-0.48 Percentage of glycosylated hemoglobin
Standard Deviation 0.618
|
-0.64 Percentage of glycosylated hemoglobin
Standard Deviation 0.838
|
-0.90 Percentage of glycosylated hemoglobin
Standard Deviation 1.277
|
-0.72 Percentage of glycosylated hemoglobin
Standard Deviation 1.124
|
|
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Week 10
|
—
|
—
|
—
|
-0.10 Percentage of glycosylated hemoglobin
Standard Deviation NA
Only one participant was analyzed, hence no data.
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Week 12
|
—
|
-0.35 Percentage of glycosylated hemoglobin
Standard Deviation 0.670
|
-0.15 Percentage of glycosylated hemoglobin
Standard Deviation 1.272
|
0.19 Percentage of glycosylated hemoglobin
Standard Deviation 0.534
|
-0.37 Percentage of glycosylated hemoglobin
Standard Deviation 0.784
|
-0.64 Percentage of glycosylated hemoglobin
Standard Deviation 1.180
|
-0.55 Percentage of glycosylated hemoglobin
Standard Deviation 1.063
|
-0.30 Percentage of glycosylated hemoglobin
Standard Deviation 1.494
|
|
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Week 6
|
—
|
—
|
—
|
0.10 Percentage of glycosylated hemoglobin
Standard Deviation NA
Only one participant was analyzed, hence no data.
|
—
|
—
|
-0.20 Percentage of glycosylated hemoglobin
Standard Deviation NA
Only one participant was analyzed, hence no data.
|
—
|
|
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Month 4
|
—
|
0.08 Percentage of glycosylated hemoglobin
Standard Deviation 0.890
|
0.35 Percentage of glycosylated hemoglobin
Standard Deviation 1.575
|
0.39 Percentage of glycosylated hemoglobin
Standard Deviation 0.545
|
-0.18 Percentage of glycosylated hemoglobin
Standard Deviation 1.061
|
0.39 Percentage of glycosylated hemoglobin
Standard Deviation 1.497
|
-0.17 Percentage of glycosylated hemoglobin
Standard Deviation 1.124
|
0.05 Percentage of glycosylated hemoglobin
Standard Deviation 1.196
|
|
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Month 5
|
—
|
0.10 Percentage of glycosylated hemoglobin
Standard Deviation 0.867
|
0.76 Percentage of glycosylated hemoglobin
Standard Deviation 1.790
|
0.42 Percentage of glycosylated hemoglobin
Standard Deviation 0.797
|
0.13 Percentage of glycosylated hemoglobin
Standard Deviation 0.999
|
0.63 Percentage of glycosylated hemoglobin
Standard Deviation 1.435
|
-0.07 Percentage of glycosylated hemoglobin
Standard Deviation 0.983
|
0.55 Percentage of glycosylated hemoglobin
Standard Deviation 1.338
|
|
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Month 6
|
—
|
-0.23 Percentage of glycosylated hemoglobin
Standard Deviation 0.819
|
0.43 Percentage of glycosylated hemoglobin
Standard Deviation 1.479
|
0.22 Percentage of glycosylated hemoglobin
Standard Deviation 1.274
|
-0.28 Percentage of glycosylated hemoglobin
Standard Deviation 0.743
|
0.61 Percentage of glycosylated hemoglobin
Standard Deviation 1.655
|
-0.25 Percentage of glycosylated hemoglobin
Standard Deviation 0.985
|
0.00 Percentage of glycosylated hemoglobin
Standard Deviation 1.699
|
|
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Month 12
|
—
|
-0.27 Percentage of glycosylated hemoglobin
Standard Deviation 0.800
|
1.31 Percentage of glycosylated hemoglobin
Standard Deviation 1.729
|
0.36 Percentage of glycosylated hemoglobin
Standard Deviation 1.330
|
0.90 Percentage of glycosylated hemoglobin
Standard Deviation 1.938
|
0.90 Percentage of glycosylated hemoglobin
Standard Deviation 2.045
|
-0.23 Percentage of glycosylated hemoglobin
Standard Deviation 0.784
|
0.35 Percentage of glycosylated hemoglobin
Standard Deviation 2.412
|
|
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Month 16
|
—
|
-0.36 Percentage of glycosylated hemoglobin
Standard Deviation 0.886
|
0.93 Percentage of glycosylated hemoglobin
Standard Deviation 1.542
|
0.45 Percentage of glycosylated hemoglobin
Standard Deviation 1.591
|
0.20 Percentage of glycosylated hemoglobin
Standard Deviation 1.284
|
1.33 Percentage of glycosylated hemoglobin
Standard Deviation 2.368
|
0.06 Percentage of glycosylated hemoglobin
Standard Deviation 0.573
|
0.00 Percentage of glycosylated hemoglobin
Standard Deviation 2.358
|
|
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Month 18
|
—
|
-0.24 Percentage of glycosylated hemoglobin
Standard Deviation 1.184
|
0.27 Percentage of glycosylated hemoglobin
Standard Deviation 1.087
|
0.58 Percentage of glycosylated hemoglobin
Standard Deviation 1.476
|
0.15 Percentage of glycosylated hemoglobin
Standard Deviation 1.323
|
1.06 Percentage of glycosylated hemoglobin
Standard Deviation 2.277
|
-0.33 Percentage of glycosylated hemoglobin
Standard Deviation 1.253
|
0.42 Percentage of glycosylated hemoglobin
Standard Deviation 2.138
|
|
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Month 24
|
—
|
-0.32 Percentage of glycosylated hemoglobin
Standard Deviation 1.172
|
—
|
0.31 Percentage of glycosylated hemoglobin
Standard Deviation 1.059
|
0.38 Percentage of glycosylated hemoglobin
Standard Deviation 1.714
|
1.66 Percentage of glycosylated hemoglobin
Standard Deviation 3.730
|
-0.25 Percentage of glycosylated hemoglobin
Standard Deviation 1.141
|
0.20 Percentage of glycosylated hemoglobin
Standard Deviation 2.117
|
|
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Month 36
|
—
|
-0.21 Percentage of glycosylated hemoglobin
Standard Deviation 1.212
|
—
|
0.85 Percentage of glycosylated hemoglobin
Standard Deviation 1.090
|
-0.10 Percentage of glycosylated hemoglobin
Standard Deviation NA
Only one participant was analyzed, hence no data.
|
2.03 Percentage of glycosylated hemoglobin
Standard Deviation 3.063
|
-0.55 Percentage of glycosylated hemoglobin
Standard Deviation 1.677
|
—
|
|
Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Month 48
|
—
|
-0.24 Percentage of glycosylated hemoglobin
Standard Deviation 0.648
|
—
|
0.20 Percentage of glycosylated hemoglobin
Standard Deviation 1.254
|
—
|
—
|
—
|
—
|
Adverse Events
Otelixizumab <3.0 mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Otelixizumab 3.1 mg
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Otelixizumab 3.1 mg (5 Days)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Otelixizumab 4.35 mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Otelixizumab 4.35 mg (ITC-15)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Otelixizumab 4.35 mg (ITC-30)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Otelixizumab 6.85 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Otelixizumab 8.85 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Otelixizumab <3.0 mg
n=8 participants at risk
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=15 participants at risk
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
n=18 participants at risk
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=19 participants at risk
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 participants at risk
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 participants at risk
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 participants at risk
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=6 participants at risk
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Meningitis enteroviral
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
Other adverse events
| Measure |
Otelixizumab <3.0 mg
n=8 participants at risk
Participants from any of the 7 cohorts \[3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg\] receiving a total Otelixizumab dose \<3.0 mg during the study were analyzed in this cohort.
|
Otelixizumab 3.1 mg
n=15 participants at risk
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 3.1 mg (5 Days)
n=18 participants at risk
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
|
Otelixizumab 4.35 mg
n=19 participants at risk
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-15)
n=7 participants at risk
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
|
Otelixizumab 4.35 mg (ITC-30)
n=9 participants at risk
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
|
Otelixizumab 6.85 mg
n=6 participants at risk
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
Otelixizumab 8.85 mg
n=6 participants at risk
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
20.0%
3/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
15.8%
3/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
3/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
50.0%
3/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
13.3%
2/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
2/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
10.5%
2/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
28.6%
2/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
2/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
3/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
15.8%
3/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Viral infection
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Ear infection bacterial
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Eye infection
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Furuncle
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Infusion site cellulitis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Lice infestation
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Paronychia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Viral skin infection
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
75.0%
6/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
60.0%
9/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
50.0%
9/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
73.7%
14/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
57.1%
4/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
44.4%
4/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
2/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
2/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
10.5%
2/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Metabolism and nutrition disorders
Weight fluctuation
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
6/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
20.0%
3/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
61.1%
11/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
52.6%
10/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
42.9%
3/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
83.3%
5/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
2/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
4/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
13.3%
2/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
38.9%
7/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
15.8%
3/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
28.6%
2/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
66.7%
4/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
2/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
13.3%
2/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
22.2%
4/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
10.5%
2/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
2/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
22.2%
4/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
10.5%
2/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
13.3%
2/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Chills
|
37.5%
3/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
27.8%
5/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
31.6%
6/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
28.6%
2/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
66.7%
4/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
2/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Pyrexia
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
20.0%
3/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
22.2%
4/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
15.8%
3/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
28.6%
2/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
2/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
50.0%
3/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Fatigue
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
20.0%
3/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
3/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
10.5%
2/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
22.2%
2/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Chest pain
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
2/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Oedema peripheral
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Asthenia
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Infusion site phlebitis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Infusion site erythema
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Temperature intolerance
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Catheter site rash
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Infusion site haematoma
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Infusion site induration
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Infusion site scab
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Injection site haematoma
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Injection site rash
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Pitting oedema
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
General disorders
Sensation of foreign body
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
2/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
26.7%
4/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
6/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
15.8%
3/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
3/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
50.0%
3/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
13.3%
2/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
22.2%
4/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
15.8%
3/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
50.0%
3/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
2/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
15.8%
3/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
2/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
28.6%
2/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
2/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Rash maculo-papular
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
2/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
2/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
10.5%
2/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
13.3%
2/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Circumoral oedema
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Dermographism
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
2/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal lesion
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
13.3%
2/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
15.8%
3/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
28.6%
2/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
50.0%
3/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Respiratory, thoracic and mediastinal disorders
Hypotension
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
10.5%
2/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
2/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
13.3%
2/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Vascular disorders
Pallor
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
13.3%
2/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
10.5%
2/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Vascular disorders
Flushing
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Vascular disorders
Hot flush
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
13.3%
2/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
21.1%
4/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Eye disorders
Photophobia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Psychiatric disorders
Depression
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
55.6%
5/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Blood and lymphatic system disorders
Platelet disorder
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
2/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
13.3%
2/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Injury, poisoning and procedural complications
Chemical eye injury
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
10.5%
2/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
10.5%
2/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
10.5%
2/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous histiocytoma
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Eye disorders
Dry eye
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Eye disorders
Eyelid pain
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Eye disorders
Visual impairment
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Investigations
Blood iron decreased
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
10.5%
2/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Investigations
Epstein-Barr virus test positive
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Investigations
Hormone level abnormal
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Reproductive system and breast disorders
Balanitis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Reproductive system and breast disorders
Breast calcifications
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Headache
|
100.0%
8/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
80.0%
12/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
100.0%
18/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
94.7%
18/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
100.0%
7/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
100.0%
9/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
100.0%
6/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
100.0%
6/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
3/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
26.3%
5/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
10.5%
2/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
50.0%
3/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
2/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Migraine
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Neurological symptom
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
20.0%
3/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
27.8%
5/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
36.8%
7/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
71.4%
5/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
22.2%
2/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
50.0%
3/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Upper respiratory tract infection
|
37.5%
3/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
20.0%
3/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
2/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
26.3%
5/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
22.2%
2/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Sinusitis
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
20.0%
3/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
2/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
15.8%
3/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
14.3%
1/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
2/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Influenza
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
2/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
22.2%
2/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
13.3%
2/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
22.2%
2/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Gastroenteritis
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
2/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
10.5%
2/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
15.8%
3/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
11.1%
1/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
10.5%
2/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Skin infection
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
6.7%
1/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Ear infection
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
33.3%
2/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Localised infection
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
10.5%
2/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.6%
1/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
5.3%
1/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
|
Infections and infestations
Tooth abscess
|
12.5%
1/8 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/15 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/18 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/19 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/7 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/9 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
16.7%
1/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
0.00%
0/6 • All SAEs and non-SAEs were collected up to Month 24
SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose \<3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER