Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly (NCT NCT00994214)
NCT ID: NCT00994214
Last Updated: 2019-11-22
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
109 participants
Primary outcome timeframe
At Month 6
Results posted on
2019-11-22
Participant Flow
This was a multicentre study conducted at 36 investigational sites in 16 countries: Czech Republic, Lithuania, Poland, Romania, Ukraine, Latvia, USA, United Kingdom (UK), Italy, Mexico, Brazil, France, Belgium, Netherlands, Germany and Sweden.
Screened subjects were 109 and screen failures were 33. Subjects randomised and treated in part A were 76. Subjects completed part A were 21 and subjects entered Part B were 12, excluding 9 subjects, who chose not to continue in part B. No subjects completed the study.
Participant milestones
| Measure |
Arm A: BIM 23A760 1 mg
BIM 23A760 1 mg subcutaneous 24 weekly injections.
|
Arm B: BIM 23A760 2 mg
BIM 23A760 2 mg subcutaneous 24 weekly injections.
|
Arm C: BIM 23A760 4 mg
BIM 23A760 4 mg subcutaneous 24 weekly injections.
|
Arm D: BIM 23A760 6 mg
BIM 23A760 6 mg subcutaneous 24 weekly injections.
|
|---|---|---|---|---|
|
ITT (Intention-to-Treat) - Part A
STARTED
|
19
|
19
|
18
|
20
|
|
ITT (Intention-to-Treat) - Part A
COMPLETED
|
5
|
6
|
5
|
5
|
|
ITT (Intention-to-Treat) - Part A
NOT COMPLETED
|
14
|
13
|
13
|
15
|
|
ITT (Intention-to-Treat) - Part B
STARTED
|
4
|
3
|
2
|
3
|
|
ITT (Intention-to-Treat) - Part B
Received Maximum Dose of 1mg
|
0
|
0
|
0
|
0
|
|
ITT (Intention-to-Treat) - Part B
Received Maximum Dose of 2mg
|
3
|
0
|
0
|
0
|
|
ITT (Intention-to-Treat) - Part B
Received Maximum Dose of 4mg
|
1
|
3
|
0
|
0
|
|
ITT (Intention-to-Treat) - Part B
Received Maximum Dose of 6mg
|
0
|
0
|
2
|
3
|
|
ITT (Intention-to-Treat) - Part B
COMPLETED
|
0
|
0
|
0
|
0
|
|
ITT (Intention-to-Treat) - Part B
NOT COMPLETED
|
4
|
3
|
2
|
3
|
Reasons for withdrawal
| Measure |
Arm A: BIM 23A760 1 mg
BIM 23A760 1 mg subcutaneous 24 weekly injections.
|
Arm B: BIM 23A760 2 mg
BIM 23A760 2 mg subcutaneous 24 weekly injections.
|
Arm C: BIM 23A760 4 mg
BIM 23A760 4 mg subcutaneous 24 weekly injections.
|
Arm D: BIM 23A760 6 mg
BIM 23A760 6 mg subcutaneous 24 weekly injections.
|
|---|---|---|---|---|
|
ITT (Intention-to-Treat) - Part A
Adverse Event
|
0
|
1
|
0
|
0
|
|
ITT (Intention-to-Treat) - Part A
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
ITT (Intention-to-Treat) - Part A
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
ITT (Intention-to-Treat) - Part A
Withdrawn - Study termination by sponsor
|
13
|
12
|
13
|
14
|
|
ITT (Intention-to-Treat) - Part B
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
ITT (Intention-to-Treat) - Part B
Withdrawn - Study termination by sponsor
|
4
|
3
|
2
|
2
|
Baseline Characteristics
Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly
Baseline characteristics by cohort
| Measure |
Arm A: BIM 23A760 1 mg
n=19 Participants
BIM 23A760 1 mg subcutaneous 24 weekly injections.
|
Arm B: BIM 23A760 2 mg
n=19 Participants
BIM 23A760 2 mg subcutaneous 24 weekly injections.
|
Arm C: BIM 23A760 4 mg
n=18 Participants
BIM 23A760 4 mg subcutaneous 24 weekly injections.
|
Arm D: BIM 23A760 6 mg
n=20 Participants
BIM 23A760 6 mg subcutaneous 24 weekly injections..
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.8 Years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
48.7 Years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
40.3 Years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
43.4 Years
STANDARD_DEVIATION 12.9 • n=4 Participants
|
43.8 Years
STANDARD_DEVIATION 11.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiple race
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
Brazil
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Region of Enrollment
Czech Republic
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
Lithuania
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
Mexico
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Region of Enrollment
Ukraine
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
Latvia
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
Sweden
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Height
|
170.1 cm
STANDARD_DEVIATION 8.1 • n=5 Participants
|
170.3 cm
STANDARD_DEVIATION 13.2 • n=7 Participants
|
175.0 cm
STANDARD_DEVIATION 10.1 • n=5 Participants
|
166.4 cm
STANDARD_DEVIATION 8.6 • n=4 Participants
|
170.3 cm
STANDARD_DEVIATION 10.4 • n=21 Participants
|
|
Diabetic status at entry
Diabetic
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Diabetic status at entry
Non-diabetic
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Insulin-like growth factor 1 (IGF-1)
|
307 Percentage of ULN(Upper limit of number)
n=5 Participants
|
315 Percentage of ULN(Upper limit of number)
n=7 Participants
|
382 Percentage of ULN(Upper limit of number)
n=5 Participants
|
335 Percentage of ULN(Upper limit of number)
n=4 Participants
|
333 Percentage of ULN(Upper limit of number)
n=21 Participants
|
|
Growth Hormone (GH)
|
16.79 ng/mL
STANDARD_DEVIATION 24.56 • n=5 Participants
|
20.99 ng/mL
STANDARD_DEVIATION 59.28 • n=7 Participants
|
28.60 ng/mL
STANDARD_DEVIATION 64.83 • n=5 Participants
|
26.59 ng/mL
STANDARD_DEVIATION 63.47 • n=4 Participants
|
23.21 ng/mL
STANDARD_DEVIATION 55.54 • n=21 Participants
|
|
Baseline Prolactin
Males (n=A:9,B:6,C:12, D:7, and Total:34)
|
11.506 μg/L
STANDARD_DEVIATION 14.233 • n=5 Participants
|
34.113 μg/L
STANDARD_DEVIATION 49.588 • n=7 Participants
|
41.657 μg/L
STANDARD_DEVIATION 60.965 • n=5 Participants
|
83.036 μg/L
STANDARD_DEVIATION 131.024 • n=4 Participants
|
40.86 μg/L
STANDARD_DEVIATION 72.52 • n=21 Participants
|
|
Baseline Prolactin
Pre-menopausal female(n=A:4,B:4,C:4,D:7,&Totl:19)
|
19.838 μg/L
STANDARD_DEVIATION 15.247 • n=5 Participants
|
26.158 μg/L
STANDARD_DEVIATION 19.798 • n=7 Participants
|
35.608 μg/L
STANDARD_DEVIATION 25.536 • n=5 Participants
|
23.634 μg/L
STANDARD_DEVIATION 23.778 • n=4 Participants
|
25.88 μg/L
STANDARD_DEVIATION 21.94 • n=21 Participants
|
|
Baseline Prolactin
Post-menopausal female(n=A:6,B:9,C:2,D:6,&Totl:23)
|
8.420 μg/L
STANDARD_DEVIATION 3.167 • n=5 Participants
|
16.409 μg/L
STANDARD_DEVIATION 24.232 • n=7 Participants
|
7.870 μg/L
STANDARD_DEVIATION 0.693 • n=5 Participants
|
25.118 μg/L
STANDARD_DEVIATION 39.986 • n=4 Participants
|
15.85 μg/L
STANDARD_DEVIATION 25.89 • n=21 Participants
|
|
Ring Finger Circumference
|
70.2 mm
STANDARD_DEVIATION 5.6 • n=5 Participants
|
68.5 mm
STANDARD_DEVIATION 6.2 • n=7 Participants
|
71.2 mm
STANDARD_DEVIATION 4.7 • n=5 Participants
|
68.4 mm
STANDARD_DEVIATION 6.3 • n=4 Participants
|
69.53 mm
STANDARD_DEVIATION 5.75 • n=21 Participants
|
PRIMARY outcome
Timeframe: At Month 6Population: Intention-to-Treat (ITT) population: All randomized subjects who received at least one dose of study medication. N=Number of subjects attended Month 6 (visit 9).
Outcome measures
| Measure |
Arm A: BIM 23A760 1 mg
n=6 Participants
BIM 23A760 1 mg subcutaneous 24 weekly injections.
|
Arm B: BIM 23A760 2 mg
n=7 Participants
BIM 23A760 2 mg subcutaneous 24 weekly injections.
|
Arm C: BIM 23A760 4 mg
n=5 Participants
BIM 23A760 4 mg subcutaneous 24 weekly injections.
|
Arm D: BIM 23A760 6 mg
n=5 Participants
BIM 23A760 6 mg subcutaneous 24 weekly injections.
|
Overall - Part A
|
Part B: Arm B: BIM 23A760 2 mg
|
Part B: Arm C: BIM 23A760 4 mg
|
Part B: Arm D: BIM 23A760 6 mg
|
Overall - Part B
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Mean GH ≤2.5 ng/mL and Normalised IGF-1: No
|
83.3 Percentage of subjects
|
100.0 Percentage of subjects
|
100.0 Percentage of subjects
|
100.0 Percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Missing
|
16.7 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 3Population: ITT population. N=Number of subjects attended Month 3 (visit 7).
Outcome measures
| Measure |
Arm A: BIM 23A760 1 mg
n=12 Participants
BIM 23A760 1 mg subcutaneous 24 weekly injections.
|
Arm B: BIM 23A760 2 mg
n=13 Participants
BIM 23A760 2 mg subcutaneous 24 weekly injections.
|
Arm C: BIM 23A760 4 mg
n=12 Participants
BIM 23A760 4 mg subcutaneous 24 weekly injections.
|
Arm D: BIM 23A760 6 mg
n=13 Participants
BIM 23A760 6 mg subcutaneous 24 weekly injections.
|
Overall - Part A
|
Part B: Arm B: BIM 23A760 2 mg
|
Part B: Arm C: BIM 23A760 4 mg
|
Part B: Arm D: BIM 23A760 6 mg
|
Overall - Part B
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
7.7 Percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Mean GH ≤2.5 ng/mL and Normalised IGF-1: No
|
100 Percentage of subjects
|
100 Percentage of subjects
|
100 Percentage of subjects
|
92.3 Percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Missing
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 1Population: ITT population. N=Number of subjects attended Month 1 (visit 5).
Outcome measures
| Measure |
Arm A: BIM 23A760 1 mg
n=19 Participants
BIM 23A760 1 mg subcutaneous 24 weekly injections.
|
Arm B: BIM 23A760 2 mg
n=18 Participants
BIM 23A760 2 mg subcutaneous 24 weekly injections.
|
Arm C: BIM 23A760 4 mg
n=18 Participants
BIM 23A760 4 mg subcutaneous 24 weekly injections.
|
Arm D: BIM 23A760 6 mg
n=20 Participants
BIM 23A760 6 mg subcutaneous 24 weekly injections.
|
Overall - Part A
|
Part B: Arm B: BIM 23A760 2 mg
|
Part B: Arm C: BIM 23A760 4 mg
|
Part B: Arm D: BIM 23A760 6 mg
|
Overall - Part B
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Missing
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes
|
5.3 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
5.0 Percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Mean GH ≤2.5 ng/mL and Normalised IGF-1: No
|
94.7 Percentage of subjects
|
100 Percentage of subjects
|
100 Percentage of subjects
|
95.0 Percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-3 hr on Baseline (Day 1) and Months 1, 3 and 6Population: N=Number of patients randomised to treatment in IGF-1 \<2.5 x upper limit of normal (ULN) stratum and IGF-1 ≥2.5 x ULN stratum.
Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline
Outcome measures
| Measure |
Arm A: BIM 23A760 1 mg
n=15 Participants
BIM 23A760 1 mg subcutaneous 24 weekly injections.
|
Arm B: BIM 23A760 2 mg
n=15 Participants
BIM 23A760 2 mg subcutaneous 24 weekly injections.
|
Arm C: BIM 23A760 4 mg
n=15 Participants
BIM 23A760 4 mg subcutaneous 24 weekly injections.
|
Arm D: BIM 23A760 6 mg
n=16 Participants
BIM 23A760 6 mg subcutaneous 24 weekly injections.
|
Overall - Part A
|
Part B: Arm B: BIM 23A760 2 mg
|
Part B: Arm C: BIM 23A760 4 mg
|
Part B: Arm D: BIM 23A760 6 mg
|
Overall - Part B
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6
At Month 1: IGF-1<2.5 x ULN
|
4.10 Percentage of change in mean GH
Standard Deviation 53.03
|
-0.55 Percentage of change in mean GH
Standard Deviation 23.98
|
-9.92 Percentage of change in mean GH
Standard Deviation 71.51
|
-17.59 Percentage of change in mean GH
Standard Deviation 41.82
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6
At Month 1: IGF-1≥2.5 x UL
|
-39.20 Percentage of change in mean GH
Standard Deviation 30.33
|
-22.24 Percentage of change in mean GH
Standard Deviation 34.72
|
-10.64 Percentage of change in mean GH
Standard Deviation 51.18
|
-23.63 Percentage of change in mean GH
Standard Deviation 39.57
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6
At Month 6: IGF-1≥2.5 x UL
|
-36.15 Percentage of change in mean GH
Standard Deviation 45.63
|
15.28 Percentage of change in mean GH
Standard Deviation 82.56
|
-10.43 Percentage of change in mean GH
Standard Deviation 28.90
|
-19.47 Percentage of change in mean GH
Standard Deviation 68.90
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6
At Month 3: IGF-1<2.5 x ULN
|
29.26 Percentage of change in mean GH
Standard Deviation 45.97
|
-18.99 Percentage of change in mean GH
Standard Deviation 21.36
|
17.48 Percentage of change in mean GH
Standard Deviation 127.97
|
-28.84 Percentage of change in mean GH
Standard Deviation 43.25
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6
At Month 6: IGF-1<2.5 x ULN
|
71.44 Percentage of change in mean GH
Standard Deviation 35.97
|
3.32 Percentage of change in mean GH
Standard Deviation 9.09
|
82.45 Percentage of change in mean GH
Standard Deviation 0
|
-38.21 Percentage of change in mean GH
Standard Deviation 27.27
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6
At Month 3: IGF-1≥2.5 x UL
|
-26.14 Percentage of change in mean GH
Standard Deviation 39.60
|
-22.35 Percentage of change in mean GH
Standard Deviation 31.71
|
-7.64 Percentage of change in mean GH
Standard Deviation 30.11
|
-20.53 Percentage of change in mean GH
Standard Deviation 42.23
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Month 6Population: ITT population
Outcome measures
| Measure |
Arm A: BIM 23A760 1 mg
n=19 Participants
BIM 23A760 1 mg subcutaneous 24 weekly injections.
|
Arm B: BIM 23A760 2 mg
n=19 Participants
BIM 23A760 2 mg subcutaneous 24 weekly injections.
|
Arm C: BIM 23A760 4 mg
n=18 Participants
BIM 23A760 4 mg subcutaneous 24 weekly injections.
|
Arm D: BIM 23A760 6 mg
n=20 Participants
BIM 23A760 6 mg subcutaneous 24 weekly injections.
|
Overall - Part A
|
Part B: Arm B: BIM 23A760 2 mg
|
Part B: Arm C: BIM 23A760 4 mg
|
Part B: Arm D: BIM 23A760 6 mg
|
Overall - Part B
|
|---|---|---|---|---|---|---|---|---|---|
|
Changes in IGF-1
|
-51.30 Percentage of ULN
Standard Deviation 136.66
|
-53.31 Percentage of ULN
Standard Deviation 80.57
|
-40.53 Percentage of ULN
Standard Deviation 56.65
|
-85.91 Percentage of ULN
Standard Deviation 95.34
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Month 6Population: ITT population. N=Number of subjects attended Month 6 (visit 9).
Percentage change from Baseline at month X = (Ring finger circumference at month X - ring finger circumference at baseline) x 100 / ring finger circumference at baseline.
Outcome measures
| Measure |
Arm A: BIM 23A760 1 mg
n=6 Participants
BIM 23A760 1 mg subcutaneous 24 weekly injections.
|
Arm B: BIM 23A760 2 mg
n=7 Participants
BIM 23A760 2 mg subcutaneous 24 weekly injections.
|
Arm C: BIM 23A760 4 mg
n=5 Participants
BIM 23A760 4 mg subcutaneous 24 weekly injections.
|
Arm D: BIM 23A760 6 mg
n=5 Participants
BIM 23A760 6 mg subcutaneous 24 weekly injections.
|
Overall - Part A
|
Part B: Arm B: BIM 23A760 2 mg
|
Part B: Arm C: BIM 23A760 4 mg
|
Part B: Arm D: BIM 23A760 6 mg
|
Overall - Part B
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in Ring Finger Circumference
|
-3.518 Percentage of Change in Ring Finger circ
Standard Deviation 3.688
|
-1.469 Percentage of Change in Ring Finger circ
Standard Deviation 2.120
|
-0.678 Percentage of Change in Ring Finger circ
Standard Deviation 2.409
|
-4.003 Percentage of Change in Ring Finger circ
Standard Deviation 3.367
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Visit 10 (An average of 6.5 Months)Population: Safety Population Part B: Arm A: BIM 23A760 1 mg- 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
For summaries of intensity and causality, individual patients may be reported in more than one category. In the event of multiple episodes of AEs being reported by the same patient during the study, the maximum intensity (severe \> moderate \> mild) and the most serious causality (related \> not related) have been chosen. TEAE (Treatment emergent adverse event) are reported by Maximum Dose Received in Each Part of the Study.
Outcome measures
| Measure |
Arm A: BIM 23A760 1 mg
n=19 Participants
BIM 23A760 1 mg subcutaneous 24 weekly injections.
|
Arm B: BIM 23A760 2 mg
n=19 Participants
BIM 23A760 2 mg subcutaneous 24 weekly injections.
|
Arm C: BIM 23A760 4 mg
n=18 Participants
BIM 23A760 4 mg subcutaneous 24 weekly injections.
|
Arm D: BIM 23A760 6 mg
n=20 Participants
BIM 23A760 6 mg subcutaneous 24 weekly injections.
|
Overall - Part A
n=76 Participants
|
Part B: Arm B: BIM 23A760 2 mg
n=3 Participants
|
Part B: Arm C: BIM 23A760 4 mg
n=4 Participants
|
Part B: Arm D: BIM 23A760 6 mg
n=5 Participants
|
Overall - Part B
n=12 Participants
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reported Adverse Events During the Study
Moderate
|
3 Participants
|
8 Participants
|
4 Participants
|
7 Participants
|
22 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects Reported Adverse Events During the Study
Related
|
7 Participants
|
8 Participants
|
10 Participants
|
11 Participants
|
36 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reported Adverse Events During the Study
Not Related
|
8 Participants
|
9 Participants
|
6 Participants
|
11 Participants
|
34 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects Reported Adverse Events During the Study
Severe
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reported Adverse Events During the Study
Mild
|
11 Participants
|
9 Participants
|
12 Participants
|
15 Participants
|
47 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
Part A: Arm A: BIM 23A760 1 mg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Part A: Arm B: BIM 23A760 2 mg
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Part A: Arm C: BIM 23A760 4 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Part A: Arm D: BIM 23A760 6 mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Overall - Part A
Serious events: 3 serious events
Other events: 50 other events
Deaths: 0 deaths
Part B: Arm B: BIM 23A760 2 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: Arm C: BIM 23A760 4 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: Arm D: BIM 23A760 6 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Overall - Part B
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Arm A: BIM 23A760 1 mg
n=19 participants at risk
|
Part A: Arm B: BIM 23A760 2 mg
n=19 participants at risk
|
Part A: Arm C: BIM 23A760 4 mg
n=18 participants at risk
|
Part A: Arm D: BIM 23A760 6 mg
n=20 participants at risk
|
Overall - Part A
n=76 participants at risk
|
Part B: Arm B: BIM 23A760 2 mg
n=3 participants at risk
|
Part B: Arm C: BIM 23A760 4 mg
n=4 participants at risk
|
Part B: Arm D: BIM 23A760 6 mg
n=5 participants at risk
|
Overall - Part B
n=12 participants at risk
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/76 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
20.0%
1/5 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
8.3%
1/12 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
2.6%
2/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/76 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
20.0%
1/5 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
8.3%
1/12 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
Other adverse events
| Measure |
Part A: Arm A: BIM 23A760 1 mg
n=19 participants at risk
|
Part A: Arm B: BIM 23A760 2 mg
n=19 participants at risk
|
Part A: Arm C: BIM 23A760 4 mg
n=18 participants at risk
|
Part A: Arm D: BIM 23A760 6 mg
n=20 participants at risk
|
Overall - Part A
n=76 participants at risk
|
Part B: Arm B: BIM 23A760 2 mg
n=3 participants at risk
|
Part B: Arm C: BIM 23A760 4 mg
n=4 participants at risk
|
Part B: Arm D: BIM 23A760 6 mg
n=5 participants at risk
|
Overall - Part B
n=12 participants at risk
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
10.0%
2/20 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
3.9%
3/76 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Eye disorders
EYE IRRITATION
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Eye disorders
LACRIMATION INCREASED
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
15.0%
3/20 • Number of events 5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
7.9%
6/76 • Number of events 9 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
10.0%
2/20 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
4/76 • Number of events 4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Gastrointestinal disorders
DIARRHOEA
|
10.5%
2/19 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 10 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
10.0%
2/20 • Number of events 7 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
7.9%
6/76 • Number of events 21 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Gastrointestinal disorders
FLATULENCE
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
11.1%
2/18 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
6.6%
5/76 • Number of events 5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Gastrointestinal disorders
GASTROINTESTINAL PAIN
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Gastrointestinal disorders
NAUSEA
|
10.5%
2/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
10.5%
2/19 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
11.1%
2/18 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
10.0%
2/20 • Number of events 5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
10.5%
8/76 • Number of events 13 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
3.9%
3/76 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
General disorders
ADMINISTRATION SITE REACTION
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 7 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 7 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
General disorders
APPLICATION SITE ERYTHEMA
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
General disorders
APPLICATION SITE INDURATION
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
2.6%
2/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
General disorders
ASTHENIA
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
2.6%
2/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
General disorders
FATIGUE
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
General disorders
HYPERTHERMIA
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
10.5%
2/19 • Number of events 4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 15 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
15.0%
3/20 • Number of events 10 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
7.9%
6/76 • Number of events 29 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
General disorders
INJECTION SITE INDURATION
|
10.5%
2/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
10.5%
2/19 • Number of events 4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
22.2%
4/18 • Number of events 5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
11.8%
9/76 • Number of events 13 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
General disorders
INJECTION SITE INFLAMMATION
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
General disorders
INJECTION SITE NODULE
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
11.1%
2/18 • Number of events 4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
10.0%
2/20 • Number of events 6 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
7.9%
6/76 • Number of events 12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
General disorders
INJECTION SITE PAIN
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
11.1%
2/18 • Number of events 6 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
10.0%
2/20 • Number of events 5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
4/76 • Number of events 11 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
General disorders
INJECTION SITE PRURITUS
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
10.5%
2/19 • Number of events 4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
16.7%
3/18 • Number of events 16 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
15.0%
3/20 • Number of events 7 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
10.5%
8/76 • Number of events 27 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
General disorders
INJECTION SITE RASH
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
General disorders
INJECTION SITE REACTION
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
10.5%
2/19 • Number of events 4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
10.0%
2/20 • Number of events 9 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
4/76 • Number of events 13 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
General disorders
INJECTION SITE SWELLING
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
3.9%
3/76 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Infections and infestations
SINUSITIS
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
2.6%
2/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
20.0%
1/5 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
8.3%
1/12 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Injury, poisoning and procedural complications
WOUND
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
10.5%
2/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
2.6%
2/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
10.5%
2/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
2.6%
2/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Investigations
BLOOD AMYLASE INCREASED
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Investigations
BLOOD PRESSURE DECREASED
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
11.1%
2/18 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
2.6%
2/76 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Investigations
BLOOD PRESSURE DIASTOLIC INCREASED
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Investigations
BLOOD THYROID STIMULATING HORMONE DECREASED
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
2.6%
2/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Investigations
RED BLOOD CELLS URINE POSITIVE
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Investigations
TRI-IODOTHYRONINE FREE INCREASED
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Investigations
WHITE BLOOD CELLS URINE POSITIVE
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Metabolism and nutrition disorders
IMPAIRED FASTING GLUCOSE
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
2.6%
2/76 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
2.6%
2/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Musculoskeletal and connective tissue disorders
SYNOVITIS
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Nervous system disorders
ACOUSTIC NEURITIS
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Nervous system disorders
DIZZINESS
|
10.5%
2/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
6.6%
5/76 • Number of events 6 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
15.0%
3/20 • Number of events 4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
4/76 • Number of events 6 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Nervous system disorders
PARAESTHESIA
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Nervous system disorders
TRIGEMINAL NEURALGIA
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Reproductive system and breast disorders
MENSTRUATION DELAYED
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
2.6%
2/76 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Skin and subcutaneous tissue disorders
HYPERKERATOSIS
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
5.3%
1/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.0%
1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
2.6%
2/76 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
16.7%
3/18 • Number of events 4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.3%
4/76 • Number of events 5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Vascular disorders
PERIPHERAL COLDNESS
|
5.3%
1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Vascular disorders
PHLEBITIS
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
5.6%
1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
1.3%
1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/12 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/76 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
20.0%
1/5 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
8.3%
1/12 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/76 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
20.0%
1/5 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
8.3%
1/12 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Hepatobiliary disorders
CYTOLYTIC HEPATITIS
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/76 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
25.0%
1/4 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/5 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
8.3%
1/12 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/19 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/18 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/20 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/76 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/3 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
0.00%
0/4 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
20.0%
1/5 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
8.3%
1/12 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months)
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place