Trial Outcomes & Findings for Phase 1/2 Study in Boys With Duchenne Muscular Dystrophy (NCT NCT02439216)
NCT ID: NCT02439216
Last Updated: 2022-09-23
Results Overview
The LLC5-T2 calculated from the unweighted average of the T2 relaxation times of all 5 lower leg muscles for each patient at each evaluation (the medial gastrocnemius, peroneals, soleus, tibialis anterior, and tibialis posterior muscles). Increases in LLC5-T2 relaxation time indicate muscle damage, inflammation, edema, and fat infiltration and are highly correlated with muscle fat
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2022-09-23
Participant Flow
This was a 3-part, Phase 1/2, multi-centre study conducted at 5 study centers in United States.
A total of 32 patients were treated with edasalonexent in this study. 17 patients were enrolled in Part A and 16 completed 7 days of dosing, 1 patient screen failed due to inability to comply with study procedures and did not continue to Part B. A total of 31 patients (16 subjects from Part A and 15 New subjects who entered Part B) were enrolled in Part B, and all completed the 12 weeks of dosing. All 31 patients included in Part B enrolled in the open-label long-term extension phase, Part C.
Participant milestones
| Measure |
Part A: Dose 1
Edasalonexent 33 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part A: Dose 2
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part A: Dose 3
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B: Dose 1
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part B: Dose 2
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B: Placebo 1
Placebo 67 mg/kg/day Capsules taken by mouth two times per day
|
Part B: Placebo 2
Placebo 100 mg/kg/day Capsules taken by mouth three times per day
|
Part C: Dose 1
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part C: Dose 2
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
|---|---|---|---|---|---|---|---|---|---|
|
PartA(7 Day Open-Label Treatment Period)
STARTED
|
5
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PartA(7 Day Open-Label Treatment Period)
COMPLETED
|
4
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PartA(7 Day Open-Label Treatment Period)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (12-week Double Blind)
STARTED
|
0
|
0
|
0
|
10
|
10
|
5
|
6
|
0
|
0
|
|
Part B (12-week Double Blind)
COMPLETED
|
0
|
0
|
0
|
10
|
10
|
5
|
6
|
0
|
0
|
|
Part B (12-week Double Blind)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part C (138-week, Open-label Treatment)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
16
|
|
Part C (138-week, Open-label Treatment)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
5
|
|
Part C (138-week, Open-label Treatment)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
11
|
Reasons for withdrawal
| Measure |
Part A: Dose 1
Edasalonexent 33 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part A: Dose 2
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part A: Dose 3
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B: Dose 1
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part B: Dose 2
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B: Placebo 1
Placebo 67 mg/kg/day Capsules taken by mouth two times per day
|
Part B: Placebo 2
Placebo 100 mg/kg/day Capsules taken by mouth three times per day
|
Part C: Dose 1
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part C: Dose 2
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
|---|---|---|---|---|---|---|---|---|---|
|
PartA(7 Day Open-Label Treatment Period)
Screen failure
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part C (138-week, Open-label Treatment)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part C (138-week, Open-label Treatment)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Part C (138-week, Open-label Treatment)
Progressive disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Part C (138-week, Open-label Treatment)
Withdrawal by Parent or Guardian
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
6
|
Baseline Characteristics
Analysis population are reported separately based on Part A and Part B.
Baseline characteristics by cohort
| Measure |
Part A -CAT-1004 33 mg/kg/Day
n=5 Participants
Edasalonexent 33 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part A - CAT-1004 67 mg/kg/Day
n=6 Participants
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part A - CAT-1004 100 mg/kg/Day
n=6 Participants
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B - CAT-1004 67 mg/kg/Day
n=10 Participants
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part B - CAT-1004 100 mg/kg/Day
n=10 Participants
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B: Overall Placebo
n=11 Participants
Placebo1:Placebo 67 mg/kg/day Capsules taken by mouth two times per day Placebo2: Placebo 100 mg/kg/day Capsules taken by mouth three times per day
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Part A
|
5.2 years
STANDARD_DEVIATION 1.10 • n=5 Participants • Analysis population are reported separately based on Part A and Part B.
|
5.5 years
STANDARD_DEVIATION 0.55 • n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
5.7 years
STANDARD_DEVIATION 1.21 • n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
—
|
—
|
—
|
5.5 years
STANDARD_DEVIATION 0.94 • n=17 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Age, Continuous
Part B
|
—
|
—
|
—
|
5.97 years
STANDARD_DEVIATION 1.137 • n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
6.00 years
STANDARD_DEVIATION 1.165 • n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
6.34 years
STANDARD_DEVIATION 1.032 • n=11 Participants • Analysis population are reported separately based on Part A and Part B.
|
6.11 years
STANDARD_DEVIATION 1.086 • n=31 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Sex: Female, Male
Part A · Female
|
0 Participants
n=5 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
—
|
—
|
—
|
0 Participants
n=17 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Sex: Female, Male
Part A · Male
|
5 Participants
n=5 Participants • Analysis population are reported separately based on Part A and Part B.
|
6 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
6 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
—
|
—
|
—
|
17 Participants
n=17 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Sex: Female, Male
Part B · Female
|
—
|
—
|
—
|
0 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=11 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=31 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Sex: Female, Male
Part B · Male
|
—
|
—
|
—
|
10 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
10 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
11 Participants
n=11 Participants • Analysis population are reported separately based on Part A and Part B.
|
31 Participants
n=31 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Ethnicity (NIH/OMB)
Part A · Hispanic or Latino
|
0 Participants
n=5 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
1 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
—
|
—
|
—
|
1 Participants
n=17 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Ethnicity (NIH/OMB)
Part A · Not Hispanic or Latino
|
4 Participants
n=5 Participants • Analysis population are reported separately based on Part A and Part B.
|
6 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
5 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
—
|
—
|
—
|
15 Participants
n=17 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Ethnicity (NIH/OMB)
Part A · Unknown or Not Reported
|
1 Participants
n=5 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
—
|
—
|
—
|
1 Participants
n=17 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Ethnicity (NIH/OMB)
Part B · Hispanic or Latino
|
—
|
—
|
—
|
2 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
1 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=11 Participants • Analysis population are reported separately based on Part A and Part B.
|
3 Participants
n=31 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Ethnicity (NIH/OMB)
Part B · Not Hispanic or Latino
|
—
|
—
|
—
|
8 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
9 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
11 Participants
n=11 Participants • Analysis population are reported separately based on Part A and Part B.
|
28 Participants
n=31 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Ethnicity (NIH/OMB)
Part B · Unknown or Not Reported
|
—
|
—
|
—
|
0 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=11 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=31 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Race (NIH/OMB)
Part A · American Indian or Alaska Native
|
0 Participants
n=5 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
—
|
—
|
—
|
0 Participants
n=17 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Race (NIH/OMB)
Part A · Asian
|
0 Participants
n=5 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
—
|
—
|
—
|
0 Participants
n=17 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Race (NIH/OMB)
Part A · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
—
|
—
|
—
|
0 Participants
n=17 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Race (NIH/OMB)
Part A · Black or African American
|
0 Participants
n=5 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
—
|
—
|
—
|
0 Participants
n=17 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Race (NIH/OMB)
Part A · White
|
5 Participants
n=5 Participants • Analysis population are reported separately based on Part A and Part B.
|
6 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
6 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
—
|
—
|
—
|
17 Participants
n=17 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Race (NIH/OMB)
Part A · More than one race
|
0 Participants
n=5 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
—
|
—
|
—
|
0 Participants
n=17 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Race (NIH/OMB)
Part A · Unknown or Not Reported
|
0 Participants
n=5 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B.
|
—
|
—
|
—
|
0 Participants
n=17 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Race (NIH/OMB)
Part B · American Indian or Alaska Native
|
—
|
—
|
—
|
0 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=11 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=31 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Race (NIH/OMB)
Part B · Asian
|
—
|
—
|
—
|
1 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=11 Participants • Analysis population are reported separately based on Part A and Part B.
|
1 Participants
n=31 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Race (NIH/OMB)
Part B · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
0 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
1 Participants
n=11 Participants • Analysis population are reported separately based on Part A and Part B.
|
1 Participants
n=31 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Race (NIH/OMB)
Part B · Black or African American
|
—
|
—
|
—
|
0 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
1 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=11 Participants • Analysis population are reported separately based on Part A and Part B.
|
1 Participants
n=31 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Race (NIH/OMB)
Part B · White
|
—
|
—
|
—
|
9 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
9 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
9 Participants
n=11 Participants • Analysis population are reported separately based on Part A and Part B.
|
27 Participants
n=31 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Race (NIH/OMB)
Part B · More than one race
|
—
|
—
|
—
|
0 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=11 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=31 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Race (NIH/OMB)
Part B · Unknown or Not Reported
|
—
|
—
|
—
|
0 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
0 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B.
|
1 Participants
n=11 Participants • Analysis population are reported separately based on Part A and Part B.
|
1 Participants
n=31 Participants • Analysis population are reported separately based on Part A and Part B.
|
|
Region of Enrollment
United States · Part A
|
5 Participants
n=5 Participants • Analysis population are reported separately based on Part A and Part B
|
6 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B
|
6 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B
|
0 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B
|
0 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B
|
0 Participants
n=11 Participants • Analysis population are reported separately based on Part A and Part B
|
17 Participants
n=48 Participants • Analysis population are reported separately based on Part A and Part B
|
|
Region of Enrollment
United States · Part B
|
0 Participants
n=5 Participants • Analysis population are reported separately based on Part A and Part B
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B
|
0 Participants
n=6 Participants • Analysis population are reported separately based on Part A and Part B
|
10 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B
|
10 Participants
n=10 Participants • Analysis population are reported separately based on Part A and Part B
|
11 Participants
n=11 Participants • Analysis population are reported separately based on Part A and Part B
|
31 Participants
n=48 Participants • Analysis population are reported separately based on Part A and Part B
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Part B Full Analysis Population: The Full Analysis Population was a modified intent-to-treat population and consisted of all patients who received at least 1 dose of investigational product (IP) in Part B and had a valid baseline and at least 1 post baseline timed function test (TFT) or MRI efficacy assessment.
The LLC5-T2 calculated from the unweighted average of the T2 relaxation times of all 5 lower leg muscles for each patient at each evaluation (the medial gastrocnemius, peroneals, soleus, tibialis anterior, and tibialis posterior muscles). Increases in LLC5-T2 relaxation time indicate muscle damage, inflammation, edema, and fat infiltration and are highly correlated with muscle fat
Outcome measures
| Measure |
Part B - CAT-1004 67 mg/kg/Day
n=10 Participants
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part B - CAT-1004 100 mg/kg/Day
n=10 Participants
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B - Placebo (Overall)
n=11 Participants
Placebo 67 mg/kg/day Capsules taken by mouth two times per day
Placebo 100 mg/kg/day Capsules taken by mouth three times per day
|
Part B - CAT-1004 67 mg/kg/Day
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part B - CAT-1004 100 mg/kg/Day
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B - Overall Placebo
Placebo 67 mg/kg/day Capsules taken by mouth two times per day
Placebo 100 mg/kg/day Capsules taken by mouth three times per day
|
Part C - CAT-1004 67 mg/kg/Day
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part C - CAT-1004 100 mg/kg/Day
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 12 in the Lower Leg Composite of the MRI T2 Relaxation Time (LLC5-T2) - Part B
Baseline to Week 12 Endpoint - Soleus
|
2.04 msec
Standard Deviation 3.179
|
1.26 msec
Standard Deviation 2.913
|
0.34 msec
Standard Deviation 2.380
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Week 12 in the Lower Leg Composite of the MRI T2 Relaxation Time (LLC5-T2) - Part B
Baseline to Week 12 Endpoint - Medial Gastrocnemius
|
0.35 msec
Standard Deviation 2.410
|
-0.16 msec
Standard Deviation 2.003
|
1.16 msec
Standard Deviation 2.517
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Week 12 in the Lower Leg Composite of the MRI T2 Relaxation Time (LLC5-T2) - Part B
Baseline to Week 12 Endpoint - Tibialis Anterior
|
-0.25 msec
Standard Deviation 2.558
|
0.01 msec
Standard Deviation 1.433
|
0.00 msec
Standard Deviation 1.878
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Week 12 in the Lower Leg Composite of the MRI T2 Relaxation Time (LLC5-T2) - Part B
Baseline to Week 12 Endpoint - Tibialis Posterior
|
0.62 msec
Standard Deviation 1.107
|
-1.05 msec
Standard Deviation 2.447
|
-0.42 msec
Standard Deviation 2.716
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Week 12 in the Lower Leg Composite of the MRI T2 Relaxation Time (LLC5-T2) - Part B
Baseline to Week 12 Endpoint - Peroneal
|
0.28 msec
Standard Deviation 2.764
|
0.63 msec
Standard Deviation 2.290
|
1.27 msec
Standard Deviation 1.630
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The Active B or C Full Analysis Population consisted of the pooled patient populations of Parts B and C that received treatment in either part and had valid baseline and efficacy measurements.
The 10MWT determines the speed to walk a distance of 10 meters. The initial measurement was made in seconds and the speed of completing the test (i.e., calculated as the reciprocals of the time to complete; speed=1/time) is provided as the measure. For patients who are not able to complete the test, the speed of 0 will be imputed.
Outcome measures
| Measure |
Part B - CAT-1004 67 mg/kg/Day
n=15 Participants
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part B - CAT-1004 100 mg/kg/Day
n=16 Participants
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B - Placebo (Overall)
n=11 Participants
Placebo 67 mg/kg/day Capsules taken by mouth two times per day
Placebo 100 mg/kg/day Capsules taken by mouth three times per day
|
Part B - CAT-1004 67 mg/kg/Day
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part B - CAT-1004 100 mg/kg/Day
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B - Overall Placebo
Placebo 67 mg/kg/day Capsules taken by mouth two times per day
Placebo 100 mg/kg/day Capsules taken by mouth three times per day
|
Part C - CAT-1004 67 mg/kg/Day
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part C - CAT-1004 100 mg/kg/Day
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Speed of Completing the 10-meter Walk/Run Test (10MWT) at Week 12 - Part B and Part C
|
-0.0008 10 meters/sec
Standard Deviation 0.01742
|
-0.0041 10 meters/sec
Standard Deviation 0.01584
|
-0.0100 10 meters/sec
Standard Deviation 0.01627
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The Active B or C Full Analysis Population consisted of the pooled patient populations of Parts B and C that received treatment in either part and had valid baseline and efficacy measurements.
The 4-stair climb test determines the speed to climb 4 standard steps. The initial measurement was made in seconds and the speed of completing the test (i.e., calculated as the reciprocals of the time to complete; speed=1/time) is provided as the measure. For patients who are not able to complete the test, the speed of 0 will be imputed.
Outcome measures
| Measure |
Part B - CAT-1004 67 mg/kg/Day
n=15 Participants
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part B - CAT-1004 100 mg/kg/Day
n=16 Participants
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B - Placebo (Overall)
n=11 Participants
Placebo 67 mg/kg/day Capsules taken by mouth two times per day
Placebo 100 mg/kg/day Capsules taken by mouth three times per day
|
Part B - CAT-1004 67 mg/kg/Day
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part B - CAT-1004 100 mg/kg/Day
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B - Overall Placebo
Placebo 67 mg/kg/day Capsules taken by mouth two times per day
Placebo 100 mg/kg/day Capsules taken by mouth three times per day
|
Part C - CAT-1004 67 mg/kg/Day
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part C - CAT-1004 100 mg/kg/Day
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Speed of Completing the 4-Stairs Climb Task at Week 12 - Part B and Part C
|
-0.0032 4 Stairs/Sec
Standard Deviation 0.07487
|
-0.0046 4 Stairs/Sec
Standard Deviation 0.06223
|
-0.0121 4 Stairs/Sec
Standard Deviation 0.06647
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Active B or C Full Analysis Population
The stand from supine test determines the speed to stand from a supine position. The initial measurement was made in seconds and the speed of completing the test (i.e., calculated as the reciprocals of the time to complete; speed=1/time) is provided as the measure. For patients who are not able to complete the test, the speed of 0 will be imputed.
Outcome measures
| Measure |
Part B - CAT-1004 67 mg/kg/Day
n=15 Participants
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part B - CAT-1004 100 mg/kg/Day
n=16 Participants
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B - Placebo (Overall)
n=11 Participants
Placebo 67 mg/kg/day Capsules taken by mouth two times per day
Placebo 100 mg/kg/day Capsules taken by mouth three times per day
|
Part B - CAT-1004 67 mg/kg/Day
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part B - CAT-1004 100 mg/kg/Day
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B - Overall Placebo
Placebo 67 mg/kg/day Capsules taken by mouth two times per day
Placebo 100 mg/kg/day Capsules taken by mouth three times per day
|
Part C - CAT-1004 67 mg/kg/Day
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part C - CAT-1004 100 mg/kg/Day
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Speed of Completing the Stand From Supine Task at Week 12 - Part B and Part C
|
-0.0293 /Sec
Standard Deviation 0.04930
|
-0.0042 /Sec
Standard Deviation 0.03890
|
-0.0007 /Sec
Standard Deviation 0.05449
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening to Week 152Population: Part A Safety Population (referred to in tables as All Dosed Patients) The Safety Population was all patients who received at least 1 dose of IP in Part A. Part B Safety Population: The Safety Population was all patients who received at least 1 dose of IP in Part B. Active B or C Safety Population: The Safety Population was all patients who received at least 1 dose of active treatment in Part B and all patients who received placebo in Part B and at least 1 dose of active treatment in Part C.
A TEAE was any adverse event (AE) that started during or after the first dose of IP through the end of the safety follow-up period. Part B TEAEs were those that started on or after the first dose date in Part B through the date of Week 12 clinic dose. TEAEs for the Part C (Active B or C) analysis were those that started on or after the first dose date of active treatment in Part B or Part C. Drug related AEs included those marked as "Related" or "Possibly Related" to the study treatment.
Outcome measures
| Measure |
Part B - CAT-1004 67 mg/kg/Day
n=5 Participants
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part B - CAT-1004 100 mg/kg/Day
n=5 Participants
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B - Placebo (Overall)
n=6 Participants
Placebo 67 mg/kg/day Capsules taken by mouth two times per day
Placebo 100 mg/kg/day Capsules taken by mouth three times per day
|
Part B - CAT-1004 67 mg/kg/Day
n=10 Participants
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part B - CAT-1004 100 mg/kg/Day
n=10 Participants
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B - Overall Placebo
n=11 Participants
Placebo 67 mg/kg/day Capsules taken by mouth two times per day
Placebo 100 mg/kg/day Capsules taken by mouth three times per day
|
Part C - CAT-1004 67 mg/kg/Day
n=15 Participants
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part C - CAT-1004 100 mg/kg/Day
n=16 Participants
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability Measured by Number of Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Patients with any TEAE leading to study drug discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability Measured by Number of Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Patients with drug-related TEAEs leading to study drug discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability Measured by Number of Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Patients with any AEs after first dose
|
2 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability Measured by Number of Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Patients with any drug-related TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
7 Participants
|
1 Participants
|
8 Participants
|
11 Participants
|
|
Safety and Tolerability Measured by Number of Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Patients with any TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
8 Participants
|
10 Participants
|
15 Participants
|
16 Participants
|
|
Safety and Tolerability Measured by Number of Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Patients with any AE related to study drug
|
2 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability Measured by Number of Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Patients with any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability Measured by Number of Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Patients with any AE leading to discontinuation from study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Part A - CAT-1004 33 mg/kg/Day
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A - CAT-1004 67 mg/kg/Day
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A - CAT-1004 100 mg/kg/Day
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B - CAT-1004 67 mg/kg/Day
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part B - CAT-1004 100 mg/kg/Day
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B - Overall Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part C - CAT-1004 67 mg/kg/Day
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Part C - CAT-1004 100 mg/kg/Day
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A - CAT-1004 33 mg/kg/Day
n=5 participants at risk
Edasalonexent 33 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part A - CAT-1004 67 mg/kg/Day
n=6 participants at risk
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part A - CAT-1004 100 mg/kg/Day
n=6 participants at risk
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B - CAT-1004 67 mg/kg/Day
n=10 participants at risk
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part B - CAT-1004 100 mg/kg/Day
n=10 participants at risk
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B - Overall Placebo
n=11 participants at risk
Placebo 67 mg/kg/day Capsules taken by mouth two times per day
Placebo 100 mg/kg/day Capsules taken by mouth three times per day
|
Part C - CAT-1004 67 mg/kg/Day
n=15 participants at risk
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part C - CAT-1004 100 mg/kg/Day
n=16 participants at risk
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
Other adverse events
| Measure |
Part A - CAT-1004 33 mg/kg/Day
n=5 participants at risk
Edasalonexent 33 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part A - CAT-1004 67 mg/kg/Day
n=6 participants at risk
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part A - CAT-1004 100 mg/kg/Day
n=6 participants at risk
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B - CAT-1004 67 mg/kg/Day
n=10 participants at risk
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part B - CAT-1004 100 mg/kg/Day
n=10 participants at risk
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
Part B - Overall Placebo
n=11 participants at risk
Placebo 67 mg/kg/day Capsules taken by mouth two times per day
Placebo 100 mg/kg/day Capsules taken by mouth three times per day
|
Part C - CAT-1004 67 mg/kg/Day
n=15 participants at risk
Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day
Edasalonexent
|
Part C - CAT-1004 100 mg/kg/Day
n=16 participants at risk
Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day
Edasalonexent
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Eye disorders
Dry eye
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Eye disorders
Excessive eye blinking
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Eye disorders
Eyelid rash
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
66.7%
4/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
40.0%
4/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
50.0%
5/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
46.7%
7/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
62.5%
10/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Gastrointestinal disorders
Faeces soft
|
20.0%
1/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
16.7%
1/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
16.7%
1/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
1/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
16.7%
1/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
2/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
2/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
3/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
25.0%
4/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
16.7%
1/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
16.7%
1/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
30.0%
3/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
46.7%
7/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
43.8%
7/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
16.7%
1/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
2/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
13.3%
2/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
2/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
3/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
18.8%
3/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
3/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
12.5%
2/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
36.4%
4/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
33.3%
5/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
50.0%
8/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
General disorders
Pain
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
12.5%
2/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
General disorders
Influenza like illness
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
3/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
General disorders
Fatigue
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
General disorders
Gait disturbance
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
16.7%
1/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
16.7%
1/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
2/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
40.0%
6/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
25.0%
4/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Ear infection
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
2/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
26.7%
4/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
31.2%
5/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Viral rash
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
18.2%
2/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
37.5%
6/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
25.0%
4/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Influenza
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
18.8%
3/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
13.3%
2/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
13.3%
2/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
16.7%
1/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
40.0%
4/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
2/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
36.4%
4/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
80.0%
12/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
75.0%
12/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
2/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
33.3%
5/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
18.8%
3/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
13.3%
2/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
12.5%
2/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
3/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
25.0%
4/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
3/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
12.5%
2/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
3/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
12.5%
2/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
12.5%
2/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Investigations
Coagulation time prolonged
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
16.7%
1/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
12.5%
2/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Investigations
Blood urine present
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Investigations
Body temperature increased
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Investigations
Cardiac murmur
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Investigations
Influenza B virus test positive
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Investigations
Protein urine present
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
16.7%
1/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
2/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
13.3%
2/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
25.0%
4/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
16.7%
1/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
3/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Musculoskeletal and connective tissue disorders
Tendinous contracture
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Musculoskeletal and connective tissue disorders
Weight bearing difficulty
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
16.7%
1/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
18.8%
3/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
16.7%
1/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
13.3%
2/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Psychiatric disorders
Impulsive behaviour
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Psychiatric disorders
Stubbornness
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Psychiatric disorders
Negativism
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Psychiatric disorders
Sleep terror
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Psychiatric disorders
Tic
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Renal and urinary disorders
Enuresis
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
16.7%
1/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
2/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
20.0%
2/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
33.3%
5/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
31.2%
5/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
18.2%
2/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
26.7%
4/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
56.2%
9/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
13.3%
2/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
18.8%
3/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
12.5%
2/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
20.0%
1/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
16.7%
1/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
16.7%
1/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
12.5%
2/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
12.5%
2/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Congenital, familial and genetic disorders
Pectus excavatum
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
General disorders
Thirst
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
General disorders
Abasia
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
General disorders
Catheter site pain
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
General disorders
Device occlusion
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
General disorders
Peripheral swelling
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Body tinea
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
9.1%
1/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Viral infection
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
10.0%
1/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Impetigo
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.2%
1/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/5 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/6 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/10 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/11 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
6.7%
1/15 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
0.00%
0/16 • Upto 152 weeks
Adverse events were collected from the time of signing the informed consent through study completion. A TEAE was an adverse event that started during or after the first dose of investigational product during Part B through the date of Week 12 clinic dose. At each level of summation (overall, system organ class, preferred term), patients reporting more than 1 AE were counted only once for the total incidence.
|
Additional Information
Andrew Nichols, PhD - Chief Scientific Officer
Astria Therapeutics, Inc
Phone: 617-349-1971
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place