Trial Outcomes & Findings for Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease (NCT NCT03225846)
NCT ID: NCT03225846
Last Updated: 2022-04-25
Results Overview
All TEAEs reported or observed during the study, including TEAEs resulting from concurrent illnesses, reactions to concurrent medications, or progression of disease states
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
88 participants
Primary outcome timeframe
Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])
Results posted on
2022-04-25
Participant Flow
Participant milestones
| Measure |
Pooled Placebo
Placebo: 0.9% Sodium Chloride
|
WVE-120102 (2 mg)
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (4 mg)
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (8 mg)
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (12 mg)
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (16 mg)
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (32 mg )
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
9
|
12
|
15
|
8
|
9
|
13
|
|
Overall Study
Single Dose Period Only
|
6
|
3
|
4
|
7
|
8
|
0
|
4
|
|
Overall Study
Multiple Dose Period Only
|
3
|
0
|
3
|
6
|
0
|
0
|
4
|
|
Overall Study
Single Dose and Multiple Dose
|
13
|
6
|
5
|
2
|
0
|
9
|
5
|
|
Overall Study
COMPLETED
|
22
|
7
|
11
|
15
|
8
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
0
|
0
|
0
|
7
|
Reasons for withdrawal
| Measure |
Pooled Placebo
Placebo: 0.9% Sodium Chloride
|
WVE-120102 (2 mg)
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (4 mg)
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (8 mg)
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (12 mg)
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (16 mg)
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (32 mg )
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Patient did not wish to comply with IC/EC
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Patient decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease
Baseline characteristics by cohort
| Measure |
Pooled Placebo
n=22 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120102 (2 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (4 mg)
n=12 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (8 mg)
n=15 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (12 mg)
n=8 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (16 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (32 mg )
n=13 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.8 Years
STANDARD_DEVIATION 10.16 • n=5 Participants
|
52.4 Years
STANDARD_DEVIATION 11.59 • n=7 Participants
|
46 Years
STANDARD_DEVIATION 10.63 • n=5 Participants
|
49.3 Years
STANDARD_DEVIATION 10.40 • n=4 Participants
|
47.1 Years
STANDARD_DEVIATION 8.48 • n=21 Participants
|
53.1 Years
STANDARD_DEVIATION 8.33 • n=8 Participants
|
54.1 Years
STANDARD_DEVIATION 8.88 • n=8 Participants
|
50.3 Years
STANDARD_DEVIATION 9.96 • n=24 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
42 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
46 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
87 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
88 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
6 participants
n=8 Participants
|
0 participants
n=8 Participants
|
26 participants
n=24 Participants
|
|
Region of Enrollment
Denmark
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
5 participants
n=24 Participants
|
|
Region of Enrollment
Poland
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
1 participants
n=8 Participants
|
13 participants
n=24 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
0 participants
n=8 Participants
|
4 participants
n=24 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
7 participants
n=8 Participants
|
9 participants
n=24 Participants
|
|
Region of Enrollment
France
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
1 participants
n=24 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
4 participants
n=8 Participants
|
5 participants
n=24 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
7 participants
n=4 Participants
|
8 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
25 participants
n=24 Participants
|
|
Time since initial diagnosis
|
6.1 Years
STANDARD_DEVIATION 5.95 • n=5 Participants
|
9.9 Years
STANDARD_DEVIATION 8.80 • n=7 Participants
|
3.8 Years
STANDARD_DEVIATION 3.62 • n=5 Participants
|
5.6 Years
STANDARD_DEVIATION 2.80 • n=4 Participants
|
3.9 Years
STANDARD_DEVIATION 3.23 • n=21 Participants
|
3.2 Years
STANDARD_DEVIATION 5.61 • n=8 Participants
|
5.6 Years
STANDARD_DEVIATION 9.28 • n=8 Participants
|
5.3 Years
STANDARD_DEVIATION 6.21 • n=24 Participants
|
|
Age at disease onset
|
40.18 Years
STANDARD_DEVIATION 10.527 • n=5 Participants
|
42.00 Years
STANDARD_DEVIATION 16.363 • n=7 Participants
|
41.75 Years
STANDARD_DEVIATION 12.129 • n=5 Participants
|
43.33 Years
STANDARD_DEVIATION 9.378 • n=4 Participants
|
42.50 Years
STANDARD_DEVIATION 9.289 • n=21 Participants
|
49.00 Years
STANDARD_DEVIATION 6.652 • n=8 Participants
|
48.08 Years
STANDARD_DEVIATION 12.796 • n=8 Participants
|
44.47 Years
STANDARD_DEVIATION 11.410 • n=24 Participants
|
|
Diagnosis stage
Stage 1
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
45 Participants
n=24 Participants
|
|
Diagnosis stage
Stage 2
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
43 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])Population: No statistical analysis has been performed on these safety results
All TEAEs reported or observed during the study, including TEAEs resulting from concurrent illnesses, reactions to concurrent medications, or progression of disease states
Outcome measures
| Measure |
Pooled Placebo
n=22 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120102 (2 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (4 mg)
n=12 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (8 mg)
n=15 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (12 mg)
n=8 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (16 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (32 mg )
n=13 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|---|
|
Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs)
|
20 Participants
|
8 Participants
|
9 Participants
|
13 Participants
|
4 Participants
|
8 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Time Frame: Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])Population: No statistical analysis has been performed on these safety results
Number of patients who experienced a severe treatment-emergent adverse event. Severity was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Outcome measures
| Measure |
Pooled Placebo
n=22 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120102 (2 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (4 mg)
n=12 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (8 mg)
n=15 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (12 mg)
n=8 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (16 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (32 mg )
n=13 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|---|
|
Safety: Number of Patients Who Experienced Severe TEAEs
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Time Frame: Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])Population: No statistical analysis has been performed on these safety results
A serious TEAE is defined as any event that results in death, is immediately life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect not present at Prescreening.
Outcome measures
| Measure |
Pooled Placebo
n=22 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120102 (2 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (4 mg)
n=12 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (8 mg)
n=13 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (12 mg)
n=4 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (16 mg)
n=8 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (32 mg )
n=13 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|---|
|
Safety: Number of Patients With Serious TEAEs
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Time Frame: Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])Population: No statistical analysis has been performed on these safety results
Outcome measures
| Measure |
Pooled Placebo
n=22 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120102 (2 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (4 mg)
n=12 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (8 mg)
n=15 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (12 mg)
n=8 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (16 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (32 mg )
n=13 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|---|
|
Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.Population: Overall number of participants analyzed represents patients with at least 1 postdose plasma or CSF measurement at Day 1. The overall number for Day 112 was different and represents patients with at least 1 postdose plasma or CSF measurement at Day 112. Specimen samples collected following administration of 12 mg dose were not analyzed or tested, and therefore no data are available to be reported for this Arm/Group.
Cmax of WVE-120102 in plasma
Outcome measures
| Measure |
Pooled Placebo
n=9 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120102 (2 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (4 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (8 mg)
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (12 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (16 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (32 mg )
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax)
Day 1
|
1.35 ng/mL
Standard Deviation 2.714
|
8.54 ng/mL
Standard Deviation 6.073
|
29.87 ng/mL
Standard Deviation 31.891
|
—
|
31.49 ng/mL
Standard Deviation 15.801
|
96.21 ng/mL
Standard Deviation 57.394
|
—
|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax)
Day 112
|
7.46 ng/mL
Standard Deviation 15.411
|
15.55 ng/mL
Standard Deviation 14.587
|
36.16 ng/mL
Standard Deviation 30.012
|
—
|
59.49 ng/mL
Standard Deviation 35.718
|
—
|
—
|
SECONDARY outcome
Timeframe: Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.Population: Overall number of participants analyzed represents patients with at least 1 postdose plasma or CSF measurement at Day 1. The overall number for Day 112 was different and represents patients with at least 1 postdose plasma or CSF measurement at Day 112. Specimen samples collected following administration of 12 mg dose were not analyzed or tested, and therefore no data are available to be reported for this Arm/Group.
tmax of WVE-120102 in plasma
Outcome measures
| Measure |
Pooled Placebo
n=9 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120102 (2 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (4 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (8 mg)
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (12 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (16 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (32 mg )
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|---|
|
PK: Time of Occurrence of Cmax (Tmax)
Day 1
|
3.33 hour
Standard Deviation 7.742
|
1.26 hour
Standard Deviation 1.044
|
1.77 hour
Standard Deviation 1.101
|
—
|
1.77 hour
Standard Deviation 1.345
|
3.09 hour
Standard Deviation 3.752
|
—
|
|
PK: Time of Occurrence of Cmax (Tmax)
Day 112
|
1.22 hour
Standard Deviation 0.314
|
1.86 hour
Standard Deviation 0.874
|
2.06 hour
Standard Deviation 1.206
|
—
|
1.98 hour
Standard Deviation 0.828
|
—
|
—
|
SECONDARY outcome
Timeframe: Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.Population: Overall number of participants analyzed represents patients with at least 1 postdose plasma or CSF measurement at Day 1. The overall number for Day 112 was different and represents patients with at least 1 postdose plasma or CSF measurement at Day 112. Specimen samples collected following administration of 12 mg dose were not analyzed or tested, and therefore no data are available to be reported for this Arm/Group.
AUC 0-t from time zero to the last quantifiable concentration of WVE-120102 in plasma
Outcome measures
| Measure |
Pooled Placebo
n=9 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120102 (2 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (4 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (8 mg)
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (12 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (16 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (32 mg )
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|---|
|
PK: Area Under the Plasma Concentration-time Curve (AUC 0-t)
Day 1
|
24.65 hr*ng/mL
Standard Deviation 9.108
|
62.05 hr*ng/mL
Standard Deviation 67.358
|
132.44 hr*ng/mL
Standard Deviation 91.913
|
—
|
804.92 hr*ng/mL
Standard Deviation 1456.786
|
919.14 hr*ng/mL
Standard Deviation 271.997
|
—
|
|
PK: Area Under the Plasma Concentration-time Curve (AUC 0-t)
Day 112
|
23.83 hr*ng/mL
Standard Deviation 23.187
|
35.47 hr*ng/mL
Standard Deviation 22.280
|
107.83 hr*ng/mL
Standard Deviation 70.198
|
—
|
133.22 hr*ng/mL
Standard Deviation 67.683
|
—
|
—
|
SECONDARY outcome
Timeframe: Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.Population: The t1/2 value was calculated using data from patients who had at least 3 postdose concentration values in the terminal phase. No patients had sufficient postdose samples at Day 112 to calculate t1/2 values. Specimen samples collected following administration of 12 mg dose were not analyzed or tested, and therefore no data are available to be reported for this Arm/Group.
Terminal elimination half life of WVE-120102 in plasma (t1/2)
Outcome measures
| Measure |
Pooled Placebo
Placebo: 0.9% Sodium Chloride
|
WVE-120102 (2 mg)
n=2 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (4 mg)
n=1 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (8 mg)
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (12 mg)
n=5 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (16 mg)
n=6 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (32 mg )
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|---|
|
PK: Terminal Elimination Half-life
|
—
|
33.42 hour
Standard Deviation 30.983
|
6.23 hour
Standard Deviation NA
Standard deviation is not applicable with an n=1
|
—
|
13.45 hour
Standard Deviation 4.604
|
18.17 hour
Standard Deviation 20.969
|
—
|
SECONDARY outcome
Timeframe: Day 1 to last observation - up to Day 140 (32 mg cohort) or Day 196 (all other cohorts)Population: The 12 mg dose group was not included in this analysis as these patients only received a single dose and did not attend the Day 140/Day 196 visit.
Percentage change from baseline to last observation in mutant huntingtin protein
Outcome measures
| Measure |
Pooled Placebo
n=16 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120102 (2 mg)
n=6 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (4 mg)
n=8 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (8 mg)
n=8 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (12 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (16 mg)
n=8 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (32 mg )
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD): Percentage Change From Baseline in Mutant Huntingtin Protein
|
-2.64 Percent change from baseline
Interval -14.89 to 11.71
|
3.46 Percent change from baseline
Interval -7.67 to 7.8
|
-3.53 Percent change from baseline
Interval -4.2 to 2.41
|
-3.45 Percent change from baseline
Interval -6.46 to 7.35
|
-5.82 Percent change from baseline
Interval -12.09 to 6.44
|
-2.06 Percent change from baseline
Interval -28.72 to 7.84
|
—
|
SECONDARY outcome
Timeframe: Day 1 Day 1 to last observation - up to Day 140 (32 mg cohort) or Day 196 (all other cohorts)Population: The 12 mg dose group was not included in this analysis as these patients only received a single dose and did not attend the Day 140/Day 196 visit.
Percentage change from baseline to the last measured time point in the Total Functional Capacity score, administered as part of the Unified Huntington's Disease Rating Scale (UHDRS). Total Functional Capacity is scored 13 (normal) to 0 (severe disability)
Outcome measures
| Measure |
Pooled Placebo
n=16 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120102 (2 mg)
n=6 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (4 mg)
n=8 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (8 mg)
n=8 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (12 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (16 mg)
n=9 Participants
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (32 mg )
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|---|
|
Clinical Effects: Total Functional Capacity (TFC)
|
0.0 Percent change from baseline
Interval 0.0 to 0.0
|
0.0 Percent change from baseline
Interval -2.0 to 0.0
|
0.0 Percent change from baseline
Interval 0.0 to 0.0
|
-4.17 Percent change from baseline
Interval -13.89 to 0.0
|
-8.33 Percent change from baseline
Interval -16.67 to 0.0
|
0.00 Percent change from baseline
Interval 0.0 to 0.0
|
—
|
Adverse Events
Pooled Placebo
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
WVE-120102 (2 mg)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
WVE-120102 (4 mg)
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
WVE-120102 (8 mg)
Serious events: 2 serious events
Other events: 15 other events
Deaths: 1 deaths
WVE-120102 (12 mg)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
WVE-120102 (16 mg)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
WVE-120102 (32 mg )
Serious events: 9 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pooled Placebo
n=22 participants at risk
Placebo: 0.9% Sodium Chloride
|
WVE-120102 (2 mg)
n=9 participants at risk
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (4 mg)
n=12 participants at risk
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (8 mg)
n=15 participants at risk
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (12 mg)
n=8 participants at risk
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (16 mg)
n=9 participants at risk
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (32 mg )
n=13 participants at risk
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Number of events 1 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Infections and infestations
Meningitis
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Number of events 1 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Accident at work
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Number of events 1 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Number of events 1 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Amnesia
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
30.8%
4/13 • Number of events 4 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Ataxia
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Number of events 1 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Cerebellar ataxia
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
15.4%
2/13 • Number of events 2 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Number of events 1 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
15.4%
2/13 • Number of events 2 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Syncope
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Number of events 1 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Vertigo CNS origin
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Number of events 1 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Aggression
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Number of events 1 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Number of events 1 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Number of events 1 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Number of events 1 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Delirium
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
30.8%
4/13 • Number of events 4 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
15.4%
2/13 • Number of events 2 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Number of events 1 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
Other adverse events
| Measure |
Pooled Placebo
n=22 participants at risk
Placebo: 0.9% Sodium Chloride
|
WVE-120102 (2 mg)
n=9 participants at risk
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (4 mg)
n=12 participants at risk
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (8 mg)
n=15 participants at risk
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (12 mg)
n=8 participants at risk
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (16 mg)
n=9 participants at risk
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120102 (32 mg )
n=13 participants at risk
WVE-120102: WVE-120102 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic throat clearing
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Vascular disorders
Hypotension
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
22.2%
2/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Vascular disorders
Varicose vein
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
CSF protein increased
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
23.1%
3/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
22.2%
2/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Eye disorders
Dry eye
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Gastrointestinal disorders
Nausea
|
13.6%
3/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
22.2%
2/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
38.5%
5/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
13.3%
2/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
General disorders
Gait disturbance
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
23.1%
3/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
General disorders
Pyrexia
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
General disorders
Fatigue
|
13.6%
3/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
General disorders
Influenza like illness
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
General disorders
Pain
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Infections and infestations
Viral upper respiratory tract infection
|
9.1%
2/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
22.2%
2/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
33.3%
4/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Infections and infestations
Respiratory tract infection
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
33.3%
3/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Infections and infestations
Eye infection
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Infections and infestations
Influenza
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Infections and infestations
Pneumonia
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Infections and infestations
Sinusitis
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Infections and infestations
Upper respiratory tract infection
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
13.6%
3/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
22.2%
2/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
25.0%
3/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
33.3%
3/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Fall
|
13.6%
3/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
55.6%
5/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
13.3%
2/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
9.1%
2/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
25.0%
3/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
13.3%
2/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
55.6%
5/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Contusion
|
9.1%
2/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
13.6%
3/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
22.2%
2/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Chemical burn
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
C-reactive protein increased
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
15.4%
2/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
Chest X-ray abnormal
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
Complement factor C3 decreased
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
Complement factor C3 increased
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
White blood cells urine
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
Blood creatinine phosphokinase increased
|
9.1%
2/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
2/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
55.6%
5/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
15.4%
2/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
22.2%
2/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Musculoskeletal and connective tissue disorders
Athralgia
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Headace
|
36.4%
8/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
33.3%
3/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
25.0%
3/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
20.0%
3/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
66.7%
6/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
38.5%
5/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Dizziness
|
9.1%
2/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
22.2%
2/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
33.3%
3/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
15.4%
2/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Amnesia
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
15.4%
2/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Ataxia
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Cerebellar ataxia
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
22.2%
2/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Hyporeflexia
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
13.3%
2/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
37.5%
3/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Paraesthesia
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
22.2%
2/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Loss of proprioception
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Presyncope
|
9.1%
2/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Syncope
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Cerebral microhaemorrhage
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Chorea
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Disturbance in attention
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Migraine
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Reflexes abnormal
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Tension headache
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Anxiety
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
22.2%
2/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
15.4%
2/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Irritability
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
15.4%
2/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Insomnia
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Abnormal behavior
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Anger
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Apathy
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Generalized anxiety disorder
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
22.2%
2/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
8.3%
1/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
6.7%
1/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
11.1%
1/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
4.5%
1/22 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/12 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/15 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/9 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
7.7%
1/13 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place