Trial Outcomes & Findings for Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease (NCT NCT03225833)
NCT ID: NCT03225833
Last Updated: 2022-02-10
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
61 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
2022-02-10
Participant Flow
Participant milestones
| Measure |
Pooled Placebo
Placebo: 0.9% Sodium Chloride
|
WVE-120101 (2 mg)
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (4 mg)
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (8 mg)
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (16 mg)
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (32 mg)
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
9
|
9
|
9
|
8
|
10
|
|
Overall Study
Single Dose Period Only
|
1
|
1
|
2
|
0
|
0
|
4
|
|
Overall Study
Multiple Dose Period Only
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Single Dose and Multiple Dose Periods
|
15
|
8
|
7
|
9
|
8
|
5
|
|
Overall Study
COMPLETED
|
11
|
8
|
7
|
9
|
7
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
2
|
0
|
1
|
10
|
Reasons for withdrawal
| Measure |
Pooled Placebo
Placebo: 0.9% Sodium Chloride
|
WVE-120101 (2 mg)
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (4 mg)
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (8 mg)
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (16 mg)
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (32 mg)
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Termination of Study by Sponsor
|
4
|
0
|
0
|
0
|
0
|
7
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease
Baseline characteristics by cohort
| Measure |
Pooled Placebo
n=16 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120101 (2 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (4 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (8 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (16 mg)
n=8 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (32 mg)
n=10 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
60 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
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=10 Participants
|
1 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
29 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
32 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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=10 Participants
|
0 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
61 Participants
n=115 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=10 Participants
|
0 Participants
n=115 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=10 Participants
|
0 Participants
n=115 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=10 Participants
|
0 Participants
n=115 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=10 Participants
|
0 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
61 Participants
n=115 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=10 Participants
|
0 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=10 Participants
|
12 participants
n=115 Participants
|
|
Region of Enrollment
Denmark
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Region of Enrollment
Poland
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=10 Participants
|
19 participants
n=115 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
6 participants
n=4 Participants
|
3 participants
n=21 Participants
|
4 participants
n=10 Participants
|
17 participants
n=115 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
2 participants
n=10 Participants
|
4 participants
n=115 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=10 Participants
|
4 participants
n=115 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
3 participants
n=115 Participants
|
|
Time since initial diagnosis
|
7 Years
STANDARD_DEVIATION 6.93 • n=5 Participants
|
4.9 Years
STANDARD_DEVIATION 4.28 • n=7 Participants
|
3.4 Years
STANDARD_DEVIATION 6.37 • n=5 Participants
|
3.2 Years
STANDARD_DEVIATION 3.03 • n=4 Participants
|
6.6 Years
STANDARD_DEVIATION 6.09 • n=21 Participants
|
8.7 Years
STANDARD_DEVIATION 7.26 • n=10 Participants
|
5.4 Years
STANDARD_DEVIATION 5.80 • n=115 Participants
|
|
Age at Disease Onset
|
40.75 Years
STANDARD_DEVIATION 11.079 • n=5 Participants
|
37.33 Years
STANDARD_DEVIATION 7.826 • n=7 Participants
|
42.89 Years
STANDARD_DEVIATION 9.280 • n=5 Participants
|
46.11 Years
STANDARD_DEVIATION 6.254 • n=4 Participants
|
44.88 Years
STANDARD_DEVIATION 12.495 • n=21 Participants
|
44.60 Years
STANDARD_DEVIATION 10.865 • n=10 Participants
|
43.16 Years
STANDARD_DEVIATION 9.625 • n=115 Participants
|
|
Diagnosis Stage
Stage 1
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
33 Participants
n=115 Participants
|
|
Diagnosis Stage
Stage 2
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])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=16 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120101 (2 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (4 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (8 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (16 mg)
n=8 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (32 mg)
n=10 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|
|
Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs)
|
12 Participants
|
8 Participants
|
8 Participants
|
9 Participants
|
7 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])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=16 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120101 (2 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (4 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (8 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (16 mg)
n=8 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (32 mg)
n=10 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|
|
Safety: Severity of Adverse Events
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])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=16 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120101 (2 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (4 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (8 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (16 mg)
n=8 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (32 mg)
n=10 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|
|
Safety: Number of Patients With Serious TEAEs
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])Outcome measures
| Measure |
Pooled Placebo
n=16 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120101 (2 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (4 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (8 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (16 mg)
n=8 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (32 mg)
n=10 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|
|
Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 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: The PK population consists of all treated patients in the safety population with at least 1 post-dose plasma or CSF WVE-120101 concentration measurement. The number of overall participants analyzed represents the number with at least 1 postdose plasma or CSF measurement at Day 1. The overall number of patients was different for Day 112, and represents patients with at least 1 postdose plasma or CSF measurement at Day 112.
Cmax of WVE-120101 in plasma
Outcome measures
| Measure |
Pooled Placebo
n=9 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120101 (2 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (4 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (8 mg)
n=8 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (16 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (32 mg)
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax)
Day 1
|
7.70 ng/mL
Standard Deviation 7.901
|
23.54 ng/mL
Standard Deviation 18.139
|
32.82 ng/mL
Standard Deviation 22.964
|
184.48 ng/mL
Standard Deviation 209.470
|
229.01 ng/mL
Standard Deviation 168.330
|
—
|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax)
Day 112
|
13.296 ng/mL
Standard Deviation 6.057
|
14.27 ng/mL
Standard Deviation 12.574
|
—
|
—
|
—
|
—
|
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 PK population consists of all treated patients in the safety population with at least 1 post-dose plasma or CSF WVE-120101 concentration measurement. The number of overall participants analyzed represents the number with at least 1 postdose plasma or CSF measurement at Day 1. The overall number of patients was different for Day 112, and represents patients with at least 1 postdose plasma or CSF measurement at Day 112.
tmax of WVE-120101 in plasma
Outcome measures
| Measure |
Pooled Placebo
n=9 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120101 (2 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (4 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (8 mg)
n=8 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (16 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (32 mg)
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|
|
PK: Time of Occurrence of Cmax (Tmax)
Day 1
|
1.34 hours
Standard Deviation 1.103
|
1.58 hours
Standard Deviation 1.081
|
2.66 hours
Standard Deviation 1.391
|
2.71 hours
Standard Deviation 3.068
|
4.61 hours
Standard Deviation 7.054
|
—
|
|
PK: Time of Occurrence of Cmax (Tmax)
Day 112
|
1.99 hours
Standard Deviation 0.934
|
2.23 hours
Standard Deviation 1.175
|
—
|
—
|
—
|
—
|
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 PK population consists of all treated patients in the safety population with at least 1 post-dose plasma or CSF WVE-120101 concentration measurement. The number of overall participants analyzed represents the number with at least 1 postdose plasma or CSF measurement at Day 1. The overall number of patients was different for Day 112, and represents patients with at least 1 postdose plasma or CSF measurement at Day 112.
AUClast from time 0 to the last quantifiable concentration of WVE-120101 in plasma
Outcome measures
| Measure |
Pooled Placebo
n=9 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120101 (2 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (4 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (8 mg)
n=8 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (16 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (32 mg)
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|
|
PK: Area Under the Plasma Concentration-time Curve (AUClast)
Day 1
|
35.20 hr*ng/mL
Standard Deviation 16.037
|
90.77 hr*ng/mL
Standard Deviation 50.672
|
255.14 hr*ng/mL
Standard Deviation 98.342
|
1133.74 hr*ng/mL
Standard Deviation 551.997
|
1968.31 hr*ng/mL
Standard Deviation 1188.173
|
—
|
|
PK: Area Under the Plasma Concentration-time Curve (AUClast)
Day 112
|
36.19 hr*ng/mL
Standard Deviation 20.135
|
49.54 hr*ng/mL
Standard Deviation 34.735
|
—
|
—
|
—
|
—
|
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.
Terminal elimination half life of WVE-120101 in plasma (t1/2)
Outcome measures
| Measure |
Pooled Placebo
Placebo: 0.9% Sodium Chloride
|
WVE-120101 (2 mg)
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (4 mg)
n=3 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (8 mg)
n=3 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (16 mg)
n=6 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (32 mg)
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|
|
PK: Terminal Elimination Half Life
|
—
|
—
|
8.12 hours
Interval 7.1 to 40.0
|
12.30 hours
Interval 6.9 to 25.5
|
14.38 hours
Interval 5.5 to 46.9
|
—
|
SECONDARY outcome
Timeframe: Day 1 to last observation - up to Day 140 (32 mg cohort) or Day 196 (all other cohorts)Percentage change from baseline in concentration of mutant huntingtin (mHTT) protein in CSF
Outcome measures
| Measure |
Pooled Placebo
n=16 Participants
Placebo: 0.9% Sodium Chloride
|
WVE-120101 (2 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (4 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (8 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (16 mg)
n=8 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (32 mg)
n=10 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics
|
-6.62 Percent change from baseline
Interval -16.76 to 7.73
|
-5.20 Percent change from baseline
Interval -10.94 to 0.15
|
-12.33 Percent change from baseline
Interval -19.81 to 9.63
|
-8.58 Percent change from baseline
Interval -11.92 to -1.79
|
-11.73 Percent change from baseline
Interval -20.44 to 3.37
|
-9.13 Percent change from baseline
Interval -37.51 to 15.29
|
SECONDARY outcome
Timeframe: Day 1 to last observation - up to Day 140 (32 mg cohort) or Day 196 (all other cohorts)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-120101 (2 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (4 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (8 mg)
n=9 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (16 mg)
n=8 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (32 mg)
n=10 Participants
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|
|
Clinical Effects: Total Functional Capacity (TFC)
|
0.00 % Change from Baseline
Interval -9.09 to 0.0
|
0.00 % Change from Baseline
Interval -4.17 to 9.09
|
0.00 % Change from Baseline
Interval -7.69 to 11.11
|
0.00 % Change from Baseline
Interval -20.0 to 0.0
|
4.17 % Change from Baseline
Interval -3.85 to 10.42
|
0.00 % Change from Baseline
Interval 0.0 to 0.0
|
Adverse Events
Pooled Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
WVE-120101 (2 mg)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
WVE-120101 (4 mg)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
WVE-120101 (8 mg)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
WVE-120101 (16 mg)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
WVE-120101 (32 mg)
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pooled Placebo
n=16 participants at risk
Placebo: 0.9% Sodium Chloride
|
WVE-120101 (2 mg)
n=9 participants at risk
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (4 mg)
n=9 participants at risk
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (8 mg)
n=9 participants at risk
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (16 mg)
n=8 participants at risk
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (32 mg)
n=10 participants at risk
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|
|
General disorders
Gait disturbance
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Ataxia
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Agitation
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Skull Fracture
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Aggression
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
Other adverse events
| Measure |
Pooled Placebo
n=16 participants at risk
Placebo: 0.9% Sodium Chloride
|
WVE-120101 (2 mg)
n=9 participants at risk
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (4 mg)
n=9 participants at risk
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (8 mg)
n=9 participants at risk
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (16 mg)
n=8 participants at risk
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
WVE-120101 (32 mg)
n=10 participants at risk
WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Migraine
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Eye disorders
Dry eye
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
General disorders
Gait disturbance
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
20.0%
2/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
General disorders
Administration site bruise
|
0.00%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
General disorders
Administration site pain
|
0.00%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
General disorders
Asthenia
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
General disorders
Fatigue
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
General disorders
Influenza like illness
|
0.00%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
General disorders
Pain
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
General disorders
Injection site pain
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
General disorders
Vessel puncture site bruise
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
General disorders
Vessel puncture site pain
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • 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
|
6.2%
1/16 • 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])
|
11.1%
1/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • 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%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Infections and infestations
Ear infection
|
0.00%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Infections and infestations
Influenza
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Procedural pain
|
18.8%
3/16 • 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])
|
22.2%
2/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
20.0%
2/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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])
|
25.0%
2/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • 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
|
12.5%
2/16 • 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])
|
22.2%
2/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Contusion
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • 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
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • 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%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • 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%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Foot fracture
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
CSF lymphocyte count increase
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
CSF protein increased
|
0.00%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
CSF white blood cell count increased
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
Neutrophil count increased
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
Platelet count increased
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
White blood cell count increased
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Metabolism and nutrition disorders
Increased appetite
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.8%
3/16 • 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])
|
11.1%
1/9 • 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])
|
37.5%
3/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
2/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
6.2%
1/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • 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%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • 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%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • 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
|
6.2%
1/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
2/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Headache
|
31.2%
5/16 • 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])
|
11.1%
1/9 • 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%
2/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
40.0%
4/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
40.0%
4/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
20.0%
2/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Ataxia
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Chorea
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Hyperreflexia
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Amnesia
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Hyporeflexia
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Lethargy
|
0.00%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Paraesthesia
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Pleocytosis
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Post-traumatic headache
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Radicular pain
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Nervous system disorders
Sensory disturbance
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Anxiety
|
12.5%
2/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Irritability
|
6.2%
1/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Delirium
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Psychiatric disorders
Restlessness
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/16 • 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])
|
11.1%
1/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Reproductive system and breast disorders
Ovarian cyst
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • 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%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • 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%
0/9 • 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])
|
12.5%
1/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Vascular disorders
Hot flush
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Vascular disorders
Flushing
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
0.00%
0/10 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/16 • 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%
0/9 • 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%
0/8 • Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
|
10.0%
1/10 • 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