Trial Outcomes & Findings for Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study) (NCT NCT01397422)
NCT ID: NCT01397422
Last Updated: 2017-12-13
Results Overview
The UDysRS is a dyskinesia rating scale from 0-104, and it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
83 participants
Primary outcome timeframe
Baseline (Day 1) and Week 8
Results posted on
2017-12-13
Participant Flow
Participants with Parkinson's disease (PD) and Levodopa-induced Dyskinesia (LID) were enrolled at 31 study sites in the United States. The first subject was randomized on 03 August 2011 and the last subject completed on 15 April 2013.
All randomized subjects (83) were treated and analyzed for safety; 80 were analyzed for efficacy and included in the Modified Intent to Treat (MITT) population. Subjects in the MITT had mild to severe dyskinesia, had periods of troublesome dyskinesia during the day, received ≥ 1 dose of study drug, and provided ≥ 1 postbaseline efficacy assessment.
Participant milestones
| Measure |
Placebo
ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (260 mg)
260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (340 mg)
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
|
ADS-5102 (420 mg)
420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
21
|
20
|
|
Overall Study
COMPLETED
|
20
|
17
|
18
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
3
|
8
|
Reasons for withdrawal
| Measure |
Placebo
ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (260 mg)
260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (340 mg)
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
|
ADS-5102 (420 mg)
420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
3
|
8
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
Increased bradykinesia related to PD
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
Baseline characteristics by cohort
| Measure |
Placebo
n=22 Participants
ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (260 mg)
n=20 Participants
260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (340 mg)
n=21 Participants
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
|
ADS-5102 (420 mg)
n=20 Participants
420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 10.17 • n=5 Participants
|
67.5 years
STANDARD_DEVIATION 8.59 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 10.03 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 9.38 • n=4 Participants
|
66.0 years
STANDARD_DEVIATION 9.47 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
78 Participants
n=21 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
75 Participants
n=21 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
|
|
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
|
|
Fatigue Severity Score (FSS)
|
4.86 units on a scale
STANDARD_DEVIATION 1.211 • n=5 Participants
|
4.40 units on a scale
STANDARD_DEVIATION 1.488 • n=7 Participants
|
4.80 units on a scale
STANDARD_DEVIATION 1.425 • n=5 Participants
|
4.78 units on a scale
STANDARD_DEVIATION 1.120 • n=4 Participants
|
4.71 units on a scale
STANDARD_DEVIATION 1.307 • n=21 Participants
|
|
Hoehn and Yahr Score
|
2.5 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 0.9 • n=7 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 0.8 • n=4 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 0.7 • n=21 Participants
|
|
Time since PD diagnosis
|
10.66 years
STANDARD_DEVIATION 7.057 • n=5 Participants
|
8.94 years
STANDARD_DEVIATION 3.395 • n=7 Participants
|
9.33 years
STANDARD_DEVIATION 4.913 • n=5 Participants
|
9.00 years
STANDARD_DEVIATION 3.484 • n=4 Participants
|
9.51 years
STANDARD_DEVIATION 4.964 • n=21 Participants
|
|
Levodopa daily dose
|
801.1 mg
STANDARD_DEVIATION 431.94 • n=5 Participants
|
714.5 mg
STANDARD_DEVIATION 449.33 • n=7 Participants
|
694.0 mg
STANDARD_DEVIATION 278.33 • n=5 Participants
|
862.5 mg
STANDARD_DEVIATION 585.94 • n=4 Participants
|
768.6 mg
STANDARD_DEVIATION 444.41 • n=21 Participants
|
|
Duration of LID
|
4.08 years
STANDARD_DEVIATION 4.051 • n=5 Participants
|
3.35 years
STANDARD_DEVIATION 2.585 • n=7 Participants
|
4.37 years
STANDARD_DEVIATION 3.364 • n=5 Participants
|
3.57 years
STANDARD_DEVIATION 2.049 • n=4 Participants
|
3.85 years
STANDARD_DEVIATION 3.106 • n=21 Participants
|
|
Subjects taking Antiparkinson Medication
Levodopa (Sinemet or Stalevo)
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
|
Subjects taking Antiparkinson Medication
Dopamine Agonist
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Subjects taking Antiparkinson Medication
MAO-B Inhibitor
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Subjects taking Antiparkinson Medication
COMT Inhibitor
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Subjects taking Antiparkinson Medication
Anticholinergic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 8Population: Participants in the MITT population with available data were analyzed.
The UDysRS is a dyskinesia rating scale from 0-104, and it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received.
Outcome measures
| Measure |
Placebo
n=22 Participants
ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (260 mg)
n=19 Participants
260 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (340 mg)
n=20 Participants
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
|
ADS-5102 (420 mg)
n=19 Participants
420 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
|
|---|---|---|---|---|
|
Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8
|
-6.7 units on a scale
Standard Error 2.68
|
-12.3 units on a scale
Standard Error 2.88
|
-17.9 units on a scale
Standard Error 2.82
|
-16.7 units on a scale
Standard Error 2.88
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 8Population: MITT population
The FSS is a 9-item self-reported scale, rating subject experience of fatigue during the previous 7 days. The total score, on a scale from 1-7, is represented by the mean of all answered items. The higher the score, the greater the fatigue severity.
Outcome measures
| Measure |
Placebo
n=22 Participants
ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (260 mg)
n=19 Participants
260 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (340 mg)
n=20 Participants
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
|
ADS-5102 (420 mg)
n=19 Participants
420 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
|
|---|---|---|---|---|
|
Change in the Fatigue Severity Score (FSS) From Baseline to Week 8
|
-0.25 units on a scale
Standard Error 0.267
|
-0.06 units on a scale
Standard Error 0.289
|
-0.55 units on a scale
Standard Error 0.280
|
0.00 units on a scale
Standard Error 0.287
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 8Population: MITT Population
UDysRS Part III measures objective impairment (dyskinesia severity, anatomic distribution, and type, based on 4 observed activities); and Part IV measures objective disability based on Part III activities. The scores for the 2 Parts combined range from 0-44; a higher score represents more severe dyskinesia.
Outcome measures
| Measure |
Placebo
n=22 Participants
ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (260 mg)
n=19 Participants
260 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (340 mg)
n=20 Participants
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
|
ADS-5102 (420 mg)
n=19 Participants
420 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
|
|---|---|---|---|---|
|
Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8
|
-1.9 units on a scale
Standard Error 1.19
|
-4.4 units on a scale
Standard Error 1.26
|
-7.1 units on a scale
Standard Error 1.24
|
-8.3 units on a scale
Standard Error 1.26
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 8Population: MITT population
A PD home diary was used to score 5 different conditions in 30-minute time intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 8 visit.
Outcome measures
| Measure |
Placebo
n=22 Participants
ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (260 mg)
n=19 Participants
260 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (340 mg)
n=20 Participants
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
|
ADS-5102 (420 mg)
n=19 Participants
420 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
|
|---|---|---|---|---|
|
Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary
|
0.9 hours
Standard Error 0.76
|
4.1 hours
Standard Error 0.82
|
3.8 hours
Standard Error 0.79
|
3.6 hours
Standard Error 0.83
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 8Population: MITT population
The MDS-UPDRS Parts I, II, and III examined non-motor experiences of daily living, motor experiences of daily living, and motor examination, respectively. Each part had sub scales ranging from normal = 0 to severe = 4.
Outcome measures
| Measure |
Placebo
n=22 Participants
ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (260 mg)
n=19 Participants
260 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (340 mg)
n=20 Participants
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
|
ADS-5102 (420 mg)
n=19 Participants
420 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
|
|---|---|---|---|---|
|
Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8
|
-1.2 units on a scale
Standard Error 3.08
|
0.0 units on a scale
Standard Error 3.22
|
-3.4 units on a scale
Standard Error 3.31
|
0.5 units on a scale
Standard Error 3.23
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 8Population: MITT population
The CGI-C consisted of a single question that assessed the investigator's global impression of the subject's change from Baseline in overall PD symptoms, including but not limited to LID. The CGI-C required that the investigator rate the extent to which the subject's PD had improved or worsened (from marked worsening to marked improvement).
Outcome measures
| Measure |
Placebo
n=22 Participants
ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (260 mg)
n=19 Participants
260 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (340 mg)
n=20 Participants
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
|
ADS-5102 (420 mg)
n=19 Participants
420 mg dose of ADS-5102 (amantadine HClextended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
|
|---|---|---|---|---|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8
Marked Improvement
|
1 Participants
|
2 Participants
|
7 Participants
|
4 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8
Moderate Improvement
|
6 Participants
|
8 Participants
|
8 Participants
|
6 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8
Minimal Improvement
|
4 Participants
|
5 Participants
|
1 Participants
|
5 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8
No Change
|
10 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8
Minimal Worsening
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8
Moderate Worsening
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8
Marked Worsening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
ADS-5102 (260 mg)
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
ADS-5102 (340 mg)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
ADS-5102 (420 mg)
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=22 participants at risk
ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (260 mg)
n=20 participants at risk
260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (340 mg)
n=21 participants at risk
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
|
ADS-5102 (420 mg)
n=20 participants at risk
420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
|
|---|---|---|---|---|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Infections and infestations
Urinary tract Infection
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Psychiatric disorders
Mental Status Change
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
Other adverse events
| Measure |
Placebo
n=22 participants at risk
ADS-5102 matching placebo: oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (260 mg)
n=20 participants at risk
260 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks
|
ADS-5102 (340 mg)
n=21 participants at risk
340 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Weeks 2-8)
|
ADS-5102 (420 mg)
n=20 participants at risk
420 mg dose of ADS-5102 (amantadine HCl extended release): oral capsules administered once daily at bedtime for 8 weeks (260 mg Week 1; 340 mg Week 2; 420 mg Weeks 3-8)
|
|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
9.1%
2/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
4.8%
1/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
10.0%
2/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Eye disorders
Vision blurred
|
4.5%
1/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
4.8%
1/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Eye disorders
Altered visual depth perception
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
10.0%
2/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Eye disorders
Dry eye
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
4.8%
1/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Eye disorders
Eye irritation
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Eye disorders
Photophobia
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
2/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
35.0%
7/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
23.8%
5/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
15.0%
3/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
15.0%
3/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
19.0%
4/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
10.0%
2/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
14.3%
3/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
1/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
4.8%
1/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
General disorders
Oedema peripheral
|
4.5%
1/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
9.5%
2/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
10.0%
2/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
General disorders
Asthenia
|
4.5%
1/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
14.3%
3/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
General disorders
Malaise
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
4.8%
1/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
General disorders
Chills
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
General disorders
Irritability
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
General disorders
Pain
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
9.5%
2/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
10.0%
2/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.5%
1/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
4.8%
1/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Injury, poisoning and procedural complications
Fall
|
13.6%
3/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
14.3%
3/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
15.0%
3/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.5%
1/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
10.0%
2/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
4.8%
1/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Injury, poisoning and procedural complications
Excoriation
|
4.5%
1/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Investigations
Blood urea increased
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
9.5%
2/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
9.5%
2/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Investigations
Blood glucose increased
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
9.5%
2/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Investigations
Glomerular filtration rate decreased
|
4.5%
1/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Investigations
Blood pressure increased
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.5%
1/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
9.5%
2/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
10.0%
2/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Nervous system disorders
Dizziness
|
4.5%
1/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
15.0%
3/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
28.6%
6/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
15.0%
3/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
14.3%
3/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
4.8%
1/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Nervous system disorders
Syncope
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
9.5%
2/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
15.0%
3/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
14.3%
3/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
10.0%
2/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Psychiatric disorders
Confusional state
|
4.5%
1/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
14.3%
3/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
10.0%
2/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
9.5%
2/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
10.0%
2/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
9.5%
2/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Psychiatric disorders
Insomnia
|
9.1%
2/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
9.5%
2/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
9.5%
2/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Psychiatric disorders
Abnormal dreams
|
4.5%
1/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
4.8%
1/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Psychiatric disorders
Anxiety
|
4.5%
1/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
9.5%
2/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
4.8%
1/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Skin and subcutaneous tissue disorders
Hyperhydrosis
|
4.5%
1/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
10.0%
2/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
2/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
10.0%
2/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Vascular disorders
Hypertension
|
4.5%
1/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Vascular disorders
Orthostatic hypertension
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/22 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
0.00%
0/21 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
5.0%
1/20 • Baseline through Week 8
The reporting threshold of 5% for Other (Not Including Serious) AEs reflects events that occurred at 5% or greater in any treatment arm.
|
Additional Information
Head, Regulatory Affairs
Adamas Pharmaceuticals, Inc.
Phone: +1 (510) 450-3500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place