Trial Outcomes & Findings for Safety and Efficacy of DA-9805 for Parkinson's Disease (NCT NCT03189563)
NCT ID: NCT03189563
Last Updated: 2022-05-24
Results Overview
Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part II, Part III and Part IV at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0\~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0\~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0\~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0\~26)
COMPLETED
PHASE2
61 participants
12 weeks
2022-05-24
Participant Flow
Participant milestones
| Measure |
Placebo
placebo, tid
Placebo: Placebo, tid
|
DA-9805 Low
DA-9805 45mg
DA-9805 45mg: DA-9805 15mg tid
|
DA-9805 High
DA-9805 90mg
DA-9805 90mg: DA-9805 30mg tid
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
20
|
|
Overall Study
ITT Population
|
20
|
21
|
19
|
|
Overall Study
Safety Population
|
20
|
21
|
19
|
|
Overall Study
COMPLETED
|
19
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of DA-9805 for Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=20 Participants
placebo, tid
Placebo: Placebo, tid
|
DA-9805 Low
n=21 Participants
DA-9805 45mg
DA-9805 45mg: DA-9805 15mg tid
|
DA-9805 High
n=19 Participants
DA-9805 90mg
DA-9805 90mg: DA-9805 30mg tid
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 7.30 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 9.24 • n=7 Participants
|
64.2 years
STANDARD_DEVIATION 9.36 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 8.75 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
37 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
55 Participants
n=4 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
|
|
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
|
|
BMI
|
28.6 kg/m^2
STANDARD_DEVIATION 6.12 • n=5 Participants
|
28.1 kg/m^2
STANDARD_DEVIATION 6.61 • n=7 Participants
|
27.1 kg/m^2
STANDARD_DEVIATION 4.23 • n=5 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 5.72 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: ITT
Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part II, Part III and Part IV at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0\~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0\~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0\~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0\~26)
Outcome measures
| Measure |
Placebo
n=20 Participants
placebo, tid
Placebo: Placebo, tid
|
DA-9805 Low
n=21 Participants
DA-9805 45mg
DA-9805 45mg: DA-9805 15mg tid
|
DA-9805 High
n=19 Participants
DA-9805 90mg
DA-9805 90mg: DA-9805 30mg tid
|
|---|---|---|---|
|
Change in Motor MDS-UPDRS Score From Baseline at Week 12
|
1.4 score on a scale
Standard Deviation 5.56
|
-0.9 score on a scale
Standard Deviation 7.03
|
-1.2 score on a scale
Standard Deviation 8.41
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT Population
Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part I, Part II, Part III and Part IV at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0\~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0\~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0\~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0\~26)
Outcome measures
| Measure |
Placebo
n=20 Participants
placebo, tid
Placebo: Placebo, tid
|
DA-9805 Low
n=21 Participants
DA-9805 45mg
DA-9805 45mg: DA-9805 15mg tid
|
DA-9805 High
n=19 Participants
DA-9805 90mg
DA-9805 90mg: DA-9805 30mg tid
|
|---|---|---|---|
|
Change in Total MDS- UPDRS Score
|
1.6 score
Standard Deviation 7.15
|
-2.4 score
Standard Deviation 7.91
|
-1.7 score
Standard Deviation 9.16
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT population
Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part I at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0\~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0\~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0\~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0\~26)
Outcome measures
| Measure |
Placebo
n=20 Participants
placebo, tid
Placebo: Placebo, tid
|
DA-9805 Low
n=21 Participants
DA-9805 45mg
DA-9805 45mg: DA-9805 15mg tid
|
DA-9805 High
n=19 Participants
DA-9805 90mg
DA-9805 90mg: DA-9805 30mg tid
|
|---|---|---|---|
|
Change in MDS-UPDRS Subscale scores_Part I
|
0.1 score on a scale
Standard Deviation 3.3
|
-1.3 score on a scale
Standard Deviation 2.82
|
-0.5 score on a scale
Standard Deviation 3.04
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT population
Change in Schwab and England (S\&E) Scale total score from baseline at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) The Schwab \& England Activities of Daily Living (ADL) scale reflects the speed, ease, and independence with which an individual performs daily activities, or personal chores, such as eating, toileting, and dressing. This scale uses a rating scale from 0% to 100%, with 100% representing complete independence in performing daily activities and 0% representing a vegetative, bedridden state.
Outcome measures
| Measure |
Placebo
n=20 Participants
placebo, tid
Placebo: Placebo, tid
|
DA-9805 Low
n=21 Participants
DA-9805 45mg
DA-9805 45mg: DA-9805 15mg tid
|
DA-9805 High
n=19 Participants
DA-9805 90mg
DA-9805 90mg: DA-9805 30mg tid
|
|---|---|---|---|
|
Change in S&E Total Score
|
2.0 score on a scale
Standard Deviation 8.34
|
1.0 score on a scale
Standard Deviation 7.00
|
0.5 score on a scale
Standard Deviation 5.24
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT
Change in Parkinson's Disease Questionnaire (PDQ-39) total score from baseline at week 12.(Change from baseline = Post Baseline Measurement - Baseline Measurement) The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility \[10 items\], activities of daily living \[6 items\], emotional wellbeing \[6 items\], stigma \[4 items\], cognition \[4 items\], social support \[3 items\], communication \[3 items\] and bodily discomfort \[3 items\]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale. The PDQ-39 Summary Index (PDQ-SI) is the sum of all answers divided by the highest score possible (i.e., number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0 - 100 scale where lower scores indicate a better perceived health status and higher scores are ass
Outcome measures
| Measure |
Placebo
n=20 Participants
placebo, tid
Placebo: Placebo, tid
|
DA-9805 Low
n=21 Participants
DA-9805 45mg
DA-9805 45mg: DA-9805 15mg tid
|
DA-9805 High
n=19 Participants
DA-9805 90mg
DA-9805 90mg: DA-9805 30mg tid
|
|---|---|---|---|
|
Change in PDQ-39 Score- Summary Index
|
-1.3 score on a scale
Standard Deviation 4.95
|
-1.7 score on a scale
Standard Deviation 4.58
|
-1.5 score on a scale
Standard Deviation 4.57
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT
Change in Hoehn and Yahr (H\&Y) scale total score from baseline at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) H\&Y describes five stages to PD progression (Score 1\~5). A lower score represent a lower amount of symptoms.
Outcome measures
| Measure |
Placebo
n=20 Participants
placebo, tid
Placebo: Placebo, tid
|
DA-9805 Low
n=21 Participants
DA-9805 45mg
DA-9805 45mg: DA-9805 15mg tid
|
DA-9805 High
n=19 Participants
DA-9805 90mg
DA-9805 90mg: DA-9805 30mg tid
|
|---|---|---|---|
|
Change in H&Y Total Score at Week 12
|
0.1 score on a scale
Standard Deviation 0.39
|
0.0 score on a scale
Standard Deviation 0.59
|
0.1 score on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT population
Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part II at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0\~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0\~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0\~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0\~26)
Outcome measures
| Measure |
Placebo
n=20 Participants
placebo, tid
Placebo: Placebo, tid
|
DA-9805 Low
n=21 Participants
DA-9805 45mg
DA-9805 45mg: DA-9805 15mg tid
|
DA-9805 High
n=19 Participants
DA-9805 90mg
DA-9805 90mg: DA-9805 30mg tid
|
|---|---|---|---|
|
Change in MDS-UPDRS Subscale scores_Part II
|
0.8 score on a scale
Standard Deviation 3.05
|
1.3 score on a scale
Standard Deviation 2.26
|
-0.6 score on a scale
Standard Deviation 3.67
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT population
Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0\~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0\~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0\~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0\~26)
Outcome measures
| Measure |
Placebo
n=20 Participants
placebo, tid
Placebo: Placebo, tid
|
DA-9805 Low
n=21 Participants
DA-9805 45mg
DA-9805 45mg: DA-9805 15mg tid
|
DA-9805 High
n=19 Participants
DA-9805 90mg
DA-9805 90mg: DA-9805 30mg tid
|
|---|---|---|---|
|
Change in MDS-UPDRS Subscale scores_Part III
|
0.7 score on a scale
Standard Deviation 5.0
|
-1.7 score on a scale
Standard Deviation 6.21
|
-0.6 score on a scale
Standard Deviation 6.02
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT population
Analysis of the Change from Baseline in the sum of the Movement Disorders Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part IV at week 12. (Change from baseline = Post Baseline Measurement - Baseline Measurement) MDS-UPDRS is a multimodal scale assessing both impairment and disability and is separated into 4 subscales. Each parkinsonian sign or symptom is rated on a 5-point severity scale (ranging from 0 to 4). The maximum total UPDRS score is 272, indicating the worst possible disability from PD. Part I: This assesses non-motor experiences of daily living (13 items, Score range: 0\~52) Part II: This assesses motor experiences of daily living (13 items, Score range: 0\~52) Part III: This assesses the motor signs of PD (33 items, Score range: 0\~132) Part IV: This assesses motor complications, dyskinesias and motor fluctuations using historical and objective information (6 items, Score range: 0\~26)
Outcome measures
| Measure |
Placebo
n=20 Participants
placebo, tid
Placebo: Placebo, tid
|
DA-9805 Low
n=21 Participants
DA-9805 45mg
DA-9805 45mg: DA-9805 15mg tid
|
DA-9805 High
n=19 Participants
DA-9805 90mg
DA-9805 90mg: DA-9805 30mg tid
|
|---|---|---|---|
|
Change in MDS-UPDRS Subscale scores_Part IV
|
0.3 score on a scale
Standard Deviation 1.38
|
-0.1 score on a scale
Standard Deviation 0.45
|
0.0 score on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT population
The Global Impression-Severity (CGI) measures global severity of illness at a given point in time, and the improvement from baseline at visits following the initial baseline visit. (Change from baseline = Post Baseline Measurement - Baseline Measurement) At the screening and baseline visit, the investigator assessed the severity on a seven-point scale. At subsequent visits, the investigator was to assess the subject's severity (CGI-S) and improvement (CGI-I) relative to baseline. Severity of Illness (CGI-S) Rating should account for severity of the patient's illness. 0 = Not assessed 1. = Normal, not at all ill 2. = Borderline ill 3. = Mildly ill 4. = Moderately ill 5. = Markedly ill 6. = Severely ill 7. = Extremely ill
Outcome measures
| Measure |
Placebo
n=20 Participants
placebo, tid
Placebo: Placebo, tid
|
DA-9805 Low
n=21 Participants
DA-9805 45mg
DA-9805 45mg: DA-9805 15mg tid
|
DA-9805 High
n=19 Participants
DA-9805 90mg
DA-9805 90mg: DA-9805 30mg tid
|
|---|---|---|---|
|
Change in Clinical Global Impression-Severity (CGI-S)
|
0.1 score on a scale
Standard Deviation 0.60
|
0.0 score on a scale
Standard Deviation 0.67
|
0.1 score on a scale
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT population
The Global Impression-Severity (CGI) measures global severity of illness at a given point in time, and the improvement from baseline at visits following the initial baseline visit. At the screening and baseline visit, the investigator assessed the severity on a seven-point scale. At subsequent visits, the investigator was to assess the subject's severity (CGI-S) and improvement (CGI-I) relative to baseline. Global Improvement (CGI-I): Compared to the patient's condition at the baseline of this study, how much has the patient's illness improved or worsened? 0 = Not assessed 1. = Very much improved 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = Very much worse
Outcome measures
| Measure |
Placebo
n=20 Participants
placebo, tid
Placebo: Placebo, tid
|
DA-9805 Low
n=21 Participants
DA-9805 45mg
DA-9805 45mg: DA-9805 15mg tid
|
DA-9805 High
n=19 Participants
DA-9805 90mg
DA-9805 90mg: DA-9805 30mg tid
|
|---|---|---|---|
|
Scores of Clinical Global Impression-Improvement (CGI-I)
|
3.6 score on a scale
Standard Deviation 0.69
|
3.8 score on a scale
Standard Deviation 0.54
|
3.9 score on a scale
Standard Deviation 1.12
|
Adverse Events
Placebo
DA-9805 Low
DA-9805 High
Serious adverse events
| Measure |
Placebo
n=20 participants at risk
placebo, tid
Placebo: Placebo, tid
|
DA-9805 Low
n=21 participants at risk
DA-9805 45mg
DA-9805 45mg: DA-9805 15mg tid
|
DA-9805 High
n=19 participants at risk
DA-9805 90mg
DA-9805 90mg: DA-9805 30mg tid
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Cardiac disorders
STRESS CARDIOMYOPATHY
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
Other adverse events
| Measure |
Placebo
n=20 participants at risk
placebo, tid
Placebo: Placebo, tid
|
DA-9805 Low
n=21 participants at risk
DA-9805 45mg
DA-9805 45mg: DA-9805 15mg tid
|
DA-9805 High
n=19 participants at risk
DA-9805 90mg
DA-9805 90mg: DA-9805 30mg tid
|
|---|---|---|---|
|
Nervous system disorders
tremor
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
10.5%
2/19 • Number of events 3 • 16 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
10.5%
2/19 • Number of events 3 • 16 weeks
|
|
Nervous system disorders
Somnolence
|
0.00%
0/20 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 2 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 2 • 16 weeks
|
10.5%
2/19 • Number of events 2 • 16 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/20 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • 16 weeks
|
9.5%
2/21 • Number of events 2 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
General disorders
Chest discomfort
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
General disorders
Fatigue
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Infections and infestations
Bronchitis
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Infections and infestations
Eye infection
|
0.00%
0/20 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/20 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/20 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
5.3%
1/19 • Number of events 2 • 16 weeks
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/20 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Investigations
Blood potassium increased
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/20 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Investigations
Oxygen saturation decreased
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Medial tibial stress syndrome
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/20 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Metabolism and nutrition disorders
Musculoskeletal pain
|
10.0%
2/20 • Number of events 2 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Renal and urinary disorders
Micturition urgency
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
4.8%
1/21 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Renal and urinary disorders
Nocturia
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/20 • 16 weeks
|
9.5%
2/21 • Number of events 2 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/20 • 16 weeks
|
4.8%
1/21 • Number of events 2 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/20 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/21 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60