Trial Outcomes & Findings for Fixed-Dose Trial in Early Parkinson's Disease (PD) (NCT NCT04201093)
NCT ID: NCT04201093
Last Updated: 2025-07-28
Results Overview
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function. Parts 2 and 3 combined is the sum of Part 2 score and Part 3 score at each assessment time for each participant. The combined score assesses 31 items with score range: 0-184.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
529 participants
Primary outcome timeframe
Week 26
Results posted on
2025-07-28
Participant Flow
In this Phase 3, Double-Blind study, a total of 529 subjects with Parkinson's Disease (PD) were randomized in a 1:1:1 ratio to 3 treatment groups: Tavapadon 5 mg, Tavapadon 15 mg, or Placebo once daily (QD) for 27 Weeks.
Participant milestones
| Measure |
Placebo
Participants will receive placebo matching to tavapadon tablet once daily once daily (QD) orally for 27 weeks.
|
Tavapadon 5 mg
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) QD orally for 27 weeks.
|
Tavapadon 15 mg
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
175
|
177
|
177
|
|
Overall Study
COMPLETED
|
148
|
134
|
118
|
|
Overall Study
NOT COMPLETED
|
27
|
43
|
59
|
Reasons for withdrawal
| Measure |
Placebo
Participants will receive placebo matching to tavapadon tablet once daily once daily (QD) orally for 27 weeks.
|
Tavapadon 5 mg
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) QD orally for 27 weeks.
|
Tavapadon 15 mg
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
29
|
35
|
|
Overall Study
Death
|
2
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
5
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Failure to Meet Continuation Criteria
|
0
|
0
|
1
|
|
Overall Study
Treatment with Prohibited Concomitant Medications
|
0
|
0
|
1
|
|
Overall Study
Non-Compliance with Study Schedule
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
0
|
|
Overall Study
Site Terminated by Sponsor
|
5
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
8
|
15
|
|
Overall Study
Other
|
0
|
1
|
2
|
Baseline Characteristics
Fixed-Dose Trial in Early Parkinson's Disease (PD)
Baseline characteristics by cohort
| Measure |
Placebo
n=175 Participants
Participants will receive placebo matching to tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon 5 mg
n=177 Participants
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) QD orally for 27 weeks.
|
Tavapadon 15 mg
n=177 Participants
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
Total
n=529 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 9.62 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 9.80 • n=7 Participants
|
63.8 years
STANDARD_DEVIATION 9.40 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 9.59 • n=4 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
187 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
342 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
154 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
465 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
168 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
514 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
MDS-UPDRS Score at Baseline (Parts II and III Combined)
|
32.0 units on a scale
STANDARD_DEVIATION 9.96 • n=5 Participants
|
31.3 units on a scale
STANDARD_DEVIATION 10.87 • n=7 Participants
|
32.1 units on a scale
STANDARD_DEVIATION 11.55 • n=5 Participants
|
31.8 units on a scale
STANDARD_DEVIATION 10.80 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 26Population: Population includes subjects who received at least one dose of study drug and had available data for analysis.
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function. Parts 2 and 3 combined is the sum of Part 2 score and Part 3 score at each assessment time for each participant. The combined score assesses 31 items with score range: 0-184.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants will receive placebo matching to tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon 5 mg
n=132 Participants
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) QD orally for 27 weeks.
|
Tavapadon 15 mg
n=116 Participants
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
|---|---|---|---|
|
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
|
1.8 score on a scale
Standard Error 0.82
|
-9.7 score on a scale
Standard Error 0.86
|
-10.2 score on a scale
Standard Error 0.88
|
SECONDARY outcome
Timeframe: Week 26Population: Population includes subjects who received at least one dose of study drug and had available data for analysis.
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants will receive placebo matching to tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon 5 mg
n=132 Participants
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) QD orally for 27 weeks.
|
Tavapadon 15 mg
n=116 Participants
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
|---|---|---|---|
|
Change From Baseline in the MDS-UPDRS Part II Score
|
0.9 score on a scale
Standard Error 0.30
|
-1.6 score on a scale
Standard Error 0.31
|
-1.7 score on a scale
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Week 26Population: Population includes subjects who received at least one dose of study drug and had available data for analysis.
The Patient Global Impression of Change (PGIC) is a 7-point response scale. The participant response to the question, "Compared to your condition at the beginning of treatment, how much has your condition changed?" was assessed. Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants will receive placebo matching to tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon 5 mg
n=132 Participants
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) QD orally for 27 weeks.
|
Tavapadon 15 mg
n=117 Participants
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
|---|---|---|---|
|
Percentage of Responders With a Score of "Much Improved" or "Very Much Improved" on PGIC
|
18 Participants
|
60 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Week 5, 8, 11, 14, 18, 22, 26, and 27Population: Population includes subjects who received at least one dose of study drug and had available data for analysis.
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function. Parts 2 and 3 combined is the sum of Part 2 score and Part 3 score at each assessment time for each participant. The combined score assesses 31 items with score range: 0-184.
Outcome measures
| Measure |
Placebo
n=174 Participants
Participants will receive placebo matching to tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon 5 mg
n=174 Participants
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) QD orally for 27 weeks.
|
Tavapadon 15 mg
n=172 Participants
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
|---|---|---|---|
|
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Week 5
|
-1.2 score on a scale
Standard Error 0.57
|
-4.4 score on a scale
Standard Error 0.59
|
-4.7 score on a scale
Standard Error 0.59
|
|
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Week 8
|
-2.2 score on a scale
Standard Error 0.62
|
-6.9 score on a scale
Standard Error 0.65
|
-6.7 score on a scale
Standard Error 0.65
|
|
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Week 11
|
-0.9 score on a scale
Standard Error 0.72
|
-8.1 score on a scale
Standard Error 0.75
|
-9.1 score on a scale
Standard Error 0.75
|
|
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Week 14
|
-1.2 score on a scale
Standard Error 0.74
|
-8.8 score on a scale
Standard Error 0.78
|
-9.4 score on a scale
Standard Error 0.78
|
|
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Week 18
|
0.4 score on a scale
Standard Error 0.78
|
-9.1 score on a scale
Standard Error 0.82
|
-9.7 score on a scale
Standard Error 0.83
|
|
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Week 22
|
0.4 score on a scale
Standard Error 0.81
|
-9.6 score on a scale
Standard Error 0.84
|
-10.9 score on a scale
Standard Error 0.86
|
|
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Week 26
|
1.8 score on a scale
Standard Error 0.82
|
-9.7 score on a scale
Standard Error 0.86
|
-10.2 score on a scale
Standard Error 0.88
|
|
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Week 27
|
2.2 score on a scale
Standard Error 0.92
|
-8.6 score on a scale
Standard Error 0.96
|
-10.0 score on a scale
Standard Error 0.99
|
SECONDARY outcome
Timeframe: Week 5, 8, 11, 14, 18, 22, 26, and 27Population: Population includes subjects who received at least one dose of study drug and had available data for analysis.
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function. Parts 1, 2, and 3 combined is the sum of Part 1, Part 2, and Part 3 scores at each assessment time for each participant. The combined score assesses 44 items with score range: 0-236.
Outcome measures
| Measure |
Placebo
n=174 Participants
Participants will receive placebo matching to tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon 5 mg
n=174 Participants
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) QD orally for 27 weeks.
|
Tavapadon 15 mg
n=172 Participants
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
|---|---|---|---|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
Week 5
|
-1.2 score on a scale
Standard Error 0.67
|
-3.9 score on a scale
Standard Error 0.69
|
-4.0 score on a scale
Standard Error 0.69
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
Week 8
|
-2.6 score on a scale
Standard Error 0.72
|
-6.4 score on a scale
Standard Error 0.76
|
-6.2 score on a scale
Standard Error 0.75
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
Week 11
|
-1.2 score on a scale
Standard Error 0.81
|
-7.7 score on a scale
Standard Error 0.86
|
-8.6 score on a scale
Standard Error 0.86
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
Week 14
|
-1.5 score on a scale
Standard Error 0.85
|
-8.8 score on a scale
Standard Error 0.89
|
-8.7 score on a scale
Standard Error 0.90
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
Week 18
|
0.3 score on a scale
Standard Error 0.91
|
-9.3 score on a scale
Standard Error 0.95
|
-9.1 score on a scale
Standard Error 0.96
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
Week 22
|
0.2 score on a scale
Standard Error 0.94
|
-9.5 score on a scale
Standard Error 0.98
|
-10.3 score on a scale
Standard Error 1.00
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
Week 26
|
2.3 score on a scale
Standard Error 0.95
|
-9.4 score on a scale
Standard Error 1.00
|
-9.7 score on a scale
Standard Error 1.02
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
Week 27
|
2.4 score on a scale
Standard Error 1.06
|
-8.5 score on a scale
Standard Error 1.11
|
-9.4 score on a scale
Standard Error 1.14
|
SECONDARY outcome
Timeframe: Week 5, 8, 11, 14, 18, 22, 26, and 27Population: Population includes subjects who received at least one dose of study drug and had available data for analysis.
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function.
Outcome measures
| Measure |
Placebo
n=174 Participants
Participants will receive placebo matching to tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon 5 mg
n=174 Participants
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) QD orally for 27 weeks.
|
Tavapadon 15 mg
n=172 Participants
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
|---|---|---|---|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part I: Week 5
|
0.0 score on a scale
Standard Error 0.23
|
0.6 score on a scale
Standard Error 0.24
|
0.7 score on a scale
Standard Error 0.24
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part I: Week 8
|
-0.4 score on a scale
Standard Error 0.23
|
0.5 score on a scale
Standard Error 0.24
|
0.4 score on a scale
Standard Error 0.24
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part I: Week 11
|
-0.3 score on a scale
Standard Error 0.23
|
0.4 score on a scale
Standard Error 0.24
|
0.4 score on a scale
Standard Error 0.25
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part I: Week 14
|
-0.2 score on a scale
Standard Error 0.25
|
0.0 score on a scale
Standard Error 0.27
|
0.6 score on a scale
Standard Error 0.27
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part I: Week 18
|
-0.1 score on a scale
Standard Error 0.25
|
-0.2 score on a scale
Standard Error 0.26
|
0.5 score on a scale
Standard Error 0.27
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part I: Week 22
|
-0.2 score on a scale
Standard Error 0.26
|
0.2 score on a scale
Standard Error 0.27
|
0.4 score on a scale
Standard Error 0.28
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part I: Week 26
|
0.5 score on a scale
Standard Error 0.27
|
0.2 score on a scale
Standard Error 0.28
|
0.4 score on a scale
Standard Error 0.29
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part I: Week 27
|
0.2 score on a scale
Standard Error 0.27
|
0.2 score on a scale
Standard Error 0.28
|
0.3 score on a scale
Standard Error 0.29
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part II: Week 5
|
-0.2 score on a scale
Standard Error 0.22
|
-0.8 score on a scale
Standard Error 0.23
|
-1.0 score on a scale
Standard Error 0.22
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part II: Week 8
|
-0.5 score on a scale
Standard Error 0.23
|
-1.0 score on a scale
Standard Error 0.25
|
-1.6 score on a scale
Standard Error 0.24
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part II: Week 11
|
0.0 score on a scale
Standard Error 0.26
|
-1.7 score on a scale
Standard Error 0.27
|
-2.0 score on a scale
Standard Error 0.27
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part II: Week 14
|
-0.1 score on a scale
Standard Error 0.27
|
-1.6 score on a scale
Standard Error 0.28
|
-2.0 score on a scale
Standard Error 0.28
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part II: Week 18
|
0.4 score on a scale
Standard Error 0.29
|
-1.9 score on a scale
Standard Error 0.31
|
-1.8 score on a scale
Standard Error 0.31
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part II: Week 22
|
0.3 score on a scale
Standard Error 0.28
|
-1.7 score on a scale
Standard Error 0.29
|
-2.1 score on a scale
Standard Error 0.29
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part II: Week 26
|
0.9 score on a scale
Standard Error 0.30
|
-1.6 score on a scale
Standard Error 0.31
|
-1.7 score on a scale
Standard Error 0.32
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part II: Week 27
|
0.9 score on a scale
Standard Error 0.31
|
-1.7 score on a scale
Standard Error 0.32
|
-1.8 score on a scale
Standard Error 0.33
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part III: Week 5
|
-1.0 score on a scale
Standard Error 0.44
|
-3.7 score on a scale
Standard Error 0.46
|
-3.7 score on a scale
Standard Error 0.45
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part III: Week 8
|
-1.7 score on a scale
Standard Error 0.50
|
-6.0 score on a scale
Standard Error 0.52
|
-5.1 score on a scale
Standard Error 0.52
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part III: Week 11
|
-1.0 score on a scale
Standard Error 0.55
|
-6.5 score on a scale
Standard Error 0.58
|
-7.1 score on a scale
Standard Error 0.59
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part III: Week 14
|
-1.1 score on a scale
Standard Error 0.58
|
-7.2 score on a scale
Standard Error 0.61
|
-7.4 score on a scale
Standard Error 0.61
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part III: Week 18
|
0.0 score on a scale
Standard Error 0.60
|
-7.3 score on a scale
Standard Error 0.63
|
-7.9 score on a scale
Standard Error 0.64
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part III: Week 22
|
0.0 score on a scale
Standard Error 0.64
|
-8.0 score on a scale
Standard Error 0.67
|
-8.8 score on a scale
Standard Error 0.68
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part III: Week 26
|
0.9 score on a scale
Standard Error 0.63
|
-8.1 score on a scale
Standard Error 0.66
|
-8.5 score on a scale
Standard Error 0.68
|
|
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Part III: Week 27
|
1.1 score on a scale
Standard Error 0.71
|
-7.1 score on a scale
Standard Error 0.75
|
-8.3 score on a scale
Standard Error 0.77
|
SECONDARY outcome
Timeframe: Week 5, 8, 11, 14, 18, 22, 26, and 27Population: Population includes subjects who received at least one dose of study drug and had available data for analysis.
The Global Impression - Severity of Illness (CGI-S) Score is a clinician's impression of a participant's severity of illness on a 7-point scale. Scores ranged from 1-7 on a scale of 1 (normal) to 7 (among the most extremely ill participants). Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=174 Participants
Participants will receive placebo matching to tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon 5 mg
n=174 Participants
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) QD orally for 27 weeks.
|
Tavapadon 15 mg
n=172 Participants
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
|---|---|---|---|
|
Change From Baseline in the CGI-S Score
Week 5
|
0.0 score on a scale
Standard Error 0.04
|
-0.1 score on a scale
Standard Error 0.05
|
0.0 score on a scale
Standard Error 0.05
|
|
Change From Baseline in the CGI-S Score
Week 8
|
0.0 score on a scale
Standard Error 0.05
|
-0.1 score on a scale
Standard Error 0.05
|
-0.1 score on a scale
Standard Error 0.05
|
|
Change From Baseline in the CGI-S Score
Week 11
|
0.0 score on a scale
Standard Error 0.05
|
-0.2 score on a scale
Standard Error 0.05
|
-0.3 score on a scale
Standard Error 0.05
|
|
Change From Baseline in the CGI-S Score
Week 14
|
0.1 score on a scale
Standard Error 0.05
|
-0.2 score on a scale
Standard Error 0.05
|
-0.3 score on a scale
Standard Error 0.05
|
|
Change From Baseline in the CGI-S Score
Week 18
|
0.1 score on a scale
Standard Error 0.05
|
-0.3 score on a scale
Standard Error 0.06
|
-0.3 score on a scale
Standard Error 0.06
|
|
Change From Baseline in the CGI-S Score
Week 22
|
0.1 score on a scale
Standard Error 0.05
|
-0.2 score on a scale
Standard Error 0.06
|
-0.3 score on a scale
Standard Error 0.06
|
|
Change From Baseline in the CGI-S Score
Week 26
|
0.2 score on a scale
Standard Error 0.05
|
-0.3 score on a scale
Standard Error 0.05
|
-0.2 score on a scale
Standard Error 0.06
|
|
Change From Baseline in the CGI-S Score
Week 27
|
0.1 score on a scale
Standard Error 0.05
|
-0.2 score on a scale
Standard Error 0.06
|
-0.2 score on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Week 5, 8, 11, 14, 18, 22, 26, and 27Population: Population includes subjects who received at least one dose of study drug and had available data for analysis.
The Clinical Global Impression - Improvement (CGI-I) Score is a clinician's impression of how much the participant's illness has improved or worsened relative to the baseline on a 7-point scale. Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=174 Participants
Participants will receive placebo matching to tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon 5 mg
n=174 Participants
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) QD orally for 27 weeks.
|
Tavapadon 15 mg
n=172 Participants
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
|---|---|---|---|
|
Change From Baseline in the CGI-I Score
Week 5
|
3.8 score on a scale
Standard Error 0.06
|
3.4 score on a scale
Standard Error 0.06
|
3.4 score on a scale
Standard Error 0.06
|
|
Change From Baseline in the CGI-I Score
Week 8
|
3.8 score on a scale
Standard Error 0.06
|
3.2 score on a scale
Standard Error 0.07
|
3.3 score on a scale
Standard Error 0.07
|
|
Change From Baseline in the CGI-I Score
Week 11
|
3.8 score on a scale
Standard Error 0.07
|
3.0 score on a scale
Standard Error 0.08
|
3.1 score on a scale
Standard Error 0.08
|
|
Change From Baseline in the CGI-I Score
Week 14
|
3.8 score on a scale
Standard Error 0.07
|
3.0 score on a scale
Standard Error 0.08
|
3.0 score on a scale
Standard Error 0.08
|
|
Change From Baseline in the CGI-I Score
Week 18
|
3.9 score on a scale
Standard Error 0.08
|
2.8 score on a scale
Standard Error 0.08
|
2.9 score on a scale
Standard Error 0.08
|
|
Change From Baseline in the CGI-I Score
Week 22
|
3.9 score on a scale
Standard Error 0.08
|
2.9 score on a scale
Standard Error 0.09
|
3.0 score on a scale
Standard Error 0.09
|
|
Change From Baseline in the CGI-I Score
Week 26
|
3.9 score on a scale
Standard Error 0.09
|
2.8 score on a scale
Standard Error 0.09
|
3.0 score on a scale
Standard Error 0.09
|
|
Change From Baseline in the CGI-I Score
Week 27
|
4.0 score on a scale
Standard Error 0.09
|
2.8 score on a scale
Standard Error 0.09
|
2.9 score on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Week 5, 8, 11, 14, 18, 22, 26, and 27Population: Population includes subjects who received at least one dose of study drug and had available data for analysis.
The Patient Global Impression of Change (PGIC) is a 7-point response scale. The participant response to the question, "Compared to your condition at the beginning of treatment, how much has your condition changed?" was assessed. Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=174 Participants
Participants will receive placebo matching to tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon 5 mg
n=174 Participants
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) QD orally for 27 weeks.
|
Tavapadon 15 mg
n=172 Participants
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
|---|---|---|---|
|
Change From Baseline in the PGIC Score
Week 5
|
3.7 score on a scale
Standard Error 0.07
|
3.5 score on a scale
Standard Error 0.07
|
3.4 score on a scale
Standard Error 0.07
|
|
Change From Baseline in the PGIC Score
Week 8
|
3.8 score on a scale
Standard Error 0.08
|
3.2 score on a scale
Standard Error 0.08
|
3.2 score on a scale
Standard Error 0.08
|
|
Change From Baseline in the PGIC Score
Week 11
|
3.8 score on a scale
Standard Error 0.08
|
3.0 score on a scale
Standard Error 0.08
|
3.1 score on a scale
Standard Error 0.08
|
|
Change From Baseline in the PGIC Score
Week 14
|
3.8 score on a scale
Standard Error 0.08
|
2.8 score on a scale
Standard Error 0.09
|
3.0 score on a scale
Standard Error 0.09
|
|
Change From Baseline in the PGIC Score
Week 18
|
3.9 score on a scale
Standard Error 0.09
|
2.8 score on a scale
Standard Error 0.10
|
2.9 score on a scale
Standard Error 0.10
|
|
Change From Baseline in the PGIC Score
Week 22
|
3.8 score on a scale
Standard Error 0.09
|
2.9 score on a scale
Standard Error 0.10
|
2.9 score on a scale
Standard Error 0.10
|
|
Change From Baseline in the PGIC Score
Week 26
|
4.0 score on a scale
Standard Error 0.10
|
2.8 score on a scale
Standard Error 0.10
|
2.8 score on a scale
Standard Error 0.11
|
|
Change From Baseline in the PGIC Score
Week 27
|
4.0 score on a scale
Standard Error 0.10
|
2.8 score on a scale
Standard Error 0.11
|
2.9 score on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Week 26Population: Population includes subjects who received at least one dose of study drug and had available data for analysis.
The ESS is an 8-question, participant questionnaire that is intended to measure daytime sleepiness. It assesses the likelihood of dozing off or falling asleep in the following common situations: sitting and reading, sitting inactive in a public place as a passenger in a car for an hour or more without stopping for a break, lying down to rest when circumstances permit, sitting and talking to someone, sitting quietly after a meal without alcohol, and in a car while stopped for a few minutes in traffic or at a light. Each situation is rated on a 4-point (0-3) scale with scores ranging from 0 (would never nod off) to 3 (high chance of nodding off). Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants will receive placebo matching to tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon 5 mg
n=134 Participants
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) QD orally for 27 weeks.
|
Tavapadon 15 mg
n=118 Participants
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Epworth Sleepiness Scale (ESS)
|
-0.2 score on a scale
Standard Error 0.23
|
-0.3 score on a scale
Standard Error 0.24
|
-0.5 score on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Week 26Population: Population includes subjects who received at least one dose of study drug and had available data for analysis.
QUIP-RS is a questionnaire for impulse-compulsive disorders in Parkinson's disease rating scale to assess impulse control disorders (ICD). The QUIP-RS has 4 primary questions that pertain to commonly reported thoughts, urges/desires, and behaviors associated with ICDs, each of which is applied to 4 ICDs (compulsive gambling, buying, eating, sexual behavior) and 3 related disorders (medication use, punding, and hobbyism). The QUIP-RS uses a 5-point Likert scale (score 0-4 \[0 means "never" and 4 means "very often"\] for each question) to gauge the frequency of behaviors. Scores for each ICD and related disorder range from 0 to 16, with a higher score indicating greater severity (frequency) of symptoms. The total QUIP-RS score for all ICDs and related disorders combined ranges from 0 to 112. A higher score indicating greater severity of symptoms.
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants will receive placebo matching to tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon 5 mg
n=134 Participants
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) QD orally for 27 weeks.
|
Tavapadon 15 mg
n=118 Participants
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS)
|
-2.1 score on a scale
Standard Error 0.46
|
-2.2 score on a scale
Standard Error 0.47
|
-2.4 score on a scale
Standard Error 0.48
|
SECONDARY outcome
Timeframe: Week 27Population: Population includes subjects who received at least one dose of study drug and had available data for analysis.
The C-SSRS is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation (SI) categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.
Outcome measures
| Measure |
Placebo
n=175 Participants
Participants will receive placebo matching to tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon 5 mg
n=177 Participants
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) QD orally for 27 weeks.
|
Tavapadon 15 mg
n=177 Participants
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
|---|---|---|---|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Participants With Any Suicidal Ideations
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Participants With Any Suicidal Behaviors
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Participants With Any Suicidal Behaviors or Ideations
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Participants With Non-Suicidal Self-Injurious Behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug until 190 days following last dose of study drug.Population: All-treated data set
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Outcome measures
| Measure |
Placebo
n=175 Participants
Participants will receive placebo matching to tavapadon tablet once daily (QD) orally for 27 weeks.
|
Tavapadon 5 mg
n=177 Participants
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) QD orally for 27 weeks.
|
Tavapadon 15 mg
n=177 Participants
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
100 Participants
|
142 Participants
|
139 Participants
|
Adverse Events
Placebo
Serious events: 11 serious events
Other events: 72 other events
Deaths: 2 deaths
Tavapadon 5mg QD
Serious events: 4 serious events
Other events: 125 other events
Deaths: 1 deaths
Tavapadon 15mg QD
Serious events: 10 serious events
Other events: 125 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=175 participants at risk
Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.
|
Tavapadon 5mg QD
n=177 participants at risk
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) once daily (QD) orally for 27 weeks.
|
Tavapadon 15mg QD
n=177 participants at risk
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
|---|---|---|---|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.56%
1/177 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.56%
1/177 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.57%
1/175 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.56%
1/177 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.56%
1/177 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.56%
1/177 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.57%
1/175 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
General disorders
DEATH
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.56%
1/177 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
General disorders
PERIPHERAL SWELLING
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.56%
1/177 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Infections and infestations
COVID-19
|
1.7%
3/175 • Number of events 3 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
1.1%
2/175 • Number of events 2 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Infections and infestations
PNEUMONIA
|
0.57%
1/175 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.1%
2/177 • Number of events 2 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Infections and infestations
TRACHEOBRONCHITIS
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.56%
1/177 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Injury, poisoning and procedural complications
FALL
|
0.57%
1/175 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.57%
1/175 • Number of events 2 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.57%
1/175 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.56%
1/177 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.57%
1/175 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.57%
1/175 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA
|
0.57%
1/175 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.56%
1/177 • Number of events 2 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Psychiatric disorders
HALLUCINATION, TACTILE
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.56%
1/177 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Reproductive system and breast disorders
PROSTATOMEGALY
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.56%
1/177 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Vascular disorders
THROMBOSIS
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.56%
1/177 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
Other adverse events
| Measure |
Placebo
n=175 participants at risk
Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.
|
Tavapadon 5mg QD
n=177 participants at risk
Participants will receive tavapadon tablet titrated up to 5 milligram (mg) once daily (QD) orally for 27 weeks.
|
Tavapadon 15mg QD
n=177 participants at risk
Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks.
|
|---|---|---|---|
|
Ear and labyrinth disorders
TINNITUS
|
0.57%
1/175 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
3.4%
6/177 • Number of events 6 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.7%
3/177 • Number of events 3 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Ear and labyrinth disorders
VERTIGO
|
1.1%
2/175 • Number of events 2 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.8%
5/177 • Number of events 6 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.7%
3/177 • Number of events 3 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.1%
2/175 • Number of events 2 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.7%
3/177 • Number of events 3 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.56%
1/177 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
3.4%
6/177 • Number of events 8 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.57%
1/175 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.8%
5/177 • Number of events 5 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.1%
2/175 • Number of events 2 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.1%
2/177 • Number of events 3 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
6.2%
11/177 • Number of events 12 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
5.1%
9/177 • Number of events 9 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
1.1%
2/175 • Number of events 3 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.8%
5/177 • Number of events 6 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
5.6%
10/177 • Number of events 10 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.57%
1/175 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
4.0%
7/177 • Number of events 7 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Gastrointestinal disorders
NAUSEA
|
1.7%
3/175 • Number of events 5 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
23.7%
42/177 • Number of events 44 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
27.1%
48/177 • Number of events 56 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Gastrointestinal disorders
SALIVARY HYPERSECRETION
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.1%
2/177 • Number of events 2 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Gastrointestinal disorders
VOMITING
|
0.57%
1/175 • Number of events 2 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
6.8%
12/177 • Number of events 13 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
5.1%
9/177 • Number of events 11 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
General disorders
ASTHENIA
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.8%
5/177 • Number of events 5 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.1%
2/177 • Number of events 2 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
General disorders
FATIGUE
|
3.4%
6/175 • Number of events 6 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
5.6%
10/177 • Number of events 11 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
9.0%
16/177 • Number of events 17 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 5 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.56%
1/177 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Infections and infestations
COVID-19
|
2.3%
4/175 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
5.1%
9/177 • Number of events 9 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
3.4%
6/177 • Number of events 6 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Infections and infestations
NASOPHARYNGITIS
|
2.3%
4/175 • Number of events 5 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.1%
2/177 • Number of events 2 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
3.4%
6/177 • Number of events 6 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.7%
3/175 • Number of events 3 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.1%
9/175 • Number of events 10 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
3.4%
6/177 • Number of events 7 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.7%
3/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Injury, poisoning and procedural complications
FALL
|
3.4%
6/175 • Number of events 6 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
4.0%
7/177 • Number of events 8 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Investigations
SARS-COV-2 TEST POSITIVE
|
1.1%
2/175 • Number of events 2 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Investigations
WEIGHT DECREASED
|
1.1%
2/175 • Number of events 2 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.7%
3/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.57%
1/175 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.7%
3/177 • Number of events 3 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.8%
5/177 • Number of events 5 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.9%
5/175 • Number of events 5 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 5 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.4%
6/175 • Number of events 6 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
4.0%
7/177 • Number of events 8 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.57%
1/175 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.7%
3/177 • Number of events 3 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
1.7%
3/175 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
3.4%
6/177 • Number of events 7 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.8%
5/177 • Number of events 5 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Nervous system disorders
AGEUSIA
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.56%
1/177 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.8%
5/177 • Number of events 6 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Nervous system disorders
DIZZINESS
|
4.6%
8/175 • Number of events 9 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
13.6%
24/177 • Number of events 32 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
11.9%
21/177 • Number of events 23 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
7.9%
14/177 • Number of events 14 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
7.9%
14/177 • Number of events 17 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Nervous system disorders
HEADACHE
|
5.1%
9/175 • Number of events 16 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
12.4%
22/177 • Number of events 25 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
20.9%
37/177 • Number of events 39 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Nervous system disorders
HYPOAESTHESIA
|
1.1%
2/175 • Number of events 2 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.7%
3/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
3.4%
6/177 • Number of events 9 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Nervous system disorders
PARAESTHESIA
|
0.57%
1/175 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.7%
3/177 • Number of events 5 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
4.5%
8/177 • Number of events 11 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Nervous system disorders
PAROSMIA
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Nervous system disorders
SOMNOLENCE
|
3.4%
6/175 • Number of events 6 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
3.4%
6/177 • Number of events 6 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.8%
5/177 • Number of events 5 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Nervous system disorders
TREMOR
|
1.1%
2/175 • Number of events 3 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.7%
3/177 • Number of events 3 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Psychiatric disorders
ABNORMAL DREAMS
|
0.57%
1/175 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
5.6%
10/177 • Number of events 10 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
3.4%
6/177 • Number of events 6 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Psychiatric disorders
ANXIETY
|
2.9%
5/175 • Number of events 5 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
5.6%
10/177 • Number of events 11 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
5.1%
9/177 • Number of events 10 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Psychiatric disorders
DEPRESSION
|
2.3%
4/175 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.1%
2/177 • Number of events 2 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Psychiatric disorders
HALLUCINATION, VISUAL
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.00%
0/177 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.8%
5/177 • Number of events 5 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Psychiatric disorders
INSOMNIA
|
2.3%
4/175 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.8%
5/177 • Number of events 5 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
4.0%
7/177 • Number of events 8 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Psychiatric disorders
SLEEP DISORDER
|
0.57%
1/175 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.7%
3/177 • Number of events 3 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.57%
1/175 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.1%
2/177 • Number of events 2 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
3.4%
6/177 • Number of events 6 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Vascular disorders
HYPERTENSION
|
4.6%
8/175 • Number of events 8 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
0.56%
1/177 • Number of events 1 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
1.1%
2/177 • Number of events 2 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Vascular disorders
HYPOTENSION
|
2.3%
4/175 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
4.0%
7/177 • Number of events 9 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
4.5%
8/177 • Number of events 9 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.00%
0/175 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
6.2%
11/177 • Number of events 11 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
2.3%
4/177 • Number of events 4 • All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER