Trial Outcomes & Findings for Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations (TEMPO-3) (NCT NCT04542499)
NCT ID: NCT04542499
Last Updated: 2025-04-04
Results Overview
The Hauser diary assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep. The total "on" time without troublesome dyskinesia will be assessed and reported at endpoint.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
507 participants
Primary outcome timeframe
Week 26
Results posted on
2025-04-04
Participant Flow
In this Phase 3, Double-Blind study, a total of 368 subjects with Parkinson's Disease(PD) were be randomized in a 1:1 ratio to receive Tavapadon (5 mg to 15 mg) or Placebo once daily (QD) for 27 Weeks.
Participant milestones
| Measure |
Placebo
Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.
Placebo: Participants will receive placebo matching to tavapadon QD orally for 27 weeks.
|
Tavapadon
Participants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks.
Tavapadon: Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
255
|
252
|
|
Overall Study
COMPLETED
|
206
|
159
|
|
Overall Study
NOT COMPLETED
|
49
|
93
|
Reasons for withdrawal
| Measure |
Placebo
Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.
Placebo: Participants will receive placebo matching to tavapadon QD orally for 27 weeks.
|
Tavapadon
Participants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks.
Tavapadon: Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
23
|
43
|
|
Overall Study
Lack of Efficacy
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Failure to Meet Continuation Criteria
|
0
|
1
|
|
Overall Study
Treatment with Prohibited Concomitant Medications
|
1
|
0
|
|
Overall Study
Non-Compliance with Study Drug
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Site Terminated by Sponsor
|
3
|
5
|
|
Overall Study
Withdrawal by Subject
|
12
|
33
|
|
Overall Study
Other
|
2
|
2
|
Baseline Characteristics
Population includes subjects who received at least one dose of study drug and had available data for analysis.
Baseline characteristics by cohort
| Measure |
Placebo
n=255 Participants
Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.
Placebo: Participants will receive placebo matching to tavapadon QD orally for 27 weeks.
|
Tavapadon
n=252 Participants
Participants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks.
Tavapadon: Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.
|
Total
n=507 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 8.52 • n=255 Participants
|
65.6 years
STANDARD_DEVIATION 8.42 • n=252 Participants
|
64.9 years
STANDARD_DEVIATION 8.49 • n=507 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=255 Participants
|
101 Participants
n=252 Participants
|
186 Participants
n=507 Participants
|
|
Sex: Female, Male
Male
|
170 Participants
n=255 Participants
|
151 Participants
n=252 Participants
|
321 Participants
n=507 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=255 Participants
|
11 Participants
n=252 Participants
|
27 Participants
n=507 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
232 Participants
n=255 Participants
|
226 Participants
n=252 Participants
|
458 Participants
n=507 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=255 Participants
|
15 Participants
n=252 Participants
|
22 Participants
n=507 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=255 Participants
|
0 Participants
n=252 Participants
|
2 Participants
n=507 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=255 Participants
|
2 Participants
n=252 Participants
|
4 Participants
n=507 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=255 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=507 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=255 Participants
|
2 Participants
n=252 Participants
|
6 Participants
n=507 Participants
|
|
Race (NIH/OMB)
White
|
245 Participants
n=255 Participants
|
246 Participants
n=252 Participants
|
491 Participants
n=507 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=255 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=507 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=255 Participants
|
2 Participants
n=252 Participants
|
4 Participants
n=507 Participants
|
|
ON Time (hours) Without Troublesome Dyskinesia at Baseline
|
10.148 hours
STANDARD_DEVIATION 2.637 • n=248 Participants • Population includes subjects who received at least one dose of study drug and had available data for analysis.
|
9.884 hours
STANDARD_DEVIATION 2.569 • n=247 Participants • Population includes subjects who received at least one dose of study drug and had available data for analysis.
|
10.016 hours
STANDARD_DEVIATION 2.604 • n=495 Participants • Population includes subjects who received at least one dose of study drug and had available data for analysis.
|
|
OFF Time (hours) at Baseline
|
5.408 hours
STANDARD_DEVIATION 2.484 • n=248 Participants • Population includes subjects who received at least one dose of study drug and had available data for analysis.
|
5.638 hours
STANDARD_DEVIATION 2.246 • n=247 Participants • Population includes subjects who received at least one dose of study drug and had available data for analysis.
|
5.523 hours
STANDARD_DEVIATION 2.369 • n=495 Participants • Population includes subjects who received at least one dose of study drug and had available data for analysis.
|
|
Movement Disorder Society - Unified Parkinson's Disease Rating Score at Baseline (Parts I, II, III)
Part I
|
7.5 units on a scale
STANDARD_DEVIATION 4.93 • n=255 Participants
|
8.0 units on a scale
STANDARD_DEVIATION 5.13 • n=252 Participants
|
7.7 units on a scale
STANDARD_DEVIATION 5.03 • n=507 Participants
|
|
Movement Disorder Society - Unified Parkinson's Disease Rating Score at Baseline (Parts I, II, III)
Part II
|
12.5 units on a scale
STANDARD_DEVIATION 7.05 • n=255 Participants
|
13.3 units on a scale
STANDARD_DEVIATION 6.54 • n=252 Participants
|
12.9 units on a scale
STANDARD_DEVIATION 6.80 • n=507 Participants
|
|
Movement Disorder Society - Unified Parkinson's Disease Rating Score at Baseline (Parts I, II, III)
Part III
|
32.4 units on a scale
STANDARD_DEVIATION 14.26 • n=255 Participants
|
32.6 units on a scale
STANDARD_DEVIATION 14.34 • n=252 Participants
|
32.5 units on a scale
STANDARD_DEVIATION 14.29 • n=507 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 Hauser diary assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep. The total "on" time without troublesome dyskinesia will be assessed and reported at endpoint.
Outcome measures
| Measure |
Placebo
n=201 Participants
Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.
Placebo: Participants will receive placebo matching to tavapadon QD orally for 27 weeks.
|
Tavapadon
n=153 Participants
Participants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks.
Tavapadon: Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary)
|
0.619 hours
Standard Error 0.188
|
1.721 hours
Standard Error 0.207
|
SECONDARY outcome
Timeframe: Week 26Population: Population includes subjects who received at least one dose of study drug and had available data for analysis.
The Hauser diary assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep. The total daily "Off" time will be assessed and reported at endpoint.
Outcome measures
| Measure |
Placebo
n=201 Participants
Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.
Placebo: Participants will receive placebo matching to tavapadon QD orally for 27 weeks.
|
Tavapadon
n=153 Participants
Participants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks.
Tavapadon: Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)
|
-0.933 hours
Standard Error 0.182
|
-1.876 hours
Standard Error 0.200
|
SECONDARY outcome
Timeframe: Week 2, 5, 8, 11, 14, 18, 22, and 26Population: Population includes subjects who received at least one dose of study drug and had available data for analysis.
The Hauser diary assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep. The total "on" time without troublesome dyskinesia will be assessed and reported at different time points.
Outcome measures
| Measure |
Placebo
n=245 Participants
Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.
Placebo: Participants will receive placebo matching to tavapadon QD orally for 27 weeks.
|
Tavapadon
n=242 Participants
Participants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks.
Tavapadon: Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary)
Week 8
|
0.470 hours
Standard Error 0.162
|
1.052 hours
Standard Error 0.168
|
|
Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary)
Week 11
|
0.705 hours
Standard Error 0.163
|
1.063 hours
Standard Error 0.171
|
|
Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary)
Week 14
|
0.584 hours
Standard Error 0.175
|
1.282 hours
Standard Error 0.187
|
|
Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary)
Week 18
|
0.623 hours
Standard Error 0.174
|
1.592 hours
Standard Error 0.185
|
|
Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary)
Week 22
|
0.870 hours
Standard Error 0.177
|
1.749 hours
Standard Error 0.190
|
|
Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary)
Week 26
|
0.619 hours
Standard Error 0.188
|
1.721 hours
Standard Error 0.207
|
|
Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary)
Week 2
|
0.535 hours
Standard Error 0.133
|
0.305 hours
Standard Error 0.133
|
|
Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary)
Week 5
|
0.516 hours
Standard Error 0.148
|
0.616 hours
Standard Error 0.151
|
SECONDARY outcome
Timeframe: Week 2, 5, 8, 11, 14, 18, 22, and 26Population: Population includes subjects who received at least one dose of study drug and had available data for analysis.
The Hauser diary assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep. The total daily "Off" time will be assessed and reported at different time points.
Outcome measures
| Measure |
Placebo
n=245 Participants
Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.
Placebo: Participants will receive placebo matching to tavapadon QD orally for 27 weeks.
|
Tavapadon
n=242 Participants
Participants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks.
Tavapadon: Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)
Week 18
|
-0.786 hours
Standard Error 0.176
|
-1.810 hours
Standard Error 0.187
|
|
Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)
Week 22
|
-1.014 hours
Standard Error 0.179
|
-1.993 hours
Standard Error 0.191
|
|
Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)
Week 2
|
-0.598 hours
Standard Error 0.127
|
-0.490 hours
Standard Error 0.127
|
|
Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)
Week 5
|
-0.612 hours
Standard Error 0.144
|
-0.849 hours
Standard Error 0.146
|
|
Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)
Week 8
|
-0.549 hours
Standard Error 0.153
|
-1.367 hours
Standard Error 0.159
|
|
Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)
Week 11
|
-0.876 hours
Standard Error 0.156
|
-1.629 hours
Standard Error 0.164
|
|
Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)
Week 14
|
-0.779 hours
Standard Error 0.173
|
-1.682 hours
Standard Error 0.185
|
|
Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)
Week 26
|
-0.933 hours
Standard Error 0.182
|
-1.876 hours
Standard Error 0.200
|
SECONDARY outcome
Timeframe: Week 26Population: Population includes subjects who received at least one dose of study drug and had available data for analysis.
The 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.
Outcome measures
| Measure |
Placebo
n=245 Participants
Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.
Placebo: Participants will receive placebo matching to tavapadon QD orally for 27 weeks.
|
Tavapadon
n=242 Participants
Participants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks.
Tavapadon: Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III Individual Score
Part I
|
0.0 units on a scale
Standard Error 0.27
|
0.4 units on a scale
Standard Error 0.30
|
|
Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III Individual Score
Part II
|
-0.1 units on a scale
Standard Error 0.35
|
-1.4 units on a scale
Standard Error 0.39
|
|
Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III Individual Score
Part III
|
-4.6 units on a scale
Standard Error 0.65
|
-7.0 units on a scale
Standard Error 0.71
|
Adverse Events
Placebo
Serious events: 14 serious events
Other events: 90 other events
Deaths: 0 deaths
Tavapadon
Serious events: 17 serious events
Other events: 130 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=255 participants at risk
Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.
Placebo: Participants will receive placebo matching to tavapadon QD orally for 27 weeks.
|
Tavapadon
n=252 participants at risk
Participants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks.
Tavapadon: Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.39%
1/255 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.00%
0/252 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.39%
1/255 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.00%
0/252 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Cardiac disorders
CARDIAC FAILURE CHRONIC
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Eye disorders
GLAUCOMA
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.79%
2/252 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
0.39%
1/255 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.00%
0/252 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Infections and infestations
BRONCHITIS BACTERIAL
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Infections and infestations
CELLULITIS
|
0.39%
1/255 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.00%
0/252 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Infections and infestations
COVID-19
|
0.78%
2/255 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.00%
0/252 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Infections and infestations
EYE INFECTION
|
0.39%
1/255 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.00%
0/252 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Infections and infestations
INFECTIVE ANEURYSM
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Infections and infestations
LYME DISEASE
|
0.39%
1/255 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.00%
0/252 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Infections and infestations
SUBACUTE ENDOCARDITIS
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
1.2%
3/252 • Number of events 3 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.39%
1/255 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.00%
0/252 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DISORDER
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATIC DISORDER
|
0.39%
1/255 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.00%
0/252 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-CELL SMALL LYMPHOCYTIC LYMPHOMA
|
0.39%
1/255 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.00%
0/252 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA METASTATIC
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Nervous system disorders
COLLOID BRAIN CYST
|
0.39%
1/255 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.00%
0/252 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Nervous system disorders
MIDDLE CEREBRAL ARTERY STROKE
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Nervous system disorders
ON AND OFF PHENOMENON
|
0.39%
1/255 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.00%
0/252 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Psychiatric disorders
ANXIETY DISORDER
|
0.39%
1/255 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.00%
0/252 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Psychiatric disorders
HALLUCINATION, VISUAL
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.39%
1/255 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.00%
0/252 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
Other adverse events
| Measure |
Placebo
n=255 participants at risk
Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.
Placebo: Participants will receive placebo matching to tavapadon QD orally for 27 weeks.
|
Tavapadon
n=252 participants at risk
Participants will receive a tavapadon tablet titrated 5 to 15milligrams (mg) once daily (QD)orally for 27 weeks.
Tavapadon: Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.39%
1/255 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
2.4%
6/252 • Number of events 6 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Gastrointestinal disorders
CONSTIPATION
|
3.1%
8/255 • Number of events 9 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
4.0%
10/252 • Number of events 10 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.78%
2/255 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
2.8%
7/252 • Number of events 7 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Gastrointestinal disorders
NAUSEA
|
4.3%
11/255 • Number of events 14 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
14.3%
36/252 • Number of events 44 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
General disorders
ASTHENIA
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
3.2%
8/252 • Number of events 8 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
General disorders
FATIGUE
|
4.3%
11/255 • Number of events 11 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
4.0%
10/252 • Number of events 11 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Infections and infestations
COVID-19
|
2.7%
7/255 • Number of events 7 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
5.2%
13/252 • Number of events 13 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Infections and infestations
NASOPHARYNGITIS
|
2.4%
6/255 • Number of events 6 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
2.8%
7/252 • Number of events 7 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.7%
7/255 • Number of events 9 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
2.8%
7/252 • Number of events 10 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
2.4%
6/255 • Number of events 7 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
1.6%
4/252 • Number of events 4 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Injury, poisoning and procedural complications
FALL
|
5.1%
13/255 • Number of events 20 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
5.2%
13/252 • Number of events 18 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Investigations
WEIGHT DECREASED
|
0.39%
1/255 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
2.8%
7/252 • Number of events 7 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.39%
1/255 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
2.4%
6/252 • Number of events 6 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.7%
7/255 • Number of events 7 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
2.0%
5/252 • Number of events 5 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Nervous system disorders
DIZZINESS
|
3.1%
8/255 • Number of events 8 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
7.1%
18/252 • Number of events 20 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
2.8%
7/252 • Number of events 7 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Nervous system disorders
DYSKINESIA
|
1.6%
4/255 • Number of events 7 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
9.9%
25/252 • Number of events 32 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Nervous system disorders
DYSTONIA
|
0.00%
0/255 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
2.8%
7/252 • Number of events 9 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Nervous system disorders
HEADACHE
|
2.7%
7/255 • Number of events 7 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
6.7%
17/252 • Number of events 23 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Nervous system disorders
SOMNOLENCE
|
4.3%
11/255 • Number of events 11 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
5.2%
13/252 • Number of events 13 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Psychiatric disorders
ANXIETY
|
2.7%
7/255 • Number of events 7 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
3.2%
8/252 • Number of events 8 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Psychiatric disorders
DEPRESSION
|
0.78%
2/255 • Number of events 2 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
2.4%
6/252 • Number of events 7 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Psychiatric disorders
HALLUCINATION, VISUAL
|
1.2%
3/255 • Number of events 3 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
5.2%
13/252 • Number of events 14 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Psychiatric disorders
INSOMNIA
|
2.7%
7/255 • Number of events 7 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
0.40%
1/252 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
2.4%
6/255 • Number of events 6 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
1.2%
3/252 • Number of events 3 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Vascular disorders
HYPOTENSION
|
0.39%
1/255 • Number of events 1 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
3.6%
9/252 • Number of events 9 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
1.2%
3/255 • Number of events 3 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
6.0%
15/252 • Number of events 15 • All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place