Trial Outcomes & Findings for Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease (NCT NCT02542696)
NCT ID: NCT02542696
Last Updated: 2023-11-22
Results Overview
Number of Participants (%) with Adverse Events in the LTS Phase
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
496 participants
Primary outcome timeframe
up to approximately 3 years
Results posted on
2023-11-22
Participant Flow
Participant milestones
| Measure |
APL-130277
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Overall Study
STARTED
|
496
|
|
Overall Study
Titration Full Analysis Population
|
449
|
|
Overall Study
LTS Phase Full Analysis Population
|
426
|
|
Overall Study
COMPLETED
|
120
|
|
Overall Study
NOT COMPLETED
|
376
|
Reasons for withdrawal
| Measure |
APL-130277
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Overall Study
Adverse Event
|
167
|
|
Overall Study
Lack of Efficacy
|
26
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Withdrawal by Subject
|
104
|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Death
|
8
|
|
Overall Study
DECREASED OFF TIME
|
1
|
|
Overall Study
DID NOT MEET CRITERIA FOR CONTINUATION
|
1
|
|
Overall Study
ELIGIBILITY CRITERIA NOT MET
|
8
|
|
Overall Study
MEDICAL HISTORY
|
1
|
|
Overall Study
PATIENT WITHDRAWN DURING TITRATION AS COULD NOT TITRATE DRUG TO GET RESPONSE OF "ON" FROM PATIENT
|
1
|
|
Overall Study
PROGRESSION OF PARKINSON'S DISEASE
|
5
|
|
Overall Study
SITE UNABLE TO COMPLY WITH PROTOCOL
|
2
|
|
Overall Study
SPONSOR DECISION
|
3
|
|
Overall Study
STUDY TERMINATED BY SPONSOR
|
36
|
|
Overall Study
SUBJECT DECISION
|
2
|
Baseline Characteristics
some subjects had missing height measurement
Baseline characteristics by cohort
| Measure |
APL-130277
n=496 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=496 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
239 Participants
n=496 Participants
|
|
Age, Categorical
>=65 years
|
257 Participants
n=496 Participants
|
|
Age, Continuous
|
64.4 Years
STANDARD_DEVIATION 8.72 • n=496 Participants
|
|
Sex: Female, Male
Female
|
163 Participants
n=496 Participants
|
|
Sex: Female, Male
Male
|
333 Participants
n=496 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=496 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
457 Participants
n=496 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=496 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=496 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=496 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=496 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=496 Participants
|
|
Race (NIH/OMB)
White
|
478 Participants
n=496 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=496 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=496 Participants
|
|
ON State Modified Hoehn and Yahr Score
0
|
2 Participants
n=496 Participants
|
|
ON State Modified Hoehn and Yahr Score
1
|
12 Participants
n=496 Participants
|
|
ON State Modified Hoehn and Yahr Score
1.5
|
9 Participants
n=496 Participants
|
|
ON State Modified Hoehn and Yahr Score
2
|
243 Participants
n=496 Participants
|
|
ON State Modified Hoehn and Yahr Score
2.5
|
53 Participants
n=496 Participants
|
|
ON State Modified Hoehn and Yahr Score
3
|
42 Participants
n=496 Participants
|
|
ON State Modified Hoehn and Yahr Score
4
|
1 Participants
n=496 Participants
|
|
ON State Modified Hoehn and Yahr Score
Missing
|
134 Participants
n=496 Participants
|
|
Age, Customized
<65 years
|
239 Participants
n=496 Participants
|
|
Age, Customized
>=65 years and <75 years
|
197 Participants
n=496 Participants
|
|
Age, Customized
>=75 years
|
60 Participants
n=496 Participants
|
|
Baseline Height (cm)
|
172.01 cm
STANDARD_DEVIATION 9.754 • n=488 Participants • some subjects had missing height measurement
|
|
Baseline Weight (kg)
|
82.14 kg
STANDARD_DEVIATION 18.740 • n=492 Participants • some subjects had missing weight at baseline
|
|
Baseline BMI (kg/m^2)
|
27.654 kg/m^2
STANDARD_DEVIATION 5.5287 • n=487 Participants • some subjects had missing BMI value at baseline
|
|
Country
Aut
|
4 Participants
n=496 Participants
|
|
Country
Can
|
7 Participants
n=496 Participants
|
|
Country
Deu
|
23 Participants
n=496 Participants
|
|
Country
Esp
|
11 Participants
n=496 Participants
|
|
Country
Gbr
|
41 Participants
n=496 Participants
|
|
Country
Ita
|
19 Participants
n=496 Participants
|
|
Country
United States
|
391 Participants
n=496 Participants
|
|
Baseline MDS-UPDRS Part III Score
|
43.0 Score
STANDARD_DEVIATION 14.85 • n=426 Participants • based on subjects with data only
|
|
Screening MDS-UPDRS Part III Score
|
42.0 Score
STANDARD_DEVIATION 14.55 • n=367 Participants • Based on subjects with data only
|
|
Mini-Mental State Examination Total Score
<26
|
3 Participants
n=496 Participants
|
|
Mini-Mental State Examination Total Score
26
|
30 Participants
n=496 Participants
|
|
Mini-Mental State Examination Total Score
27
|
38 Participants
n=496 Participants
|
|
Mini-Mental State Examination Total Score
28
|
53 Participants
n=496 Participants
|
|
Mini-Mental State Examination Total Score
29
|
114 Participants
n=496 Participants
|
|
Mini-Mental State Examination Total Score
30
|
183 Participants
n=496 Participants
|
|
Mini-Mental State Examination Total Score
Missing
|
75 Participants
n=496 Participants
|
|
Baseline MDS-UPDRS Part I Score
|
11.0 Score
STANDARD_DEVIATION 5.42 • n=492 Participants • Only subjects with data were summarized
|
|
Baseline MDS-UPDRS Part II Score
|
14.6 Score
STANDARD_DEVIATION 7.15 • n=492 Participants • based on subjects with data only
|
PRIMARY outcome
Timeframe: up to approximately 3 yearsPopulation: Based on Long Term Safety Full Analysis Set
Number of Participants (%) with Adverse Events in the LTS Phase
Outcome measures
| Measure |
APL-130277
n=426 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Evaluation of Safety and Tolerability Data Collected, Based on Number of Participants With Adverse Events in the LTS Phase
|
365 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Based on the number of subjects who provided data at the specified timepoint in the analysis population
The percentage of instances where a full "ON" response was achieved
Outcome measures
| Measure |
APL-130277
n=167 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
The Percentage of Instances Where a Full "ON" Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 24 Visit (LTS V4) of the LTS Phase Based on the Home Dosing Diary Entries.
|
80.7 percentage of instances
Standard Deviation 32.55
|
SECONDARY outcome
Timeframe: Week 36Population: Based on the number of subjects who provided data at the specified timepoint in the analysis population
Outcome measures
| Measure |
APL-130277
n=80 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
The Percentage of Instances Where a Full "ON" Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 36 Visit (LTS V5) of the LTS Phase Based on the Home Dosing Diary Entries.
|
87.3 percentage of instances
Standard Deviation 28.70
|
SECONDARY outcome
Timeframe: Week 48Population: Based on the number of subjects who provided data at the specified timepoint in the analysis population
Outcome measures
| Measure |
APL-130277
n=70 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
The Percentage of Instances Where a Full "ON" Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 48 Visit (LTS V6) of the LTS Phase Based on the Home Dosing Diary Entries.
|
84.1 percentage of instances
Standard Deviation 30.74
|
SECONDARY outcome
Timeframe: Week 24Population: Based on the number of subjects who provided data at the specified timepoint in the analysis population
Outcome measures
| Measure |
APL-130277
n=224 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Percentage of Subjects With a Subject-rated Full "ON" Response Within 30 Minutes at Week 24 Visit (LTS V4) of the LTS Phase.
|
77.2 percent of participants
|
SECONDARY outcome
Timeframe: Week 36Population: Based on the number of subjects who provided data at the specified timepoint in the analysis population
Outcome measures
| Measure |
APL-130277
n=112 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Percentage of Subjects With a Subject-rated Full "ON" Response Within 30 Minutes at Week 36 Visit (LTS V5) of the LTS Phase.
|
83.9 percent of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Based on the number of subjects who provided data at the specified timepoint in the analysis population
Outcome measures
| Measure |
APL-130277
n=90 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Percentage of Subjects With a Subject-rated Full "ON" Response Within 30 Minutes at Week 48 Visit (LTS V6) of the LTS Phase.
|
84.4 percent of participants
|
SECONDARY outcome
Timeframe: Week 24, 15 mins after dosingPopulation: Based on the number of subjects who provided data at the specified timepoint in the analysis population
The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Outcome measures
| Measure |
APL-130277
n=223 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 15 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase.
|
-14.2 Units on a scale
Standard Deviation 11.91
|
SECONDARY outcome
Timeframe: Week 24, 30 mins after dosingPopulation: Based on the number of subjects who provided data at the specified timepoint in the analysis population
The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Outcome measures
| Measure |
APL-130277
n=222 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 30 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase.
|
-22.1 Units on a scale
Standard Deviation 13.04
|
SECONDARY outcome
Timeframe: Week 24, 60 mins after dosingPopulation: Based on the number of subjects who provided data at the specified timepoint in the analysis population
The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Outcome measures
| Measure |
APL-130277
n=221 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 60 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase.
|
-21.0 Units on a scale
Standard Deviation 13.34
|
SECONDARY outcome
Timeframe: Week 24, 90 mins after dosingPopulation: Based on the number of subjects who provided data at the specified timepoint in the analysis population
The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Outcome measures
| Measure |
APL-130277
n=48 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 90 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase.
|
-16.9 Units on a scale
Standard Deviation 13.58
|
SECONDARY outcome
Timeframe: Week 36, 15 mins after dosingPopulation: Based on the number of subjects who provided data at the specified timepoint in the analysis population
The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Outcome measures
| Measure |
APL-130277
n=111 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 15 Minutes After Dosing at Week 36 Visit (LTS V5) of the LTS Phase.
|
-11.7 Units on a scale
Standard Deviation 10.48
|
SECONDARY outcome
Timeframe: Week 36, 30 mins after dosingPopulation: Based on the number of subjects who provided data at the specified timepoint in the analysis population
The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Outcome measures
| Measure |
APL-130277
n=110 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 30 Minutes After Dosing at Week 36 Visit (LTS V5) of the LTS Phase.
|
-22.3 Units on a scale
Standard Deviation 12.22
|
SECONDARY outcome
Timeframe: Week 36, 60 mins after dosingPopulation: Based on the number of subjects who provided data at the specified timepoint in the analysis population
The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Outcome measures
| Measure |
APL-130277
n=112 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 60 Minutes After Dosing at Week 36 Visit (LTS V5) of the LTS Phase.
|
-21.3 Units on a scale
Standard Deviation 13.54
|
SECONDARY outcome
Timeframe: Week 36, 90 mins after dosingPopulation: Based on the number of subjects who provided data at the specified timepoint in the analysis population
The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Outcome measures
| Measure |
APL-130277
n=54 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 90 Minutes After Dosing at Week 36 Visit (LTS V5) of the LTS Phase.
|
-13.3 Units on a scale
Standard Deviation 13.11
|
SECONDARY outcome
Timeframe: Week 48, 15 mins after dosingPopulation: Based on the number of subjects who provided data at the specified timepoint in the analysis population
The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Outcome measures
| Measure |
APL-130277
n=90 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 15 Minutes After Dosing at Week 48 Visit (LTS V6) of the LTS Phase.
|
-13.3 Units on a scale
Standard Deviation 10.17
|
SECONDARY outcome
Timeframe: Week 48, 30 mins after dosingPopulation: Based on the number of subjects who provided data at the specified timepoint in the analysis population
The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Outcome measures
| Measure |
APL-130277
n=90 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 30 Minutes After Dosing at Week 48 Visit (LTS V6) of the LTS Phase.
|
-23.2 Units on a scale
Standard Deviation 12.44
|
SECONDARY outcome
Timeframe: Week 48, 60 mins after dosingPopulation: Based on the number of subjects who provided data at the specified timepoint in the analysis population
The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Outcome measures
| Measure |
APL-130277
n=90 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 60 Minutes After Dosing at Week 48 Visit (LTS V6) of the LTS Phase.
|
-22.3 Units on a scale
Standard Deviation 13.35
|
SECONDARY outcome
Timeframe: Week 48, 90 mins after dosingPopulation: Based on the number of subjects who provided data at the specified timepoint in the analysis population
The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Outcome measures
| Measure |
APL-130277
n=48 Participants
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 90 Minutes After Dosing at Week 48 Visit (LTS V6) of the LTS Phase.
|
-16.6 Units on a scale
Standard Deviation 10.93
|
Adverse Events
APL-130277
Serious events: 64 serious events
Other events: 319 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
APL-130277
n=496 participants at risk
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.60%
3/496 • Number of events 3 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Cardiac disorders
Angina unstable
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Cardiac disorders
Arrhythmia
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Cardiac disorders
Atrial fibrillation
|
0.40%
2/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Cardiac disorders
Cardiac arrest
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.60%
3/496 • Number of events 3 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Cardiac disorders
Myocardial infarction
|
0.40%
2/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Eye disorders
Retinal artery occlusion
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Gastrointestinal disorders
Constipation
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Gastrointestinal disorders
Duodenitis
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Gastrointestinal disorders
Dysphagia
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Gastrointestinal disorders
Lip blister
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.40%
2/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
General disorders
Chest pain
|
0.20%
1/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
General disorders
Drowning
|
0.40%
2/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
General disorders
General physical health deterioration
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Infections and infestations
Abscess limb
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Infections and infestations
Cellulitis
|
0.40%
2/496 • Number of events 3 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Infections and infestations
Corona virus infection
|
0.40%
2/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Infections and infestations
Kidney infection
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Infections and infestations
Oral candidiasis
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Infections and infestations
Osteomyelitis
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Infections and infestations
Pneumonia
|
1.0%
5/496 • Number of events 5 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Infections and infestations
Psoas abscess
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Infections and infestations
Sepsis
|
0.40%
2/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Infections and infestations
Septic shock
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Infections and infestations
Streptococcal sepsis
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Infections and infestations
Urinary tract infection
|
0.81%
4/496 • Number of events 6 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Infections and infestations
Urosepsis
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Infections and infestations
Wound infection
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Injury, poisoning and procedural complications
Adjacent segment degeneration
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
5/496 • Number of events 5 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.40%
2/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Investigations
Carbon dioxide increased
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.20%
1/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.60%
3/496 • Number of events 3 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.20%
1/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.40%
2/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.40%
2/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage II
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.40%
2/496 • Number of events 3 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.40%
2/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Nervous system disorders
Coma
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Nervous system disorders
Encephalopathy
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Nervous system disorders
Facial paresis
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Nervous system disorders
Hypoaesthesia
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Nervous system disorders
Myelopathy
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Nervous system disorders
Parkinson's disease
|
0.40%
2/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Nervous system disorders
Subarachnoid haematoma
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Nervous system disorders
Syncope
|
0.40%
2/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Psychiatric disorders
Adjustment disorder with mixed anxiety and depressed mood
|
0.20%
1/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Psychiatric disorders
Depression
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Psychiatric disorders
Dopamine dysregulation syndrome
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Psychiatric disorders
Mental status changes
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Psychiatric disorders
Psychotic disorder
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Renal and urinary disorders
Calculus bladder
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.20%
1/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural thickening
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.40%
2/496 • Number of events 2 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Skin and subcutaneous tissue disorders
Nail fold inflammation
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Vascular disorders
Deep vein thrombosis
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Vascular disorders
Hypotension
|
0.20%
1/496 • Number of events 1 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
Other adverse events
| Measure |
APL-130277
n=496 participants at risk
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
|
|---|---|
|
Gastrointestinal disorders
Lip swelling
|
5.4%
27/496 • Number of events 36 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.6%
28/496 • Number of events 37 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Gastrointestinal disorders
Nausea
|
27.4%
136/496 • Number of events 197 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
8.7%
43/496 • Number of events 60 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Gastrointestinal disorders
Stomatitis
|
5.0%
25/496 • Number of events 39 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
General disorders
Fatigue
|
7.1%
35/496 • Number of events 48 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Injury, poisoning and procedural complications
Fall
|
8.9%
44/496 • Number of events 63 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Nervous system disorders
Dizziness
|
10.5%
52/496 • Number of events 70 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Nervous system disorders
Dyskinesia
|
6.9%
34/496 • Number of events 47 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Nervous system disorders
Headache
|
6.2%
31/496 • Number of events 43 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Nervous system disorders
Somnolence
|
11.5%
57/496 • Number of events 81 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
11.1%
55/496 • Number of events 99 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
25/496 • Number of events 33 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
|
Vascular disorders
Orthostatic hypotension
|
5.2%
26/496 • Number of events 34 • Up to approximately 3 years for Long Term Safety Phase, including up to approximately 22 weeks for titration phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER