Trial Outcomes & Findings for A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938) (NCT NCT01155466)
NCT ID: NCT01155466
Last Updated: 2018-11-06
Results Overview
The "on" state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The "off" state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as "off", "on", or "asleep" on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week-12 visit. The mean change from baseline in "off" time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
778 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2018-11-06
Participant Flow
A total 1076 participants were screened and 778 were randomized.
Participant milestones
| Measure |
Preladenant 2 mg
Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
|
Preladenant 5 mg
Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
|
Preladenant 10 mg
Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
|
Placebo
Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
|
Rasagiline 1 mg
Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
156
|
155
|
156
|
155
|
156
|
|
Overall Study
Treated
|
154
|
153
|
153
|
155
|
154
|
|
Overall Study
COMPLETED
|
134
|
130
|
136
|
134
|
129
|
|
Overall Study
NOT COMPLETED
|
22
|
25
|
20
|
21
|
27
|
Reasons for withdrawal
| Measure |
Preladenant 2 mg
Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
|
Preladenant 5 mg
Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
|
Preladenant 10 mg
Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
|
Placebo
Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
|
Rasagiline 1 mg
Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
13
|
15
|
6
|
17
|
18
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
9
|
4
|
4
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
0
|
1
|
|
Overall Study
Administrative
|
0
|
3
|
0
|
0
|
0
|
|
Overall Study
Randomized not treated
|
2
|
2
|
3
|
0
|
2
|
Baseline Characteristics
A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938)
Baseline characteristics by cohort
| Measure |
Preladenant 2 mg
n=156 Participants
Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
|
Preladenant 5 mg
n=155 Participants
Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
|
Preladenant 10 mg
n=156 Participants
Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
|
Placebo
n=155 Participants
Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
|
Rasagiline 1 mg
n=156 Participants
Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
|
Total
n=778 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.7 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
62.6 Years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
63.6 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
63.0 Years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
63.8 Years
STANDARD_DEVIATION 9.0 • n=21 Participants
|
62.9 Years
STANDARD_DEVIATION 8.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
332 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
446 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The number of randomized and treated participants with at least one post baseline value.
The "on" state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The "off" state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as "off", "on", or "asleep" on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week-12 visit. The mean change from baseline in "off" time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect.
Outcome measures
| Measure |
Preladenant 2 mg
n=152 Participants
Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
|
Preladenant 5 mg
n=149 Participants
Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
|
Preladenant 10 mg
n=149 Participants
Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
|
Placebo
n=151 Participants
Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
|
Rasagiline 1 mg
n=152 Participants
Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean "Off" Time
|
-0.9 Hours/day
Standard Error 0.21
|
-0.9 Hours/day
Standard Error 0.21
|
-0.8 Hours/day
Standard Error 0.21
|
-0.8 Hours/day
Standard Error 0.21
|
-1.1 Hours/day
Standard Error 0.21
|
PRIMARY outcome
Timeframe: Up to Week 14Population: The number of participants who received at least one dose of study drug
The number of participants with Systolic Blood Pressure \>=180 mm Hg was reported.
Outcome measures
| Measure |
Preladenant 2 mg
n=154 Participants
Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
|
Preladenant 5 mg
n=153 Participants
Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
|
Preladenant 10 mg
n=153 Participants
Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
|
Placebo
n=155 Participants
Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
|
Rasagiline 1 mg
n=154 Participants
Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
|
|---|---|---|---|---|---|
|
Numberof Participants With Systolic Blood Pressure >=180 mm Hg
|
1 Participants
0.21
|
1 Participants
0.21
|
3 Participants
0.21
|
1 Participants
0.21
|
0 Participants
0.21
|
PRIMARY outcome
Timeframe: Up to Week 14Population: The number of participants who received at least one dose of study drug
The number of participants with Diastolic Blood Pressure \>=105 mm Hg was reported.
Outcome measures
| Measure |
Preladenant 2 mg
n=154 Participants
Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
|
Preladenant 5 mg
n=153 Participants
Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
|
Preladenant 10 mg
n=153 Participants
Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
|
Placebo
n=155 Participants
Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
|
Rasagiline 1 mg
n=154 Participants
Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
|
|---|---|---|---|---|---|
|
Number of Participants With Diastolic Blood Pressure >=105 mm Hg
|
3 Participants
0.21
|
4 Participants
0.21
|
9 Participants
0.21
|
7 Participants
0.21
|
4 Participants
0.21
|
PRIMARY outcome
Timeframe: Up to Week 14Population: The number of participants who received at least one dose of study drug
The number of participants with alanine aminotransferase \>=3 times the upper limit of normal and a \>=10% increase was reported.
Outcome measures
| Measure |
Preladenant 2 mg
n=154 Participants
Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
|
Preladenant 5 mg
n=153 Participants
Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
|
Preladenant 10 mg
n=153 Participants
Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
|
Placebo
n=155 Participants
Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
|
Rasagiline 1 mg
n=154 Participants
Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
|
|---|---|---|---|---|---|
|
Number of Participants With Alanine Aminotransferase >=3 Times the Upper Limit of Normal
|
1 Participants
0.21
|
1 Participants
0.21
|
1 Participants
0.21
|
1 Participants
0.21
|
0 Participants
0.21
|
PRIMARY outcome
Timeframe: Up to Week 14Population: The number of participants who received at least one dose of study drug
The number of participants with aspartate aminotransferase \>=3 times the upper limit of normal and a \>=10% increase was reported.
Outcome measures
| Measure |
Preladenant 2 mg
n=154 Participants
Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
|
Preladenant 5 mg
n=153 Participants
Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
|
Preladenant 10 mg
n=153 Participants
Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
|
Placebo
n=155 Participants
Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
|
Rasagiline 1 mg
n=154 Participants
Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
|
|---|---|---|---|---|---|
|
Number of Participants With Aspartate Aminotransferase >=3 Times the Upper Limit of Normal
|
1 Participants
0.21
|
1 Participants
0.21
|
1 Participants
0.21
|
0 Participants
0.21
|
0 Participants
0.21
|
PRIMARY outcome
Timeframe: Up to Week 12Population: The number of participants who received at least one dose of study drug
The percentage of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.
Outcome measures
| Measure |
Preladenant 2 mg
n=154 Participants
Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
|
Preladenant 5 mg
n=153 Participants
Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
|
Preladenant 10 mg
n=153 Participants
Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
|
Placebo
n=155 Participants
Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
|
Rasagiline 1 mg
n=154 Participants
Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
|
|---|---|---|---|---|---|
|
Percentage of Participants With Suicidality
|
2.6 Percentage of participants
0.21
|
2.6 Percentage of participants
0.21
|
0.7 Percentage of participants
0.21
|
3.2 Percentage of participants
0.21
|
0.6 Percentage of participants
0.21
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The number of participants who received at least one dose of study drug and had baseline and Week 12 data
The ESS is a self-administered questionnaire providing a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24.
Outcome measures
| Measure |
Preladenant 2 mg
n=127 Participants
Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
|
Preladenant 5 mg
n=121 Participants
Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
|
Preladenant 10 mg
n=132 Participants
Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
|
Placebo
n=127 Participants
Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
|
Rasagiline 1 mg
n=121 Participants
Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline at Week 12 in Epworth Sleepiness Scale (ESS)
|
-0.3 Scores on a scale
Standard Deviation 3.4
|
-0.1 Scores on a scale
Standard Deviation 3.1
|
0.0 Scores on a scale
Standard Deviation 3.5
|
-0.3 Scores on a scale
Standard Deviation 3.1
|
0.1 Scores on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The number of randomized and treated participants with a Week 12 value.
The "on" state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The "off" state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as "off", "on", or "asleep" on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit.
Outcome measures
| Measure |
Preladenant 2 mg
n=125 Participants
Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
|
Preladenant 5 mg
n=122 Participants
Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
|
Preladenant 10 mg
n=131 Participants
Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
|
Placebo
n=131 Participants
Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
|
Rasagiline 1 mg
n=121 Participants
Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
|
|---|---|---|---|---|---|
|
Percentage of Participants With >30% Change (Reduction) From Baseline at Week 12 in Mean "Off" Time
|
30.4 Percentage of participants
|
33.6 Percentage of participants
|
35.1 Percentage of participants
|
32.8 Percentage of participants
|
33.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The number of randomized and treated participants with at least one post baseline value.
When a participant is "on" without dyskinesias, parkinsonian symptoms have dissipated and the participant is experiencing no uncontrollable extraneous movements. Study participants reported their parkinsonian symptoms at half-hour intervals as "off", "on without dyskinesia", "on with non-troublesome dyskinesia", "on with troublesome dyskinesia", or "asleep" on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit. The mean change from baseline in "on without troublesome dyskinesia" time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect.
Outcome measures
| Measure |
Preladenant 2 mg
n=152 Participants
Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
|
Preladenant 5 mg
n=149 Participants
Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
|
Preladenant 10 mg
n=149 Participants
Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
|
Placebo
n=151 Participants
Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
|
Rasagiline 1 mg
n=152 Participants
Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline at Week 12 in Mean "On" Time Without Troublesome Dyskinesia
|
0.8 Hours/day
Standard Error 0.24
|
0.9 Hours/day
Standard Error 0.24
|
0.5 Hours/day
Standard Error 0.23
|
0.4 Hours/day
Standard Error 0.24
|
0.7 Hours/day
Standard Error 0.24
|
Adverse Events
Preladenant 2 mg
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
Preladenant 5 mg
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Preladenant 10 mg
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
Rasagiline 1 mg
Serious events: 9 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Preladenant 2 mg
n=154 participants at risk
Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
|
Preladenant 5 mg
n=153 participants at risk
Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
|
Preladenant 10 mg
n=153 participants at risk
Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
|
Placebo
n=155 participants at risk
Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
|
Rasagiline 1 mg
n=154 participants at risk
Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/153 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/153 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/155 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/155 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Periproctitis
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/153 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/155 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/153 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Cardiac disorders
Myocardial infarction
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/153 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
General disorders
Hyperthermia malignant
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
General disorders
Pyrexia
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/155 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Infections and infestations
Pneumonia
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/155 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/155 • Number of events 2 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/155 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/155 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/153 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma stage IV
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/153 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Nervous system disorders
Ischaemic stroke
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/155 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/155 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Nervous system disorders
Syncope
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/153 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/153 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Psychiatric disorders
Delusion
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/153 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/153 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/155 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
1.3%
2/154 • Number of events 2 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/155 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Vascular disorders
Thrombosis
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/153 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/155 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
Other adverse events
| Measure |
Preladenant 2 mg
n=154 participants at risk
Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
|
Preladenant 5 mg
n=153 participants at risk
Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
|
Preladenant 10 mg
n=153 participants at risk
Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
|
Placebo
n=155 participants at risk
Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
|
Rasagiline 1 mg
n=154 participants at risk
Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
3.2%
5/154 • Number of events 5 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
3.3%
5/153 • Number of events 5 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
10.5%
16/153 • Number of events 17 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/155 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
1.3%
2/154 • Number of events 2 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
4/154 • Number of events 4 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
1.3%
2/153 • Number of events 2 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
1.3%
2/153 • Number of events 2 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
5.2%
8/155 • Number of events 8 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.65%
1/154 • Number of events 1 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Nervous system disorders
Dyskinesia
|
3.2%
5/154 • Number of events 5 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
6.5%
10/153 • Number of events 13 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
4.6%
7/153 • Number of events 7 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
5.2%
8/155 • Number of events 9 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
13.6%
21/154 • Number of events 23 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Nervous system disorders
Headache
|
4.5%
7/154 • Number of events 7 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
2.0%
3/153 • Number of events 4 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
4.6%
7/153 • Number of events 7 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
10.3%
16/155 • Number of events 17 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
2.6%
4/154 • Number of events 4 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
|
Nervous system disorders
Tremor
|
1.3%
2/154 • Number of events 2 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/153 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
5.2%
8/155 • Number of events 8 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
0.00%
0/154 • All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
The safety population included all participants who received at least one dose of study drug
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation with regard to proprietary information, accuracy, fair balance, and compliance.
- Publication restrictions are in place
Restriction type: OTHER