Trial Outcomes & Findings for An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153) (NCT NCT01215227)

NCT ID: NCT01215227

Last Updated: 2018-11-06

Results Overview

The percentage of participants with Systolic Blood Pressure ≥180 mm Hg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 839 participants
• Primary outcome timeframe: Up to 42 weeks
• Results posted on: 2018-11-06

Participant Flow

Participant milestones

Measure	Preladenant 2 mg Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg (on Placebo in Parent Study) Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 10 mg Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Rasagiline 1 mg Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.	Rasagiline 1 mg (on Placebo in Parent Study) Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Overall Study STARTED	218	215	107	97	93	109
Overall Study Treated	218	215	106	96	93	108
Overall Study COMPLETED	97	96	50	48	45	51
Overall Study NOT COMPLETED	121	119	57	49	48	58

Reasons for withdrawal

Measure	Preladenant 2 mg Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg (on Placebo in Parent Study) Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 10 mg Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Rasagiline 1 mg Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.	Rasagiline 1 mg (on Placebo in Parent Study) Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Overall Study Adverse Event	11	11	4	8	7	6
Overall Study Treatment Failure	8	4	1	5	1	1
Overall Study Lost to Follow-up	1	4	1	1	1	2
Overall Study Subject Withdrew Consent	16	20	7	10	11	8
Overall Study Non-Compliance With Protocol	2	6	1	0	0	0
Overall Study Administrative	83	73	42	24	28	40
Overall Study Missing Status	0	1	0	0	0	0
Overall Study Randomized but not treated	0	0	1	1	0	1

Baseline Characteristics

An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)

Baseline characteristics by cohort

Measure	Preladenant 2 mg n=218 Participants Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg n=215 Participants Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg (on Placebo in Parent Study) n=106 Participants Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 10 mg n=96 Participants Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Rasagiline 1 mg n=93 Participants Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.	Rasagiline 1 mg (on Placebo in Parent Study) n=108 Participants Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.	Total n=836 Participants Total of all reporting groups
Age, Continuous	62.4 Years STANDARD_DEVIATION 8.5 • n=5 Participants	63.0 Years STANDARD_DEVIATION 8.7 • n=7 Participants	64.4 Years STANDARD_DEVIATION 8.7 • n=5 Participants	63.9 Years STANDARD_DEVIATION 8.0 • n=4 Participants	63.8 Years STANDARD_DEVIATION 9.9 • n=21 Participants	63.9 Years STANDARD_DEVIATION 7.8 • n=8 Participants	63.3 Years STANDARD_DEVIATION 8.6 • n=8 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	100 Participants n=7 Participants	55 Participants n=5 Participants	40 Participants n=4 Participants	37 Participants n=21 Participants	41 Participants n=8 Participants	341 Participants n=8 Participants
Sex: Female, Male Male	150 Participants n=5 Participants	115 Participants n=7 Participants	51 Participants n=5 Participants	56 Participants n=4 Participants	56 Participants n=21 Participants	67 Participants n=8 Participants	495 Participants n=8 Participants

PRIMARY outcome

Timeframe: Up to 42 weeks

Population: All Participants as Treated (APaT) population, which consisted of all participants who received at least one dose of study drug.

The percentage of participants with Systolic Blood Pressure ≥180 mm Hg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).

Outcome measures

Measure	Preladenant 2 mg n=218 Participants Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg n=215 Participants Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg (on Placebo in Parent Study) n=106 Participants Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 10 mg n=96 Participants Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Rasagiline 1 mg n=93 Participants Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.	Rasagiline 1 mg (on Placebo in Parent Study) n=108 Participants Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Percentage of Participants With Systolic Blood Pressure ≥180 mmHg	1.4 Percentage of participants	0.0 Percentage of participants	0.9 Percentage of participants	1.0 Percentage of participants	0.0 Percentage of participants	0.9 Percentage of participants

PRIMARY outcome

Timeframe: Up to 42 weeks

Population: APaT population, which consisted of all participants who received at least one dose of study drug.

The percentage of participants with Diastolic Blood Pressure ≥105 mmHg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).

Outcome measures

Measure	Preladenant 2 mg n=218 Participants Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg n=215 Participants Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg (on Placebo in Parent Study) n=106 Participants Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 10 mg n=96 Participants Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Rasagiline 1 mg n=93 Participants Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.	Rasagiline 1 mg (on Placebo in Parent Study) n=108 Participants Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Percentage of Participants With Diastolic Blood Pressure ≥105 mmHg	5.0 Percentage of participants	4.2 Percentage of participants	5.7 Percentage of participants	5.2 Percentage of participants	7.5 Percentage of participants	8.3 Percentage of participants

PRIMARY outcome

Timeframe: Up to 42 weeks

Population: APaT population, which consisted of all participants who received at least one dose of study drug.

The number of participants with ALT ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.

Outcome measures

Measure	Preladenant 2 mg n=218 Participants Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg n=215 Participants Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg (on Placebo in Parent Study) n=106 Participants Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 10 mg n=96 Participants Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Rasagiline 1 mg n=93 Participants Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.	Rasagiline 1 mg (on Placebo in Parent Study) n=108 Participants Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Percentage of Participants With Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline	1.4 Percentage of participants	0.5 Percentage of participants	0.0 Percentage of participants	1.0 Percentage of participants	0.0 Percentage of participants	1.9 Percentage of participants

PRIMARY outcome

Timeframe: Up to 42 weeks

Population: APaT population, which consisted of all participants who received at least one dose of study drug.

The number of participants with AST ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.

Outcome measures

Measure	Preladenant 2 mg n=218 Participants Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg n=215 Participants Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg (on Placebo in Parent Study) n=106 Participants Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 10 mg n=96 Participants Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Rasagiline 1 mg n=93 Participants Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.	Rasagiline 1 mg (on Placebo in Parent Study) n=108 Participants Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Percentage of Participants With Aspartate Aminotransferase (AST) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline	1.4 Percentage of participants	0.5 Percentage of participants	0.0 Percentage of participants	2.1 Percentage of participants	1.1 Percentage of participants	2.8 Percentage of participants

PRIMARY outcome

Timeframe: Up to 42 weeks

Population: APaT population, which consisted of all participants who received at least one dose of study drug.

The number 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=218 Participants Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg n=215 Participants Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg (on Placebo in Parent Study) n=106 Participants Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 10 mg n=96 Participants Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Rasagiline 1 mg n=93 Participants Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.	Rasagiline 1 mg (on Placebo in Parent Study) n=108 Participants Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Percentage of Participants With Suicidality	4.1 Percentage of participants	5.6 Percentage of participants	0.0 Percentage of participants	4.2 Percentage of participants	2.2 Percentage of participants	2.8 Percentage of participants

PRIMARY outcome

Timeframe: Baseline and Week 40

Population: Participants in the Full Analysis Set (FAS) population (all randomized participants who received at least one dose of study drug) that had a baseline value and data at Week 40 for Total ESS Score

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 with a higher score indicating greater sleepiness.

Outcome measures

Measure	Preladenant 2 mg n=90 Participants Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg n=88 Participants Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg (on Placebo in Parent Study) n=47 Participants Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 10 mg n=49 Participants Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Rasagiline 1 mg n=48 Participants Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.	Rasagiline 1 mg (on Placebo in Parent Study) n=49 Participants Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Percentage Change From Baseline in Total Epworth Sleepiness Scale (ESS) Score at Week 40	15.5 Percentage change 95% Confidence Interval 3.4 • Interval -15.0 to 46.2	24.0 Percentage change 95% Confidence Interval 3.9 • Interval 7.8 to 40.3	22.5 Percentage change Interval -9.5 to 54.5	13.2 Percentage change Interval -5.9 to 32.4	8.3 Percentage change Interval -6.8 to 23.4	16.3 Percentage change Interval -3.3 to 35.9

Adverse Events

Preladenant 2 mg

Serious events: 11 serious events

Other events: 64 other events

Deaths: 0 deaths

Preladenant 5 mg

Serious events: 15 serious events

Other events: 71 other events

Deaths: 0 deaths

Preladenant 5 mg (on Placebo in Parent Study)

Serious events: 6 serious events

Other events: 30 other events

Deaths: 0 deaths

Preladenant 10 mg

Serious events: 12 serious events

Other events: 35 other events

Deaths: 0 deaths

Rasagiline 1 mg

Serious events: 5 serious events

Other events: 25 other events

Deaths: 0 deaths

Rasagiline 1 mg (on Placebo in Parent Study)

Serious events: 4 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Measure	Preladenant 2 mg n=218 participants at risk Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg n=215 participants at risk Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg (on Placebo in Parent Study) n=106 participants at risk Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 10 mg n=96 participants at risk Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Rasagiline 1 mg n=93 participants at risk Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.	Rasagiline 1 mg (on Placebo in Parent Study) n=108 participants at risk Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Blood and lymphatic system disorders LEUKOPENIA	0.46% 1/218 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Cardiac disorders ACUTE CORONARY SYNDROME	0.46% 1/218 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.46% 1/218 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Cardiac disorders ANGINA PECTORIS	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Cardiac disorders ANGINA UNSTABLE	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.93% 2/215 • Number of events 2 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.1% 1/93 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Cardiac disorders CARDIAC ARREST	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Cardiac disorders CARDIAC FAILURE	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Cardiac disorders CORONARY ARTERY DISEASE	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Cardiac disorders HYPERTENSIVE CARDIOMYOPATHY	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Cardiac disorders SICK SINUS SYNDROME	0.46% 1/218 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Eye disorders RETINAL DETACHMENT	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 2 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Gastrointestinal disorders CROHN'S DISEASE	0.46% 1/218 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.94% 1/106 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.93% 1/108 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Gastrointestinal disorders HIATUS HERNIA	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.94% 1/106 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Gastrointestinal disorders ILEUS	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.94% 1/106 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OVARIAN ADENOMA	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.1% 1/93 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Gastrointestinal disorders OBSTRUCTION GASTRIC	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.94% 1/106 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Gastrointestinal disorders VOLVULUS	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.94% 1/106 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
General disorders ASTHENIA	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
General disorders CHEST DISCOMFORT	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
General disorders CHEST PAIN	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
General disorders MALAISE	0.46% 1/218 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Infections and infestations BRONCHOPNEUMONIA	0.46% 1/218 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Infections and infestations ENCEPHALITIS VIRAL	0.46% 1/218 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Infections and infestations NOSOCOMIAL INFECTION	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.1% 1/93 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Infections and infestations OROPHARYNGEAL CANDIDIASIS	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Infections and infestations PERITONSILLAR ABSCESS	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.94% 1/106 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Infections and infestations PNEUMONIA ESCHERICHIA	0.46% 1/218 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications CONCUSSION	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.93% 1/108 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications FALL	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.94% 1/106 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.93% 1/108 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications FOREARM FRACTURE	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications HAND FRACTURE	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.94% 1/106 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications JOINT DISLOCATION	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.94% 1/106 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications LOWER LIMB FRACTURE	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.1% 1/93 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications NEAR DROWNING	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.94% 1/106 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications RIB FRACTURE	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Investigations BLOOD SODIUM INCREASED	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders PATELLOFEMORAL PAIN SYNDROME	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.93% 1/108 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders TORTICOLLIS	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 2 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.1% 1/93 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BOWEN'S DISEASE	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Nervous system disorders CEREBRAL HYPOPERFUSION	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.93% 1/108 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Nervous system disorders CONVULSION	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.93% 1/108 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Nervous system disorders PARKINSON'S DISEASE	0.46% 1/218 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Nervous system disorders THALAMIC INFARCTION	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Psychiatric disorders MENTAL DISORDER	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Psychiatric disorders PSYCHOTIC DISORDER	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.1% 1/93 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Renal and urinary disorders CYSTITIS GLANDULARIS	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.1% 1/93 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.94% 1/106 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.46% 1/218 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders PULMONARY THROMBOSIS	0.46% 1/218 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders RESPIRATORY PARALYSIS	0.46% 1/218 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Vascular disorders DEEP VEIN THROMBOSIS	0.92% 2/218 • Number of events 2 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Vascular disorders HYPERTENSION	0.46% 1/218 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/215 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Vascular disorders LYMPHOSTASIS	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Vascular disorders ORTHOSTATIC HYPOTENSION	0.00% 0/218 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.47% 1/215 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/96 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.

Other adverse events

Measure	Preladenant 2 mg n=218 participants at risk Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg n=215 participants at risk Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 5 mg (on Placebo in Parent Study) n=106 participants at risk Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Preladenant 10 mg n=96 participants at risk Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.	Rasagiline 1 mg n=93 participants at risk Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.	Rasagiline 1 mg (on Placebo in Parent Study) n=108 participants at risk Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Gastrointestinal disorders CONSTIPATION	4.1% 9/218 • Number of events 10 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	5.6% 12/215 • Number of events 14 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	6.6% 7/106 • Number of events 7 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	5.2% 5/96 • Number of events 5 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.1% 1/93 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	2.8% 3/108 • Number of events 5 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Gastrointestinal disorders NAUSEA	2.8% 6/218 • Number of events 6 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	3.7% 8/215 • Number of events 11 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	2.8% 3/106 • Number of events 3 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	2.2% 2/93 • Number of events 2 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	6.5% 7/108 • Number of events 8 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
General disorders FATIGUE	3.2% 7/218 • Number of events 7 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	2.8% 6/215 • Number of events 6 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	2.8% 3/106 • Number of events 3 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	5.2% 5/96 • Number of events 5 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.9% 2/108 • Number of events 2 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Infections and infestations NASOPHARYNGITIS	5.5% 12/218 • Number of events 14 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	3.3% 7/215 • Number of events 7 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	2.8% 3/106 • Number of events 3 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	2.1% 2/96 • Number of events 2 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	4.3% 4/93 • Number of events 4 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	6.5% 7/108 • Number of events 7 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Infections and infestations URINARY TRACT INFECTION	4.6% 10/218 • Number of events 10 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	4.7% 10/215 • Number of events 12 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	5.7% 6/106 • Number of events 7 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	5.2% 5/96 • Number of events 9 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	2.2% 2/93 • Number of events 2 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	5.6% 6/108 • Number of events 6 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications FALL	3.2% 7/218 • Number of events 8 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	7.4% 16/215 • Number of events 21 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	4.7% 5/106 • Number of events 5 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	3.1% 3/96 • Number of events 3 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	3.2% 3/93 • Number of events 3 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	3.7% 4/108 • Number of events 5 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	3.2% 7/218 • Number of events 7 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.9% 4/215 • Number of events 5 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.94% 1/106 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	5.2% 5/96 • Number of events 5 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	3.2% 3/93 • Number of events 3 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.93% 1/108 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Investigations WEIGHT DECREASED	0.46% 1/218 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.93% 2/215 • Number of events 2 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	5.4% 5/93 • Number of events 5 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.9% 2/108 • Number of events 2 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders ARTHRALGIA	1.4% 3/218 • Number of events 3 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.93% 2/215 • Number of events 3 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/106 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	5.2% 5/96 • Number of events 7 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	2.2% 2/93 • Number of events 2 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	8.3% 9/108 • Number of events 10 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders BACK PAIN	2.3% 5/218 • Number of events 5 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	3.3% 7/215 • Number of events 7 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	6.6% 7/106 • Number of events 7 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	1.0% 1/96 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	3.2% 3/93 • Number of events 3 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	4.6% 5/108 • Number of events 6 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Nervous system disorders DYSKINESIA	4.6% 10/218 • Number of events 11 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	8.8% 19/215 • Number of events 22 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	4.7% 5/106 • Number of events 6 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	8.3% 8/96 • Number of events 12 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	8.6% 8/93 • Number of events 8 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	8.3% 9/108 • Number of events 11 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Nervous system disorders PARKINSON'S DISEASE	4.6% 10/218 • Number of events 12 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	5.6% 12/215 • Number of events 13 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	3.8% 4/106 • Number of events 5 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	4.2% 4/96 • Number of events 6 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	3.2% 3/93 • Number of events 3 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/108 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.
Nervous system disorders TREMOR	2.3% 5/218 • Number of events 5 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.93% 2/215 • Number of events 2 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.94% 1/106 • Number of events 1 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	5.2% 5/96 • Number of events 5 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.00% 0/93 • Up to 42 weeks APaT population, which consisted of all participants who received at least one dose of study drug.	0.93% 1/108 • Number of events 1 • Up to 42 weeks APaT population, which consisted of 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: ClinicalTrialsDisclosure@merck.com

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 (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media, eg, any computer access system such as the Internet, World Wide Web, etc) that report any results of the trial.
• Publication restrictions are in place

Restriction type: OTHER