## Protocol Section
### Identification Module
**NCT ID:** NCT01155479

**Acronym:** PARADYSE

**Brief Title:** A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664)

**Official Title:** A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's Disease

#### Organization Study ID Info
**ID:** P05664
#### Organization
**Class:** INDUSTRY
**Full Name:** Merck Sharp & Dohme LLC
#### Secondary ID Infos
**ID:** 2009-013552-72
**Type:** EUDRACT_NUMBER
**Domain:** Merck Study Number
**ID:** MK-3814-024
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2013-07-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-11-07

**Type:** ACTUAL

**Last Update Submit Date:** 2018-10-09

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2013-07-16

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2016-07-28

**Type:** ESTIMATED

**Results First Submit Date:** 2016-06-15

**Results First Submit QC Date:** 2016-06-15

#### Start Date
**Date:** 2010-07-06

**Type:** ACTUAL

**Status Verified Date:** 2018-10

#### Study First Post Date
**Date:** 2010-07-01
**Type:** ESTIMATED
**Study First Submit Date:** 2010-06-30
**Study First Submit QC Date:** 2010-06-30
**Why Stopped:** Termininated for business reasons
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Merck Sharp & Dohme LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This is a one year, 2-part study to determine the efficacy and safety of preladenant, an adenosine type 2a (A2a) receptor antagonist. The purpose of Part 1 (first 26 weeks) is to determine if preladenant is effective in the treatment of early Parkinson's Disease. The purpose of Part 2 (second 26 weeks) is to determine if preladenant is safe and well tolerated. The primary efficacy hypothesis is that at least the 10 mg twice daily dose of preladenant is superior to placebo as measured by the change from Baseline to Week 26 in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts 2 and 3 scores (UPDRS2+3).

### Conditions Module

**Conditions:**

- Parkinson Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 1022

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Preladenant 2 mg oral tablet and placebo for rasagiline taken in the morning (AM) followed by preladenant 2 mg oral tablet taken in the evening (PM) for 26 weeks (Part 1) and then for another 26 weeks (Part 2).

**Intervention Names:**

- Drug: Preladenant 2 mg tablet

- Drug: Placebo for Rasagiline 1 mg capsule

**Label:** Preladenant 2 mg

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Preladenant 5 mg oral tablet and placebo for rasagiline taken in the AM followed by preladenant 5 mg taken in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).

**Intervention Names:**

- Drug: Preladenant 5 mg tablet

- Drug: Placebo for Rasagiline 1 mg capsule

**Label:** Preladenant 5 mg

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Preladenant 10 mg oral tablet and placebo for rasagiline taken in the AM followed by preladenant 10 mg taken in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).

**Intervention Names:**

- Drug: Preladenant 10 mg tablet

- Drug: Placebo for Rasagiline 1 mg capsule

**Label:** Preladenant 10 mg

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Placebo for preladenant and placebo for rasagiline taken in the AM followed by placebo for preladenant taken in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).

**Intervention Names:**

- Drug: Preladenant 5 mg tablet

- Drug: Placebo for Rasagiline 1 mg capsule

- Drug: Placebo for Preladenant

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

#### Arm Group 5

**Description:** Rasagiline 1 mg oral capsule and placebo for preladenant taken in the AM followed by placebo for preladenant taken in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).

**Intervention Names:**

- Drug: Rasagiline 1 mg capsule

- Drug: Placebo for Preladenant

**Label:** Rasagiline

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Preladenant 2 mg

**Description:** Preladenant 2 mg oral tablet taken twice daily

**Name:** Preladenant 2 mg tablet

**Other Names:**

- SCH 420814

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

- Preladenant 5 mg

**Description:** Preladenant 5 mg oral tablet taken twice daily

**Name:** Preladenant 5 mg tablet

**Other Names:**

- SCH 420814

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Preladenant 10 mg

**Description:** Preladenant 10 mg oral tablet taken twice daily

**Name:** Preladenant 10 mg tablet

**Other Names:**

- SCH 420814

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Rasagiline

**Description:** Rasagiline 1 mg oral capsule taken once daily

**Name:** Rasagiline 1 mg capsule

**Other Names:**

- Azilect

**Type:** DRUG

#### Intervention 5

**Arm Group Labels:**

- Placebo

- Preladenant 10 mg

- Preladenant 2 mg

- Preladenant 5 mg

**Description:** Placebo for rasagiline 1 mg oral capsule taken once daily

**Name:** Placebo for Rasagiline 1 mg capsule

**Type:** DRUG

#### Intervention 6

**Arm Group Labels:**

- Placebo

- Rasagiline

**Description:** Placebo for preladenant 2 mg, 5 mg, or 10 mg oral tablet taken twice daily

**Name:** Placebo for Preladenant

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part 3 is the Motor Examination (Total Motor Score \[TMS\]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. Change from baseline was analyzed using a constrained longitudinal analysis (cLDA) model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.

**Measure:** Change From Baseline in the Sum of Unified Parkinson's Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3)

**Time Frame:** Baseline and Week 26

**Description:** An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.

**Measure:** Number of Participants With Adverse Events (AEs) in Part 1

**Time Frame:** Day 1 to Week 26

**Description:** An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.

**Measure:** Number of Participants Who Discontinued Study Due to an AE in Part 1

**Time Frame:** Day 1 to Week 26

**Description:** An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.

**Measure:** Number of Participants With Adverse Events (AEs) in Part 2

**Time Frame:** Week 27 to Week 52

**Description:** An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.

**Measure:** Number of Participants Who Discontinued Study Due to an AE in Part 2

**Time Frame:** Week 27 to Week 52

#### Secondary Outcomes

**Description:** UPDRS is a clinician based rating scale used to measure motor impairments and disability; it assesses 6 features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. UPDRS Part 2 is Activities of Daily Living score and ranges from 0-52. UPDRS Part 3 is Motor Examination and ranges from 0-108. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. A Responder is defined as a participant with at least 20% improvement in UPDRS2+3 from Baseline to Week 26 (End of Part 1 Treatment); a participant with at least a 20% decrease from Baseline score in UPDRS2+3 is defined as a responder. The proportion of Responders was analyzed using a generalized linear mixed model with treatment effect, strata and Baseline UPDRS2+3 as a covariate, and treatment-by-time interaction as fixed effects and subject as random effect.

**Measure:** Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3)

**Time Frame:** Baseline and Week 26

**Description:** The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician with the higher score indicating the worse condition. Change from baseline was analyzed using a cLDA model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.

**Measure:** Change From Baseline in the UPDRS Part 2 Score (Activities of Daily Living [ADL])

**Time Frame:** Baseline and Week 26

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Has a diagnosis of idiopathic PD for \< 5 years.
* If receiving amantadine and/or anticholinergics, must have been on a stable regimen of treatment for at least the 5 weeks immediately before Screening. (Note: Participants who are not taking any medications for PD are permitted to enroll in this trial.)
* Must have a UPDRS Part 3 score of ≥10, a Hoehn and Yahr Stage ≤3, be ≥30 to ≤85 years of age, and have results of Screening clinical laboratory tests drawn within 5 weeks prior to randomization, clinically acceptable to the investigator, and not within the parameters specified for exclusion.
* If sexually active or plan to be sexually active, must agree to use a highly effective method of birth control while the participant is in the study and for 2 weeks after the last dose of study drug. A male participant must also not donate sperm during the trial and within 2 weeks after the last dose of study drug.

Exclusion Criteria:

* Must not have a form of drug-induced or atypical Parkinsonism, cognitive impairment (ie, Montreal Cognitive Assessment \[MoCA\] score \<22), bipolar disorder, untreated major depressive disorder, schizophrenia, or other psychotic disorder; history of exposure to a known neurotoxin, or any neurological features not consistent with the diagnosis of PD as assessed by the investigator.
* Must not have had surgery for PD.
* Must not have a history of repeated strokes with stepwise progression of Parkinsonism or head injuries, or a stroke within 6 months of screening; poorly controlled diabetes; abnormal renal function; or a severe or ongoing unstable medical condition.
* Must not have failed to show a therapeutic response if a diagnostic levodopa (L dopa) challenge had been done with a large test dose (\>500 mg) of L dopa (if malabsorption excluded), or failed to respond to an adequate previous treatment with dopaminergic therapy.
* Must not have been treated with L dopa or dopamine agonists for 30 days or more. A participant who has been treated with L-dopa or dopamine agonists for \<30 days will be allowed to enter the study. These participants must stop taking dopaminergic medication 30 days prior to Randomization.
* Must not be at imminent risk of self-harm or harm to others.
* Must not have elevated blood pressure (BP) (systolic BP ≥150 mm Hg or diastolic BP ≥95 mm Hg) that cannot be adequately controlled with antihypertensive medication, as demonstrated by 2 BP measurements meeting acceptable BP criterion at consecutive scheduled or unscheduled visits between Screening and Randomization (a 5-6 week period), one of which must be the Randomization visit.
* Must not have had any clinically significant cardiovascular event or procedure for 6 months prior to Randomization, including, but not limited to, myocardial infarction, angioplasty, unstable angina, or heart failure; and a participant must not have heart failure staged New York Heart Association Class III or IV.
* Must not have an alanine aminotransferase (ALT) or aspartate amino transferase (AST) ≥ 3 x the upper limit of normal (ULN) or total bilirubin (T BIL) ≥ 1.5 x ULN.
* Must not have active serologically-confirmed hepatic dysfunction (defined as viral infection \[Hepatitis B, C, or E; Epstein-Barr virus (EBV)\]; cytomegalovirus \[CMV\] or a history of diagnosis of drug- or alcohol-induced hepatic toxicity or frank hepatitis, or a history of diagnosis of drug- or alcohol-induced hepatic toxicity or frank hepatitis.)
* Must not have a history within the past 5 years of a primary or recurrent malignant disease with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with a normal prostate-specific antigen (PSA) post resection.
* Must not have received certain prespecified medications or ingested high tyramine-containing aged cheeses (eg, Stilton) for a prespecified time window before the trial, during the trial, and for 2 weeks after the trial.
* Must not have an average daily consumption of more than three 4 ounce glasses (118 mL) of wine or the equivalent.
* Must not have a severe or ongoing unstable medical condition (eg, any form of clinically significant cardiac disease, symptomatic orthostatic hypotension, seizures, or alcohol/drug dependence.)
* Must not have allergy/sensitivity to investigational product(s) or its/their excipients.
* Must not be breast-feeding, considering breast-feeding, pregnant or intending to become pregnant.
* Must not have used preladenant ever, or any investigational drugs within 90 days immediately before screening.

**Maximum Age:** 85 Years

**Minimum Age:** 30 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Merck Sharp & Dohme LLC

**Name:** Medical Director

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

**IPD Sharing:** YES

**URL:** http://engagezone.msd.com/ds_documentation.php

### References Module

#### Available IPDs

**Type:** CSR Synopsis

**URL:** http://www.merck.com/clinical-trials/study.html?id=P05664&kw=P05664&tab=access

#### References

**Citation:** Stocchi F, Rascol O, Hauser RA, Huyck S, Tzontcheva A, Capece R, Ho TW, Sklar P, Lines C, Michelson D, Hewitt DJ; Preladenant Early Parkinson Disease Study Group. Randomized trial of preladenant, given as monotherapy, in patients with early Parkinson disease. Neurology. 2017 Jun 6;88(23):2198-2206. doi: 10.1212/WNL.0000000000004003. Epub 2017 May 10.

**PMID:** 28490648

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020734

- Term: Parkinsonian Disorders

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009069

- Term: Movement Disorders

- ID: D000080874

- Term: Synucleinopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M13213

- Name: Parkinson Disease

- Relevance: HIGH

- As Found: Parkinson's Disease

- ID: M22494

- Name: Parkinsonian Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2217

- Name: Synucleinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010300

- Term: Parkinson Disease

### Intervention Browse Module - Ancestors

- ID: D000008996

- Term: Monoamine Oxidase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018696

- Term: Neuroprotective Agents

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: NeuroAg

- Name: Neuroprotective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M213846

- Name: Rasagiline

- Relevance: HIGH

- As Found: Sudden

- ID: M11960

- Name: Monoamine Oxidase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M20773

- Name: Neuroprotective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000031967

- Term: Rasagiline

### Misc Info Module

#### Removed Countries

- Country: Argentina

- Country: Bulgaria

- Country: Canada

- Country: Chile

- Country: Colombia

- Country: Czech Republic

- Country: Finland

- Country: France

- Country: Germany

- Country: Hungary

- Country: India

- Country: Israel

- Country: Italy

- Country: Mexico

- Country: Peru

- Country: Poland

- Country: Russian Federation

- Country: Spain

- Country: Sweden

- Country: Turkey

- Country: United Kingdom

- Country: United States

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.

#### Event Groups

**Group ID:** EG000

**Title:** Preladenant 2 mg - Part 1

**Description:** Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1).

**ID:** EG000

**Other Num Affected:** 33

**Other Num at Risk:** 200

**Serious Number Affected:** 4

**Serious Number At Risk:** 200

**Title:** Preladenant 2 mg - Part 1

**Group ID:** EG001

**Title:** Preladenant 5 mg - Part 1

**Description:** Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1).

**ID:** EG001

**Other Num Affected:** 39

**Other Num at Risk:** 202

**Serious Number Affected:** 5

**Serious Number At Risk:** 202

**Title:** Preladenant 5 mg - Part 1

**Group ID:** EG002

**Title:** Preladenant 10 mg - Part 1

**Description:** Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1).

**ID:** EG002

**Other Num Affected:** 40

**Other Num at Risk:** 204

**Serious Number Affected:** 8

**Serious Number At Risk:** 204

**Title:** Preladenant 10 mg - Part 1

**Group ID:** EG003

**Title:** Placebo - Part 1

**Description:** Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1).

**ID:** EG003

**Other Num Affected:** 36

**Other Num at Risk:** 198

**Serious Number Affected:** 3

**Serious Number At Risk:** 198

**Title:** Placebo - Part 1

**Group ID:** EG004

**Title:** Rasagiline - Part 1

**Description:** Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1).

**ID:** EG004

**Other Num Affected:** 34

**Other Num at Risk:** 203

**Serious Number Affected:** 9

**Serious Number At Risk:** 203

**Title:** Rasagiline - Part 1

**Group ID:** EG005

**Title:** Preladenant 2 mg - Part 2

**Description:** Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 2).

**ID:** EG005

**Other Num Affected:** 18

**Other Num at Risk:** 166

**Serious Number Affected:** 7

**Serious Number At Risk:** 166

**Title:** Preladenant 2 mg - Part 2

**Group ID:** EG006

**Title:** Preladenant 5 mg - Part 2

**Description:** Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 2).

**ID:** EG006

**Other Num Affected:** 22

**Other Num at Risk:** 177

**Serious Number Affected:** 1

**Serious Number At Risk:** 177

**Title:** Preladenant 5 mg - Part 2

**Group ID:** EG007

**Title:** Preladenant 10 mg - Part 2

**Description:** Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 2).

**ID:** EG007

**Other Num Affected:** 17

**Other Num at Risk:** 167

**Serious Number Affected:** 8

**Serious Number At Risk:** 167

**Title:** Preladenant 10 mg - Part 2

**Group ID:** EG008

**Title:** Placebo/Preladenant 5 Mg-Part 2

**Description:** Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg oral tablet in the PM for 26 weeks (Part 2).

**ID:** EG008

**Other Num Affected:** 16

**Other Num at Risk:** 177

**Serious Number Affected:** 4

**Serious Number At Risk:** 177

**Title:** Placebo/Preladenant 5 Mg-Part 2

**Group ID:** EG009

**Title:** Rasagiline - Part 2

**Description:** Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 2).

**ID:** EG009

**Other Num Affected:** 19

**Other Num at Risk:** 181

**Serious Number Affected:** 8

**Serious Number At Risk:** 181

**Title:** Rasagiline - Part 2

**Frequency Threshold:** 5

#### Other Events

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Back Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Tremor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 17.0

#### Serious Events

**Term:** Atrial Fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 204

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 166

**Num Events:** 1

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Acute Coronary Syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 202

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Acute Myocardial Infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num Affected:** 1

**Num At Risk:** 167

**Num Events:** 1

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Angina Pectoris

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num Affected:** 1

**Num At Risk:** 181

**Num Events:** 1

**Term:** Angina Unstable

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 203

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num Affected:** 1

**Num At Risk:** 181

**Num Events:** 1

**Term:** Cardiac Failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 204

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num Affected:** 1

**Num At Risk:** 177

**Num Events:** 1

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Coronary Artery Disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 203

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Left Ventricular Failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num Affected:** 1

**Num At Risk:** 177

**Num Events:** 1

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Myocardial Infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 203

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num Affected:** 1

**Num At Risk:** 167

**Num Events:** 1

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Pancreatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Pancreatitis Acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 203

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Chest Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 203

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Local Swelling

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num Affected:** 1

**Num At Risk:** 181

**Num Events:** 1

**Term:** Cholecystitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num Affected:** 1

**Num At Risk:** 177

**Num Events:** 1

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Cholecystitis Acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Jaundice Cholestatic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Appendicitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 204

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 166

**Num Events:** 1

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Erysipelas

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num Affected:** 1

**Num At Risk:** 167

**Num Events:** 1

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Gastroenteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 204

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Lower Respiratory Tract Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num Affected:** 1

**Num At Risk:** 177

**Num Events:** 1

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 166

**Num Events:** 1

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Pneumonia Bacterial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 203

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 203

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num Affected:** 1

**Num At Risk:** 177

**Num Events:** 1

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Upper Respiratory Tract Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 204

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Urinary Tract Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 200

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Brain Contusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 204

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Femur Fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 166

**Num Events:** 1

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Fibula Fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num Affected:** 1

**Num At Risk:** 177

**Num Events:** 1

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Hip Fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num Affected:** 1

**Num At Risk:** 181

**Num Events:** 1

**Term:** Pelvic Fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num Affected:** 1

**Num At Risk:** 181

**Num Events:** 1

**Term:** Tendon Rupture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 203

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Tibia Fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num Affected:** 1

**Num At Risk:** 177

**Num Events:** 1

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Alanine Aminotransferase Increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 202

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Antinuclear Antibody Increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 204

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Aspartate Aminotransferase Increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 202

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Hepatic Enzyme Increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 202

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 204

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Vitamin B12 Deficiency

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 204

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Back Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 202

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Colon Cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 204

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Osteoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num Affected:** 1

**Num At Risk:** 167

**Num Events:** 1

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Sinonasal Papilloma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num Affected:** 1

**Num At Risk:** 181

**Num Events:** 1

**Term:** Uterine Leiomyoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 166

**Num Events:** 1

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Cerebrovascular Accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num Affected:** 1

**Num At Risk:** 167

**Num Events:** 1

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Haemorrhagic Stroke

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 204

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Parkinson's Disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num Affected:** 1

**Num At Risk:** 167

**Num Events:** 1

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num Affected:** 1

**Num At Risk:** 181

**Num Events:** 1

**Term:** Sciatica

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Vertebrobasilar Insufficiency

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num Affected:** 1

**Num At Risk:** 177

**Num Events:** 1

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Depression Suicidal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 203

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Suicidal Ideation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 200

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Suicide Attempt

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 166

**Num Events:** 1

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Cystitis Haemorrhagic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 166

**Num Events:** 1

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Nephrolithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 204

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Renal Failure Acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 200

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Renal Failure Chronic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 202

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Benign Prostatic Hyperplasia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 200

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num Affected:** 1

**Num At Risk:** 167

**Num Events:** 1

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Pulmonary Embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 166

**Num Events:** 1

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num Affected:** 1

**Num At Risk:** 181

**Num Events:** 1

**Term:** Pulmonary Fibrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num Affected:** 1

**Num At Risk:** 177

**Num Events:** 1

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Pregnancy of Partner

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Social circumstances

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 203

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Phlebitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 166

**Num Events:** 1

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num At Risk:** 167

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Term:** Sudden Cardiac Death

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 200

**Group ID:** EG001

**Num At Risk:** 202

**Group ID:** EG002

**Num At Risk:** 204

**Group ID:** EG003

**Num At Risk:** 198

**Group ID:** EG004

**Num At Risk:** 203

**Group ID:** EG005

**Num At Risk:** 166

**Group ID:** EG006

**Num At Risk:** 177

**Group ID:** EG007

**Num Affected:** 1

**Num At Risk:** 167

**Num Events:** 1

**Group ID:** EG008

**Num At Risk:** 177

**Group ID:** EG009

**Num At Risk:** 181

**Time Frame:** Up to 54 weeks (including 2 weeks of follow-up)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 204

**Group ID:** BG001

**Value:** 204

**Group ID:** BG002

**Value:** 206

**Group ID:** BG003

**Value:** 204

**Group ID:** BG004

**Value:** 204

**Group ID:** BG005

**Value:** 1022

**Units:** Participants

### Group

**ID:** BG000

**Title:** Preladenant 2 mg

**Description:** Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).

### Group

**ID:** BG001

**Title:** Preladenant 5 mg

**Description:** Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).

### Group

**ID:** BG002

**Title:** Preladenant 10 mg

**Description:** Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).

### Group

**ID:** BG003

**Title:** Placebo

**Description:** Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).

### Group

**ID:** BG004

**Title:** Rasagiline

**Description:** Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).

### Group

**ID:** BG005

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10.5

**Value:** 63.0

#### Measurement

**Group ID:** BG001

**Spread:** 10.2

**Value:** 62.3

#### Measurement

**Group ID:** BG002

**Spread:** 11.1

**Value:** 63.8

#### Measurement

**Group ID:** BG003

**Spread:** 10.0

**Value:** 63.3

#### Measurement

**Group ID:** BG004

**Spread:** 10.2

**Value:** 62.9

#### Measurement

**Group ID:** BG005

**Spread:** 10.4

**Value:** 63.1

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 78

#### Measurement

**Group ID:** BG001

**Value:** 90

#### Measurement

**Group ID:** BG002

**Value:** 90

#### Measurement

**Group ID:** BG003

**Value:** 82

#### Measurement

**Group ID:** BG004

**Value:** 85

#### Measurement

**Group ID:** BG005

**Value:** 425

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 126

#### Measurement

**Group ID:** BG001

**Value:** 114

#### Measurement

**Group ID:** BG002

**Value:** 116

#### Measurement

**Group ID:** BG003

**Value:** 122

#### Measurement

**Group ID:** BG004

**Value:** 119

#### Measurement

**Group ID:** BG005

**Value:** 597

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
**Population Description:** All Participants as Randomized
## Results Section - More Information Module
### Certain Agreement
**Other Details:** The Investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The Investigator further agrees to provide the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** ClinicalTrialsDisclosure@merck.com
**Organization:** Merck Sharp & Dohme Corp.
**Phone:** 1-800-672-6372
**Title:** Senior Vice President, Global Clinical Development
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.86
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 4.30
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Preladenant 2 mg (Part 1) vs Placebo (Part 1)
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0033
**P-Value Comment:** 
**Parameter Type:** Difference in Estimated Means
**Parameter Value:** 2.60
**Statistical Comment:** 
**Statistical Method:** constrained longitudinal analysis
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.41
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.94
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Preladenant 5 mg (Part 1) vs Placebo (Part 1)
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1382
**P-Value Comment:** 
**Parameter Type:** Difference in Estimated Means
**Parameter Value:** 1.30
**Statistical Comment:** 
**Statistical Method:** constrained longitudinal analysis
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -1.29
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.11
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Preladenant 10 mg (Part 1) vs Placebo (Part 1)
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.6378
**P-Value Comment:** 
**Parameter Type:** Difference in Estimated Means
**Parameter Value:** 0.40
**Statistical Comment:** 
**Statistical Method:** constrained longitudinal analysis
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -1.35
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.03
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Rasagiline (Part 1) vs Placebo (Part 1)
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.6923
**P-Value Comment:** 
**Parameter Type:** Difference in Estimated Means
**Parameter Value:** 0.30
**Statistical Comment:** 
**Statistical Method:** constrained longitudinal analysis
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** -21.0
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.82
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Preladenant 2 mg (Part 1) vs Placebo (Part 1)
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0785
**P-Value Comment:** p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.
**Parameter Type:** Difference vs Placebo (%)
**Parameter Value:** -9.7
**Statistical Comment:** 
**Statistical Method:** generalized linear mixed model
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -17.6
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 5.05
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Preladenant 5 mg (Part 1) vs Placebo (Part 1)
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2735
**P-Value Comment:** p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.
**Parameter Type:** Difference vs Placebo (%)
**Parameter Value:** -6.3
**Statistical Comment:** 
**Statistical Method:** generalized linear mixed model
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -15.2
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 7.99
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Preladenant 10 mg (Part 1) vs Placebo (Part 1)
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.4823
**P-Value Comment:** p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.
**Parameter Type:** Difference vs Placebo (%)
**Parameter Value:** -3.7
**Statistical Comment:** 
**Statistical Method:** generalized linear mixed model
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -13.9
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 9.24
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Rasagiline (Part 1) vs Placebo (Part 1)
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.6827
**P-Value Comment:** p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.
**Parameter Type:** Difference vs Placebo (%)
**Parameter Value:** -2.3
**Statistical Comment:** 
**Statistical Method:** generalized linear mixed model
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 0.09
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.27
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Preladenant 2 mg (Part 1) vs Placebo (Part 1)
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0235
**P-Value Comment:** 
**Parameter Type:** Difference in Estimated Means
**Parameter Value:** 0.70
**Statistical Comment:** 
**Statistical Method:** constrained longitudinal analysis
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.11
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.04
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Preladenant 5 mg (Part 1) vs Placebo (Part 1)
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1093
**P-Value Comment:** 
**Parameter Type:** Difference in Estimated Means
**Parameter Value:** 0.50
**Statistical Comment:** 
**Statistical Method:** constrained longitudinal analysis
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.42
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.75
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Preladenant 10 mg (Part 1) vs Placebo (Part 1)
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.5756
**P-Value Comment:** 
**Parameter Type:** Difference in Estimated Means
**Parameter Value:** 0.20
**Statistical Comment:** 
**Statistical Method:** constrained longitudinal analysis
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.45
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.70
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Rasagiline (Part 1) vs Placebo (Part 1)
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.6657
**P-Value Comment:** 
**Parameter Type:** Difference in Estimated Means
**Parameter Value:** 0.10
**Statistical Comment:** 
**Statistical Method:** constrained longitudinal analysis
**Tested Non-Inferiority:** 
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.63
- **Upper Limit:** 
- **Value:** 0.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.60
- **Upper Limit:** 
- **Value:** -1.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.61
- **Upper Limit:** 
- **Value:** -1.8
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.61
- **Upper Limit:** 
- **Value:** -2.2
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 0.61
- **Upper Limit:** 
- **Value:** -1.9
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 18.95
- **Spread:** 
- **Upper Limit:** 34.33
- **Value:** 25.90
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 22.50
- **Spread:** 
- **Upper Limit:** 37.72
- **Value:** 29.50
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 24.06
- **Spread:** 
- **Upper Limit:** 40.02
- **Value:** 31.50
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 27.49
- **Spread:** 
- **Upper Limit:** 43.82
- **Value:** 35.20
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 25.60
- **Spread:** 
- **Upper Limit:** 41.51
- **Value:** 33.10
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.22
- **Upper Limit:** 
- **Value:** 0.30
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.21
- **Upper Limit:** 
- **Value:** 0.10
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.21
- **Upper Limit:** 
- **Value:** -0.20
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.21
- **Upper Limit:** 
- **Value:** -0.40
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 0.21
- **Upper Limit:** 
- **Value:** -0.20
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 108
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 110
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 121
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 102
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 105
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 116
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 120
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 113
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 120
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 119
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part 3 is the Motor Examination (Total Motor Score \[TMS\]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. Change from baseline was analyzed using a constrained longitudinal analysis (cLDA) model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 26
**Title:** Change From Baseline in the Sum of Unified Parkinson's Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3)
**Type:** PRIMARY
**Unit of Measure:** Score on a Scale
##### Group
**Description:** Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
**ID:** OG000
**Title:** Preladenant 2 mg (Part 1)
##### Group
**Description:** Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
**ID:** OG001
**Title:** Preladenant 5 mg (Part 1)
##### Group
**Description:** Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
**ID:** OG002
**Title:** Preladenant 10 mg (Part 1)
##### Group
**Description:** Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
**ID:** OG003
**Title:** Placebo (Part 1)
##### Group
**Description:** Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
**ID:** OG004
**Title:** Rasagiline (Part 1)
#### Outcome Measure 2
**Description:** UPDRS is a clinician based rating scale used to measure motor impairments and disability; it assesses 6 features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. UPDRS Part 2 is Activities of Daily Living score and ranges from 0-52. UPDRS Part 3 is Motor Examination and ranges from 0-108. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. A Responder is defined as a participant with at least 20% improvement in UPDRS2+3 from Baseline to Week 26 (End of Part 1 Treatment); a participant with at least a 20% decrease from Baseline score in UPDRS2+3 is defined as a responder. The proportion of Responders was analyzed using a generalized linear mixed model with treatment effect, strata and Baseline UPDRS2+3 as a covariate, and treatment-by-time interaction as fixed effects and subject as random effect.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 26
**Title:** Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3)
**Type:** SECONDARY
**Unit of Measure:** Percentage of Responders
##### Group
**Description:** Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
**ID:** OG000
**Title:** Preladenant 2 mg (Part 1)
##### Group
**Description:** Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks. The number of participants analyzed (202) represents the number of randomized and treated participants with at least one post-treatment value.
**ID:** OG001
**Title:** Preladenant 5 mg (Part 1)
##### Group
**Description:** Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks. The number of participants analyzed (200) represents the number of randomized and treated participants with at least one post-treatment value.
**ID:** OG002
**Title:** Preladenant 10 mg (Part 1)
##### Group
**Description:** Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
**ID:** OG003
**Title:** Placebo (Part 1)
##### Group
**Description:** Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
**ID:** OG004
**Title:** Rasagiline (Part 1)
#### Outcome Measure 3
**Description:** The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician with the higher score indicating the worse condition. Change from baseline was analyzed using a cLDA model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 26
**Title:** Change From Baseline in the UPDRS Part 2 Score (Activities of Daily Living [ADL])
**Type:** SECONDARY
**Unit of Measure:** Score on a Scale
##### Group
**Description:** Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
**ID:** OG000
**Title:** Preladenant 2 mg (Part 1)
##### Group
**Description:** Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
**ID:** OG001
**Title:** Preladenant 5 mg (Part 1)
##### Group
**Description:** Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
**ID:** OG002
**Title:** Preladenant 10 mg (Part 1)
##### Group
**Description:** Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
**ID:** OG003
**Title:** Placebo (Part 1)
##### Group
**Description:** Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
**ID:** OG004
**Title:** Rasagiline (Part 1)
#### Outcome Measure 4
**Description:** An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
**Parameter Type:** NUMBER
**Population Description:** All Participants as Treated: All participants who received at least one dose of study treatment.
**Reporting Status:** POSTED
**Time Frame:** Day 1 to Week 26
**Title:** Number of Participants With Adverse Events (AEs) in Part 1
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
**ID:** OG000
**Title:** Preladenant 2 mg (Part 1)
##### Group
**Description:** Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
**ID:** OG001
**Title:** Preladenant 5 mg (Part 1)
##### Group
**Description:** Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
**ID:** OG002
**Title:** Preladenant 10 mg (Part 1)
##### Group
**Description:** Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
**ID:** OG003
**Title:** Placebo (Part 1)
##### Group
**Description:** Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
**ID:** OG004
**Title:** Rasagiline (Part 1)
#### Outcome Measure 5
**Description:** An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
**Parameter Type:** NUMBER
**Population Description:** All Participants as Treated: All participants who received at least one dose of study treatment.
**Reporting Status:** POSTED
**Time Frame:** Day 1 to Week 26
**Title:** Number of Participants Who Discontinued Study Due to an AE in Part 1
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
**ID:** OG000
**Title:** Preladenant 2 mg (Part 1)
##### Group
**Description:** Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
**ID:** OG001
**Title:** Preladenant 5 mg (Part 1)
##### Group
**Description:** Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
**ID:** OG002
**Title:** Preladenant 10 mg (Part 1)
##### Group
**Description:** Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
**ID:** OG003
**Title:** Placebo (Part 1)
##### Group
**Description:** Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
**ID:** OG004
**Title:** Rasagiline (Part 1)
#### Outcome Measure 6
**Description:** An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
**Parameter Type:** NUMBER
**Population Description:** All Participants as Treated: All participants who received at least one dose of study treatment.
**Reporting Status:** POSTED
**Time Frame:** Week 27 to Week 52
**Title:** Number of Participants With Adverse Events (AEs) in Part 2
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
**ID:** OG000
**Title:** Preladenant 2 mg (Part 2)
##### Group
**Description:** Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
**ID:** OG001
**Title:** Preladenant 5 mg (Part 2)
##### Group
**Description:** Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
**ID:** OG002
**Title:** Preladenant 10 mg (Part 2)
##### Group
**Description:** Participants who had received placebo to preladenant in Part 1 received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
**ID:** OG003
**Title:** Placebo (Part 2)
##### Group
**Description:** Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
**ID:** OG004
**Title:** Rasagiline (Part 2)
#### Outcome Measure 7
**Description:** An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
**Parameter Type:** NUMBER
**Population Description:** All Participants as Treated (APaT): All participants who received at least one dose of study treatment.
**Reporting Status:** POSTED
**Time Frame:** Week 27 to Week 52
**Title:** Number of Participants Who Discontinued Study Due to an AE in Part 2
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
**ID:** OG000
**Title:** Preladenant 2 mg (Part 2)
##### Group
**Description:** Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
**ID:** OG001
**Title:** Preladenant 5 mg (Part 2)
##### Group
**Description:** Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
**ID:** OG002
**Title:** Preladenant 10 mg (Part 2)
##### Group
**Description:** Participants who had received placebo to preladenant in Part 1 received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
**ID:** OG003
**Title:** Placebo (Part 2)
##### Group
**Description:** Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
**ID:** OG004
**Title:** Rasagiline (Part 2)
### Participant Flow Module
#### Group
**Description:** Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
**ID:** FG000
**Title:** Preladenant 2 mg
#### Group
**Description:** Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
**ID:** FG001
**Title:** Preladenant 5 mg
#### Group
**Description:** Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
**ID:** FG002
**Title:** Preladenant 10 mg
#### Group
**Description:** Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
**ID:** FG003
**Title:** Placebo
#### Group
**Description:** Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
**ID:** FG004
**Title:** Rasagiline
#### Period
**Title:** Part I
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 13
###### Reason
**Group ID:** FG001
**Number of Subjects:** 8
###### Reason
**Group ID:** FG002
**Number of Subjects:** 18
###### Reason
**Group ID:** FG003
**Number of Subjects:** 7
###### Reason
**Group ID:** FG004
**Number of Subjects:** 6
##### Withdraw
**Type:** Administrative
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
##### Withdraw
**Type:** Did Not Meet Protocol Eligibility
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 3
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 11
###### Reason
**Group ID:** FG001
**Number of Subjects:** 13
###### Reason
**Group ID:** FG002
**Number of Subjects:** 8
###### Reason
**Group ID:** FG003
**Number of Subjects:** 8
###### Reason
**Group ID:** FG004
**Number of Subjects:** 9
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
##### Withdraw
**Type:** Treatment Failure
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 2
##### Withdraw
**Type:** Did Not Receive Treatment
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
###### Reason
**Group ID:** FG003
**Number of Subjects:** 6
###### Reason
**Group ID:** FG004
**Number of Subjects:** 1
##### Withdraw
**Type:** Non-Compliance with Protocol
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
###### Reason
**Group ID:** FG003
**Number of Subjects:** 3
###### Reason
**Group ID:** FG004
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 204
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 204
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 206
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 204
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 204
##### Milestone
**Type:** Treated
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 200
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 202
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 204
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 198
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 203
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 166
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 177
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 167
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 177
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 181
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 38
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 27
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 39
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 27
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 23
#### Period
**Title:** Part II
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
###### Reason
**Group ID:** FG002
**Number of Subjects:** 8
###### Reason
**Group ID:** FG003
**Number of Subjects:** 3
###### Reason
**Group ID:** FG004
**Number of Subjects:** 4
##### Withdraw
**Type:** Administrative
###### Reason
**Group ID:** FG000
**Number of Subjects:** 43
###### Reason
**Group ID:** FG001
**Number of Subjects:** 49
###### Reason
**Group ID:** FG002
**Number of Subjects:** 36
###### Reason
**Group ID:** FG003
**Number of Subjects:** 38
###### Reason
**Group ID:** FG004
**Number of Subjects:** 46
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
###### Reason
**Group ID:** FG002
**Number of Subjects:** 12
###### Reason
**Group ID:** FG003
**Number of Subjects:** 7
###### Reason
**Group ID:** FG004
**Number of Subjects:** 3
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 1
##### Withdraw
**Type:** Treatment Failure
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 1
##### Withdraw
**Type:** Non-Compliance with Protocol
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 2
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 166
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 177
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 167
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 177
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 181
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 107
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 116
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 109
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 127
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 126
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 59
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 61
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 58
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 50
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 55
**Pre-Assignment Details:** In Part 1, participants were randomized to one of five treatment groups and treated for 26 weeks. In Part 2, which was conducted for an additional 26 weeks, participants continued taking the same study treatment from Part 1, except for placebo participants who were re-assigned to receive preladenant 5 mg twice daily.
**Recruitment Details:** Participants with a diagnosis of idiopathic PD for less than 5 years were selected to participate in this study.
**Has Results:** True