PF-06669571

The total MDS-UPDRS score is the most common method of evaluating the severity of Parkinson's disease across behaviors, activities of daily living, motor abilities, and other complications of Parkinson's disease. The MDS-UPDRS focuses primarily on measuring impairments associated with Parkinson's disease, with subsections organized according to motor and non-motor aspects of the disease. Part III assesses the motor signs of Parkinson's disease. Higher total scores indicate more severe motor signs of Parkinson's disease. Negative changes from baseline indicate improvement. MDS-UPDRS Part III total motor score is comprised of 33 sub-scores based on 18 items, several with right, left or other body distribution scores. Each question is anchored with five responses that are linked to commonly accepted clinical terms: 0 = normal, 1 = slight, 2 = mild, 3 = moderate and 4 = severe.

The number of participants in each C-CASA category was mapped from Columbia-Suicide Severity Rating Scale (C-SSRS) data. C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act or some intent to act, with specific plan and intent"), any suicidal behavior or ideation, self-injurious behavior (7) ("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").

Number of participants with new onset and worsening of post-baseline suicidality was reported

An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.

Number of participants with supine and standing vital signs data of absolute values meeting criteria of potential clinical concern. Absolute values were analyzed for supine/standing systolic blood pressure (SBP), supine/standing diastolic blood pressure (DBP), and supine/standing pulse rate. Number of participants with vital signs data meeting the following criteria was reported: (1) absolute supine SBP \<90 millimeters of mercury (mmHg); (2) absolute standing SBP \<90 mmHg; (3)absolute supine DBP\<50mmHg; (4)absolute standing DBP\<50mmHg (5) absolute supine pulse rate \<40 beats per minute (bpm); (6) absolute supine pulse rate \>120 bpm;(7) absolute standing pulse rate \<40 bpm; (8) absolute standing pulse rate \>140 bpm.

The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in supine systolic BP (SBP) \>=30 millimeters of mercury (mmHg); Criterion B maximum increase from baseline in standing SBP \>=30 mmHg; Criterion C: maximum increase from baseline in supine diastolic BP(DBP) \>=20 mmHg; Criterion D: maximum increase from baseline in standing diastolic BP(DBP) \>=20 mmHg

The number of participants with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in supine systolic BP (SBP) \>=30 mmHg; Criterion B: maximum decrease from baseline in standing SBP \>=30 mmHg; Criterion C: maximum decrease from baseline in supine diastolic BP(DBP) \>=20 mmHg; Criterion D: maximum decrease from baseline in standing diastolic BP(DBP) \>=20 mmHg

The number of participants with ECG absolute values meeting the following criteria was reported: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) \>=300 msec; Criterion B: maximum QRs complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) \>=140 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula) 450-\<480 msec; Criterion D: maximum QTcF interval 480-\<500 msec; Criterion E: maximum QTcF interval (Fridericia's correction) \>=500 msec

Number of participants with ECG(standard 12-lead) meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)\>=25/50%; Criterion B: maximum QRs complex increase from baseline PctChg \>=50%; Criterion C: maximum QTcF interval increase from baseline 30\<=change\<60 msec; Criterion D: maximum QTcF interval increase from baseline change \>=60 msec.

Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute total neutrophils, absolute eosinophils, absolute basophils, absolute monocytes, and absolute lymphocytes),liver function(total bilirubin, direct bilirubin, aspartate, aspartate aminotransferase, alanine, alanine aminotransferase, alkaline phosphatase, total protein, and albumin), renal function (blood urea nitrogen, creatinine, and uric acid), electrolytes (sodium, potassium, chloride, calcium, and venous bicarbonate), clinical chemistry(glucose) ,and urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, qualitative ketones, qualitative bilirubin, nitrites, leukocyte esterase, urine urobilinogen, urine leukocyte, esterase and microscopy).

C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").