An Open Label Extension Study To Investigate The Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Previously Completed Study A8241021

Number of Participants With Abnormal White Blood Cell Count and Absolute Neutrophil Count (Without Regard to Baseline Abnormality)

时间窗: 1 year

Number of participants with white blood cell (WBC) count and absolute neutrophil count (ANC) meeting the following criteria is presented: (1) WBC count \<0.6 \*the lower limit of normal (LLN); (2) WBC count \>1.5 times the upper limit of normal (ULN); (3) ANC \<0.8\*LLN; and (4) ANC \>1.2\*ULN.

Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

时间窗: 1 year

The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, creatinine, glucose, glycosylated hemoglobin \[diabetics only\], calcium, phosphorus, magnesium, creatine kinase, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (color, appearance, specific gravity, pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, and microscopy), and other tests (follicle stimulating hormone, urine drug screen, urine pregnancy \[human chorionic gonadotropin, hCG\], serum beta hCG). Abnormality was determined by the investigator.

Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria

时间窗: 1 year

Number of participants with vital signs data meeting the following criteria is presented: (1) supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); (2) standing SBP \<90 mmHg; (3) supine diastolic blood pressure (DBP) \<50 mmHg; (4) standing DBP \<50 mmHg; (5) supine pulse rate \<40 beats per minute (bpm); (6) supine pulse rate \>120 bpm; (7) standing pulse rate \<40 bpm; (8) standing pulse rate \>140 bpm; (9) maximum increase from baseline in supine SBP \>= 30 mmHg; (10) maximum increase from baseline in standing SBP \>= 30 mmHg; (11) maximum increase from baseline in supine DBP \>= 20 mmHg; (12) maximum increase from baseline in standing DBP \>= 20 mmHg; (13) maximum decrease from baseline in supine SBP \>=30 mmHg; (14) maximum decrease from baseline in standing SBP \>=30 mmHg; (15) maximum decrease from baseline in supine DBP \>=20 mmHg; (16) maximum decrease from baseline in standing DBP \>=20 mmHg.

Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity

时间窗: 1 year

Adverse events related to extrapyramidal symptoms included dystonia, akathisia, tardive dyskinesia). Severity was assessed by the investigator. Mild means the AE didn't interfere with the participant's usual function. Moderate means the AE interfered to some extent the participant's usual function. Severe means the AE interfered significantly with the participant's usual function.

Number of Participants With Laboratory Test Abnormalities (Normal Baseline)

时间窗: 1 year

The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, creatinine, glucose, glycosylated hemoglobin \[diabetics only\], calcium, phosphorus, magnesium, creatine kinase, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (color, appearance, specific gravity, pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, and microscopy), and other tests (follicle stimulating hormone, urine drug screen, urine pregnancy \[human chorionic gonadotropin, hCG\], serum beta hCG). Abnormality was determined by the investigator.

Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category

时间窗: Baseline (Day 1), Weeks 2 and 4, Months 3, 6, 9 and 12, follow-up visit (7-14 days after the last dose of Month 12)

Columbia Suicide Severity Rating Scale (C-SSRS) was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior, and was used in this study. C-SSRS responses were mapped onto the Columbia Classification Algorithm of Suicide Assessment (C-CASA). Number of participants with any of the following behaviors occurring since last visit was summarized: completed suicide; suicide attempt; preparatory acts towards suicide; suicidal ideation; self-injurious behavior (no suicidal intent).

Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events

时间窗: 1 year

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study treatment and up to 28 calendar days after the last administration of study treatment that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs.

Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria

时间窗: 1 year

Maximum absolute values and increases from baseline were summarized for PR interval (interval between the start of the ECG P wave and the start of the QRS complex corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization), QRS complex (time from Q wave to the end of the S wave corresponding to ventricular depolarization), and QTcF interval (time from ECG Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula). Number of participants with ECG data meeting the following criteria is presented: (1) PR interval \>=300 msec; (2) QRS complex \>=140 msec; (3) QTcF interval: 450 to \<480 msec; (4) QTcF interval: 480 to \<500 msec; (5) QTcF interval \>=500 msec; (6) PR interval increase from baseline \>=25/50 percent; (7) QRS complex increase from baseline \>=50 percent; (8) QTcF interval increase from baseline: 30 to \<60 msec; (9) QTcF interval increase from baseline \>=60 msec.