Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures | Clari

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Primary Outcomes

Incidences of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Through study completion, an average of 4 years

The incidences of adverse events (AEs) and serious adverse events (SAEs) will be recorded.

Urinalysis(pH)

Through study completion, an average of 4 years

Measurement of urine pH.

Urinalysis(Specific Gravity)

Through study completion, an average of 4 years

Measurement of urine specific gravity (g/mL).

Urinalysis(Protein)

Through study completion, an average of 4 years

Measurement of urine protein (mg/dL).

Urinalysis(Glucose)

Through study completion, an average of 4 years

Measurement of urine glucose (mg/dL).

Urinalysis(Ketone)

Through study completion, an average of 4 years

Measurement of urine ketone (mg/dL).

Urinalysis(Bilirubin)

Through study completion, an average of 4 years

Measurement of urine bilirubin (mg/dL).

Urinalysis(Blood)

Through study completion, an average of 4 years

Measurement of urine blood (presence/absence).

Urinalysis(Nitrite)

Through study completion, an average of 4 years

Measurement of urine nitrite (presence/absence).

Urinalysis(Urobilinogen)

Through study completion, an average of 4 years

Measurement of urine urobilinogen (mg/dL).

Urinalysis( Microscopic Examination)

Through study completion, an average of 4 years

Microscopic examination of urine (if abnormal).

Liver function tests(total protein)

Through study completion, an average of 4 years

Measurement of total protein(g/dL)

Liver function tests(albumin)

Through study completion, an average of 4 years

Measurement of albumin(g/dL)

Liver function tests(total bilirubin)

Through study completion, an average of 4 years

Measurement of total bilirubin(mg/dL)

Liver function tests(aspartate transaminase)

Through study completion, an average of 4 years

Measurement of aspartate transaminase(U/L)

Liver function tests(alanine aminotransferase)

Through study completion, an average of 4 years

Measurement of alanine aminotransferase(U/L)

Liver function tests(alkaline phosphatase)

Through study completion, an average of 4 years

alkaline phosphatase(U/L)

Liver function tests(gamma-glutamyl transferase)

Through study completion, an average of 4 years

Measurement of gamma-glutamyl transferase(U/L)

Hematology(Hemoglobin)

Through study completion, an average of 4 years

Measurement of hemoglobin(g/dL)

Hematology(hematocrit)

Through study completion, an average of 4 years

Measurement of hematocrit(%)

Hematology(white blood cell count)

Through study completion, an average of 4 years

Measurement of white blood cell count（/μL）

Hematology(red blood cell count)

Through study completion, an average of 4 years

Measurement of red blood cell count（/μL)

Hematology(mean corpuscular volume)

Through study completion, an average of 4 years

Measurement of mean corpuscular volume(fL)

Hematology(mean corpuscular hemoglobin)

Through study completion, an average of 4 years

Measurement of mean corpuscular hemoglobin(pg)

Hematology(red blood cell distribution width)

Through study completion, an average of 4 years

Measurement of red blood cell distribution width(％)

Hematology(platelet count)

Through study completion, an average of 4 years

Measurement of platelet count(/μL)

Serum chemistry(blood urea nitrogen)

Through study completion, an average of 4 years

Measurement of blood urea nitrogen(mg/dL)

Serum chemistry(calcium)

Through study completion, an average of 4 years

Measurement of calcium(mg/dL)

Serum chemistry(chloride)

Through study completion, an average of 4 years

Measurement of chloride(mEq/L)

Serum chemistry(creatinine)

Through study completion, an average of 4 years

Measurement of creatinine(mg/dL)

Serum chemistry(total bilirubin)

Through study completion, an average of 4 years

Measurement of total bilirubin(mg/dL)

Serum chemistry(direct bilirubin)

Through study completion, an average of 4 years

Measurement of direct bilirubin(mg/dL)

Serum chemistry(alkaline phosphatase)

Through study completion, an average of 4 years

Measurement of alkaline phosphatas（U/L）

Serum chemistry(alanine aminotransferase)

Through study completion, an average of 4 years

Measurement of alanine aminotransferase(U/L)

Serum chemistry(gamma-glutamyl transferase)

Through study completion, an average of 4 years

Measurement of gamma-glutamyl transferase(U/L)

Serum chemistry(total protein)

Through study completion, an average of 4 years

Measurement of total protein(g/dL)

Serum chemistry(albumin)

Through study completion, an average of 4 years

Measurement of albumin(g/dL)

Serum chemistry(globulin)

Through study completion, an average of 4 years

Measurement of globulin(g/dL)

Serum chemistry(sodium)

Through study completion, an average of 4 years

Measurement of sodium(mEq/L)

Serum chemistry(potassium)

Through study completion, an average of 4 years

Measurement of potassium(mEq/L)

Serum chemistry(phosphorus)

Through study completion, an average of 4 years

Measurement of phosphorus(mq/dL)

Serum chemistry(glucose)

Through study completion, an average of 4 years

Measurement of glucose(mq/dL)

Heart rate

Through study completion, an average of 4 years

heart rate (beats per minute)

Respiratory Rate

Through study completion, an average of 4 years

Respiratory Rate (breaths per minute),

Blood Pressure

Through study completion, an average of 4 years

blood pressure, both of systolic and diastolic (mm Hg)

Electrocardiogram (ECG) Findings

Through study completion, an average of 4 years

ECG findings, including heart rate (beats per minute), PR Interval (milliseconds), PQ Interval (milliseconds), RR Interval (milliseconds), QRS Interval (milliseconds), and QT Interval (milliseconds), will be recorded.

Columbia-Suicide Severity Rating Scale (C-SSRS) Scores

Through study completion, an average of 4 years

Scores on the Columbia-Suicide Severity Rating Scale (C-SSRS) will be recorded. Questions regarding suicide are recorded as yes or no, and the percentage of subject with suicide risk (yes) is assessed.