Suvecaltamide

The TETRAS composite outcome score is the sum of modified items 1 - 11 of the TETRAS-ADL subscale and modified items 6a, 6b, and 7 of the TETRAS-PS. The TETRAS-ADL subscale is a patient-rated scale administered by a trained interviewer that assesses the impact of tremor on day-to-day functioning, such as eating, drinking, dressing, and other fine motor skills. The TETRAS-PS is a clinical rating scale that quantifies tremor in the head, face voice, limbs and trunk. Items 6a, 6b, and 7 of the TETRAS-PS evaluate the impact of upper limb tremor on performance. Each item from the modified subscales ranges from 0 - 3, with 0 representing normal or slightly abnormal and 3 representing severely abnormal. The sum of the 14 items provides the TETRAS composite outcome score, which ranges from 0 - 42, with higher scores representing more severe tremor. The change from baseline is being reported where the greater the change from baseline indicates improvement in outcome.

The TETRAS composite outcome score is the sum of modified items 1 - 11 of the TETRAS-ADL subscale and modified items 6 - 7 of the TETRAS-PS. The TETRAS-ADL subscale is a patient-rated scale administered by a trained interviewer that assesses the impact of tremor on day-to-day functioning, such as eating, drinking, dressing, and other fine motor skills. The TETRAS-PS is a clinical rating scale that quantifies tremor in the head, face voice, limbs and trunk. Items 6 (drawing an Archimedes spiral using left and right hands) and 7 (handwriting) of the TETRAS-PS evaluate the impact of upper limb tremor on performance. Each item from the modified subscales ranges from 0 - 3, with 0 representing normal or slightly abnormal and 3 representing severely abnormal. The sum of the 14 items provides the TETRAS composite outcome score, which ranges from 0 - 42, with higher scores representing more severe ET.

Fridericia's Correction Formula (QTCF) is a formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates.

Clinical safety laboratory assessment in alanine aminotransferase serum chemistry concentration.

Clinical safety laboratory assessment in albumin serum chemistry.

Clinical safety laboratory assessment in albumin/globulin serum chemistry.

Clinical safety laboratory assessment in alkaline phosphatase serum chemistry.

Clinical safety laboratory assessment in aspartate aminotransferase serum chemistry.

Clinical safety laboratory assessment in BUN/Creatinine serum chemistry.

Clinical safety laboratory assessment in bilirubin serum chemistry.

Clinical safety laboratory assessment in blood urea nitrogen serum chemistry.

Clinical safety laboratory assessment in carbon dioxide serum chemistry.

Clinical safety laboratory assessment in chloride serum chemistry.

Clinical safety laboratory assessment in calcium serum chemistry.

Clinical safety laboratory assessment in cholesterol serum chemistry.

Clinical safety laboratory assessment in cholesterol/HDL-cholesterol serum chemistry.

Clinical safety laboratory assessment in creatine kinase serum chemistry.

Clinical safety laboratory assessment in creatinine serum chemistry.

Clinical safety laboratory assessment in globulin serum chemistry.

Clinical safety laboratory assessment in glomerular filtration rate adjusted for BSA chemistry.

Clinical safety laboratory assessment in GFR serum chemistry.

Clinical safety laboratory assessment in glucose serum chemistry.

Clinical safety laboratory assessment in HDL cholesterol serum chemistry.

Clinical safety laboratory assessment in LDL cholesterol serum chemistry.

Clinical safety laboratory assessment in lactate dehydrogenase serum chemistry.

Clinical safety laboratory assessment in magnesium serum chemistry.

Clinical safety laboratory assessment in non-HDL cholesterol serum chemistry.

Clinical safety laboratory assessment in phosphate serum chemistry.

Clinical safety laboratory assessment in potassium serum chemistry.

Clinical safety laboratory assessment in protein serum chemistry.

Clinical safety laboratory assessment in sodium serum chemistry.

Clinical safety laboratory assessment in triglycerides serum chemistry.

Clinical safety laboratory assessment in urate serum chemistry.

Clinical safety laboratory basophils hematology assessment.

Clinical safety laboratory basophils/leukocytes hematology assessment.

Clinical safety laboratory eosinophils hematology assessment.

Clinical safety laboratory eosinophils/leukocytes hematology assessment.

Clinical safety laboratory mean corpuscular HGB concentration hematology assessment.

Clinical safety laboratory mean corpuscular HGB hematology assessment.

Clinical safety laboratory mean corpuscular volume hematology assessment.

Clinical safety laboratory erythrocytes hematology assessment.

Clinical safety laboratory erythrocytes distribution width hematology assessment.

Clinical safety laboratory hematocrit hematology assessment.

Clinical safety laboratory hemaglobin hematology assessment.

Clinical safety laboratory leukocytes hematology assessment.

Clinical safety laboratory lymphocytes hematology assessment.

Clinical safety laboratory lymphocytes/leukocytes hematology assessment.

Clinical safety laboratory mean platelet volume hematology assessment.

Clinical safety laboratory monocytes hematology assessment.

Clinical safety laboratory monocytes/leukocytes hematology assessment.

Clinical safety laboratory neutrophils hematology assessment.

Clinical safety laboratory neutrophils/leukocytes hematology assessment.

Clinical safety laboratory platelets hematology assessment.

Clinical safety laboratory bacteria urinalysis assessment.

Clinical safety laboratory urine bilirubin urinalysis assessment.

Clinical safety laboratory epithelial cells urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-10 epithelial cells/high power field (hpf). A worse outcome is \>10 epithelial cells.

Clinical safety laboratory urine erythrocytes urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-2 erythrocytes/high power field (hpf). A better outcome is 0 or "none seen."

Clinical safety laboratory urine glucose urinalysis assessment.

Clinical safety laboratory ketones urinalysis assessment.

Clinical safety laboratory leukocyte esterase urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is "negative." An abnormal assessment or worse outcome is a positive assessment (i.e., 2+).

Clinical safety laboratory urine leukocytes urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-5 leukocytes/high power field (hpf). An abnormal assessment or worse outcome is \>5 leukocytes/hpf (i.e., 11-30).

Clinical safety laboratory mucous threads urinalysis assessment.

Clinical safety laboratory nitrite urinalysis assessment.

Clinical safety laboratory occult blood urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is "negative." An abnormal assessment or worse outcome is a positive assessment (i.e., 2+).

Clinical safety laboratory protein urinalysis assessment.

Clinical safety laboratory specific gravity urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is 1.005-1.030. An abnormal assessment or worse outcome is a value outside of this range.

Clinical safety laboratory specimen appearance urinalysis assessment.

Clinical safety laboratory urobilinogen urinalysis assessment.

Clinical safety laboratory pH urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed.

Clinical safety laboratory urine color urinalysis assessment.

Treatment-emergent adverse events are all adverse events occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period as assessed by CTCAE v4.0.

An adverse event of special interest is a serious adverse event as defined in Outcome 6. This includes, however is not limited to, increased seizure frequency, new seizure types, worsening of EEG parameters, systemic adverse events based on safety profile as assessed by CTCAE v4.0.

The change from baseline to end of treatment in participants' pulses was assessed. The changes in recumbent pulse, standing pulse, and the change from recumbent to standing pulse are reported. Change from recumbent to standing pulse was measured by the difference in recumbent pulse change and standing pulse change.

The change from baseline to end of treatment in participants' systolic blood pressure (sbp) was assessed. The changes in recumbent sbp, standing sbp, and the change from recumbent to standing sbp are reported. Change from recumbent to standing sbp was measured by the difference in recumbent sbp change and standing sbp change.

The change from baseline to end of treatment in participants' diastolic blood pressure (dbp) was assessed. The changes in recumbent dbp, standing dbp, and the change from recumbent to standing dbp are reported. Change from recumbent to standing dbp was measured by the difference in recumbent dbp change and standing dbp change.

The Essential Tremor Rating Assessment Scale Performance Subscale (TETRAS-PS) was used to assess the efficacy of CX-8998 in reducing essential tremor as scored by the independent video raters. TETRAS-PS quantifies tremor in the head, face, voice, limbs, and trunk. The overall subscale score ranges from a minimum of 0 to a maximum of 64. A lower score is indicative of improvement and a better outcome.

The Essential Tremor Rating Assessment Scale Performance Subscale (TETRAS-PS) was used to assess the efficacy of CX-8998 in reducing essential tremor as scored by the independent video raters. TETRAS-PS quantifies tremor in the head, face, voice, limbs, and trunk. The overall subscale score ranges from a minimum of 0 to a maximum of 64. A decrease or negative change in the score is indicative of improvement in outcome.