Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Number of Participants with Spontaneously Reported Adverse Events (AEs) |
Number of participants with spontaneously reported AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
Up to 1 year |
|
Primary |
Number of Participants with AEs Collected through Generic Assessment of Side Effects (GASE) |
Number of participants with AEs collected through GASE will be reported. The GASE is an instrument to assess side effects in clinical studies that allows the detection of drug induced AEs. |
Up to 1 year |
|
Primary |
Number of Participants with Hospitalization for Psychiatric Reasons |
Number of participants with hospitalizations for psychiatric reasons will be reported. |
Up to 1 year |
|
Primary |
Number of Participants with Hospitalization for Medical Reasons |
Number of participants with hospitalizations for medical reasons will be reported. |
Up to 1 year |
|
Primary |
Number of Participants with Other Serious Adverse Events (SAEs) |
SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. |
Up to 1 year |
|
Primary |
Number of Participants with Deaths |
Number of participants with deaths will be reported. |
Up to 1 year |
|
Primary |
Number of Participants with Suicide Attempts and Completed Suicides |
Number of participants with suicide attempts and completed suicides will be reported. |
Up to 1 year |
|
Primary |
Suicidality Assessment Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score |
Suicidality assessment using the C-SSRS will be reported. C-SSRS is semi structured clinician-administered questionnaire designed to solicit the occurrence, severity, and frequency of suicide-related ideation and behaviors. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 yes/no items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Worsening of suicidal ideation will be an increase in severity of suicidal ideation from baseline. |
Up to 1 year |
|
Primary |
Number of Participants with Suicidal Ideation as Assessed by C-SSRS |
Number of participants with suicidal ideation as assessed by C-SSRS, particularly codes of 4 or 5 will be reported. C-SSRS is semi structured clinician-administered questionnaire designed to solicit the occurrence, severity, and frequency of suicide-related ideation and behaviors. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 yes/no items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Worsening of suicidal ideation will be an increase in severity of suicidal ideation from baseline. |
Up to 1 year |
|
Secondary |
Number of Participants with Adverse Events of Special Interest (AESI) |
Number of participants with AESI: Cataplexy, Sleep paralysis, Complex sleep-related behaviors, Falls, Motor vehicle accidents will be reported. |
Up to 1 year |
|
Secondary |
Change from Baseline in Weight Over Time |
Change from baseline in weight over time will be reported. |
Baseline (Week 1) up to 1 year |
|
Secondary |
Percentage of Participants with Clinically Meaningful Change in Weight |
Percentage of participants with clinically meaningful change in weight (greater than or equal to [>=] 7 percent [%]) from baseline to end of study will be reported. |
Baseline (Week 1) to end of study (up to 1 Year) |
|
Secondary |
Change from Baseline in Hemoglobin Level Over Time |
Change from baseline in hemoglobin level over time will be reported. |
Baseline (Week 1), Week 26 and Week 52 |
|
Secondary |
Change from Baseline in Platelet and White Blood Cell (WBC) Count Over Time |
Change from baseline in platelet and WBC count with differential over time will be reported. |
Baseline (Week 1), Week 26 and Week 52 |
|
Secondary |
Change from Baseline in Hematocrit Level Over Time |
Change from baseline in hematocrit level over time will be reported. |
Baseline (Week 1), Week 26 and Week 52 |
|
Secondary |
Change from Baseline in Red Blood Cell (RBC) Count Over Time |
Change from baseline in RBC count over time will be reported. |
Baseline (Week 1), Week 26 and Week 52 |
|
Secondary |
Change from Baseline in Sodium, Potassium, Chloride and Bicarbonate Level Over Time |
Change from baseline in sodium, potassium, chloride and bicarbonate level over time will be reported. |
Baseline (Week 1), Week 26 and Week 52 |
|
Secondary |
Change from Baseline in Blood Urea Nitrogen (BUN), Creatinine, Glucose, Total and Direct Bilirubin, Calcium and Phosphate Level Over Time |
Change from baseline in BUN, creatinine, glucose, total and direct bilirubin, calcium and phosphate level over time will be reported. |
Baseline (Week 1), Week 26 and Week 52 |
|
Secondary |
Change from Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase Level Over Time |
Change from baseline in AST, ALT, alkaline phosphatase level over time will be reported. |
Baseline (Week 1), Week 26 and Week 52 |
|
Secondary |
Change from Baseline in Albumin and Total Protein Level Over Time |
Change from baseline in albumin and total protein level over time will be reported. |
Baseline (Week 1), Week 26 and Week 52 |
|
Secondary |
Change from Baseline in Total Cholesterol, Low-density Lipoprotein Cholesterol, Triglycerides, High-density Lipoprotein Cholesterol Level Over Time |
Change from baseline in total cholesterol, low-density lipoprotein cholesterol (calculated), triglycerides, high-density lipoprotein cholesterol level over time will be reported. |
Baseline (Week 1), Week 26 and Week 52 |
|