Huntington's Disease
Conditions
Keywords
Huntington's Disease, SAGE-718
Brief summary
The primary purpose of the study is to evaluate the safety and tolerability of SAGE-718 softgel lipid capsule in participants with Huntington's Disease (HD)
Interventions
DRUGSAGE-718
Oral softgel lipid capsules
Sponsors
Supernus Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
For all participants: * Completed 718-CIH-201 (NCT05107128) or 718-CIH-202 (NCT05358821) studies or meet eligibility criteria for the de novo cohort. * Agree to refrain from drugs of abuse for the duration of the study and from alcohol during the 48 hours preceding each study visit. * Be willing to invite a study partner, if available, who is reliable, competent, and at least 18 years of age to participate in the study. * Be able to travel to the study center, and, judged by the investigator, is likely to be able to continue to travel to the study center to complete study visits for the duration of the study. Additional inclusion criteria for the de novo cohort (Cohort 3): * Be at least 25 years old, but not older than 65 years of age at Screening. * Genetically confirmed disease with cytosine-adenine-guanine (CAG) expansion ≥40 * No features of juvenile HD * CAG-Age-Product (CAP) score ≥90, as calculated using the CAP formula: AGE × (CAG - 30) / 6.49. * At screening, scores of either: a) Unified Huntington's Disease Rating Scale (UHDRS) -Total Functional Capacity (TFC)=13 and Montreal Cognitive Assessment (MoCA) ≤25 score, or b) UHDRS-TFC ≤12 and MoCA \>25
Exclusion criteria
For all participants * Have a diagnosis of an ongoing neurodegenerative condition other than HD, including but not limited to, Alzheimer's Disease, vascular dementia, dementia with Lewy bodies, or Parkinson's Disease. * Had gastric bypass surgery, has a gastric sleeve or lap band, or has had any related procedures that interfere with gastrointestinal transit. * Is known to be allergic to any of SAGE-718 excipients, including soy lecithin. * Receive any prohibited medications within 30 days of screening and during participation in the study. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) | Up to 24 months | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. |
| Number of Participants With at Least One TEAE by Severity | Up to 24 months | A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Severity was assessed as: Mild: symptoms barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptoms. Moderate: symptoms of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptoms may be needed. Severe: symptoms cause severe discomfort; symptoms cause incapacitation or significant impact on participant's daily life; severity may cause cessation of treatment with IP; treatment for symptoms may be given and/or participant hospitalized. Participant with multiple instances of events is counted only once using maximum intensity. |
| Number of Participants Who Withdrew From Study Due to TEAEs | Up to 24 months | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as any AE with onset or after the start of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. |
| Change From Baseline in Vital Signs: Blood Pressure | Baseline; Last Value on Study (up to 24 months) | Vital signs parameter for blood pressure included systolic blood pressure (supine), systolic blood pressure (standing 1 minute), systolic blood pressure (standing 3 minutes), diastolic blood pressure (supine), diastolic blood pressure (standing 1 minute), and diastolic blood pressure (standing 3 minutes). Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Vital Signs: Heart Rate | Baseline, Last value on study (up to 24 months) | Vital signs for heart rate included heart rate (supine), heart rate (standing 1 minute), and heart rate (standing 3 minute). Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Vital Signs: Respiratory Rate | Baseline; Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Vital Signs: Temperature | Baseline, Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | Baseline; Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes | Baseline, Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Clinical Laboratory Parameters: Hematology- Erythrocytes (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin | Baseline, Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Clinical Laboratory Parameters: Hematology - Erythrocytes Mean Corpuscular Hemoglobin | Baseline; Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Clinical Laboratory Parameters: Hematology - Erythrocytes Mean Corpuscular Volume | Baseline, Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Clinical Laboratory Parameters: Hematology - Hematocrit | Baseline, Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | Baseline, Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | Baseline; Last value on study (up to 24 months) | HDL= high-density lipoprotein LDL= low-density lipoprotein Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Albumin and Protein | Baseline; Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin | Baseline; Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyrotropin | Baseline; Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyroxine Free, Triiodothyronine Free | Baseline; Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells | Baseline; Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Hyaline Casts | Baseline; Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Clinical Laboratory Parameters: Urinalysis- pH | Baseline; Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Clinical Laboratory Parameters: Coagulation- Activated Partial Thromboplastin Time, Prothrombin Time | Baseline; Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Clinical Laboratory Parameters: Coagulation- Prothrombin International (Intl) Normalized Ratio | Baseline; Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in Electrocardiograms (ECGs) Parameters: Mean Heart Rate | Baseline; Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Change From Baseline in ECG Parameters - PR Interval Aggregate, QRS Duration Aggregate, QT Interval Aggregate and QTcF Interval Aggregate | Baseline; Last value on study (up to 24 months) | Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study. |
| Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30, Day 60, Day 90, Day 365, Day 395, Safety Follow-up (up to 24 months) | Columbia Suicide Severity Rating Scale evaluates and assesses the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and post-baseline evaluation that focuses on suicidality since last study visit. C-SSRS includes yes or no' responses for assessment of SI and SB as well as numeric ratings for severity of ideation. If present \[from 1 (minor physical damage) to 5 (death), with 5 being most severe\]. If any of the available assessments in suicidal behavior is Yes, the category is considered as 'Suicidal behavior'. If any of these available assessments in suicidal ideation is Yes but all available assessments in suicidal behavior is NO, the category is considered as 'Suicidal Ideation'. Data is reported for only those timepoints where there was a change in assessment (response) from Baseline. Baseline is the worst of assessments done in any question in SI/SB prior to first dose of IP, excluding lifetime assessment. |
Countries
Australia, Canada, United Kingdom, United States
Participant flow
Recruitment details
Participation of a study partner was optional in this study and was only to support completion of study activities and answer questions about the participant's condition. Only participants with Huntington's Disease enrolled in this study represented enrollment number. Data presented in all the sections of the results represents data exclusively collected and analyzed for participants with Huntington's Disease enrolled in this study.
Pre-assignment details
A total of 165 participants were screened, of which, 153 participants were enrolled and received study treatment in either Cohort 1 (Direct rollover) or Cohort 2 (Gap rollover). The study was terminated early by the Sponsor and hence, no participants were enrolled in Cohort 3 (De novo) and therefore no data was collected and reported. No additional milestone.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 (Direct Rollover) Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards. | 72 |
| Cohort 2 (Gap Rollover) Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards. | 81 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Non-Compliance with Study Drug | 0 | 2 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Study Terminated by Sponsor | 61 | 68 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Cohort 2 (Gap Rollover) | Total | Cohort 1 (Direct Rollover) |
|---|---|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 9.21 | 51.6 years STANDARD_DEVIATION 8.65 | 51.9 years STANDARD_DEVIATION 8.02 |
| Race/Ethnicity, Customized Ethnicity Hispanice or Latino | 5 Participants | 13 Participants | 8 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 76 Participants | 140 Participants | 64 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Multiple | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Race White | 77 Participants | 145 Participants | 68 Participants |
| Sex: Female, Male Female | 38 Participants | 72 Participants | 34 Participants |
| Sex: Female, Male Male | 43 Participants | 81 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 81 |
| other Total, other adverse events | 46 / 72 | 22 / 81 |
| serious Total, serious adverse events | 3 / 72 | 6 / 81 |
Outcome results
Primary
Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline, Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure and Number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | CFB: Alanine Aminotransferase | -1.2 units per liter (U/L) | Standard Deviation 10.8 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | CFB: Alkaline Phosphatase | 1.7 units per liter (U/L) | Standard Deviation 13.17 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | CFB: Aspartate Aminotransferase | -1.7 units per liter (U/L) | Standard Deviation 5.56 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | CFB: Creatinine Kinase | -28.6 units per liter (U/L) | Standard Deviation 135.53 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | CFB: Gamma Glutamyl Transferase | 3.1 units per liter (U/L) | Standard Deviation 14.47 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | CFB: Lactate Dehydrogenase | -9.6 units per liter (U/L) | Standard Deviation 19.89 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | CFB: Gamma Glutamyl Transferase | 4.0 units per liter (U/L) | Standard Deviation 31.75 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | CFB: Alanine Aminotransferase | 0.6 units per liter (U/L) | Standard Deviation 11.42 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | CFB: Creatinine Kinase | -0.8 units per liter (U/L) | Standard Deviation 83.46 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | CFB: Alkaline Phosphatase | 2.2 units per liter (U/L) | Standard Deviation 13.04 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | CFB: Lactate Dehydrogenase | 4.2 units per liter (U/L) | Standard Deviation 25.26 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | CFB: Aspartate Aminotransferase | 1.0 units per liter (U/L) | Standard Deviation 9.79 |
Primary
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Albumin and Protein
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Albumin and Protein | CFB: Albumin | 0.2 grams per liter (g/L) | Standard Deviation 2.78 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Albumin and Protein | CFB: Protein | -1.0 grams per liter (g/L) | Standard Deviation 3.6 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Albumin and Protein | CFB: Albumin | 0.4 grams per liter (g/L) | Standard Deviation 2.11 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Albumin and Protein | CFB: Protein | -0.2 grams per liter (g/L) | Standard Deviation 3.09 |
Primary
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen
HDL= high-density lipoprotein LDL= low-density lipoprotein Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure and Number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Bicarbonate | -0.1 millimole per liter (mmol/L) | Standard Deviation 2.68 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Calcium | -0.005 millimole per liter (mmol/L) | Standard Deviation 0.0905 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Chloride | 0.7 millimole per liter (mmol/L) | Standard Deviation 2.31 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Cholesterol | -0.02 millimole per liter (mmol/L) | Standard Deviation 0.777 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Glucose | -0.04 millimole per liter (mmol/L) | Standard Deviation 1.128 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: HDL Cholesterol | -0.00 millimole per liter (mmol/L) | Standard Deviation 0.188 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: LDL Cholesterol | -0.01 millimole per liter (mmol/L) | Standard Deviation 0.636 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Phosphate | 0.009 millimole per liter (mmol/L) | Standard Deviation 0.1688 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Potassium | -0.07 millimole per liter (mmol/L) | Standard Deviation 0.463 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Sodium | 0.4 millimole per liter (mmol/L) | Standard Deviation 1.99 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Triglycerides | -0.125 millimole per liter (mmol/L) | Standard Deviation 0.9411 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Urea Nitrogen | 0.33 millimole per liter (mmol/L) | Standard Deviation 1.371 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Triglycerides | 0.080 millimole per liter (mmol/L) | Standard Deviation 0.8615 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Bicarbonate | 0.0 millimole per liter (mmol/L) | Standard Deviation 2.51 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: LDL Cholesterol | 0.08 millimole per liter (mmol/L) | Standard Deviation 0.671 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Calcium | 0.006 millimole per liter (mmol/L) | Standard Deviation 0.0861 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Sodium | 0.7 millimole per liter (mmol/L) | Standard Deviation 2.02 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Chloride | 1.0 millimole per liter (mmol/L) | Standard Deviation 2.31 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Phosphate | -0.017 millimole per liter (mmol/L) | Standard Deviation 0.1937 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Cholesterol | 0.22 millimole per liter (mmol/L) | Standard Deviation 0.735 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Urea Nitrogen | -0.11 millimole per liter (mmol/L) | Standard Deviation 1.344 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Glucose | -0.26 millimole per liter (mmol/L) | Standard Deviation 1.274 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: Potassium | -0.06 millimole per liter (mmol/L) | Standard Deviation 0.319 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | CFB: HDL Cholesterol | 0.05 millimole per liter (mmol/L) | Standard Deviation 0.218 |
Primary
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin | CFB: Bilirubin | -0.43 micromoles per liter (µmol/L) | Standard Deviation 3.149 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin | CFB: Creatinine | 0.7 micromoles per liter (µmol/L) | Standard Deviation 8.14 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin | CFB: Direct Bilirubin | -0.04 micromoles per liter (µmol/L) | Standard Deviation 1.201 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin | CFB: Indirect Bilirubin | -0.39 micromoles per liter (µmol/L) | Standard Deviation 2.367 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin | CFB: Indirect Bilirubin | 0.15 micromoles per liter (µmol/L) | Standard Deviation 2.137 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin | CFB: Bilirubin | -0.10 micromoles per liter (µmol/L) | Standard Deviation 2.912 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin | CFB: Direct Bilirubin | -0.25 micromoles per liter (µmol/L) | Standard Deviation 1.223 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin | CFB: Creatinine | 3.0 micromoles per liter (µmol/L) | Standard Deviation 9.95 |
Primary
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyrotropin
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyrotropin | -0.061 milli-international units per liter | Standard Deviation 2.2278 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyrotropin | -0.181 milli-international units per liter | Standard Deviation 1.2943 |
Primary
Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyroxine Free, Triiodothyronine Free
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyroxine Free, Triiodothyronine Free | CFB: Thyroxine, Free | 2.55 picomoles per liter (pmol/L) | Standard Deviation 20.153 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyroxine Free, Triiodothyronine Free | CFB: Triiodothyronine, Free | 0.85 picomoles per liter (pmol/L) | Standard Deviation 1.909 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyroxine Free, Triiodothyronine Free | CFB: Thyroxine, Free | 6.40 picomoles per liter (pmol/L) | — |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyroxine Free, Triiodothyronine Free | CFB: Triiodothyronine, Free | 1.70 picomoles per liter (pmol/L) | — |
Primary
Change From Baseline in Clinical Laboratory Parameters: Coagulation- Activated Partial Thromboplastin Time, Prothrombin Time
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Coagulation- Activated Partial Thromboplastin Time, Prothrombin Time | CFB: Activated Partial Thromboplastin Time | 0.86 seconds | Standard Deviation 5.876 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Coagulation- Activated Partial Thromboplastin Time, Prothrombin Time | CFB: Prothrombin Time | 0.14 seconds | Standard Deviation 1.008 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Coagulation- Activated Partial Thromboplastin Time, Prothrombin Time | CFB: Activated Partial Thromboplastin Time | -1.12 seconds | Standard Deviation 2.947 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Coagulation- Activated Partial Thromboplastin Time, Prothrombin Time | CFB: Prothrombin Time | -0.05 seconds | Standard Deviation 0.673 |
Primary
Change From Baseline in Clinical Laboratory Parameters: Coagulation- Prothrombin International (Intl) Normalized Ratio
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Coagulation- Prothrombin International (Intl) Normalized Ratio | 0.011 prothrombin intl normalized ratio | Standard Deviation 0.1071 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Coagulation- Prothrombin International (Intl) Normalized Ratio | -0.011 prothrombin intl normalized ratio | Standard Deviation 0.074 |
Primary
Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure and Number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | CFB: Basophils | 0.00 cells*10^9/L | Standard Deviation 0.039 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | CFB: Eosinophils | 0.00 cells*10^9/L | Standard Deviation 0.091 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | CFB: Erythrocytes | 0.004 cells*10^9/L | Standard Deviation 0.2369 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | CFB: Leukocytes | -0.21 cells*10^9/L | Standard Deviation 1.609 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | CFB: Lymphocytes | -0.03 cells*10^9/L | Standard Deviation 0.317 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | CFB: Monocytes | 0.01 cells*10^9/L | Standard Deviation 0.134 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | CFB: Neutrophils | -0.20 cells*10^9/L | Standard Deviation 1.561 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | CFB: Platelets | 6.6 cells*10^9/L | Standard Deviation 37.38 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | CFB: Platelets | 4.2 cells*10^9/L | Standard Deviation 30.31 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | CFB: Basophils | 0.01 cells*10^9/L | Standard Deviation 0.052 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | CFB: Lymphocytes | -0.04 cells*10^9/L | Standard Deviation 0.362 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | CFB: Eosinophils | 0.02 cells*10^9/L | Standard Deviation 0.101 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | CFB: Neutrophils | 0.06 cells*10^9/L | Standard Deviation 1.23 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | CFB: Erythrocytes | 0.015 cells*10^9/L | Standard Deviation 0.2312 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | CFB: Monocytes | 0.03 cells*10^9/L | Standard Deviation 0.115 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | CFB: Leukocytes | 0.07 cells*10^9/L | Standard Deviation 1.328 |
Primary
Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline, Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes | CFB: Eosinophils/Leukocytes | 0.04 percent | Standard Deviation 1.259 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes | CFB: Monocytes/Leukocytes | 0.32 percent | Standard Deviation 2.427 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes | CFB: Lymphocytes/Leukocytes | -0.11 percent | Standard Deviation 6.984 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes | CFB: Neutrophils/Leukocytes | -0.25 percent | Standard Deviation 8.792 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes | CFB: Basophils/Leukocytes | 0.02 percent | Standard Deviation 0.313 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes | CFB: Neutrophils/Leukocytes | -0.20 percent | Standard Deviation 7.208 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes | CFB: Basophils/Leukocytes | -0.02 percent | Standard Deviation 0.24 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes | CFB: Eosinophils/Leukocytes | 0.32 percent | Standard Deviation 1.268 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes | CFB: Lymphocytes/Leukocytes | -0.66 percent | Standard Deviation 6.023 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes | CFB: Monocytes/Leukocytes | 0.57 percent | Standard Deviation 1.547 |
Primary
Change From Baseline in Clinical Laboratory Parameters: Hematology- Erythrocytes (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline, Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology- Erythrocytes (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin | CFB: Ery. Mean Corpuscular HGB Concentration | -2.7 grams per liter (g/L) | Standard Deviation 11.85 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology- Erythrocytes (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin | CFB: Hemoglobin | -0.0 grams per liter (g/L) | Standard Deviation 6.69 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology- Erythrocytes (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin | CFB: Ery. Mean Corpuscular HGB Concentration | -4.9 grams per liter (g/L) | Standard Deviation 9.24 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology- Erythrocytes (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin | CFB: Hemoglobin | -0.3 grams per liter (g/L) | Standard Deviation 8.15 |
Primary
Change From Baseline in Clinical Laboratory Parameters: Hematology - Erythrocytes Mean Corpuscular Hemoglobin
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Erythrocytes Mean Corpuscular Hemoglobin | -0.02 picograms (pg) | Standard Deviation 0.74 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Erythrocytes Mean Corpuscular Hemoglobin | -0.17 picograms (pg) | Standard Deviation 0.953 |
Primary
Change From Baseline in Clinical Laboratory Parameters: Hematology - Erythrocytes Mean Corpuscular Volume
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline, Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Erythrocytes Mean Corpuscular Volume | 0.61 femtoliters (fL) | Standard Deviation 3.091 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Erythrocytes Mean Corpuscular Volume | 0.85 femtoliters (fL) | Standard Deviation 2.884 |
Primary
Change From Baseline in Clinical Laboratory Parameters: Hematology - Hematocrit
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline, Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Hematocrit | 0.0033 liters per liter (L/L) | Standard Deviation 0.0256 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Hematology - Hematocrit | 0.0055 liters per liter (L/L) | Standard Deviation 0.0271 |
Primary
Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure and Number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells | CFB: Leukocytes in Urine | -2.4 cells per high power field | Standard Deviation 4.45 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells | CFB: Squamous Epithelial Cells | -1.3 cells per high power field | Standard Deviation 16.29 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells | CFB: Renal Epithelial Casts | 0.00 cells per high power field | Standard Deviation 0 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells | CFB: Transitional Epithelial Cells | 0.0 cells per high power field | Standard Deviation 0.89 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells | CFB: Erythrocytes in Urine | 0.9 cells per high power field | Standard Deviation 3.3 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells | CFB: Transitional Epithelial Cells | 0.5 cells per high power field | Standard Deviation 1.12 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells | CFB: Erythrocytes in Urine | -0.2 cells per high power field | Standard Deviation 2.09 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells | CFB: Leukocytes in Urine | 0.8 cells per high power field | Standard Deviation 7.53 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells | CFB: Renal Epithelial Casts | 0.00 cells per high power field | Standard Deviation 0 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells | CFB: Squamous Epithelial Cells | 0.8 cells per high power field | Standard Deviation 4.98 |
Primary
Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Hyaline Casts
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Hyaline Casts | 0.9 casts per low power field (/lpf) | Standard Deviation 3.56 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Hyaline Casts | -0.6 casts per low power field (/lpf) | Standard Deviation 1.89 |
Primary
Change From Baseline in Clinical Laboratory Parameters: Urinalysis- pH
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Clinical Laboratory Parameters: Urinalysis- pH | -0.13 pH | Standard Deviation 0.667 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Clinical Laboratory Parameters: Urinalysis- pH | 0.06 pH | Standard Deviation 0.679 |
Primary
Change From Baseline in ECG Parameters - PR Interval Aggregate, QRS Duration Aggregate, QT Interval Aggregate and QTcF Interval Aggregate
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for ECG parameter for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in ECG Parameters - PR Interval Aggregate, QRS Duration Aggregate, QT Interval Aggregate and QTcF Interval Aggregate | CFB: PR Interval, Aggregate | -2.8 millisecond (msec) | Standard Deviation 13.39 |
| Cohort 1 (Direct Rollover) | Change From Baseline in ECG Parameters - PR Interval Aggregate, QRS Duration Aggregate, QT Interval Aggregate and QTcF Interval Aggregate | CFB: QRS Duration, Aggregate | 1.8 millisecond (msec) | Standard Deviation 9 |
| Cohort 1 (Direct Rollover) | Change From Baseline in ECG Parameters - PR Interval Aggregate, QRS Duration Aggregate, QT Interval Aggregate and QTcF Interval Aggregate | CFB: QT Interval, Aggregate | -1.4 millisecond (msec) | Standard Deviation 22.72 |
| Cohort 1 (Direct Rollover) | Change From Baseline in ECG Parameters - PR Interval Aggregate, QRS Duration Aggregate, QT Interval Aggregate and QTcF Interval Aggregate | CFB: QTcF Interval, Aggregate | 0.8 millisecond (msec) | Standard Deviation 15.32 |
| Cohort 2 (Gap Rollover) | Change From Baseline in ECG Parameters - PR Interval Aggregate, QRS Duration Aggregate, QT Interval Aggregate and QTcF Interval Aggregate | CFB: QTcF Interval, Aggregate | -0.0 millisecond (msec) | Standard Deviation 14.81 |
| Cohort 2 (Gap Rollover) | Change From Baseline in ECG Parameters - PR Interval Aggregate, QRS Duration Aggregate, QT Interval Aggregate and QTcF Interval Aggregate | CFB: PR Interval, Aggregate | -0.2 millisecond (msec) | Standard Deviation 12.94 |
| Cohort 2 (Gap Rollover) | Change From Baseline in ECG Parameters - PR Interval Aggregate, QRS Duration Aggregate, QT Interval Aggregate and QTcF Interval Aggregate | CFB: QT Interval, Aggregate | -2.9 millisecond (msec) | Standard Deviation 20.94 |
| Cohort 2 (Gap Rollover) | Change From Baseline in ECG Parameters - PR Interval Aggregate, QRS Duration Aggregate, QT Interval Aggregate and QTcF Interval Aggregate | CFB: QRS Duration, Aggregate | -0.8 millisecond (msec) | Standard Deviation 9.11 |
Primary
Change From Baseline in Electrocardiograms (ECGs) Parameters: Mean Heart Rate
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for ECG parameter for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Electrocardiograms (ECGs) Parameters: Mean Heart Rate | 1.3 beats per minute (beats/min) | Standard Deviation 9.54 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Electrocardiograms (ECGs) Parameters: Mean Heart Rate | 1.6 beats per minute (beats/min) | Standard Deviation 8.8 |
Primary
Change From Baseline in Vital Signs: Blood Pressure
Vital signs parameter for blood pressure included systolic blood pressure (supine), systolic blood pressure (standing 1 minute), systolic blood pressure (standing 3 minutes), diastolic blood pressure (supine), diastolic blood pressure (standing 1 minute), and diastolic blood pressure (standing 3 minutes). Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last Value on Study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for vital sign parameters for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Vital Signs: Blood Pressure | Change From Baseline (CFB): Systolic Blood Pressure (Supine) | 0.2 mmHg | Standard Deviation 11.49 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Vital Signs: Blood Pressure | CFB: Systolic Blood Pressure (Standing 1 minute) | -1.8 mmHg | Standard Deviation 17.63 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Vital Signs: Blood Pressure | CFB: Systolic Blood Pressure (Standing 3 minute) | -2.0 mmHg | Standard Deviation 13.85 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Vital Signs: Blood Pressure | CFB: Diastolic Blood Pressure (Supine) | 1.2 mmHg | Standard Deviation 8.1 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Vital Signs: Blood Pressure | CFB: Diastolic Blood Pressure (Standing 1 minute) | 1.4 mmHg | Standard Deviation 11.41 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Vital Signs: Blood Pressure | CFB: Diastolic Blood Pressure (Standing 3 minute) | 0.5 mmHg | Standard Deviation 10.33 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Vital Signs: Blood Pressure | CFB: Diastolic Blood Pressure (Standing 1 minute) | -0.7 mmHg | Standard Deviation 10.27 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Vital Signs: Blood Pressure | Change From Baseline (CFB): Systolic Blood Pressure (Supine) | 0.4 mmHg | Standard Deviation 14.61 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Vital Signs: Blood Pressure | CFB: Diastolic Blood Pressure (Supine) | -1.1 mmHg | Standard Deviation 9.02 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Vital Signs: Blood Pressure | CFB: Systolic Blood Pressure (Standing 1 minute) | 1.0 mmHg | Standard Deviation 14.72 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Vital Signs: Blood Pressure | CFB: Diastolic Blood Pressure (Standing 3 minute) | -1.3 mmHg | Standard Deviation 11.02 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Vital Signs: Blood Pressure | CFB: Systolic Blood Pressure (Standing 3 minute) | -0.3 mmHg | Standard Deviation 13.94 |
Primary
Change From Baseline in Vital Signs: Heart Rate
Vital signs for heart rate included heart rate (supine), heart rate (standing 1 minute), and heart rate (standing 3 minute). Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline, Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for vital sign parameters for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Vital Signs: Heart Rate | CFB: Heart Rate Supine | 2.2 beats/min | Standard Deviation 9.66 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Vital Signs: Heart Rate | CFB: Heart Rate Standing 1 Minute | 1.8 beats/min | Standard Deviation 13.13 |
| Cohort 1 (Direct Rollover) | Change From Baseline in Vital Signs: Heart Rate | CFB: Heart Rate Standing 3 Minute | 1.7 beats/min | Standard Deviation 12.65 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Vital Signs: Heart Rate | CFB: Heart Rate Supine | 2.7 beats/min | Standard Deviation 9.91 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Vital Signs: Heart Rate | CFB: Heart Rate Standing 1 Minute | 2.2 beats/min | Standard Deviation 11.45 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Vital Signs: Heart Rate | CFB: Heart Rate Standing 3 Minute | 2.1 beats/min | Standard Deviation 14 |
Primary
Change From Baseline in Vital Signs: Respiratory Rate
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline; Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for vital sign parameters for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Vital Signs: Respiratory Rate | 0.0 breaths/min | Standard Deviation 2.64 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Vital Signs: Respiratory Rate | -0.1 breaths/min | Standard Deviation 2.76 |
Primary
Change From Baseline in Vital Signs: Temperature
Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.
Time frame: Baseline, Last value on study (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for vital sign parameters for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (Direct Rollover) | Change From Baseline in Vital Signs: Temperature | 0.9 degree Celsius | Standard Deviation 7.519 |
| Cohort 2 (Gap Rollover) | Change From Baseline in Vital Signs: Temperature | 0.058 degree Celsius | Standard Deviation 0.365 |
Primary
Number of Participants Who Withdrew From Study Due to TEAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as any AE with onset or after the start of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.
Time frame: Up to 24 months
Population: The Safety Set included all participants who were administered IP during the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 (Direct Rollover) | Number of Participants Who Withdrew From Study Due to TEAEs | 2 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants Who Withdrew From Study Due to TEAEs | 3 Participants |
Primary
Number of Participants With at Least One TEAE by Severity
A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Severity was assessed as: Mild: symptoms barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptoms. Moderate: symptoms of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptoms may be needed. Severe: symptoms cause severe discomfort; symptoms cause incapacitation or significant impact on participant's daily life; severity may cause cessation of treatment with IP; treatment for symptoms may be given and/or participant hospitalized. Participant with multiple instances of events is counted only once using maximum intensity.
Time frame: Up to 24 months
Population: The Safety Set included all participants who were administered IP during the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 (Direct Rollover) | Number of Participants With at Least One TEAE by Severity | Mild | 21 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With at Least One TEAE by Severity | Moderate | 22 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With at Least One TEAE by Severity | Severe | 3 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With at Least One TEAE by Severity | Mild | 24 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With at Least One TEAE by Severity | Moderate | 18 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With at Least One TEAE by Severity | Severe | 4 Participants |
Primary
Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.
Time frame: Up to 24 months
Population: The Safety Set included all participants who were administered IP during the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 (Direct Rollover) | Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) | 46 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) | 46 Participants |
Primary
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
Columbia Suicide Severity Rating Scale evaluates and assesses the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and post-baseline evaluation that focuses on suicidality since last study visit. C-SSRS includes yes or no' responses for assessment of SI and SB as well as numeric ratings for severity of ideation. If present \[from 1 (minor physical damage) to 5 (death), with 5 being most severe\]. If any of the available assessments in suicidal behavior is Yes, the category is considered as 'Suicidal behavior'. If any of these available assessments in suicidal ideation is Yes but all available assessments in suicidal behavior is NO, the category is considered as 'Suicidal Ideation'. Data is reported for only those timepoints where there was a change in assessment (response) from Baseline. Baseline is the worst of assessments done in any question in SI/SB prior to first dose of IP, excluding lifetime assessment.
Time frame: Day 30, Day 60, Day 90, Day 365, Day 395, Safety Follow-up (up to 24 months)
Population: The Safety Set included all participants who were administered IP during the study. Number analyzed is the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | Suicidal Ideation to Suicidal Ideation | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | No suicidal ideation/behavior to No suicidal ideation/behavior | 65 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | No suicidal ideation/behavior to Suicidal ideation | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | No suicidal ideation/behavior to Suicidal Behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | Suicidal Ideation to No suicidal ideation/behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | Suicidal Ideation to Suicidal Ideation | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | Suicidal Ideation to Suicidal Behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | Suicidal Behavior to No suicidal ideation/behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | Suicidal Behavior to Suicidal Ideation | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | Suicidal Behavior to Suicidal Behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | No suicidal ideation/behavior to No suicidal ideation/behavior | 59 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | No suicidal ideation/behavior to Suicidal ideation | 1 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | No suicidal ideation/behavior to Suicidal Behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | Suicidal Ideation to No suicidal ideation/behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | Suicidal Ideation to Suicidal Ideation | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | Suicidal Ideation to Suicidal Behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | Suicidal Behavior to No suicidal ideation/behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | Suicidal Behavior to Suicidal Ideation | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | Suicidal Behavior to Suicidal Behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | No suicidal ideation/behavior to No suicidal ideation/behavior | 51 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | No suicidal ideation/behavior to Suicidal ideation | 2 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | No suicidal ideation/behavior to Suicidal Behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | Suicidal Ideation to No suicidal ideation/behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | Suicidal Ideation to Suicidal Ideation | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | Suicidal Ideation to Suicidal Behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | Suicidal Behavior to No suicidal ideation/behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | Suicidal Behavior to Suicidal Ideation | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | Suicidal Behavior to Suicidal Behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | No suicidal ideation/behavior to No suicidal ideation/behavior | 20 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | No suicidal ideation/behavior to Suicidal ideation | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | No suicidal ideation/behavior to Suicidal Behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | Suicidal Ideation to No suicidal ideation/behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | Suicidal Ideation to Suicidal Ideation | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | Suicidal Ideation to Suicidal Behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | Suicidal Behavior to No suicidal ideation/behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | Suicidal Behavior to Suicidal Ideation | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | Suicidal Behavior to Suicidal Behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | No suicidal ideation/behavior to No suicidal ideation/behavior | 7 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | No suicidal ideation/behavior to Suicidal ideation | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | No suicidal ideation/behavior to Suicidal Behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | Suicidal Ideation to No suicidal ideation/behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | Suicidal Ideation to Suicidal Behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | Suicidal Behavior to No suicidal ideation/behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | Suicidal Behavior to Suicidal Ideation | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | Suicidal Behavior to Suicidal Behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | No suicidal ideation/behavior to No suicidal ideation/behavior | 50 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | No suicidal ideation/behavior to Suicidal ideation | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | No suicidal ideation/behavior to Suicidal Behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | Suicidal Ideation to No suicidal ideation/behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | Suicidal Ideation to Suicidal Ideation | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | Suicidal Ideation to Suicidal Behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | Suicidal Behavior to No suicidal ideation/behavior | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | Suicidal Behavior to Suicidal Ideation | 0 Participants |
| Cohort 1 (Direct Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | Suicidal Behavior to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | Suicidal Behavior to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | Suicidal Ideation to Suicidal Ideation | 1 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | No suicidal ideation/behavior to No suicidal ideation/behavior | 73 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | No suicidal ideation/behavior to No suicidal ideation/behavior | 31 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | No suicidal ideation/behavior to Suicidal ideation | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | No suicidal ideation/behavior to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | No suicidal ideation/behavior to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | No suicidal ideation/behavior to Suicidal ideation | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | Suicidal Ideation to No suicidal ideation/behavior | 1 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | Suicidal Ideation to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | Suicidal Ideation to Suicidal Ideation | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | No suicidal ideation/behavior to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | Suicidal Ideation to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | Suicidal Behavior to Suicidal Ideation | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | Suicidal Behavior to No suicidal ideation/behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | Suicidal Ideation to No suicidal ideation/behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | Suicidal Behavior to Suicidal Ideation | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | Suicidal Behavior to No suicidal ideation/behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 30 | Suicidal Behavior to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | Suicidal Ideation to Suicidal Ideation | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | No suicidal ideation/behavior to No suicidal ideation/behavior | 69 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | Suicidal Ideation to No suicidal ideation/behavior | 1 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | No suicidal ideation/behavior to Suicidal ideation | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | Suicidal Ideation to Suicidal Behavior | 1 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | No suicidal ideation/behavior to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | Suicidal Behavior to No suicidal ideation/behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | Suicidal Ideation to No suicidal ideation/behavior | 1 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | Suicidal Behavior to No suicidal ideation/behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | Suicidal Ideation to Suicidal Ideation | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | Suicidal Behavior to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | Suicidal Ideation to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | Suicidal Behavior to Suicidal Ideation | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | Suicidal Behavior to No suicidal ideation/behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | Suicidal Ideation to Suicidal Ideation | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | Suicidal Behavior to Suicidal Ideation | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 365 | Suicidal Behavior to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 60 | Suicidal Behavior to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | No suicidal ideation/behavior to No suicidal ideation/behavior | 58 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | No suicidal ideation/behavior to No suicidal ideation/behavior | 63 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | No suicidal ideation/behavior to No suicidal ideation/behavior | 7 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | No suicidal ideation/behavior to Suicidal ideation | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | Suicidal Behavior to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | No suicidal ideation/behavior to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | No suicidal ideation/behavior to Suicidal ideation | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | Suicidal Ideation to No suicidal ideation/behavior | 1 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | No suicidal ideation/behavior to Suicidal ideation | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | Suicidal Ideation to Suicidal Ideation | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | No suicidal ideation/behavior to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | Suicidal Ideation to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Safety Follow-up (up to 24 months) | Suicidal Ideation to Suicidal Behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | Suicidal Behavior to No suicidal ideation/behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | Suicidal Ideation to No suicidal ideation/behavior | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 90 | Suicidal Behavior to Suicidal Ideation | 0 Participants |
| Cohort 2 (Gap Rollover) | Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Day 395 | Suicidal Behavior to Suicidal Ideation | 0 Participants |