| 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. | The Safety Set included all participants who were administered IP during the study. | Posted | | Count of Participants | | Participants | | Up to 24 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The Safety Set included all participants who were administered IP during the study. | Posted | | Count of Participants | | Participants | | Up to 24 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Cohort 2 (Gap Rollover) |
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| 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. | The Safety Set included all participants who were administered IP during the study. | Posted | | Count of Participants | | Participants | | Up to 24 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | mmHg | | Baseline; Last Value on Study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | beats/min | | Baseline, Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | breaths/min | | Baseline; Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | degree Celsius | | Baseline, Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | cells*10^9/L | | Baseline; Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | percent | | Baseline, Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | grams per liter (g/L) | | Baseline, Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | picograms (pg) | | Baseline; Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | femtoliters (fL) | | Baseline, Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | liters per liter (L/L) | | Baseline, Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units per liter (U/L) | | Baseline, Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | millimole per liter (mmol/L) | | Baseline; Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | grams per liter (g/L) | | Baseline; Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | micromoles per liter (µmol/L) | | Baseline; Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | milli-international units per liter | | Baseline; Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | picomoles per liter (pmol/L) | | Baseline; Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | cells per high power field | | Baseline; Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | casts per low power field (/lpf) | | Baseline; Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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 milligrams (mg), orally once daily from Day 1 onwards. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | pH | | Baseline; Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | seconds | | Baseline; Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | prothrombin intl normalized ratio | | Baseline; Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | beats per minute (beats/min) | | Baseline; Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | millisecond (msec) | | Baseline; Last value on study (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | Day 30, Day 60, Day 90, Day 365, Day 395, Safety Follow-up (up to 24 months) | | | | ID | Title | Description |
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| OG000 | 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. |
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