Super-refractory Status Epilepticus
Conditions
Keywords
Status Epilepticus, Refractory status epilepticus, Super-refractory status epilepticus, SAGE-547, SAGE, Sage Therapeutics
Brief summary
The purpose of this study is to evaluate the safety and tolerability of SAGE-547 in participants in super-refractory status epilepticus (SRSE).
Detailed description
This is an open-label study consisting of a screening period (1 day), 4-day treatment period (96 hours) followed by a 1-day dose taper period (24 hours), a 2-day acute follow-up period, and a 3 week extended follow-up period. On Day 1 of treatment SRSE participants under seizure suppression or burst-suppression with a continuous intravenous (IV) anti-epileptic drug (AED) (third-line agent) were given a 1-hour IV loading infusion of SAGE-547 followed by a maintenance infusion. After 48 hours of SAGE-547 treatment, the continuous IV AED (third-line agent) was weaned while continuing SAGE-547 at the maintenance infusion for the remainder of the treatment period. After 96 hours (4 days) of therapy with SAGE-547, the dose was to be tapered and discontinued over 24 hours. The participants would have routine continuous electroencephalogram (EEG) monitoring during the screening period, and continuing until 48 hours after SAGE-547 treatment had completed. Participants would then have follow-up examinations weekly for the next 3 weeks (Days 8, 15, 22, and 29), during which safety and functional assessments would be obtained. Apart from treatment with SAGE-547, all participants would receive the standard of care for adults in SRSE along with ongoing treatment for all underlying medical conditions.
Interventions
DRUGSAGE-547
Solution for injection for IV infusion
Sponsors
Supernus Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants 2 years of age and older. * Participants with an EEG-confirmed SRSE diagnosis under concomitant therapy with a continuous IV AED (third-line agent) for ≥ 24 hours. For this study, SRSE is defined by the following criteria and in accordance with those used at major epilepsy treatment centers: * Failure to respond to the administration of at least one first-line agent (e.g., benzodiazepine or other emergent initial AED treatment), according to institution standard of care, and * Failure to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam or other urgent control AED) according to institution standard of care, and * Presence of one or more breakthrough seizures \> 6 hours after initiation of the continuous IV AED/third-line agent (e.g., pentobarbital, midazolam, propofol).
Exclusion criteria
* Participants with SRSE due to anoxic/hypoxic encephalopathy, children (participants aged less than 18 years) with an encephalopathy due to an underlying progressive neurological disorder. * Participants with clinically significant electrocardiogram abnormalities. * Participants with a significant medical or surgical condition that may compromise vital organ systems, or other conditions that would place the participants at increased risk such as dialysis or acute respiratory distress syndrome, severe cardiogenic or vasodilatory shock requiring 2 or more pressors, fulminant hepatic failure, etc. * Participants who are receiving a continuous IV AED (third-line agent) for seizure suppression or burst-suppression that would require greater than 24 hours to wean.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | ECG measures included heart rate, PR interval, QT interval, QRS duration and QTc interval. CFB in heart rate is reported in this outcome measure. |
| Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | ECG measures included heart rate, PR interval, QT interval, QRS duration and QTc interval. CFB in PR interval, QT interval, QRS duration and QTc interval is reported in this outcome measure. |
| Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in erythrocytes mean corpuscular hemoglobin concentration levels is reported in this outcome measure. |
| Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in erythrocytes mean corpuscular hemoglobin levels is reported in this outcome measure. |
| Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in erythrocytes mean corpuscular volume levels is reported in this outcome measure. |
| Change From Baseline in Hematology Parameter: Erythrocyte Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in erythrocyte levels is reported in this outcome measure. |
| Change From Baseline in Hematology Parameter: Hematocrit Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in hematocrit levels is reported in this outcome measure. |
| Change From Baseline in Hematology Parameter: Hemoglobin Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in hemoglobin levels is reported in this outcome measure. |
| Number of Participants With Prior Anti-epileptic Drugs (AEDs) and Pressors Usage | Up to Day 29 | Prior AEDs and Pressors are those medications that ended before the initiation of SAGE-547 infusion. |
| Change From Baseline in Hematology Parameter: Leukocyte Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in leukocyte levels is reported in this outcome measure. |
| Change From Baseline in Hematology Parameter: Lymphocyte Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in lymphocyte levels is reported in this outcome measure. |
| Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in lymphocytes to leukocytes ratio is reported in terms of percentage of cells in this outcome measure. |
| Change From Baseline in Hematology Parameter: Monocyte Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in monocyte levels is reported in this outcome measure. |
| Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in monocytes to leukocytes ratio is reported in terms of percentage of cells in this outcome measure. |
| Change From Baseline in Hematology Parameter: Neutrophil Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in neutrophil levels is reported in this outcome measure. |
| Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in neutrophils to leukocytes ratio is reported in terms of percentage of cells in this outcome measure. |
| Change From Baseline in Hematology Parameter: Platelet Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in platelet levels is reported in this outcome measure. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to Day 29 | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAEs are defined as those that begin on or after initiation of the infusion of SAGE-547. |
| Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | The National Institutes of Health Stroke Scale (NIH-SS) was used to examine the physical and neurological state of the participants. The NIH-SS is a 15-item assessment with measures of level of consciousness, visual gaze and vision loss, facial palsy, motor ability, ataxia, sensory ability, aphasia, dysarthria, and inattention. The total NIHSS score range is from 0 (normal) to 42 (severe impairment), with higher values indicating greater level of neurological impairment. |
| Change From Baseline in Vital Sign Parameter: Body Weight | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Vital signs included weight, heart rate, blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP)), respiratory rate, temperature, oxygen saturation. CFB in body weight is reported in this outcome measure. |
| Change From Baseline in Vital Sign Parameter: Heart Rate | Baseline (Screening) to infusion at 0-24 hours: Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours; Extended Follow-up at Days 8, 15, 22 and 29 | Vital signs included weight, heart rate, blood pressure (SBP and DBP), respiratory rate, temperature, oxygen saturation. CFB in heart rate is reported in this outcome measure. |
| Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | Baseline (Screening) to infusion at 0-24 hours:Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72: 72 hour;73-96: 96 hour;97-120:120 hour;Acute follow-up at 121-144,145-168 hours;Extended follow-up at Days 8,15,22 and 29 | Vital signs included weight, heart rate, blood pressure (SBP and DBP), respiratory rate, temperature, oxygen saturation. CFB in SBP and DBP is reported in this outcome measure. |
| Change From Baseline in Vital Sign Parameter: Respiratory Rate | Baseline (Screening) to infusion at 0-24 hours:Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours;Extended follow-up at Days 8, 15, 22 and 29 | Vital signs included weight, heart rate, blood pressure (SBP and DBP), respiratory rate, temperature, oxygen saturation. CFB in respiratory rate is reported in this outcome measure. |
| Change From Baseline in Vital Sign Parameter: Body Temperature | Baseline (Screening) to infusion at 0-24 hours: Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Vital signs included weight, heart rate, blood pressure (SBP and DBP), respiratory rate, temperature, oxygen saturation. CFB in body temperature is reported in this outcome measure. |
| Change From Baseline in Vital Sign Parameter: Oxygen Saturation | Baseline (Screening) to infusion at 0-24 hours: Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Vital signs included weight, heart rate, blood pressure (SBP and DBP), respiratory rate, temperature, oxygen saturation. Oxygen saturation is a measure of how much hemoglobin is currently bound to oxygen compared to how much hemoglobin remains unbound. CFB in oxygen saturation is reported in this outcome measure. |
| Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in alanine aminotransferase levels is reported in this outcome measure. |
| Change From Baseline in Serum Chemistry Parameter: Albumin Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in albumin levels is reported in this outcome measure. |
| Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in aspartate aminotransferase levels is reported in this outcome measure. |
| Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in bicarbonate levels is reported in this outcome measure. |
| Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in bilirubin levels is reported in this outcome measure. |
| Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in blood urea nitrogen levels is reported in this outcome measure. |
| Change From Baseline in Serum Chemistry Parameter: Calcium Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in calcium levels is reported in this outcome measure. |
| Change From Baseline in Serum Chemistry Parameter: Chloride Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in chloride levels is reported in this outcome measure. |
| Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in creatine kinase levels is reported in this outcome measure. |
| Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in creatinine levels is reported in this outcome measure. |
| Change From Baseline in Serum Chemistry Parameter: Glucose Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in glucose levels is reported in this outcome measure. |
| Change From Baseline in Serum Chemistry Parameter: Lipase Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in lipase levels is reported in this outcome measure. |
| Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in magnesium levels is reported in this outcome measure. |
| Change From Baseline in Serum Chemistry Parameter: Potassium Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in potassium levels is reported in this outcome measure. |
| Change From Baseline in Serum Chemistry Parameter: Protein Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in protein levels is reported in this outcome measure. |
| Change From Baseline in Serum Chemistry Parameter: Sodium Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in sodium levels is reported in this outcome measure. |
| Change From Baseline in Hematology Parameter: Basophil Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in basophil levels is reported in this outcome measure. |
| Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in basophils to leukocytes ratio is reported in terms of percentage of cells in this outcome measure. |
| Change From Baseline in Hematology Parameter: Eosinophil Levels | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in eosinophils levels is reported in this outcome measure. |
| Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in eosinophils to leukocytes ratio is reported in terms of percentage of cells in this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Relapse - Re-Initiation of Third-Line Agent | Up to Day 29 | Relapse of participants is defined as successfully weaning from a continuous IV third-line agent but subsequent requirement of re-initiation of a third-line agent following conclusion of SAGE-547 treatment. |
| Number of Participants With Treatment Response (Treatment Responders) | Up to 96 hours | A responder was defined as a participant for whom it was not required to re-initiate continuous IV third-line therapy for refractory seizure control during the administration of SAGE-547 at the maintenance dose (prior to SAGE-547 taper infusion). |
| Maximum Plasma Concentration (Cmax) of SAGE-547 | Pre-dose (0 hours), 1, 2, 4, 8, 24, 48, 72, 96, 104, 112, 120 and 144 hours post-dose | — |
| Time to Attain Maximum Observed Plasma Concentration (Tmax) of SAGE-547 | Pre-dose (0 hours), 1, 2, 4, 8, 24, 48, 72, 96, 104, 112, 120 and 144 hours post-dose | — |
| Areas Under the Plasma SAGE-547 Concentration Time Curves From the Start of the Infusion Until the Time to the Last Sample (AUClast) | Pre-dose (0 hours), 1, 2, 4, 8, 24, 48, 72, 96, 104, 112, 120 and 144 hours post-dose | — |
| Area Under the Plasma SAGE-547 Concentration-Time Curve in a 24 Hour Period (AUC24) | Pre-dose (0 hours), 1, 2, 4, 8 and 24 hours post-dose | — |
| Area Under the Plasma SAGE-547 Concentration-Time Curve (AUC1-96) | Pre-dose (0 hours), 1, 2, 4, 8, 24, 48, 72 and 96 hours post-dose | — |
| Average Plasma Concentration (Cav) of SAGE-547 | Pre-dose (0 hours), 1, 2, 4, 8, 24, 48, 72 and 96 hours post-dose | — |
| Plasma Clearance (CL) of SAGE-547 | Pre-dose (0 hours), 1, 2, 4, 8, 24, 48, 72, 96, 104, 112, 120 and 144 hours post-dose | Clearance is defined as the volume of plasma from which a substance is completely removed per unit time. |
| Change From Baseline in Modified Rankin Scale (mRS-9Q) Scores | Baseline (Screening) to Infusion at 49-72 hour, 73-96 hour; Extended follow-up at Day 8, 15, 22 and 29 | The mRS-9Q is a commonly used scale to determine disability and functional dependence due to neurological insult such as a stroke. It is a shortened version consisting of 9 questions. The score was categorized on the scale of 0 to 5 (0 = No symptoms, 1 = No significant disability, able to carry out all usual activities, despite some symptoms, 2 = Slight disability, able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability, requires some help, but able to walk unassisted, 4 = Moderately severe disability, unable to attend to own bodily needs without assistance or unable to walk unassisted, and 5 = Severe disability, requires constant nursing care and attention, bedridden). Higher scores indicated worsening of symptoms. |
| Change From Baseline in Clinical Global Impression: Severity Scale (CGI-S) | Baseline (Screening), Extended follow-up at Days 8, 15, 22, and 29 | The CGI-Severity (CGI-S) scale employs a 7-point Likert scale to assess the severity of participant's current illness state. Clinician responded to a question Considering your total clinical experience with this particular population, how mentally ill is your patient at this time? on the following scores: 1 = Normal, not at all ill, 2 = Borderline ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, and 7 = Among the most extremely ill, where higher score = more affected. |
| Clinical Global Impression: Improvement Scale (CGI-I) Scores | Infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | The CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved). CGI-I item employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse; where higher scores indicated worst outcomes. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions. |
| Change From Baseline in Glasgow Coma Scale (GCS) Scores | Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | The Glasgow Coma Scale is divided into three components which are scored separately: ocular response (assessment 1-4 points), motor response (assessment 1-6 points), verbal response (evaluation of 1-5 points). Scores for each component are added together to get the total score that will range between a minimum of 3 points (which corresponds to a participant who does not open his/her eyes and no motor response to stimulation or verbal response) and a maximum value of 15 points (corresponding to a participant with open eyes, obeying orders and maintaining a consistent language). It has been considered that the GCS score between 15 and 13 points corresponds to a slight alteration of consciousness, a score of 12-9 points with moderate impairment and 8 points or less with a serious deterioration in level of consciousness. |
| Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | Baseline (Screening) to Infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29 | The RASS was an assessment of agitation and sedation in hospitalized participants, using a 10 point scale (ranged from -5 to +4), where, -5 = Unarousable, -4 = Deep sedation, -3 = Moderate sedation, -2 = Light sedation, -1 = Drowsy, 0 = Alert and calm, +1 = Restless, +2 = Agitated, +3 = Very agitated and +4 = Combative. Lower scores signify higher levels of sedation and higher scores signify heightened agitation. Participant in a calm and alert state would score a 0. |
| Number of Participants Who Survived | Up to Day 29 | Survival time was defined as duration of survival from screening up to Day 29. |
| Duration of Response | Up to Day 29 | Duration of response was defined as the time from the stop date/time of SAGE-547 maintenance to re-initiation of a third-line agent. If no re-initiation of a third-line agent was required, duration of response was not estimable and censored at Day 29 or death date, whichever occurred first. Kaplan-Meier method was used for the analysis. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 12 sites in United States from 21 March 2014 to 03 May 2015.
Pre-assignment details
A total of 25 participants were enrolled into the study to receive either SAGE-547 standard dose or SAGE-547 high dose,19 participants of whom completed the study.
Participants by arm
| Arm | Count |
|---|---|
| SAGE-547 Standard Dose Participants received SAGE-547 IV loading infusion of 286.6 μg/kg/hr for 1 hour on Day 1 followed by maintenance infusion of 86 μg/kg/hr for next 95 hours from Days 1 to 4 (i.e. up to Hour 96) followed by taper infusions of 64.5 μg/kg/hr, 43.0 μg/kg/hr, 21.5 μg/kg/hr at a duration of 8 hours each, on Day 5. | 19 |
| SAGE-547 High Dose Participants received SAGE-547 IV loading infusion of 286.6 μg/kg/hr for 1 hour on Day 1 followed by maintenance infusion A of SAGE-547 86 μg/kg/hr for 23 hours on Day 1 followed by maintenance infusion B of SAGE-547 156 μg/kg/hr for 72 hours from Days 2 to 4 followed by taper infusions of 125 μg/kg/hr, 94 μg/kg/hr, 62 μg/kg/hr, 31 μg/kg/hr at a duration of 6 hours each, on Day 5. | 6 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Participant Died | 2 | 1 |
| Overall Study | Withdrew due to Adverse Event | 3 | 0 |
Baseline characteristics
| Characteristic | SAGE-547 High Dose | Total | SAGE-547 Standard Dose |
|---|---|---|---|
| Age, Continuous | 42.3 years STANDARD_DEVIATION 22.11 | 47.6 years STANDARD_DEVIATION 19.52 | 49.3 years STANDARD_DEVIATION 18.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 23 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 19 Participants | 15 Participants |
| Sex: Female, Male Female | 1 Participants | 9 Participants | 8 Participants |
| Sex: Female, Male Male | 5 Participants | 16 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 19 | 1 / 6 |
| other Total, other adverse events | 15 / 19 | 6 / 6 |
| serious Total, serious adverse events | 14 / 19 | 2 / 6 |
Outcome results
Primary
Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score
The National Institutes of Health Stroke Scale (NIH-SS) was used to examine the physical and neurological state of the participants. The NIH-SS is a 15-item assessment with measures of level of consciousness, visual gaze and vision loss, facial palsy, motor ability, ataxia, sensory ability, aphasia, dysarthria, and inattention. The total NIHSS score range is from 0 (normal) to 42 (severe impairment), with higher values indicating greater level of neurological impairment.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Infusion: 0-24 hours | 0.7 score on a scale | Standard Deviation 2.3 |
| SAGE-547 Standard Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Infusion: 25-48 hours | 0.8 score on a scale | Standard Deviation 3.47 |
| SAGE-547 Standard Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Infusion: 49-72 hours | -2.2 score on a scale | Standard Deviation 6.7 |
| SAGE-547 Standard Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Infusion: 73-96 hours | -2.9 score on a scale | Standard Deviation 8.08 |
| SAGE-547 Standard Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Infusion: 97-120 hours | -5.6 score on a scale | Standard Deviation 7.44 |
| SAGE-547 Standard Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Acute Follow-up: 121-144 hours | -7.0 score on a scale | Standard Deviation 8.75 |
| SAGE-547 Standard Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | Baseline | 34.2 score on a scale | Standard Deviation 4.69 |
| SAGE-547 Standard Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Acute Follow-up: 145-168 hours | -7.5 score on a scale | Standard Deviation 9.78 |
| SAGE-547 Standard Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Extended Follow-up: Day 8 | -9.0 score on a scale | Standard Deviation 9.54 |
| SAGE-547 Standard Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Extended Follow-up: Day 15 | -16.8 score on a scale | Standard Deviation 12.1 |
| SAGE-547 Standard Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Extended Follow-up: Day 22 | -15.1 score on a scale | Standard Deviation 14.35 |
| SAGE-547 Standard Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Extended Follow-up: Day 29 | -16.7 score on a scale | Standard Deviation 15.34 |
| SAGE-547 High Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | Baseline | 33.0 score on a scale | Standard Deviation 4.86 |
| SAGE-547 High Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Infusion: 0-24 hours | 0.3 score on a scale | Standard Deviation 1.51 |
| SAGE-547 High Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Infusion: 73-96 hours | -5.5 score on a scale | Standard Deviation 6.63 |
| SAGE-547 High Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Infusion: 25-48 hours | -1.5 score on a scale | Standard Deviation 6.19 |
| SAGE-547 High Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Acute Follow-up: 121-144 hours | -10.8 score on a scale | Standard Deviation 10.13 |
| SAGE-547 High Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Infusion: 49-72 hours | -2.3 score on a scale | Standard Deviation 4.63 |
| SAGE-547 High Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Extended Follow-up: Day 22 | -17.2 score on a scale | Standard Deviation 14.55 |
| SAGE-547 High Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Acute Follow-up: 145-168 hours | -12.0 score on a scale | Standard Deviation 8.76 |
| SAGE-547 High Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Infusion: 97-120 hours | -6.7 score on a scale | Standard Deviation 7.2 |
| SAGE-547 High Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Extended Follow-up: Day 15 | -16.6 score on a scale | Standard Deviation 13.3 |
| SAGE-547 High Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Extended Follow-up: Day 29 | -20.6 score on a scale | Standard Deviation 13.09 |
| SAGE-547 High Dose | Change From Baseline (CFB) in National Institutes of Health Stroke Scale (NIH-SS) Total Score | CFB at Extended Follow-up: Day 8 | -15.4 score on a scale | Standard Deviation 11.82 |
Primary
Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate
ECG measures included heart rate, PR interval, QT interval, QRS duration and QTc interval. CFB in heart rate is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | Baseline | 84.3 beats/min | Standard Deviation 13.31 |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Infusion: 97-120 hours | 15.9 beats/min | Standard Deviation 15.37 |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Acute Follow-up: 121-144 hours | 13.2 beats/min | Standard Deviation 14.25 |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Acute Follow-up: 145-168 hours | 16.6 beats/min | Standard Deviation 16.91 |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Infusion: 0-24 hours | -1.4 beats/min | Standard Deviation 16.87 |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Infusion: 25-48 hours | -0.9 beats/min | Standard Deviation 16.58 |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Infusion: 49-72 hours | 10.9 beats/min | Standard Deviation 21.74 |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Infusion: 73-96 hours | 9.7 beats/min | Standard Deviation 15.49 |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Extended Follow-up: Day 8 | 19.2 beats/min | Standard Deviation 16 |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Extended Follow-up: Day 15 | 15.0 beats/min | Standard Deviation 23.09 |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Extended Follow-up: Day 22 | 13.8 beats/min | Standard Deviation 20.71 |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Extended Follow-up: Day 29 | 8.6 beats/min | Standard Deviation 13.6 |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Extended Follow-up: Day 22 | 4.3 beats/min | Standard Deviation 26.73 |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Infusion: 73-96 hours | 7.7 beats/min | Standard Deviation 18.48 |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Infusion: 49-72 hours | -6.5 beats/min | Standard Deviation 22.28 |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Infusion: 97-120 hours | 7.0 beats/min | Standard Deviation 19.62 |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Extended Follow-up: Day 15 | 5.5 beats/min | Standard Deviation 13.13 |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Acute Follow-up: 121-144 hours | 11.7 beats/min | Standard Deviation 22.76 |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Acute Follow-up: 145-168 hours | 17.0 beats/min | Standard Deviation 26.47 |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | Baseline | 84.3 beats/min | Standard Deviation 19.64 |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Extended Follow-up: Day 29 | 7.0 beats/min | Standard Deviation 31.19 |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Infusion: 0-24 hours | -6.8 beats/min | Standard Deviation 8.54 |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Extended Follow-up: Day 8 | 5.5 beats/min | Standard Deviation 22.87 |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate | CFB at Infusion: 25-48 hours | -1.2 beats/min | Standard Deviation 6.85 |
Primary
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval
ECG measures included heart rate, PR interval, QT interval, QRS duration and QTc interval. CFB in PR interval, QT interval, QRS duration and QTc interval is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Infusion: 97-120 hours | -12.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Infusion: 49-72 hours | -13.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Extended Follow-up: Day 22 | -4.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Infusion: 25-48 hours | 19.5 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Infusion: 73-96 hours | -4.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Extended Follow-up: Day 8 | -36.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Extended Follow-up: Day 15 | -32.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Infusion: 73-96 hours | 8.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: Baseline | 151.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Infusion: 0-24 hours | 2.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Infusion: 25-48 hours | 3.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Infusion: 73-96 hours | -2.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Acute Follow-up: 121-144 hours | -8.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Acute Follow-up: 145-168 hours | -11.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Extended Follow-up: Day 8 | -10.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Extended Follow-up: Day 15 | 0.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Extended Follow-up: Day 22 | 2.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Extended Follow-up: Day 29 | 2.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: Baseline | 85.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Infusion: 0-24 hours | 1.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Infusion: 25-48 hours | 0.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Infusion: 49-72 hours | -3.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Infusion: 73-96 hours | 0.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Infusion: 97-120 hours | -4.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Acute Follow-up: 121-144 hours | -2.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Acute Follow-up: 145-168 hours | -6.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Extended Follow-up: Day 8 | -2.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Extended Follow-up: Day 15 | -5.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Extended Follow-up: Day 29 | 2.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: Baseline | 363.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Infusion: 0-24 hours | 19.5 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Infusion: 49-72 hours | 1.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Infusion: 97-120 hours | -34.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Acute Follow-up: 121-144 hours | -28.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Acute Follow-up: 145-168 hours | -32.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Extended Follow-up: Day 22 | -28.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Extended Follow-up: Day 29 | -28.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: Baseline | 435.5 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Infusion: 0-24 hours | 7.5 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Infusion: 25-48 hours | 11.5 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Infusion: 49-72 hours | 3.5 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Infusion: 97-120 hours | -2.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Acute Follow-up: 121-144 hours | -12.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Acute Follow-up: 145-168 hours | -4.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Extended Follow-up: Day 8 | -15.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Extended Follow-up: Day 15 | 2.0 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Extended Follow-up: Day 22 | -8.5 milliseconds (msec) |
| SAGE-547 Standard Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Extended Follow-up: Day 29 | -2.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Extended Follow-up: Day 22 | -22.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Infusion: 97-120 hours | 0.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Infusion: 49-72 hours | -2.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Extended Follow-up: Day 22 | -33.5 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Infusion: 0-24 hours | 24.5 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Acute Follow-up: 121-144 hours | 0.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Infusion: 25-48 hours | 3.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Extended Follow-up: Day 29 | -63.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Infusion: 73-96 hours | 0.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Infusion: 97-120 hours | -36.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Acute Follow-up: 121-144 hours | -32.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Acute Follow-up: 145-168 hours | -34.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Acute Follow-up: 145-168 hours | -3.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Extended Follow-up: Day 8 | -35.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Acute Follow-up: 121-144 hours | -9.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Extended Follow-up: Day 8 | -3.5 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Infusion: 73-96 hours | -13.5 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: Baseline | 438.5 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: Baseline | 151.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Extended Follow-up: Day 15 | 2.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Infusion: 0-24 hours | -2.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Extended Follow-up: Day 22 | -1.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Extended Follow-up: Day 15 | -6.5 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Infusion: 73-96 hours | -4.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Infusion: 25-48 hours | 3.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Infusion: 97-120 hours | 2.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Extended Follow-up: Day 29 | 5.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Acute Follow-up: 121-144 hours | 3.5 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Infusion: 0-24 hours | 7.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Acute Follow-up: 145-168 hours | -2.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: Baseline | 372.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Extended Follow-up: Day 8 | 0.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Acute Follow-up: 145-168 hours | -17.5 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Extended Follow-up: Day 15 | 4.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Infusion: 25-48 hours | -12.5 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Extended Follow-up: Day 22 | -6.5 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Infusion: 49-72 hours | -14.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | PR interval: CFB at Extended Follow-up: Day 29 | -8.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Extended Follow-up: Day 29 | -19.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: Baseline | 78.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Infusion: 49-72 hours | -14.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Infusion: 0-24 hours | 1.5 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Extended Follow-up: Day 8 | -54.5 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Infusion: 25-48 hours | -1.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QT Interval: CFB at Extended Follow-up: Day 15 | -8.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Infusion: 49-72 hours | 2.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QTc Interval: CFB at Infusion: 97-120 hours | -17.0 milliseconds (msec) |
| SAGE-547 High Dose | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval and QTc Interval | QRS Interval: CFB at Infusion: 73-96 hours | 0.0 milliseconds (msec) |
Primary
Change From Baseline in Hematology Parameter: Basophil Levels
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in basophil levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophil Levels | Baseline | 0.031 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0509 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Acute Follow-up: 121-144 hours | 0.033 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0369 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Infusion: 0-24 hours | 0.013 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0308 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Infusion: 25-48 hours | -0.008 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0319 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Infusion: 49-72 hours | 0.009 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.023 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Infusion: 73-96 hours | 0.013 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0433 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Infusion: 97-120 hours | 0.004 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0662 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Acute Follow-up: 145-168 hours | 0.006 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0669 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Extended Follow-up: Day 8 | 0.014 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0745 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Extended Follow-up: Day 15 | 0.031 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0366 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Extended Follow-up: Day 22 | 0.020 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0216 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Extended Follow-up: Day 29 | 0.017 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0288 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Extended Follow-up: Day 22 | 0.000 10^3 cells per microliter(10^3 cells/uL) | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Infusion: 97-120 hours | -0.010 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0141 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Acute Follow-up: 121-144 hours | 0.087 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.1848 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophil Levels | Baseline | 0.037 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0321 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Extended Follow-up: Day 15 | 0.040 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0849 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Infusion: 0-24 hours | 0.003 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0058 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Acute Follow-up: 145-168 hours | -0.017 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0153 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Infusion: 25-48 hours | -0.023 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0321 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Extended Follow-up: Day 29 | -0.005 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0071 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Infusion: 49-72 hours | -0.007 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0208 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Extended Follow-up: Day 8 | -0.017 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0153 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophil Levels | CFB at Infusion: 73-96 hours | -0.013 10^3 cells per microliter(10^3 cells/uL) | Standard Deviation 0.0115 |
Primary
Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in basophils to leukocytes ratio is reported in terms of percentage of cells in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety Population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 29 | 0.00 percentage of cells | Standard Deviation 0 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline | 0.50 percentage of cells | Standard Deviation 0.707 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 0-24 hours | 0.00 percentage of cells | — |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 25-48 hours | 0.00 percentage of cells | Standard Deviation 0 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 49-72 hours | 0.00 percentage of cells | Standard Deviation 0 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 73-96 hours | 0.50 percentage of cells | Standard Deviation 0.707 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 97-120 hours | 0.00 percentage of cells | Standard Deviation 0 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 145-168 hours | 0.00 percentage of cells | Standard Deviation 0 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 15 | -0.50 percentage of cells | Standard Deviation 0.707 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 22 | 0.50 percentage of cells | Standard Deviation 0.707 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 121-144 hours | 0.00 percentage of cells | Standard Deviation 0 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 8 | 0.00 percentage of cells | Standard Deviation 0 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 73-96 hours | 1.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 0-24 hours | 0.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 121-144 hours | 0.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 49-72 hours | 0.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 145-168 hours | 0.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline | 0.00 percentage of cells | Standard Deviation 0 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 22 | 0.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 97-120 hours | 1.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Basophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 25-48 hours | 1.00 percentage of cells | — |
Primary
Change From Baseline in Hematology Parameter: Eosinophil Levels
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in eosinophils levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Acute Follow-up: 121-144 hours | -0.2211 10^3 cells/uL | Standard Deviation 0.44552 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | Baseline | 0.3364 10^3 cells/uL | Standard Deviation 0.42711 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Infusion: 0-24 hours | 0.0580 10^3 cells/uL | Standard Deviation 0.17813 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Infusion: 25-48 hours | 0.0660 10^3 cells/uL | Standard Deviation 0.23538 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Infusion: 49-72 hours | -0.0911 10^3 cells/uL | Standard Deviation 0.35069 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Infusion: 73-96 hours | -0.0811 10^3 cells/uL | Standard Deviation 0.36381 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Infusion: 97-120 hours | -0.1878 10^3 cells/uL | Standard Deviation 0.45535 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Acute Follow-up: 145-168 hours | -0.1643 10^3 cells/uL | Standard Deviation 0.42177 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Extended Follow-up: Day 8 | -0.1056 10^3 cells/uL | Standard Deviation 0.40423 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Extended Follow-up: Day 15 | -0.0078 10^3 cells/uL | Standard Deviation 0.33774 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Extended Follow-up: Day 22 | -0.0543 10^3 cells/uL | Standard Deviation 0.42496 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Extended Follow-up: Day 29 | -0.0229 10^3 cells/uL | Standard Deviation 0.39982 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Extended Follow-up: Day 22 | -0.3000 10^3 cells/uL | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Acute Follow-up: 121-144 hours | -0.5567 10^3 cells/uL | Standard Deviation 0.16258 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Infusion: 97-120 hours | -0.4200 10^3 cells/uL | Standard Deviation 0.4194 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | Baseline | 0.7433 10^3 cells/uL | Standard Deviation 0.20108 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Extended Follow-up: Day 15 | 0.0100 10^3 cells/uL | Standard Deviation 0.2687 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Infusion: 0-24 hours | -0.2700 10^3 cells/uL | Standard Deviation 0.24269 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Acute Follow-up: 145-168 hours | -0.5567 10^3 cells/uL | Standard Deviation 0.17898 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Infusion: 25-48 hours | -0.2333 10^3 cells/uL | Standard Deviation 0.45654 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Extended Follow-up: Day 29 | -0.5650 10^3 cells/uL | Standard Deviation 0.33234 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Infusion: 49-72 hours | -0.6467 10^3 cells/uL | Standard Deviation 0.14189 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Extended Follow-up: Day 8 | -0.5400 10^3 cells/uL | Standard Deviation 0.17776 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophil Levels | CFB at Infusion: 73-96 hours | -0.5867 10^3 cells/uL | Standard Deviation 0.07095 |
Primary
Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in eosinophils to leukocytes ratio is reported in terms of percentage of cells in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 25-48 hours | 0.50 percentage of cells | Standard Deviation 0.707 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 121-144 hours | -1.50 percentage of cells | Standard Deviation 0.707 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 15 | 2.00 percentage of cells | Standard Deviation 1.414 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 22 | 1.00 percentage of cells | Standard Deviation 2.828 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 29 | 1.50 percentage of cells | Standard Deviation 0.707 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline | 3.00 percentage of cells | Standard Deviation 0 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 0-24 hours | 5.00 percentage of cells | — |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 49-72 hours | -0.50 percentage of cells | Standard Deviation 2.121 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 73-96 hours | 0.50 percentage of cells | Standard Deviation 0.707 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 97-120 hours | -1.00 percentage of cells | Standard Deviation 0 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 145-168 hours | -2.00 percentage of cells | Standard Deviation 1.414 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 8 | 0.50 percentage of cells | Standard Deviation 2.121 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 121-144 hours | -3.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 0-24 hours | -2.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 25-48 hours | 0.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 145-168 hours | -3.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 22 | -1.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 49-72 hours | 0.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 97-120 hours | -2.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline | 3.00 percentage of cells | Standard Deviation 0 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 73-96 hours | -2.00 percentage of cells | — |
Primary
Change From Baseline in Hematology Parameter: Erythrocyte Levels
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in erythrocyte levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Extended Follow-up: Day 29 | 0.607 10^6 cells per microliter | Standard Deviation 0.4754 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Infusion: 0-24 hours | -0.078 10^6 cells per microliter | Standard Deviation 0.3236 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Infusion: 25-48 hours | -0.106 10^6 cells per microliter | Standard Deviation 0.4059 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Infusion: 73-96 hours | -0.175 10^6 cells per microliter | Standard Deviation 0.4261 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Infusion: 97-120 hours | -0.152 10^6 cells per microliter | Standard Deviation 0.3718 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Acute Follow-up: 121-144 hours | -0.259 10^6 cells per microliter | Standard Deviation 0.4001 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Acute Follow-up: 145-168 hours | -0.199 10^6 cells per microliter | Standard Deviation 0.3819 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Extended Follow-up: Day 8 | -0.196 10^6 cells per microliter | Standard Deviation 0.4508 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Extended Follow-up: Day 15 | 0.115 10^6 cells per microliter | Standard Deviation 0.7317 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Infusion: 49-72 hours | -0.162 10^6 cells per microliter | Standard Deviation 0.4112 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Extended Follow-up: Day 22 | 0.285 10^6 cells per microliter | Standard Deviation 0.9424 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | Baseline | 3.261 10^6 cells per microliter | Standard Deviation 0.7152 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Acute Follow-up: 121-144 hours | -0.256 10^6 cells per microliter | Standard Deviation 0.5786 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Extended Follow-up: Day 8 | -0.463 10^6 cells per microliter | Standard Deviation 0.4367 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Infusion: 0-24 hours | -0.022 10^6 cells per microliter | Standard Deviation 0.1816 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Extended Follow-up: Day 15 | -0.133 10^6 cells per microliter | Standard Deviation 0.5821 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Infusion: 25-48 hours | -0.184 10^6 cells per microliter | Standard Deviation 0.2799 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Extended Follow-up: Day 29 | 0.248 10^6 cells per microliter | Standard Deviation 0.2924 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Infusion: 73-96 hours | -0.132 10^6 cells per microliter | Standard Deviation 0.3041 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | Baseline | 3.406 10^6 cells per microliter | Standard Deviation 0.5297 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Infusion: 97-120 hours | -0.158 10^6 cells per microliter | Standard Deviation 0.5079 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Extended Follow-up: Day 22 | 0.105 10^6 cells per microliter | Standard Deviation 0.3493 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Infusion: 49-72 hours | -0.218 10^6 cells per microliter | Standard Deviation 0.2072 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocyte Levels | CFB at Acute Follow-up: 145-168 hours | -0.200 10^6 cells per microliter | Standard Deviation 0.7139 |
Primary
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in erythrocytes mean corpuscular hemoglobin concentration levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | Baseline | 328.4 g/L | Standard Deviation 12.54 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Infusion: 49-72 hours | -3.4 g/L | Standard Deviation 7.88 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Infusion: 73-96 hours | -3.6 g/L | Standard Deviation 10 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Infusion: 97-120 hours | -4.1 g/L | Standard Deviation 9.33 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Acute Follow-up: 145-168 hours | -7.6 g/L | Standard Deviation 10.44 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Extended Follow-up: Day 8 | -7.7 g/L | Standard Deviation 11.07 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Extended Follow-up: Day 15 | -5.5 g/L | Standard Deviation 14.28 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Extended Follow-up: Day 22 | -6.9 g/L | Standard Deviation 18.4 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Extended Follow-up: Day 29 | -4.6 g/L | Standard Deviation 16.1 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Infusion: 0-24 hours | -1.2 g/L | Standard Deviation 12.52 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Infusion: 25-48 hours | -4.7 g/L | Standard Deviation 10.43 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Acute Follow-up: 121-144 hours | -6.1 g/L | Standard Deviation 10.65 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Infusion: 25-48 hours | 10.4 g/L | Standard Deviation 12.18 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | Baseline | 322.6 g/L | Standard Deviation 12.54 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Extended Follow-up: Day 22 | 11.5 g/L | Standard Deviation 32.25 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Infusion: 49-72 hours | 5.4 g/L | Standard Deviation 6.19 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Infusion: 73-96 hours | 3.6 g/L | Standard Deviation 6.35 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Extended Follow-up: Day 29 | -9.3 g/L | Standard Deviation 7.5 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Infusion: 97-120 hours | 1.8 g/L | Standard Deviation 3.03 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Acute Follow-up: 145-168 hours | 0.4 g/L | Standard Deviation 5.5 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Infusion: 0-24 hours | 1.0 g/L | Standard Deviation 5.66 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Extended Follow-up: Day 8 | -2.3 g/L | Standard Deviation 9.54 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Acute Follow-up: 121-144 hours | -0.4 g/L | Standard Deviation 2.61 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration Levels | CFB at Extended Follow-up: Day 15 | -0.5 g/L | Standard Deviation 13.77 |
Primary
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in erythrocytes mean corpuscular hemoglobin levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | Baseline | 1.8611 femtomoles (fmol) | Standard Deviation 0.17564 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Infusion: 0-24 hours | 0.0110 femtomoles (fmol) | Standard Deviation 0.0418 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Infusion: 49-72 hours | -0.0097 femtomoles (fmol) | Standard Deviation 0.03719 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Infusion: 97-120 hours | -0.0164 femtomoles (fmol) | Standard Deviation 0.04034 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Acute Follow-up: 121-144 hours | -0.0194 femtomoles (fmol) | Standard Deviation 0.03684 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Acute Follow-up: 145-168 hours | -0.0112 femtomoles (fmol) | Standard Deviation 0.04763 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Extended Follow-up: Day 8 | -0.0058 femtomoles (fmol) | Standard Deviation 0.04491 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Extended Follow-up: Day 15 | -0.0087 femtomoles (fmol) | Standard Deviation 0.09182 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Extended Follow-up: Day 22 | -0.0306 femtomoles (fmol) | Standard Deviation 0.14055 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Extended Follow-up: Day 29 | -0.0412 femtomoles (fmol) | Standard Deviation 0.11506 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Infusion: 25-48 hours | -0.0134 femtomoles (fmol) | Standard Deviation 0.03603 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Infusion: 73-96 hours | -0.0107 femtomoles (fmol) | Standard Deviation 0.04378 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Extended Follow-up: Day 29 | 0.0341 femtomoles (fmol) | Standard Deviation 0.07457 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | Baseline | 1.8335 femtomoles (fmol) | Standard Deviation 0.09869 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Extended Follow-up: Day 8 | 0.0155 femtomoles (fmol) | Standard Deviation 0.04927 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Infusion: 0-24 hours | -0.0149 femtomoles (fmol) | Standard Deviation 0.02996 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Infusion: 25-48 hours | 0.0261 femtomoles (fmol) | Standard Deviation 0.0958 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Infusion: 73-96 hours | -0.0099 femtomoles (fmol) | Standard Deviation 0.02177 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Extended Follow-up: Day 15 | 0.0310 femtomoles (fmol) | Standard Deviation 0.07868 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Infusion: 97-120 hours | 0.0112 femtomoles (fmol) | Standard Deviation 0.03147 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Infusion: 49-72 hours | 0.0074 femtomoles (fmol) | Standard Deviation 0.03911 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Acute Follow-up: 121-144 hours | 0.0099 femtomoles (fmol) | Standard Deviation 0.03582 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Extended Follow-up: Day 22 | 0.0729 femtomoles (fmol) | Standard Deviation 0.14436 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Levels | CFB at Acute Follow-up: 145-168 hours | 0.0161 femtomoles (fmol) | Standard Deviation 0.03662 |
Primary
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in erythrocytes mean corpuscular volume levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Extended Follow-up: Day 22 | 0.29 femtoliters (fL) | Standard Deviation 5.675 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Infusion: 25-48 hours | 0.65 femtoliters (fL) | Standard Deviation 2.202 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | Baseline | 91.36 femtoliters (fL) | Standard Deviation 7.651 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Infusion: 49-72 hours | 0.46 femtoliters (fL) | Standard Deviation 2.168 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Infusion: 97-120 hours | 0.47 femtoliters (fL) | Standard Deviation 2.56 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Acute Follow-up: 121-144 hours | 0.70 femtoliters (fL) | Standard Deviation 2.362 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Infusion: 0-24 hours | 0.68 femtoliters (fL) | Standard Deviation 1.773 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Extended Follow-up: Day 8 | 1.30 femtoliters (fL) | Standard Deviation 3.507 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Acute Follow-up: 145-168 hours | 1.60 femtoliters (fL) | Standard Deviation 3.27 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Extended Follow-up: Day 15 | 1.20 femtoliters (fL) | Standard Deviation 4.337 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Extended Follow-up: Day 29 | -0.96 femtoliters (fL) | Standard Deviation 5.315 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Infusion: 73-96 hours | 0.38 femtoliters (fL) | Standard Deviation 2.202 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Extended Follow-up: Day 29 | 4.27 femtoliters (fL) | Standard Deviation 1.775 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Infusion: 0-24 hours | -0.42 femtoliters (fL) | Standard Deviation 0.95 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Infusion: 25-48 hours | -0.82 femtoliters (fL) | Standard Deviation 1.487 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Infusion: 73-96 hours | -1.04 femtoliters (fL) | Standard Deviation 1.146 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Acute Follow-up: 121-144 hours | 0.76 femtoliters (fL) | Standard Deviation 1.977 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Extended Follow-up: Day 15 | 2.25 femtoliters (fL) | Standard Deviation 4.124 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Extended Follow-up: Day 22 | 0.75 femtoliters (fL) | Standard Deviation 3.747 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Infusion: 49-72 hours | -1.12 femtoliters (fL) | Standard Deviation 1.314 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Infusion: 97-120 hours | 0.10 femtoliters (fL) | Standard Deviation 1.954 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Acute Follow-up: 145-168 hours | 0.36 femtoliters (fL) | Standard Deviation 1.23 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | CFB at Extended Follow-up: Day 8 | 1.08 femtoliters (fL) | Standard Deviation 1.09 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Levels | Baseline | 91.50 femtoliters (fL) | Standard Deviation 4.785 |
Primary
Change From Baseline in Hematology Parameter: Hematocrit Levels
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in hematocrit levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Infusion: 25-48 hours | -0.0058 proportion of 1.0 (in liters) | Standard Deviation 0.0343 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Acute Follow-up: 121-144 hours | -0.0209 proportion of 1.0 (in liters) | Standard Deviation 0.03369 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Infusion: 0-24 hours | -0.0042 proportion of 1.0 (in liters) | Standard Deviation 0.02561 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Acute Follow-up: 145-168 hours | -0.0135 proportion of 1.0 (in liters) | Standard Deviation 0.03487 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Infusion: 49-72 hours | -0.0123 proportion of 1.0 (in liters) | Standard Deviation 0.03371 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Extended Follow-up: Day 8 | -0.0142 proportion of 1.0 (in liters) | Standard Deviation 0.03823 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Infusion: 97-120 hours | -0.0108 proportion of 1.0 (in liters) | Standard Deviation 0.03167 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Extended Follow-up: Day 15 | 0.0143 proportion of 1.0 (in liters) | Standard Deviation 0.05903 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Extended Follow-up: Day 22 | 0.0188 proportion of 1.0 (in liters) | Standard Deviation 0.06186 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Infusion: 73-96 hours | -0.0131 proportion of 1.0 (in liters) | Standard Deviation 0.03564 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Extended Follow-up: Day 29 | 0.0516 proportion of 1.0 (in liters) | Standard Deviation 0.04241 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | Baseline | 0.2955 proportion of 1.0 (in liters) | Standard Deviation 0.05601 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Infusion: 97-120 hours | -0.0160 proportion of 1.0 (in liters) | Standard Deviation 0.04813 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Extended Follow-up: Day 15 | -0.0058 proportion of 1.0 (in liters) | Standard Deviation 0.05967 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Extended Follow-up: Day 29 | 0.0370 proportion of 1.0 (in liters) | Standard Deviation 0.0267 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | Baseline | 0.3110 proportion of 1.0 (in liters) | Standard Deviation 0.05443 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Infusion: 0-24 hours | -0.0028 proportion of 1.0 (in liters) | Standard Deviation 0.01591 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Infusion: 25-48 hours | -0.0192 proportion of 1.0 (in liters) | Standard Deviation 0.02013 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Infusion: 49-72 hours | -0.0238 proportion of 1.0 (in liters) | Standard Deviation 0.01487 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Infusion: 73-96 hours | -0.0142 proportion of 1.0 (in liters) | Standard Deviation 0.0286 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Acute Follow-up: 121-144 hours | -0.0238 proportion of 1.0 (in liters) | Standard Deviation 0.05369 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Acute Follow-up: 145-168 hours | -0.0182 proportion of 1.0 (in liters) | Standard Deviation 0.06883 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Extended Follow-up: Day 8 | -0.0375 proportion of 1.0 (in liters) | Standard Deviation 0.04888 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hematocrit Levels | CFB at Extended Follow-up: Day 22 | 0.0128 proportion of 1.0 (in liters) | Standard Deviation 0.03157 |
Primary
Change From Baseline in Hematology Parameter: Hemoglobin Levels
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in hemoglobin levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Infusion: 25-48 hours | -3.8 g/L | Standard Deviation 11.81 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Acute Follow-up: 145-168 hours | -6.8 g/L | Standard Deviation 12.78 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Infusion: 73-96 hours | -5.8 g/L | Standard Deviation 12.89 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Extended Follow-up: Day 8 | -6.7 g/L | Standard Deviation 14.41 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Infusion: 0-24 hours | -2.1 g/L | Standard Deviation 9.96 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Extended Follow-up: Day 15 | 2.7 g/L | Standard Deviation 22.1 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Extended Follow-up: Day 22 | 3.8 g/L | Standard Deviation 21.36 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Infusion: 97-120 hours | -5.4 g/L | Standard Deviation 11.54 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Extended Follow-up: Day 29 | 15.3 g/L | Standard Deviation 14.5 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Infusion: 49-72 hours | -5.2 g/L | Standard Deviation 12.37 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Acute Follow-up: 121-144 hours | -8.8 g/L | Standard Deviation 12.69 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | Baseline | 97.3 g/L | Standard Deviation 19.93 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Extended Follow-up: Day 15 | -2.0 g/L | Standard Deviation 18.65 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | Baseline | 100.4 g/L | Standard Deviation 18.28 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Infusion: 0-24 hours | -0.8 g/L | Standard Deviation 5.26 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Infusion: 25-48 hours | -3.4 g/L | Standard Deviation 4.77 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Infusion: 49-72 hours | -5.8 g/L | Standard Deviation 4.21 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Infusion: 73-96 hours | -4.0 g/L | Standard Deviation 7.97 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Infusion: 97-120 hours | -4.4 g/L | Standard Deviation 14.99 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Acute Follow-up: 121-144 hours | -7.2 g/L | Standard Deviation 16.75 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Acute Follow-up: 145-168 hours | -5.6 g/L | Standard Deviation 20.67 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Extended Follow-up: Day 8 | -12.3 g/L | Standard Deviation 12.97 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Extended Follow-up: Day 22 | 8.3 g/L | Standard Deviation 12.58 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Hemoglobin Levels | CFB at Extended Follow-up: Day 29 | 9.5 g/L | Standard Deviation 9.26 |
Primary
Change From Baseline in Hematology Parameter: Leukocyte Levels
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in leukocyte levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Extended Follow-up: Day 29 | -0.790 10^3 cells/uL | Standard Deviation 6.1582 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Acute Follow-up: 145-168 hours | -0.123 10^3 cells/uL | Standard Deviation 10.4153 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Extended Follow-up: Day 8 | -1.145 10^3 cells/uL | Standard Deviation 7.3294 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Infusion: 0-24 hours | 1.438 10^3 cells/uL | Standard Deviation 2.5891 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Infusion: 25-48 hours | 0.186 10^3 cells/uL | Standard Deviation 4.5526 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Infusion: 49-72 hours | -0.227 10^3 cells/uL | Standard Deviation 6.1765 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Infusion: 73-96 hours | -0.577 10^3 cells/uL | Standard Deviation 7.1508 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Infusion: 97-120 hours | 0.591 10^3 cells/uL | Standard Deviation 10.3636 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Acute Follow-up: 121-144 hours | -1.002 10^3 cells/uL | Standard Deviation 8.9938 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Extended Follow-up: Day 15 | -1.692 10^3 cells/uL | Standard Deviation 5.0282 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Extended Follow-up: Day 22 | -1.132 10^3 cells/uL | Standard Deviation 4.3853 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | Baseline | 11.383 10^3 cells/uL | Standard Deviation 4.3503 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Extended Follow-up: Day 8 | -2.188 10^3 cells/uL | Standard Deviation 6.7041 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Infusion: 49-72 hours | -3.090 10^3 cells/uL | Standard Deviation 5.5029 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Infusion: 73-96 hours | -3.798 10^3 cells/uL | Standard Deviation 5.5846 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Acute Follow-up: 145-168 hours | -1.652 10^3 cells/uL | Standard Deviation 7.3674 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Extended Follow-up: Day 22 | -7.248 10^3 cells/uL | Standard Deviation 7.3886 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Extended Follow-up: Day 29 | -5.840 10^3 cells/uL | Standard Deviation 4.6825 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | Baseline | 16.538 10^3 cells/uL | Standard Deviation 8.5348 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Infusion: 97-120 hours | -3.964 10^3 cells/uL | Standard Deviation 5.3646 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Infusion: 0-24 hours | -0.902 10^3 cells/uL | Standard Deviation 2.4833 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Extended Follow-up: Day 15 | -6.118 10^3 cells/uL | Standard Deviation 7.0178 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Infusion: 25-48 hours | -3.306 10^3 cells/uL | Standard Deviation 4.7047 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Leukocyte Levels | CFB at Acute Follow-up: 121-144 hours | -1.306 10^3 cells/uL | Standard Deviation 7.594 |
Primary
Change From Baseline in Hematology Parameter: Lymphocyte Levels
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in lymphocyte levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Extended Follow-up: Day 29 | 0.427 10^3 cells/uL | Standard Deviation 0.8182 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Infusion: 25-48 hours | 0.189 10^3 cells/uL | Standard Deviation 1.3559 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Extended Follow-up: Day 22 | 0.343 10^3 cells/uL | Standard Deviation 0.6667 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Infusion: 0-24 hours | 0.213 10^3 cells/uL | Standard Deviation 0.8923 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Infusion: 49-72 hours | 0.302 10^3 cells/uL | Standard Deviation 1.0584 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Infusion: 73-96 hours | 0.200 10^3 cells/uL | Standard Deviation 1.158 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Infusion: 97-120 hours | 0.428 10^3 cells/uL | Standard Deviation 1.1946 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Acute Follow-up: 121-144 hours | 0.152 10^3 cells/uL | Standard Deviation 0.9193 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Acute Follow-up: 145-168 hours | 0.360 10^3 cells/uL | Standard Deviation 0.8965 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Extended Follow-up: Day 8 | 0.482 10^3 cells/uL | Standard Deviation 0.8724 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Extended Follow-up: Day 15 | 0.392 10^3 cells/uL | Standard Deviation 0.8363 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | Baseline | 1.791 10^3 cells/uL | Standard Deviation 0.8043 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Acute Follow-up: 121-144 hours | -0.987 10^3 cells/uL | Standard Deviation 1.004 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Infusion: 73-96 hours | -0.780 10^3 cells/uL | Standard Deviation 0.4358 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Extended Follow-up: Day 8 | -0.700 10^3 cells/uL | Standard Deviation 0.672 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Extended Follow-up: Day 15 | -1.140 10^3 cells/uL | Standard Deviation 0.9334 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Extended Follow-up: Day 22 | -2.200 10^3 cells/uL | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Extended Follow-up: Day 29 | -0.845 10^3 cells/uL | Standard Deviation 1.0677 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | Baseline | 2.323 10^3 cells/uL | Standard Deviation 0.5193 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Infusion: 97-120 hours | -0.777 10^3 cells/uL | Standard Deviation 0.6516 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Infusion: 0-24 hours | -0.470 10^3 cells/uL | Standard Deviation 0.2427 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Infusion: 25-48 hours | -1.147 10^3 cells/uL | Standard Deviation 0.9771 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Acute Follow-up: 145-168 hours | -1.013 10^3 cells/uL | Standard Deviation 0.8799 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocyte Levels | CFB at Infusion: 49-72 hours | -0.640 10^3 cells/uL | Standard Deviation 1.1037 |
Primary
Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in lymphocytes to leukocytes ratio is reported in terms of percentage of cells in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 29 | 0.50 percentage of cells | Standard Deviation 2.121 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 73-96 hours | -5.50 percentage of cells | Standard Deviation 4.95 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | Baseline | 10.67 percentage of cells | Standard Deviation 7.024 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 0-24 hours | -1.00 percentage of cells | Standard Deviation 0 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 25-48 hours | -2.50 percentage of cells | Standard Deviation 2.121 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 49-72 hours | 0.67 percentage of cells | Standard Deviation 5.033 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 97-120 hours | -4.50 percentage of cells | Standard Deviation 6.364 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 121-144 hours | -6.00 percentage of cells | Standard Deviation 4.243 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 145-168 hours | -6.00 percentage of cells | Standard Deviation 2.828 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 8 | -6.00 percentage of cells | Standard Deviation 1.414 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 15 | -3.50 percentage of cells | Standard Deviation 3.536 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 22 | 7.00 percentage of cells | Standard Deviation 4.243 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | Baseline | 6.50 percentage of cells | Standard Deviation 7.778 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 0-24 hours | 4.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 121-144 hours | 1.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 25-48 hours | 8.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 22 | 11.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 49-72 hours | 10.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 73-96 hours | 6.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 145-168 hours | 1.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 97-120 hours | 8.00 percentage of cells | — |
Primary
Change From Baseline in Hematology Parameter: Monocyte Levels
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in monocyte levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | Baseline | 0.6182 10^3 cells/uL | Standard Deviation 0.26966 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Infusion: 0-24 hours | 0.2720 10^3 cells/uL | Standard Deviation 0.39137 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Infusion: 25-48 hours | 0.2830 10^3 cells/uL | Standard Deviation 0.54878 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Infusion: 49-72 hours | 0.1267 10^3 cells/uL | Standard Deviation 0.52906 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Infusion: 73-96 hours | 0.2978 10^3 cells/uL | Standard Deviation 0.44409 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Infusion: 97-120 hours | 0.2322 10^3 cells/uL | Standard Deviation 0.42364 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Acute Follow-up: 121-144 hours | 0.2856 10^3 cells/uL | Standard Deviation 0.4771 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Acute Follow-up: 145-168 hours | 0.2800 10^3 cells/uL | Standard Deviation 0.39418 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Extended Follow-up: Day 8 | 0.1900 10^3 cells/uL | Standard Deviation 0.2485 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Extended Follow-up: Day 15 | 0.1767 10^3 cells/uL | Standard Deviation 0.41602 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Extended Follow-up: Day 22 | 0.3029 10^3 cells/uL | Standard Deviation 0.63746 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Extended Follow-up: Day 29 | 0.0414 10^3 cells/uL | Standard Deviation 0.21396 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Extended Follow-up: Day 22 | 1.7000 10^3 cells/uL | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | Baseline | 1.2567 10^3 cells/uL | Standard Deviation 0.83584 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Acute Follow-up: 121-144 hours | -0.1400 10^3 cells/uL | Standard Deviation 0.34176 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Infusion: 0-24 hours | 0.3470 10^3 cells/uL | Standard Deviation 0.83703 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Extended Follow-up: Day 15 | -0.1100 10^3 cells/uL | Standard Deviation 1.99404 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Infusion: 25-48 hours | -0.1200 10^3 cells/uL | Standard Deviation 1.05399 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Acute Follow-up: 145-168 hours | -0.4533 10^3 cells/uL | Standard Deviation 0.36295 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Infusion: 49-72 hours | -0.0667 10^3 cells/uL | Standard Deviation 0.0611 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Extended Follow-up: Day 29 | 0.4850 10^3 cells/uL | Standard Deviation 0.44548 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Infusion: 73-96 hours | 0.4533 10^3 cells/uL | Standard Deviation 0.39068 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Extended Follow-up: Day 8 | -0.2400 10^3 cells/uL | Standard Deviation 0.72194 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocyte Levels | CFB at Infusion: 97-120 hours | 0.1300 10^3 cells/uL | Standard Deviation 0.96016 |
Primary
Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in monocytes to leukocytes ratio is reported in terms of percentage of cells in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 15 | -4.50 percentage of cells | Standard Deviation 6.364 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | Baseline | 7.67 percentage of cells | Standard Deviation 5.508 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 25-48 hours | -5.50 percentage of cells | Standard Deviation 7.778 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 49-72 hours | -2.33 percentage of cells | Standard Deviation 0.577 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 73-96 hours | -4.50 percentage of cells | Standard Deviation 4.95 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 97-120 hours | -6.50 percentage of cells | Standard Deviation 9.192 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 121-144 hours | -6.50 percentage of cells | Standard Deviation 9.192 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 145-168 hours | -7.00 percentage of cells | Standard Deviation 9.899 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 8 | -3.00 percentage of cells | Standard Deviation 8.485 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 22 | -2.50 percentage of cells | Standard Deviation 4.95 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 29 | -5.50 percentage of cells | Standard Deviation 9.192 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 0-24 hours | 2.00 percentage of cells | Standard Deviation 0 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | Baseline | 5.00 percentage of cells | Standard Deviation 4.243 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 22 | 0.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 0-24 hours | 1.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 97-120 hours | 8.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 25-48 hours | 13.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 145-168 hours | -2.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 49-72 hours | 15.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 121-144 hours | -1.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 73-96 hours | 8.00 percentage of cells | — |
Primary
Change From Baseline in Hematology Parameter: Neutrophil Levels
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in neutrophil levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Acute Follow-up: 145-168 hours | -1.440 10^3 cells/uL | Standard Deviation 4.1338 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Infusion: 73-96 hours | -1.727 10^3 cells/uL | Standard Deviation 3.6351 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | Baseline | 7.957 10^3 cells/uL | Standard Deviation 4.1505 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Infusion: 97-120 hours | -0.743 10^3 cells/uL | Standard Deviation 3.397 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Acute Follow-up: 121-144 hours | -1.848 10^3 cells/uL | Standard Deviation 4.2871 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Infusion: 0-24 hours | 0.152 10^3 cells/uL | Standard Deviation 2.4078 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Extended Follow-up: Day 8 | -1.731 10^3 cells/uL | Standard Deviation 4.436 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Extended Follow-up: Day 15 | -2.372 10^3 cells/uL | Standard Deviation 4.3518 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Extended Follow-up: Day 22 | -0.877 10^3 cells/uL | Standard Deviation 3.231 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Infusion: 25-48 hours | -0.552 10^3 cells/uL | Standard Deviation 3.1815 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Extended Follow-up: Day 29 | -1.590 10^3 cells/uL | Standard Deviation 2.6196 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Infusion: 49-72 hours | -1.406 10^3 cells/uL | Standard Deviation 3.4517 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Extended Follow-up: Day 29 | -6.323 10^3 cells/uL | Standard Deviation 3.88 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Extended Follow-up: Day 8 | -1.953 10^3 cells/uL | Standard Deviation 7.7993 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Infusion: 97-120 hours | -2.653 10^3 cells/uL | Standard Deviation 5.7315 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | Baseline | 13.863 10^3 cells/uL | Standard Deviation 8.8017 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Infusion: 0-24 hours | -0.043 10^3 cells/uL | Standard Deviation 1.7435 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Infusion: 49-72 hours | -0.167 10^3 cells/uL | Standard Deviation 7.0002 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Infusion: 73-96 hours | -1.620 10^3 cells/uL | Standard Deviation 6.092 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Acute Follow-up: 121-144 hours | -4.247 10^3 cells/uL | Standard Deviation 6.7336 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Acute Follow-up: 145-168 hours | -3.517 10^3 cells/uL | Standard Deviation 7.8465 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Extended Follow-up: Day 15 | -9.825 10^3 cells/uL | Standard Deviation 6.965 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Extended Follow-up: Day 22 | -10.645 10^3 cells/uL | Standard Deviation 7.9832 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophil Levels | CFB at Infusion: 25-48 hours | -0.783 10^3 cells/uL | Standard Deviation 2.9957 |
Primary
Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in neutrophils to leukocytes ratio is reported in terms of percentage of cells in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 0-24 hours | -3.50 percentage of cells | Standard Deviation 9.192 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 97-120 hours | 13.50 percentage of cells | Standard Deviation 17.678 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline | 75.67 percentage of cells | Standard Deviation 11.24 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 25-48 hours | 5.00 percentage of cells | Standard Deviation 5.657 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 49-72 hours | 5.67 percentage of cells | Standard Deviation 10.504 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 73-96 hours | 11.00 percentage of cells | Standard Deviation 11.314 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 121-144 hours | 15.00 percentage of cells | Standard Deviation 14.142 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 145-168 hours | 11.00 percentage of cells | Standard Deviation 8.485 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 8 | 11.00 percentage of cells | Standard Deviation 11.314 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 15 | 7.50 percentage of cells | Standard Deviation 9.192 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 22 | -4.00 percentage of cells | Standard Deviation 7.071 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 29 | 6.50 percentage of cells | Standard Deviation 14.849 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline | 71.00 percentage of cells | Standard Deviation 8.485 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 0-24 hours | 19.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 145-168 hours | 25.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 25-48 hours | 6.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Acute Follow-up: 121-144 hours | 31.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 49-72 hours | 3.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Extended Follow-up: Day 22 | -10.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 73-96 hours | 2.00 percentage of cells | — |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | CFB at Infusion: 97-120 hours | 9.00 percentage of cells | — |
Primary
Change From Baseline in Hematology Parameter: Platelet Levels
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes mean corpuscular hemoglobin concentration, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets. CFB in platelet levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Platelet Levels | Baseline | 260.76 10^3 cells/uL | Standard Deviation 95.417 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Infusion: 0-24 hours | 2.93 10^3 cells/uL | Standard Deviation 68.821 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Infusion: 25-48 hours | 17.38 10^3 cells/uL | Standard Deviation 92.854 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Infusion: 49-72 hours | 21.59 10^3 cells/uL | Standard Deviation 109.995 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Infusion: 73-96 hours | 31.92 10^3 cells/uL | Standard Deviation 112.963 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Infusion: 97-120 hours | 57.49 10^3 cells/uL | Standard Deviation 125.277 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Acute Follow-up: 121-144 hours | 63.04 10^3 cells/uL | Standard Deviation 138.415 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Acute Follow-up: 145-168 hours | 81.98 10^3 cells/uL | Standard Deviation 141.65 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Extended Follow-up: Day 8 | 58.33 10^3 cells/uL | Standard Deviation 120.436 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Extended Follow-up: Day 15 | 153.89 10^3 cells/uL | Standard Deviation 166.919 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Extended Follow-up: Day 22 | 86.35 10^3 cells/uL | Standard Deviation 204.827 |
| SAGE-547 Standard Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Extended Follow-up: Day 29 | 25.76 10^3 cells/uL | Standard Deviation 118.996 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Extended Follow-up: Day 22 | 49.75 10^3 cells/uL | Standard Deviation 75.292 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Platelet Levels | Baseline | 284.20 10^3 cells/uL | Standard Deviation 80.707 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Acute Follow-up: 121-144 hours | 61.80 10^3 cells/uL | Standard Deviation 106.767 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Infusion: 0-24 hours | 21.40 10^3 cells/uL | Standard Deviation 40.265 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Extended Follow-up: Day 15 | 87.25 10^3 cells/uL | Standard Deviation 177.265 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Infusion: 25-48 hours | 34.40 10^3 cells/uL | Standard Deviation 69.263 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Acute Follow-up: 145-168 hours | 50.80 10^3 cells/uL | Standard Deviation 130.555 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Infusion: 49-72 hours | 58.00 10^3 cells/uL | Standard Deviation 95.533 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Extended Follow-up: Day 29 | 56.75 10^3 cells/uL | Standard Deviation 112.512 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Infusion: 73-96 hours | 77.80 10^3 cells/uL | Standard Deviation 89.461 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Extended Follow-up: Day 8 | 48.75 10^3 cells/uL | Standard Deviation 136.231 |
| SAGE-547 High Dose | Change From Baseline in Hematology Parameter: Platelet Levels | CFB at Infusion: 97-120 hours | 64.80 10^3 cells/uL | Standard Deviation 101.043 |
Primary
Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels
Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in alanine aminotransferase levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | Baseline | 48.7 international units per liter (IU/L) | Standard Deviation 82.92 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Infusion: 0-24 hours | 8.2 international units per liter (IU/L) | Standard Deviation 23.96 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Infusion: 25-48 hours | 11.0 international units per liter (IU/L) | Standard Deviation 39.62 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Infusion: 49-72 hours | 5.6 international units per liter (IU/L) | Standard Deviation 42.77 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Infusion: 73-96 hours | 1.9 international units per liter (IU/L) | Standard Deviation 50.97 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Infusion: 97-120 hours | 4.3 international units per liter (IU/L) | Standard Deviation 64.93 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Acute Follow-up: 121-144 hours | 4.6 international units per liter (IU/L) | Standard Deviation 75.63 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Acute Follow-up: 145-168 hours | 5.6 international units per liter (IU/L) | Standard Deviation 72.25 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Extended Follow-up: Day 8 | 4.9 international units per liter (IU/L) | Standard Deviation 69.89 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Extended Follow-up: Day 15 | -4.5 international units per liter (IU/L) | Standard Deviation 85.06 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Extended Follow-up: Day 22 | -3.6 international units per liter (IU/L) | Standard Deviation 46.91 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Extended Follow-up: Day 29 | 61.2 international units per liter (IU/L) | Standard Deviation 309.38 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Extended Follow-up: Day 22 | 44.0 international units per liter (IU/L) | Standard Deviation 65.01 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | Baseline | 40.0 international units per liter (IU/L) | Standard Deviation 32.47 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Acute Follow-up: 121-144 hours | 109.5 international units per liter (IU/L) | Standard Deviation 222.8 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Infusion: 0-24 hours | 17.0 international units per liter (IU/L) | Standard Deviation 42.85 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Extended Follow-up: Day 15 | 32.2 international units per liter (IU/L) | Standard Deviation 47.21 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Infusion: 25-48 hours | 39.3 international units per liter (IU/L) | Standard Deviation 69.34 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Acute Follow-up: 145-168 hours | 48.5 international units per liter (IU/L) | Standard Deviation 107.03 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Infusion: 49-72 hours | 36.5 international units per liter (IU/L) | Standard Deviation 48.02 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Extended Follow-up: Day 29 | 374.0 international units per liter (IU/L) | Standard Deviation 404.96 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Infusion: 73-96 hours | 84.0 international units per liter (IU/L) | Standard Deviation 124.28 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Extended Follow-up: Day 8 | 0.4 international units per liter (IU/L) | Standard Deviation 29.8 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase Levels | CFB at Infusion: 97-120 hours | 233.3 international units per liter (IU/L) | Standard Deviation 475.33 |
Primary
Change From Baseline in Serum Chemistry Parameter: Albumin Levels
Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in albumin levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | Baseline | 26.7 grams per liter (g/L) | Standard Deviation 4.87 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Infusion: 0-24 hours | -0.3 grams per liter (g/L) | Standard Deviation 1.75 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Infusion: 25-48 hours | -0.5 grams per liter (g/L) | Standard Deviation 1.84 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Infusion: 49-72 hours | -0.2 grams per liter (g/L) | Standard Deviation 2.32 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Infusion: 73-96 hours | 0.1 grams per liter (g/L) | Standard Deviation 2.26 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Infusion: 97-120 hours | -0.1 grams per liter (g/L) | Standard Deviation 2.45 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Acute Follow-up: 121-144 hours | 0.3 grams per liter (g/L) | Standard Deviation 2.82 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Acute Follow-up: 145-168 hours | 0.6 grams per liter (g/L) | Standard Deviation 3.61 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Extended Follow-up: Day 8 | 1.2 grams per liter (g/L) | Standard Deviation 4.34 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Extended Follow-up: Day 15 | 2.8 grams per liter (g/L) | Standard Deviation 6.45 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Extended Follow-up: Day 22 | 5.7 grams per liter (g/L) | Standard Deviation 7.46 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Extended Follow-up: Day 29 | 4.8 grams per liter (g/L) | Standard Deviation 7.91 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Extended Follow-up: Day 22 | 9.5 grams per liter (g/L) | Standard Deviation 1.73 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | Baseline | 21.3 grams per liter (g/L) | Standard Deviation 3.67 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Acute Follow-up: 121-144 hours | 5.3 grams per liter (g/L) | Standard Deviation 8.71 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Infusion: 0-24 hours | -1.3 grams per liter (g/L) | Standard Deviation 3.33 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Extended Follow-up: Day 15 | 10.2 grams per liter (g/L) | Standard Deviation 6.22 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Infusion: 25-48 hours | -0.7 grams per liter (g/L) | Standard Deviation 7.17 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Acute Follow-up: 145-168 hours | 7.5 grams per liter (g/L) | Standard Deviation 8.96 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Infusion: 49-72 hours | 0.7 grams per liter (g/L) | Standard Deviation 5.28 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Extended Follow-up: Day 29 | 12.3 grams per liter (g/L) | Standard Deviation 4.04 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Infusion: 73-96 hours | 3.8 grams per liter (g/L) | Standard Deviation 8.54 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Extended Follow-up: Day 8 | 9.2 grams per liter (g/L) | Standard Deviation 9.44 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Albumin Levels | CFB at Infusion: 97-120 hours | 5.0 grams per liter (g/L) | Standard Deviation 6.6 |
Primary
Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels
Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in aspartate aminotransferase levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Acute Follow-up: 121-144 hours | 11.8 IU/L | Standard Deviation 35.16 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Infusion: 0-24 hours | 0.9 IU/L | Standard Deviation 43.24 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Acute Follow-up: 145-168 hours | 12.6 IU/L | Standard Deviation 29.27 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Infusion: 73-96 hours | 2.4 IU/L | Standard Deviation 39.23 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Extended Follow-up: Day 8 | 10.8 IU/L | Standard Deviation 34.72 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Infusion: 25-48 hours | 7.5 IU/L | Standard Deviation 43.28 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Extended Follow-up: Day 15 | 2.9 IU/L | Standard Deviation 33.33 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | Baseline | 43.8 IU/L | Standard Deviation 50.41 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Extended Follow-up: Day 22 | 15.8 IU/L | Standard Deviation 68.73 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Infusion: 97-120 hours | 8.7 IU/L | Standard Deviation 39.62 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Extended Follow-up: Day 29 | 24.9 IU/L | Standard Deviation 121.92 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Infusion: 49-72 hours | -0.8 IU/L | Standard Deviation 40.4 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Extended Follow-up: Day 29 | 1888.0 IU/L | Standard Deviation 3115.96 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Infusion: 49-72 hours | 24.5 IU/L | Standard Deviation 24.99 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | Baseline | 44.8 IU/L | Standard Deviation 35.87 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Infusion: 0-24 hours | 18.3 IU/L | Standard Deviation 31.42 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Infusion: 73-96 hours | 146.7 IU/L | Standard Deviation 328.43 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Infusion: 97-120 hours | 854.5 IU/L | Standard Deviation 2056.68 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Acute Follow-up: 121-144 hours | 440.3 IU/L | Standard Deviation 1067.48 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Acute Follow-up: 145-168 hours | 264.7 IU/L | Standard Deviation 654.96 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Extended Follow-up: Day 8 | -5.2 IU/L | Standard Deviation 16.63 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Extended Follow-up: Day 15 | 29.0 IU/L | Standard Deviation 48.93 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Extended Follow-up: Day 22 | 25.0 IU/L | Standard Deviation 55.47 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase Levels | CFB at Infusion: 25-48 hours | 32.7 IU/L | Standard Deviation 30.66 |
Primary
Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels
Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in bicarbonate levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | Baseline | 22.29 millimoles per liter (mmol/L) | Standard Deviation 5.247 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Infusion: 0-24 hours | 0.29 millimoles per liter (mmol/L) | Standard Deviation 2.077 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Infusion: 25-48 hours | 0.68 millimoles per liter (mmol/L) | Standard Deviation 3.607 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Infusion: 49-72 hours | 1.12 millimoles per liter (mmol/L) | Standard Deviation 3.252 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Infusion: 73-96 hours | 1.10 millimoles per liter (mmol/L) | Standard Deviation 3.258 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Infusion: 97-120 hours | 1.42 millimoles per liter (mmol/L) | Standard Deviation 4.187 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Acute Follow-up: 121-144 hours | 1.68 millimoles per liter (mmol/L) | Standard Deviation 4.834 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Acute Follow-up: 145-168 hours | 1.85 millimoles per liter (mmol/L) | Standard Deviation 5.119 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Extended Follow-up: Day 8 | 1.27 millimoles per liter (mmol/L) | Standard Deviation 5.397 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Extended Follow-up: Day 15 | 0.95 millimoles per liter (mmol/L) | Standard Deviation 5.309 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Extended Follow-up: Day 22 | 1.45 millimoles per liter (mmol/L) | Standard Deviation 6.239 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Extended Follow-up: Day 29 | 2.59 millimoles per liter (mmol/L) | Standard Deviation 6.432 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Extended Follow-up: Day 22 | 1.56 millimoles per liter (mmol/L) | Standard Deviation 5.447 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | Baseline | 24.52 millimoles per liter (mmol/L) | Standard Deviation 4.481 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Acute Follow-up: 121-144 hours | -1.75 millimoles per liter (mmol/L) | Standard Deviation 5.511 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Infusion: 0-24 hours | -0.85 millimoles per liter (mmol/L) | Standard Deviation 2.411 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Extended Follow-up: Day 15 | 1.14 millimoles per liter (mmol/L) | Standard Deviation 6.527 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Infusion: 25-48 hours | -0.90 millimoles per liter (mmol/L) | Standard Deviation 2.205 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Acute Follow-up: 145-168 hours | -2.15 millimoles per liter (mmol/L) | Standard Deviation 5.829 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Infusion: 49-72 hours | -0.98 millimoles per liter (mmol/L) | Standard Deviation 3.06 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Extended Follow-up: Day 29 | 0.25 millimoles per liter (mmol/L) | Standard Deviation 6.85 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Infusion: 73-96 hours | -0.20 millimoles per liter (mmol/L) | Standard Deviation 3.2 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Extended Follow-up: Day 8 | -0.06 millimoles per liter (mmol/L) | Standard Deviation 4.463 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bicarbonate Levels | CFB at Infusion: 97-120 hours | -0.83 millimoles per liter (mmol/L) | Standard Deviation 4.262 |
Primary
Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels
Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in bilirubin levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | Baseline | 15.3900 micromoles per liter (μmol/L) | Standard Deviation 37.32086 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Infusion: 0-24 hours | -2.8165 micromoles per liter (μmol/L) | Standard Deviation 7.32863 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Infusion: 25-48 hours | -3.0176 micromoles per liter (μmol/L) | Standard Deviation 8.68845 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Infusion: 49-72 hours | -1.0688 micromoles per liter (μmol/L) | Standard Deviation 3.1142 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Infusion: 73-96 hours | 1.9237 micromoles per liter (μmol/L) | Standard Deviation 5.14423 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Infusion: 97-120 hours | 1.3680 micromoles per liter (μmol/L) | Standard Deviation 6.27296 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Acute Follow-up: 121-144 hours | 1.4657 micromoles per liter (μmol/L) | Standard Deviation 6.56677 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Acute Follow-up: 145-168 hours | 3.9086 micromoles per liter (μmol/L) | Standard Deviation 10.20347 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Extended Follow-up: Day 8 | 7.2064 micromoles per liter (μmol/L) | Standard Deviation 18.06184 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Extended Follow-up: Day 15 | 7.6292 micromoles per liter (μmol/L) | Standard Deviation 25.00165 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Extended Follow-up: Day 22 | 4.4197 micromoles per liter (μmol/L) | Standard Deviation 18.18369 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Extended Follow-up: Day 29 | 26.5050 micromoles per liter (μmol/L) | Standard Deviation 69.1476 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Extended Follow-up: Day 22 | -0.4275 micromoles per liter (μmol/L) | Standard Deviation 5.10619 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | Baseline | 6.8400 micromoles per liter (μmol/L) | Standard Deviation 7.41438 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Acute Follow-up: 121-144 hours | 0.5700 micromoles per liter (μmol/L) | Standard Deviation 9.34522 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Infusion: 0-24 hours | 0.8550 micromoles per liter (μmol/L) | Standard Deviation 2.35707 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Extended Follow-up: Day 15 | -2.3940 micromoles per liter (μmol/L) | Standard Deviation 7.31512 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Infusion: 25-48 hours | 0.0000 micromoles per liter (μmol/L) | Standard Deviation 5.72275 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Acute Follow-up: 145-168 hours | 3.7050 micromoles per liter (μmol/L) | Standard Deviation 14.56682 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Infusion: 49-72 hours | -1.4250 micromoles per liter (μmol/L) | Standard Deviation 6.15758 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Extended Follow-up: Day 29 | 2.2800 micromoles per liter (μmol/L) | Standard Deviation 1.97454 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Infusion: 73-96 hours | -0.8550 micromoles per liter (μmol/L) | Standard Deviation 5.59356 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Extended Follow-up: Day 8 | -2.0520 micromoles per liter (μmol/L) | Standard Deviation 7.49284 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Bilirubin Levels | CFB at Infusion: 97-120 hours | 0.0000 micromoles per liter (μmol/L) | Standard Deviation 7.33508 |
Primary
Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels
Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in blood urea nitrogen levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Infusion: 49-72 hours | 1.3090 mmol/L | Standard Deviation 1.79547 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | Baseline | 4.7162 mmol/L | Standard Deviation 2.04935 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Infusion: 0-24 hours | 0.5752 mmol/L | Standard Deviation 0.90926 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Infusion: 25-48 hours | 1.2025 mmol/L | Standard Deviation 1.55708 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Infusion: 73-96 hours | 1.6462 mmol/L | Standard Deviation 2.02001 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Infusion: 97-120 hours | 2.0160 mmol/L | Standard Deviation 2.22925 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Acute Follow-up: 121-144 hours | 2.1000 mmol/L | Standard Deviation 2.37104 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Acute Follow-up: 145-168 hours | 2.1197 mmol/L | Standard Deviation 2.64106 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Extended Follow-up: Day 8 | 1.8743 mmol/L | Standard Deviation 2.74527 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Extended Follow-up: Day 15 | 1.5396 mmol/L | Standard Deviation 2.64507 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Extended Follow-up: Day 22 | 2.0145 mmol/L | Standard Deviation 5.10015 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Extended Follow-up: Day 29 | 1.0115 mmol/L | Standard Deviation 3.40329 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Extended Follow-up: Day 22 | -0.0714 mmol/L | Standard Deviation 3.73914 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Infusion: 49-72 hours | -0.8925 mmol/L | Standard Deviation 1.16778 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Acute Follow-up: 121-144 hours | 2.0825 mmol/L | Standard Deviation 2.79663 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | Baseline | 4.9980 mmol/L | Standard Deviation 1.62817 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Extended Follow-up: Day 15 | 0.0714 mmol/L | Standard Deviation 2.14794 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Infusion: 0-24 hours | -0.1785 mmol/L | Standard Deviation 0.58661 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Acute Follow-up: 145-168 hours | 1.9040 mmol/L | Standard Deviation 2.7989 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Infusion: 25-48 hours | -0.7140 mmol/L | Standard Deviation 1.17322 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Extended Follow-up: Day 29 | 1.3388 mmol/L | Standard Deviation 0.7916 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Infusion: 73-96 hours | -0.1785 mmol/L | Standard Deviation 1.9909 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Extended Follow-up: Day 8 | 1.1424 mmol/L | Standard Deviation 2.55448 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Blood Urea Nitrogen Levels | CFB at Infusion: 97-120 hours | 0.6545 mmol/L | Standard Deviation 2.82384 |
Primary
Change From Baseline in Serum Chemistry Parameter: Calcium Levels
Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in calcium levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | Baseline | 0.2037 mmol/L | Standard Deviation 0.01153 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Infusion: 0-24 hours | 0.0015 mmol/L | Standard Deviation 0.00733 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Infusion: 25-48 hours | 0.0036 mmol/L | Standard Deviation 0.00984 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Infusion: 49-72 hours | 0.0056 mmol/L | Standard Deviation 0.01521 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Infusion: 73-96 hours | 0.0078 mmol/L | Standard Deviation 0.01522 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Infusion: 97-120 hours | 0.0084 mmol/L | Standard Deviation 0.01714 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Acute Follow-up: 121-144 hours | 0.0071 mmol/L | Standard Deviation 0.01703 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Acute Follow-up: 145-168 hours | 0.0100 mmol/L | Standard Deviation 0.0118 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Extended Follow-up: Day 8 | 0.0114 mmol/L | Standard Deviation 0.01016 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Extended Follow-up: Day 15 | 0.0172 mmol/L | Standard Deviation 0.01873 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Extended Follow-up: Day 22 | 0.0202 mmol/L | Standard Deviation 0.03017 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Extended Follow-up: Day 29 | 0.0121 mmol/L | Standard Deviation 0.02749 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Extended Follow-up: Day 22 | 0.0219 mmol/L | Standard Deviation 0.00688 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | Baseline | 0.1950 mmol/L | Standard Deviation 0.02074 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Acute Follow-up: 121-144 hours | 0.0125 mmol/L | Standard Deviation 0.02766 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Infusion: 0-24 hours | 0.0021 mmol/L | Standard Deviation 0.00732 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Extended Follow-up: Day 15 | 0.0170 mmol/L | Standard Deviation 0.01681 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Infusion: 25-48 hours | 0.0017 mmol/L | Standard Deviation 0.01765 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Acute Follow-up: 145-168 hours | 0.0092 mmol/L | Standard Deviation 0.02553 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Infusion: 49-72 hours | 0.0067 mmol/L | Standard Deviation 0.02149 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Extended Follow-up: Day 29 | 0.0300 mmol/L | Standard Deviation 0.0075 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Infusion: 73-96 hours | 0.0079 mmol/L | Standard Deviation 0.02947 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Extended Follow-up: Day 8 | 0.0170 mmol/L | Standard Deviation 0.01866 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Calcium Levels | CFB at Infusion: 97-120 hours | 0.0117 mmol/L | Standard Deviation 0.02493 |
Primary
Change From Baseline in Serum Chemistry Parameter: Chloride Levels
Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in chloride levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Acute Follow-up: 121-144 hours | -2.5 mmol/L | Standard Deviation 6.96 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Infusion: 25-48 hours | -0.6 mmol/L | Standard Deviation 3.32 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Acute Follow-up: 145-168 hours | -4.1 mmol/L | Standard Deviation 7.36 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Infusion: 97-120 hours | -2.9 mmol/L | Standard Deviation 5.07 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Extended Follow-up: Day 8 | -4.0 mmol/L | Standard Deviation 7.32 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Infusion: 49-72 hours | -1.1 mmol/L | Standard Deviation 3.74 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Extended Follow-up: Day 15 | -5.9 mmol/L | Standard Deviation 9.02 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Infusion: 0-24 hours | 0.2 mmol/L | Standard Deviation 2.82 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Extended Follow-up: Day 22 | -4.1 mmol/L | Standard Deviation 8.63 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Infusion: 73-96 hours | -1.6 mmol/L | Standard Deviation 4.22 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Extended Follow-up: Day 29 | -7.2 mmol/L | Standard Deviation 6.73 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | Baseline | 110.0 mmol/L | Standard Deviation 6.21 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Extended Follow-up: Day 29 | -11.0 mmol/L | Standard Deviation 4.69 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | Baseline | 109.7 mmol/L | Standard Deviation 3.72 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Infusion: 0-24 hours | -3.5 mmol/L | Standard Deviation 3.56 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Infusion: 25-48 hours | -0.5 mmol/L | Standard Deviation 5.17 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Infusion: 49-72 hours | 0.5 mmol/L | Standard Deviation 6.6 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Infusion: 97-120 hours | -2.7 mmol/L | Standard Deviation 2.73 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Acute Follow-up: 121-144 hours | -1.8 mmol/L | Standard Deviation 4.92 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Acute Follow-up: 145-168 hours | -1.2 mmol/L | Standard Deviation 3.97 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Extended Follow-up: Day 8 | -3.4 mmol/L | Standard Deviation 5.55 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Extended Follow-up: Day 15 | -4.6 mmol/L | Standard Deviation 12.12 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Extended Follow-up: Day 22 | -10.8 mmol/L | Standard Deviation 5.81 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Chloride Levels | CFB at Infusion: 73-96 hours | -0.3 mmol/L | Standard Deviation 4.63 |
Primary
Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels
Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in creatine kinase levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Infusion: 97-120 hours | -69.4 IU/L | Standard Deviation 267.62 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Infusion: 25-48 hours | -41.5 IU/L | Standard Deviation 204.71 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Acute Follow-up: 121-144 hours | -94.9 IU/L | Standard Deviation 280.01 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Extended Follow-up: Day 29 | 5.9 IU/L | Standard Deviation 51.57 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Acute Follow-up: 145-168 hours | -43.8 IU/L | Standard Deviation 269.89 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Infusion: 49-72 hours | -52.8 IU/L | Standard Deviation 240.39 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Extended Follow-up: Day 8 | -39.5 IU/L | Standard Deviation 286.63 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Infusion: 0-24 hours | -5.4 IU/L | Standard Deviation 99.29 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Extended Follow-up: Day 15 | -70.5 IU/L | Standard Deviation 293.08 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Infusion: 73-96 hours | -54.8 IU/L | Standard Deviation 250.36 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Extended Follow-up: Day 22 | -108.7 IU/L | Standard Deviation 284.99 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | Baseline | 164.6 IU/L | Standard Deviation 297.58 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Extended Follow-up: Day 29 | -356.7 IU/L | Standard Deviation 596.58 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | Baseline | 1056.4 IU/L | Standard Deviation 1476.88 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Infusion: 0-24 hours | 80.0 IU/L | Standard Deviation 343.91 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Infusion: 25-48 hours | -77.0 IU/L | Standard Deviation 226.45 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Infusion: 49-72 hours | -35.2 IU/L | Standard Deviation 375.74 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Infusion: 73-96 hours | 187.8 IU/L | Standard Deviation 428.72 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Infusion: 97-120 hours | 1034.6 IU/L | Standard Deviation 2557.56 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Acute Follow-up: 121-144 hours | 864.2 IU/L | Standard Deviation 2487.87 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Acute Follow-up: 145-168 hours | 1462.6 IU/L | Standard Deviation 3745.02 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Extended Follow-up: Day 8 | -67.0 IU/L | Standard Deviation 684.14 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Extended Follow-up: Day 15 | -294.5 IU/L | Standard Deviation 520.14 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatine Kinase Levels | CFB at Extended Follow-up: Day 22 | -245.5 IU/L | Standard Deviation 217.08 |
Primary
Change From Baseline in Serum Chemistry Parameter: Creatinine Levels
Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in creatinine levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | Baseline | 61.8335 μmol/L | Standard Deviation 38.35138 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Infusion: 0-24 hours | 3.5851 μmol/L | Standard Deviation 21.18016 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Infusion: 25-48 hours | -0.3257 μmol/L | Standard Deviation 17.04796 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Infusion: 49-72 hours | -5.4513 μmol/L | Standard Deviation 17.92081 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Infusion: 73-96 hours | -9.0364 μmol/L | Standard Deviation 24.69353 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Infusion: 97-120 hours | -11.1800 μmol/L | Standard Deviation 28.19797 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Acute Follow-up: 121-144 hours | -10.4000 μmol/L | Standard Deviation 30.51166 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Acute Follow-up: 145-168 hours | -6.5748 μmol/L | Standard Deviation 39.93224 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Extended Follow-up: Day 8 | -9.8345 μmol/L | Standard Deviation 34.60628 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Extended Follow-up: Day 15 | -7.1825 μmol/L | Standard Deviation 30.9642 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Extended Follow-up: Day 22 | -4.6726 μmol/L | Standard Deviation 33.5874 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Extended Follow-up: Day 29 | 11.7867 μmol/L | Standard Deviation 78.66321 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Extended Follow-up: Day 22 | -11.6688 μmol/L | Standard Deviation 33.48365 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | Baseline | 66.1527 μmol/L | Standard Deviation 26.85624 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Acute Follow-up: 121-144 hours | 32.4133 μmol/L | Standard Deviation 73.92834 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Infusion: 0-24 hours | -4.2727 μmol/L | Standard Deviation 3.96981 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Extended Follow-up: Day 15 | -3.3592 μmol/L | Standard Deviation 13.75749 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Infusion: 25-48 hours | -2.7993 μmol/L | Standard Deviation 9.97654 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Acute Follow-up: 145-168 hours | 37.8647 μmol/L | Standard Deviation 103.07822 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Infusion: 49-72 hours | -5.1567 μmol/L | Standard Deviation 13.1525 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Extended Follow-up: Day 29 | 0.0000 μmol/L | Standard Deviation 23.0632 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Infusion: 73-96 hours | 2.6520 μmol/L | Standard Deviation 34.21891 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Extended Follow-up: Day 8 | -1.5912 μmol/L | Standard Deviation 12.81648 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Creatinine Levels | CFB at Infusion: 97-120 hours | 15.1753 μmol/L | Standard Deviation 34.57069 |
Primary
Change From Baseline in Serum Chemistry Parameter: Glucose Levels
Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in glucose levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | Baseline | 7.0731 mmol/L | Standard Deviation 1.6094 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Infusion: 0-24 hours | 0.7247 mmol/L | Standard Deviation 1.21847 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Infusion: 25-48 hours | 0.2542 mmol/L | Standard Deviation 1.75414 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Infusion: 49-72 hours | 1.0886 mmol/L | Standard Deviation 2.99912 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Infusion: 73-96 hours | 0.0956 mmol/L | Standard Deviation 1.98021 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Infusion: 97-120 hours | 0.4539 mmol/L | Standard Deviation 1.53147 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Acute Follow-up: 121-144 hours | 0.1437 mmol/L | Standard Deviation 2.20744 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Acute Follow-up: 145-168 hours | -0.1457 mmol/L | Standard Deviation 1.83254 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Extended Follow-up: Day 8 | -0.1596 mmol/L | Standard Deviation 1.85981 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Extended Follow-up: Day 15 | -0.4788 mmol/L | Standard Deviation 1.91895 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Extended Follow-up: Day 22 | -0.4084 mmol/L | Standard Deviation 2.50478 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Extended Follow-up: Day 29 | -1.1565 mmol/L | Standard Deviation 1.79106 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Extended Follow-up: Day 22 | -0.1554 mmol/L | Standard Deviation 4.07581 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | Baseline | 7.1238 mmol/L | Standard Deviation 2.4886 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Acute Follow-up: 121-144 hours | 0.5644 mmol/L | Standard Deviation 1.44173 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Infusion: 0-24 hours | 2.5905 mmol/L | Standard Deviation 3.70841 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Extended Follow-up: Day 15 | -0.0999 mmol/L | Standard Deviation 3.18721 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Infusion: 25-48 hours | 0.6661 mmol/L | Standard Deviation 1.44582 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Acute Follow-up: 145-168 hours | -0.2683 mmol/L | Standard Deviation 1.26456 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Infusion: 49-72 hours | 1.4155 mmol/L | Standard Deviation 3.1569 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Extended Follow-up: Day 29 | -1.5959 mmol/L | Standard Deviation 2.239 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Infusion: 73-96 hours | 0.2405 mmol/L | Standard Deviation 1.85063 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Extended Follow-up: Day 8 | -1.4766 mmol/L | Standard Deviation 2.48794 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Glucose Levels | CFB at Infusion: 97-120 hours | 0.2035 mmol/L | Standard Deviation 2.89966 |
Primary
Change From Baseline in Serum Chemistry Parameter: Lipase Levels
Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in lipase levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Acute Follow-up: 121-144 hours | -20.3 IU/L | Standard Deviation 91.54 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Infusion: 25-48 hours | -7.5 IU/L | Standard Deviation 34.95 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Acute Follow-up: 145-168 hours | -11.7 IU/L | Standard Deviation 99.6 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Infusion: 73-96 hours | -22.4 IU/L | Standard Deviation 64.01 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Extended Follow-up: Day 8 | -3.7 IU/L | Standard Deviation 100.78 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Infusion: 49-72 hours | -14.4 IU/L | Standard Deviation 36.77 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Extended Follow-up: Day 15 | 24.7 IU/L | Standard Deviation 44.42 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Infusion: 0-24 hours | -13.4 IU/L | Standard Deviation 43.77 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Extended Follow-up: Day 22 | 14.1 IU/L | Standard Deviation 38.25 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Infusion: 97-120 hours | -20.5 IU/L | Standard Deviation 63.33 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Extended Follow-up: Day 29 | -8.3 IU/L | Standard Deviation 35.42 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | Baseline | 69.7 IU/L | Standard Deviation 108.56 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Extended Follow-up: Day 29 | 0.0 IU/L | Standard Deviation 31 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | Baseline | 48.3 IU/L | Standard Deviation 55.19 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Infusion: 0-24 hours | 3.3 IU/L | Standard Deviation 3.21 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Infusion: 25-48 hours | 9.3 IU/L | Standard Deviation 13.58 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Infusion: 73-96 hours | 18.0 IU/L | Standard Deviation 25.36 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Infusion: 97-120 hours | -6.7 IU/L | Standard Deviation 22.74 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Acute Follow-up: 121-144 hours | -10.7 IU/L | Standard Deviation 37.87 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Acute Follow-up: 145-168 hours | 9.3 IU/L | Standard Deviation 16.92 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Extended Follow-up: Day 8 | 37.0 IU/L | Standard Deviation 28.16 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Extended Follow-up: Day 15 | 19.7 IU/L | Standard Deviation 100.17 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Extended Follow-up: Day 22 | -15.0 IU/L | Standard Deviation 84.85 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Lipase Levels | CFB at Infusion: 49-72 hours | 0.0 IU/L | Standard Deviation 1.73 |
Primary
Change From Baseline in Serum Chemistry Parameter: Magnesium Levels
Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in magnesium levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | Baseline | 0.8969 mmol/L | Standard Deviation 0.19546 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Infusion: 0-24 hours | -0.0219 mmol/L | Standard Deviation 0.11853 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Infusion: 25-48 hours | -0.0194 mmol/L | Standard Deviation 0.14406 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Infusion: 49-72 hours | -0.0430 mmol/L | Standard Deviation 0.11666 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Infusion: 73-96 hours | -0.0374 mmol/L | Standard Deviation 0.17268 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Infusion: 97-120 hours | -0.0151 mmol/L | Standard Deviation 0.22358 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Acute Follow-up: 121-144 hours | -0.0348 mmol/L | Standard Deviation 0.18742 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Acute Follow-up: 145-168 hours | -0.0151 mmol/L | Standard Deviation 0.21498 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Extended Follow-up: Day 8 | -0.0435 mmol/L | Standard Deviation 0.15736 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Extended Follow-up: Day 15 | -0.0645 mmol/L | Standard Deviation 0.1532 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Extended Follow-up: Day 22 | -0.0564 mmol/L | Standard Deviation 0.19263 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Extended Follow-up: Day 29 | -0.1484 mmol/L | Standard Deviation 0.28794 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Extended Follow-up: Day 22 | -0.1264 mmol/L | Standard Deviation 0.15097 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | Baseline | 0.8607 mmol/L | Standard Deviation 0.14418 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Acute Follow-up: 121-144 hours | 0.0534 mmol/L | Standard Deviation 0.13315 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Infusion: 0-24 hours | -0.0441 mmol/L | Standard Deviation 0.06638 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Extended Follow-up: Day 15 | -0.0494 mmol/L | Standard Deviation 0.09381 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Infusion: 25-48 hours | -0.0319 mmol/L | Standard Deviation 0.11737 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Acute Follow-up: 145-168 hours | 0.0519 mmol/L | Standard Deviation 0.15865 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Infusion: 49-72 hours | -0.0167 mmol/L | Standard Deviation 0.12869 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Extended Follow-up: Day 29 | -0.0608 mmol/L | Standard Deviation 0.08902 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Infusion: 73-96 hours | 0.0304 mmol/L | Standard Deviation 0.16521 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Extended Follow-up: Day 8 | -0.0811 mmol/L | Standard Deviation 0.1686 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Magnesium Levels | CFB at Infusion: 97-120 hours | 0.0754 mmol/L | Standard Deviation 0.10859 |
Primary
Change From Baseline in Serum Chemistry Parameter: Potassium Levels
Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in potassium levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | Baseline | 3.76 mmol/L | Standard Deviation 0.439 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Infusion: 0-24 hours | 0.01 mmol/L | Standard Deviation 0.515 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Infusion: 25-48 hours | 0.15 mmol/L | Standard Deviation 0.717 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Infusion: 49-72 hours | 0.17 mmol/L | Standard Deviation 0.788 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Infusion: 73-96 hours | 0.05 mmol/L | Standard Deviation 0.651 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Infusion: 97-120 hours | 0.00 mmol/L | Standard Deviation 0.446 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Acute Follow-up: 121-144 hours | -0.02 mmol/L | Standard Deviation 0.542 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Acute Follow-up: 145-168 hours | -0.06 mmol/L | Standard Deviation 0.578 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Extended Follow-up: Day 8 | 0.07 mmol/L | Standard Deviation 0.585 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Extended Follow-up: Day 15 | 0.04 mmol/L | Standard Deviation 0.734 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Extended Follow-up: Day 22 | 0.12 mmol/L | Standard Deviation 0.654 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Extended Follow-up: Day 29 | 0.21 mmol/L | Standard Deviation 0.442 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Extended Follow-up: Day 22 | 0.32 mmol/L | Standard Deviation 0.683 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | Baseline | 3.87 mmol/L | Standard Deviation 0.301 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Acute Follow-up: 121-144 hours | 0.37 mmol/L | Standard Deviation 0.582 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Infusion: 0-24 hours | -0.03 mmol/L | Standard Deviation 0.242 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Extended Follow-up: Day 15 | 0.42 mmol/L | Standard Deviation 0.657 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Infusion: 25-48 hours | -0.10 mmol/L | Standard Deviation 0.329 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Acute Follow-up: 145-168 hours | 0.75 mmol/L | Standard Deviation 0.946 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Infusion: 49-72 hours | -0.37 mmol/L | Standard Deviation 1.117 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Extended Follow-up: Day 29 | 0.38 mmol/L | Standard Deviation 0.741 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Infusion: 73-96 hours | 0.22 mmol/L | Standard Deviation 0.601 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Extended Follow-up: Day 8 | 0.10 mmol/L | Standard Deviation 0.255 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Potassium Levels | CFB at Infusion: 97-120 hours | 0.35 mmol/L | Standard Deviation 0.497 |
Primary
Change From Baseline in Serum Chemistry Parameter: Protein Levels
Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in protein levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Acute Follow-up: 121-144 hours | 2.5 g/L | Standard Deviation 5.05 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Infusion: 25-48 hours | 1.1 g/L | Standard Deviation 2.34 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Acute Follow-up: 145-168 hours | 4.1 g/L | Standard Deviation 4.87 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Infusion: 73-96 hours | 2.5 g/L | Standard Deviation 4.1 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Extended Follow-up: Day 8 | 4.3 g/L | Standard Deviation 5.06 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Infusion: 49-72 hours | 1.3 g/L | Standard Deviation 4.08 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Extended Follow-up: Day 15 | 5.9 g/L | Standard Deviation 9.21 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Infusion: 0-24 hours | 0.4 g/L | Standard Deviation 1.71 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Extended Follow-up: Day 22 | 6.7 g/L | Standard Deviation 10.18 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Infusion: 97-120 hours | 2.8 g/L | Standard Deviation 2.96 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Extended Follow-up: Day 29 | 7.1 g/L | Standard Deviation 11.56 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | Baseline | 56.5 g/L | Standard Deviation 9.91 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Extended Follow-up: Day 29 | 20.0 g/L | Standard Deviation 7.21 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | Baseline | 52.2 g/L | Standard Deviation 7.52 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Infusion: 0-24 hours | 1.0 g/L | Standard Deviation 5.51 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Infusion: 25-48 hours | 1.5 g/L | Standard Deviation 5.92 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Infusion: 73-96 hours | 6.5 g/L | Standard Deviation 5.99 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Infusion: 97-120 hours | 8.8 g/L | Standard Deviation 7.41 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Acute Follow-up: 121-144 hours | 6.3 g/L | Standard Deviation 5.89 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Acute Follow-up: 145-168 hours | 7.5 g/L | Standard Deviation 5.05 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Extended Follow-up: Day 8 | 5.6 g/L | Standard Deviation 5.68 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Extended Follow-up: Day 15 | 11.0 g/L | Standard Deviation 6.44 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Extended Follow-up: Day 22 | 16.5 g/L | Standard Deviation 8.19 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Protein Levels | CFB at Infusion: 49-72 hours | 4.0 g/L | Standard Deviation 6.69 |
Primary
Change From Baseline in Serum Chemistry Parameter: Sodium Levels
Serum chemistry measures included alanine aminotransferase, albumin, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, calcium, chloride, creatine kinase, creatinine, glucose, lipase, magnesium, potassium, protein, sodium. CFB in sodium levels is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | Baseline | 140.6 mmol/L | Standard Deviation 4.84 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Infusion: 97-120 hours | 0.0 mmol/L | Standard Deviation 4.8 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Infusion: 25-48 hours | 0.7 mmol/L | Standard Deviation 4.31 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Acute Follow-up: 121-144 hours | -0.3 mmol/L | Standard Deviation 5.12 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Extended Follow-up: Day 29 | -1.8 mmol/L | Standard Deviation 6.34 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Acute Follow-up: 145-168 hours | -1.2 mmol/L | Standard Deviation 5.64 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Infusion: 49-72 hours | 0.4 mmol/L | Standard Deviation 3.88 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Extended Follow-up: Day 8 | -1.8 mmol/L | Standard Deviation 5.65 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Infusion: 0-24 hours | 0.1 mmol/L | Standard Deviation 2.87 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Extended Follow-up: Day 15 | -2.8 mmol/L | Standard Deviation 5.51 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Infusion: 73-96 hours | 0.4 mmol/L | Standard Deviation 3.5 |
| SAGE-547 Standard Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Extended Follow-up: Day 22 | 0.0 mmol/L | Standard Deviation 5.53 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Extended Follow-up: Day 29 | -4.5 mmol/L | Standard Deviation 1.29 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Extended Follow-up: Day 22 | -3.2 mmol/L | Standard Deviation 4.32 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | Baseline | 141.7 mmol/L | Standard Deviation 4.84 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Infusion: 0-24 hours | -3.8 mmol/L | Standard Deviation 4.12 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Infusion: 25-48 hours | 0.3 mmol/L | Standard Deviation 5.72 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Infusion: 49-72 hours | 1.7 mmol/L | Standard Deviation 6.19 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Infusion: 73-96 hours | 1.5 mmol/L | Standard Deviation 3.94 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Infusion: 97-120 hours | -0.5 mmol/L | Standard Deviation 4.04 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Acute Follow-up: 121-144 hours | -1.0 mmol/L | Standard Deviation 4.6 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Acute Follow-up: 145-168 hours | 0.2 mmol/L | Standard Deviation 5.85 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Extended Follow-up: Day 8 | 0.0 mmol/L | Standard Deviation 5.79 |
| SAGE-547 High Dose | Change From Baseline in Serum Chemistry Parameter: Sodium Levels | CFB at Extended Follow-up: Day 15 | -0.4 mmol/L | Standard Deviation 7.64 |
Primary
Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP
Vital signs included weight, heart rate, blood pressure (SBP and DBP), respiratory rate, temperature, oxygen saturation. CFB in SBP and DBP is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24 hours:Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72: 72 hour;73-96: 96 hour;97-120:120 hour;Acute follow-up at 121-144,145-168 hours;Extended follow-up at Days 8,15,22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Extended Follow-up: Day 22 | 1.6 millimeters of mercury (mmHg) | Standard Deviation 27.6 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: 8 hours | -5.1 millimeters of mercury (mmHg) | Standard Deviation 18.55 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Extended Follow-up: Day 29 | 2.0 millimeters of mercury (mmHg) | Standard Deviation 24.2 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: 1 hour | -3.4 millimeters of mercury (mmHg) | Standard Deviation 8.17 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP Baseline | 59.7 millimeters of mercury (mmHg) | Standard Deviation 8.51 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: 24 hour | -5.6 millimeters of mercury (mmHg) | Standard Deviation 19.26 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: Loading - Pre-Dose | 1.3 millimeters of mercury (mmHg) | Standard Deviation 10.53 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: Loading - Pre-Dose | 1.3 millimeters of mercury (mmHg) | Standard Deviation 13.23 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: Loading - 15 minutes | -2.1 millimeters of mercury (mmHg) | Standard Deviation 5.83 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 25-48 hours: 48 hours | -3.1 millimeters of mercury (mmHg) | Standard Deviation 21.49 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: Loading - 30 minutes | -2.6 millimeters of mercury (mmHg) | Standard Deviation 10.38 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: 2 hours | -6.1 millimeters of mercury (mmHg) | Standard Deviation 15.96 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: Loading - 45 minutes | -3.3 millimeters of mercury (mmHg) | Standard Deviation 6.26 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 49-72 hours: 72 hours | -2.1 millimeters of mercury (mmHg) | Standard Deviation 27.72 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: 2 hours | -2.8 millimeters of mercury (mmHg) | Standard Deviation 6.7 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: Loading - 15 minutes | -3.2 millimeters of mercury (mmHg) | Standard Deviation 8.36 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: 4 hours | -1.7 millimeters of mercury (mmHg) | Standard Deviation 7.36 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 73-96 hours: 96 hours | 6.2 millimeters of mercury (mmHg) | Standard Deviation 24.06 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: 8 hours | -2.5 millimeters of mercury (mmHg) | Standard Deviation 7.11 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: 24 hours | -2.9 millimeters of mercury (mmHg) | Standard Deviation 12.61 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 25-48 hours: 48 hours | -2.9 millimeters of mercury (mmHg) | Standard Deviation 9.01 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 97-120 hours: 120 hours | -6.9 millimeters of mercury (mmHg) | Standard Deviation 22.13 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 49-72 hours: 72 hours | -1.2 millimeters of mercury (mmHg) | Standard Deviation 16.37 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: Loading - 45 minutes | -5.3 millimeters of mercury (mmHg) | Standard Deviation 12.55 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 73-96 hours: 96 hours | 1.1 millimeters of mercury (mmHg) | Standard Deviation 12.09 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Acute Follow-up: 121-144 hours | -2.2 millimeters of mercury (mmHg) | Standard Deviation 18.67 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 97-120 hours: 120 hours | -3.4 millimeters of mercury (mmHg) | Standard Deviation 12.65 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: Loading - 30 minutes | -4.3 millimeters of mercury (mmHg) | Standard Deviation 12.64 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Acute Follow-up: 121-144 hours | -1.8 millimeters of mercury (mmHg) | Standard Deviation 11.53 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Acute Follow-up: 145-168 hours | -0.2 millimeters of mercury (mmHg) | Standard Deviation 24.46 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Acute Follow-up: 145-168 hours | 0.8 millimeters of mercury (mmHg) | Standard Deviation 18.15 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: 1 hour | -7.4 millimeters of mercury (mmHg) | Standard Deviation 11.96 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Extended Follow-up: Day 8 | 1.1 millimeters of mercury (mmHg) | Standard Deviation 12.4 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Extended Follow-up: Day 8 | -0.9 millimeters of mercury (mmHg) | Standard Deviation 21.12 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Extended Follow-up: Day 15 | 7.9 millimeters of mercury (mmHg) | Standard Deviation 11.13 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: 4 hours | -1.1 millimeters of mercury (mmHg) | Standard Deviation 14.4 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Extended Follow-up: Day 22 | 7.3 millimeters of mercury (mmHg) | Standard Deviation 14.67 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Extended Follow-up: Day 15 | 8.9 millimeters of mercury (mmHg) | Standard Deviation 19.55 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Extended Follow-up: Day 29 | 7.9 millimeters of mercury (mmHg) | Standard Deviation 11.02 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP Baseline | 111.1 millimeters of mercury (mmHg) | Standard Deviation 14.55 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Extended Follow-up: Day 29 | 12.4 millimeters of mercury (mmHg) | Standard Deviation 22.78 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: 1 hour | -6.8 millimeters of mercury (mmHg) | Standard Deviation 11.39 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: 2 hours | -5.7 millimeters of mercury (mmHg) | Standard Deviation 19.72 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: 1 hour | -1.8 millimeters of mercury (mmHg) | Standard Deviation 3.25 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: 24 hours | 6.3 millimeters of mercury (mmHg) | Standard Deviation 24.99 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP Baseline | 111.8 millimeters of mercury (mmHg) | Standard Deviation 7.46 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: Loading - Pre-Dose | 20.0 millimeters of mercury (mmHg) | Standard Deviation 28.28 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: Loading - 30 minutes | 3.8 millimeters of mercury (mmHg) | Standard Deviation 11.12 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: Loading - 45 minutes | -9.4 millimeters of mercury (mmHg) | Standard Deviation 12.22 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: 4 hours | -1.7 millimeters of mercury (mmHg) | Standard Deviation 11.81 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: 8 hours | -1.3 millimeters of mercury (mmHg) | Standard Deviation 18.02 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: 24 hour | 5.7 millimeters of mercury (mmHg) | Standard Deviation 17.63 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 25-48 hours: 48 hours | 2.5 millimeters of mercury (mmHg) | Standard Deviation 21.55 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 49-72 hours: 72 hours | 3.0 millimeters of mercury (mmHg) | Standard Deviation 23.83 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 73-96 hours: 96 hours | 11.8 millimeters of mercury (mmHg) | Standard Deviation 24.39 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 97-120 hours: 120 hours | -1.8 millimeters of mercury (mmHg) | Standard Deviation 21.04 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Acute Follow-up: 121-144 hours | 12.8 millimeters of mercury (mmHg) | Standard Deviation 21.58 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Acute Follow-up: 145-168 hours | 7.0 millimeters of mercury (mmHg) | Standard Deviation 25.93 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Extended Follow-up: Day 8 | 5.0 millimeters of mercury (mmHg) | Standard Deviation 16.02 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Extended Follow-up: Day 15 | 3.2 millimeters of mercury (mmHg) | Standard Deviation 11.52 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Extended Follow-up: Day 22 | 7.0 millimeters of mercury (mmHg) | Standard Deviation 6.75 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Extended Follow-up: Day 29 | 2.8 millimeters of mercury (mmHg) | Standard Deviation 19.77 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP Baseline | 60.8 millimeters of mercury (mmHg) | Standard Deviation 10.69 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: Loading - Pre-Dose | 7.5 millimeters of mercury (mmHg) | Standard Deviation 10.61 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: Loading - 15 minutes | 2.2 millimeters of mercury (mmHg) | Standard Deviation 4.15 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: Loading - 30 minutes | 3.6 millimeters of mercury (mmHg) | Standard Deviation 5.41 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: Loading - 45 minutes | -3.6 millimeters of mercury (mmHg) | Standard Deviation 7.33 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: 2 hours | -3.2 millimeters of mercury (mmHg) | Standard Deviation 9.56 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: 4 hours | 0.0 millimeters of mercury (mmHg) | Standard Deviation 8.67 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 0-24 hours: 8 hours | -5.0 millimeters of mercury (mmHg) | Standard Deviation 12.17 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 25-48 hours: 48 hours | -4.0 millimeters of mercury (mmHg) | Standard Deviation 7.87 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 49-72 hours: 72 hours | -4.2 millimeters of mercury (mmHg) | Standard Deviation 5.42 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 73-96 hours: 96 hours | 3.3 millimeters of mercury (mmHg) | Standard Deviation 7.58 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Infusion: 97-120 hours: 120 hours | 1.0 millimeters of mercury (mmHg) | Standard Deviation 12.13 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Acute Follow-up: 121-144 hours | 6.6 millimeters of mercury (mmHg) | Standard Deviation 8.99 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Acute Follow-up: 145-168 hours | 3.0 millimeters of mercury (mmHg) | Standard Deviation 18.59 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Extended Follow-up: Day 8 | 1.0 millimeters of mercury (mmHg) | Standard Deviation 10.89 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Extended Follow-up: Day 15 | 4.8 millimeters of mercury (mmHg) | Standard Deviation 6.22 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | DBP CFB at Extended Follow-up: Day 22 | 13.4 millimeters of mercury (mmHg) | Standard Deviation 11.72 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Blood Pressure - SBP and DBP | SBP CFB at Infusion: 0-24 hours: Loading - 15 minutes | 5.0 millimeters of mercury (mmHg) | Standard Deviation 11.85 |
Primary
Change From Baseline in Vital Sign Parameter: Body Temperature
Vital signs included weight, heart rate, blood pressure (SBP and DBP), respiratory rate, temperature, oxygen saturation. CFB in body temperature is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24 hours: Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: 4 hours | -0.17 degrees Fahrenheit (F) | Standard Deviation 1.269 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: 24 hours | -0.20 degrees Fahrenheit (F) | Standard Deviation 1.704 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: Loading - Pre-Dose | -0.80 degrees Fahrenheit (F) | Standard Deviation 0.883 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 25-48 hours: 48 hours | -0.51 degrees Fahrenheit (F) | Standard Deviation 1.467 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Acute Follow-up: 145-168 hours | -0.29 degrees Fahrenheit (F) | Standard Deviation 1.896 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 49-72 hours: 72 hours | -0.53 degrees Fahrenheit (F) | Standard Deviation 1.522 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: Loading - 15 minutes | -0.38 degrees Fahrenheit (F) | Standard Deviation 0.471 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 73-96 hour: 96 hours | -0.32 degrees Fahrenheit (F) | Standard Deviation 1.263 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: 8 hours | -0.74 degrees Fahrenheit (F) | Standard Deviation 1.361 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 97-120 hours: 120 hours | -0.14 degrees Fahrenheit (F) | Standard Deviation 1.23 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: Loading - 30 minutes | -0.54 degrees Fahrenheit (F) | Standard Deviation 0.628 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Acute Follow-up: 121-144 hours | 0.06 degrees Fahrenheit (F) | Standard Deviation 1.36 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Extended Follow-up: Day 8 | 0.03 degrees Fahrenheit (F) | Standard Deviation 1.01 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: Loading - 45 minutes | -0.58 degrees Fahrenheit (F) | Standard Deviation 0.662 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Extended Follow-up: Day 15 | -0.44 degrees Fahrenheit (F) | Standard Deviation 1.852 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | Baseline | 99.21 degrees Fahrenheit (F) | Standard Deviation 1.195 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Extended Follow-up: Day 22 | -0.62 degrees Fahrenheit (F) | Standard Deviation 1.834 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: 1 hour | -0.51 degrees Fahrenheit (F) | Standard Deviation 0.614 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Extended Follow-up: Day 29 | -0.69 degrees Fahrenheit (F) | Standard Deviation 1.515 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: 2 hours | -0.44 degrees Fahrenheit (F) | Standard Deviation 0.902 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Extended Follow-up: Day 29 | -1.20 degrees Fahrenheit (F) | Standard Deviation 2.164 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: 2 hours | -0.48 degrees Fahrenheit (F) | Standard Deviation 0.407 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: 4 hours | -0.47 degrees Fahrenheit (F) | Standard Deviation 0.596 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: 8 hours | -0.52 degrees Fahrenheit (F) | Standard Deviation 0.985 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Acute Follow-up: 145-168 hours | -0.20 degrees Fahrenheit (F) | Standard Deviation 0.652 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | Baseline | 98.98 degrees Fahrenheit (F) | Standard Deviation 2.312 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: Loading - Pre-Dose | -0.30 degrees Fahrenheit (F) | Standard Deviation 0.707 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: Loading - 15 minutes | -0.04 degrees Fahrenheit (F) | Standard Deviation 0.329 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: Loading - 30 minutes | -0.14 degrees Fahrenheit (F) | Standard Deviation 0.371 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: Loading - 45 minutes | -0.32 degrees Fahrenheit (F) | Standard Deviation 0.432 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: 1 hour | -0.55 degrees Fahrenheit (F) | Standard Deviation 0.468 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 0-24 hours: 24 hours | 0.20 degrees Fahrenheit (F) | Standard Deviation 1.474 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 25-48 hours: 48 hours | -0.47 degrees Fahrenheit (F) | Standard Deviation 1.335 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 49-72 hours: 72 hours | -0.47 degrees Fahrenheit (F) | Standard Deviation 1.296 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 73-96 hour: 96 hours | -0.62 degrees Fahrenheit (F) | Standard Deviation 1.283 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Infusion: 97-120 hours: 120 hours | -0.92 degrees Fahrenheit (F) | Standard Deviation 1.514 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Acute Follow-up: 121-144 hours | -0.16 degrees Fahrenheit (F) | Standard Deviation 1.45 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Extended Follow-up: Day 8 | -0.46 degrees Fahrenheit (F) | Standard Deviation 0.684 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Extended Follow-up: Day 15 | -0.42 degrees Fahrenheit (F) | Standard Deviation 0.74 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Temperature | CFB at Extended Follow-up: Day 22 | -0.96 degrees Fahrenheit (F) | Standard Deviation 1.79 |
Primary
Change From Baseline in Vital Sign Parameter: Body Weight
Vital signs included weight, heart rate, blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP)), respiratory rate, temperature, oxygen saturation. CFB in body weight is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Weight | Baseline | 78.263 kilograms (kg) | Standard Deviation 25.3905 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Infusion: 25-48 hours | 1.095 kilograms (kg) | Standard Deviation 3.9392 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Infusion: 73-96 hours | 1.517 kilograms (kg) | Standard Deviation 4.5509 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Infusion: 97-120 hours | 0.688 kilograms (kg) | Standard Deviation 4.3148 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Extended Follow-up: Day 15 | -0.708 kilograms (kg) | Standard Deviation 10.1362 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Infusion: 0-24 hours | 0.253 kilograms (kg) | Standard Deviation 3.3321 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Infusion: 49-72 hours | 1.444 kilograms (kg) | Standard Deviation 3.5787 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Acute Follow-up: 121-144 hours | -0.631 kilograms (kg) | Standard Deviation 6.3734 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Acute Follow-up: 145-168 hours | -0.930 kilograms (kg) | Standard Deviation 7.708 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Extended Follow-up: Day 8 | 0.436 kilograms (kg) | Standard Deviation 9.5258 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Extended Follow-up: Day 22 | 0.644 kilograms (kg) | Standard Deviation 8.9288 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Extended Follow-up: Day 29 | -6.130 kilograms (kg) | Standard Deviation 13.5243 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Acute Follow-up: 145-168 hours | -5.100 kilograms (kg) | Standard Deviation 4.8298 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Weight | Baseline | 81.667 kilograms (kg) | Standard Deviation 20.3141 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Infusion: 0-24 hours | 0.250 kilograms (kg) | Standard Deviation 0.3987 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Infusion: 49-72 hours | -0.933 kilograms (kg) | Standard Deviation 2.9561 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Infusion: 25-48 hours | 1.083 kilograms (kg) | Standard Deviation 2.1424 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Infusion: 97-120 hours | 1.567 kilograms (kg) | Standard Deviation 8.8672 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Infusion: 73-96 hours | -0.033 kilograms (kg) | Standard Deviation 4.4275 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Extended Follow-up: Day 22 | -3.420 kilograms (kg) | Standard Deviation 12.4474 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Extended Follow-up: Day 8 | -1.720 kilograms (kg) | Standard Deviation 7.6392 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Acute Follow-up: 121-144 hours | 1.650 kilograms (kg) | Standard Deviation 12.6751 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Extended Follow-up: Day 15 | -6.100 kilograms (kg) | Standard Deviation 4.7589 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Body Weight | CFB at Extended Follow-up: Day 29 | 0.108 kilograms (kg) | Standard Deviation 19.4907 |
Primary
Change From Baseline in Vital Sign Parameter: Heart Rate
Vital signs included weight, heart rate, blood pressure (SBP and DBP), respiratory rate, temperature, oxygen saturation. CFB in heart rate is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24 hours: Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours; Extended Follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: 2 hours | -1.6 beats per minute (beats/min) | Standard Deviation 4.92 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: Loading - 45 minutes | -0.9 beats per minute (beats/min) | Standard Deviation 3.98 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Extended Follow-up: Day 8 | 11.8 beats per minute (beats/min) | Standard Deviation 12.69 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: 1 hour | -1.3 beats per minute (beats/min) | Standard Deviation 4.18 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: 4 hours | -0.6 beats per minute (beats/min) | Standard Deviation 7.65 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: Loading - Pre-Dose | -2.3 beats per minute (beats/min) | Standard Deviation 4.65 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: 8 hours | -3.5 beats per minute (beats/min) | Standard Deviation 9.87 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Extended Follow-up: Day 15 | 12.8 beats per minute (beats/min) | Standard Deviation 15.66 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: 24 hours | -2.2 beats per minute (beats/min) | Standard Deviation 13.52 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 97-120 hours: 120 hours | 12.9 beats per minute (beats/min) | Standard Deviation 13.43 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 25-48 hours: 48 hours | 1.9 beats per minute (beats/min) | Standard Deviation 15.09 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Extended Follow-up: Day 22 | 13.3 beats per minute (beats/min) | Standard Deviation 11.92 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 49-72 hours: 72 hours | 5.4 beats per minute (beats/min) | Standard Deviation 13.65 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | Baseline | 89.3 beats per minute (beats/min) | Standard Deviation 14.33 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 73-96 hours: 96 hours | 6.8 beats per minute (beats/min) | Standard Deviation 14.03 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: Loading - 15 minutes | -0.7 beats per minute (beats/min) | Standard Deviation 3.36 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Acute Follow-up: 145-168 hours | 10.9 beats per minute (beats/min) | Standard Deviation 15.77 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Acute Follow-up: 121-144 hours | 10.1 beats per minute (beats/min) | Standard Deviation 13.1 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Extended Follow-up: Day 29 | 9.5 beats per minute (beats/min) | Standard Deviation 16.19 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: Loading - 30 minutes | 0.2 beats per minute (beats/min) | Standard Deviation 5.26 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Extended Follow-up: Day 29 | 11.2 beats per minute (beats/min) | Standard Deviation 26.54 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | Baseline | 81.8 beats per minute (beats/min) | Standard Deviation 20.9 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: 1 hour | -4.7 beats per minute (beats/min) | Standard Deviation 7.26 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: 2 hours | -0.5 beats per minute (beats/min) | Standard Deviation 7.56 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 97-120 hours: 120 hours | 10.7 beats per minute (beats/min) | Standard Deviation 28.86 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Acute Follow-up: 121-144 hours | 18.0 beats per minute (beats/min) | Standard Deviation 23.33 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Extended Follow-up: Day 8 | 5.6 beats per minute (beats/min) | Standard Deviation 15.34 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Extended Follow-up: Day 15 | 6.0 beats per minute (beats/min) | Standard Deviation 12.63 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: Loading - Pre-Dose | -0.5 beats per minute (beats/min) | Standard Deviation 2.12 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: Loading - 15 minutes | 0.6 beats per minute (beats/min) | Standard Deviation 1.52 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: Loading - 30 minutes | -2.0 beats per minute (beats/min) | Standard Deviation 2.45 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: Loading - 45 minutes | -3.6 beats per minute (beats/min) | Standard Deviation 4.1 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: 4 hours | -2.8 beats per minute (beats/min) | Standard Deviation 8.52 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: 8 hours | -10.7 beats per minute (beats/min) | Standard Deviation 10.07 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 0-24 hours: 24 hours | 1.8 beats per minute (beats/min) | Standard Deviation 7.11 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 25-48 hours: 48 hours | -4.8 beats per minute (beats/min) | Standard Deviation 8.04 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 49-72 hours: 72 hours | 2.7 beats per minute (beats/min) | Standard Deviation 12.42 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Infusion: 73-96 hours: 96 hours | 8.0 beats per minute (beats/min) | Standard Deviation 14.38 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Acute Follow-up: 145-168 hours | 14.8 beats per minute (beats/min) | Standard Deviation 17.17 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Heart Rate | CFB at Extended Follow-up: Day 22 | 13.6 beats per minute (beats/min) | Standard Deviation 27.88 |
Primary
Change From Baseline in Vital Sign Parameter: Oxygen Saturation
Vital signs included weight, heart rate, blood pressure (SBP and DBP), respiratory rate, temperature, oxygen saturation. Oxygen saturation is a measure of how much hemoglobin is currently bound to oxygen compared to how much hemoglobin remains unbound. CFB in oxygen saturation is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24 hours: Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: Loading - 45 minutes | -0.2 percentage of oxygen saturation | Standard Deviation 1.08 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 25-48 hours: 48 hours | -0.6 percentage of oxygen saturation | Standard Deviation 2.75 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | Baseline | 98.8 percentage of oxygen saturation | Standard Deviation 2.26 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: Loading - Pre-Dose | 0.0 percentage of oxygen saturation | Standard Deviation 0 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: Loading - 15 minutes | 0.0 percentage of oxygen saturation | Standard Deviation 0.33 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: Loading - 30 minutes | -0.3 percentage of oxygen saturation | Standard Deviation 1.45 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: 1 hour | -0.5 percentage of oxygen saturation | Standard Deviation 2.48 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: 2 hours | 0.1 percentage of oxygen saturation | Standard Deviation 1.1 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: 4 hours | -0.2 percentage of oxygen saturation | Standard Deviation 0.69 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: 8 hours | -0.1 percentage of oxygen saturation | Standard Deviation 1.45 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: 24 hours | 0.0 percentage of oxygen saturation | Standard Deviation 1.15 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 49-72 hours: 72 hours | -0.1 percentage of oxygen saturation | Standard Deviation 2.01 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 73-96 hours: 96 hours | -0.3 percentage of oxygen saturation | Standard Deviation 2.95 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 97-120 hours: 120 hours | -0.5 percentage of oxygen saturation | Standard Deviation 2.62 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Acute Follow-up: 121-144 hours | 0.1 percentage of oxygen saturation | Standard Deviation 2.11 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Acute Follow-up: 145-168 hours | -0.3 percentage of oxygen saturation | Standard Deviation 2.31 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Extended Follow-up: Day 8 | -0.5 percentage of oxygen saturation | Standard Deviation 2.58 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Extended Follow-up: Day 15 | -1.1 percentage of oxygen saturation | Standard Deviation 2.9 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Extended Follow-up: Day 22 | -6.9 percentage of oxygen saturation | Standard Deviation 22.32 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Extended Follow-up: Day 29 | -1.3 percentage of oxygen saturation | Standard Deviation 3.54 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Extended Follow-up: Day 15 | 0.4 percentage of oxygen saturation | Standard Deviation 0.55 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: Loading - 45 minutes | 0.2 percentage of oxygen saturation | Standard Deviation 1.92 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: 24 hours | -0.7 percentage of oxygen saturation | Standard Deviation 1.75 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 25-48 hours: 48 hours | 0.8 percentage of oxygen saturation | Standard Deviation 0.98 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Acute Follow-up: 145-168 hours | -0.8 percentage of oxygen saturation | Standard Deviation 2.86 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | Baseline | 98.6 percentage of oxygen saturation | Standard Deviation 1.67 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 49-72 hours: 72 hours | 0.3 percentage of oxygen saturation | Standard Deviation 1.97 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: Loading - Pre-Dose | 0.5 percentage of oxygen saturation | Standard Deviation 0.71 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Extended Follow-up: Day 29 | -1.2 percentage of oxygen saturation | Standard Deviation 1.3 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: Loading - 15 minutes | 0.2 percentage of oxygen saturation | Standard Deviation 0.45 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 73-96 hours: 96 hours | -0.8 percentage of oxygen saturation | Standard Deviation 2.48 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: Loading - 30 minutes | 0.4 percentage of oxygen saturation | Standard Deviation 1.52 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Extended Follow-up: Day 8 | -0.2 percentage of oxygen saturation | Standard Deviation 1.64 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: 1 hour | 0.0 percentage of oxygen saturation | Standard Deviation 1.55 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 97-120 hours: 120 hours | -1.3 percentage of oxygen saturation | Standard Deviation 2.34 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: 2 hours | -1.3 percentage of oxygen saturation | Standard Deviation 4.76 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Extended Follow-up: Day 22 | 0.6 percentage of oxygen saturation | Standard Deviation 1.52 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: 4 hours | 1.2 percentage of oxygen saturation | Standard Deviation 1.33 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Acute Follow-up: 121-144 hours | 0.0 percentage of oxygen saturation | Standard Deviation 1.58 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Oxygen Saturation | CFB at Infusion: 0-24 hours: 8 hours | 1.0 percentage of oxygen saturation | Standard Deviation 0.89 |
Primary
Change From Baseline in Vital Sign Parameter: Respiratory Rate
Vital signs included weight, heart rate, blood pressure (SBP and DBP), respiratory rate, temperature, oxygen saturation. CFB in respiratory rate is reported in this outcome measure.
Time frame: Baseline (Screening) to infusion at 0-24 hours:Loading-predose and at 15,30,45 minutes;1,2,4,8 and 24 hour;25-48: 48 hour;49-72:72 hours;73-96: 96 hour;97-120:120 hours;Acute follow-up at 121-144,145-168 hours;Extended follow-up at Days 8, 15, 22 and 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: Loading - 30 minutes | -0.3 breaths per min (breaths/min) | Standard Deviation 3.05 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: 24 hours | 0.3 breaths per min (breaths/min) | Standard Deviation 4.08 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | Baseline | 17.4 breaths per min (breaths/min) | Standard Deviation 4.66 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 25-48 hours: 48 hours | -0.1 breaths per min (breaths/min) | Standard Deviation 3.21 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: Loading - 45 minutes | -0.3 breaths per min (breaths/min) | Standard Deviation 2.64 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 49-72 hours: 72 hours | 1.6 breaths per min (breaths/min) | Standard Deviation 3.65 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Extended Follow-up: Day 15 | 3.7 breaths per min (breaths/min) | Standard Deviation 5.87 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 73-96 hours: 96 hours | 4.7 breaths per min (breaths/min) | Standard Deviation 6.87 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: 1 hour | 0.2 breaths per min (breaths/min) | Standard Deviation 2.24 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 97-120 hours: 120 hours | 2.5 breaths per min (breaths/min) | Standard Deviation 5.62 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: Loading - 15 minutes | 0.2 breaths per min (breaths/min) | Standard Deviation 2.39 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Acute Follow-up: 121-144 hours | 3.2 breaths per min (breaths/min) | Standard Deviation 4.25 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: 4 hours | 0.6 breaths per min (breaths/min) | Standard Deviation 1.98 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Acute Follow-up: 145-168 hours | 4.2 breaths per min (breaths/min) | Standard Deviation 6.08 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: 2 hours | 1.1 breaths per min (breaths/min) | Standard Deviation 2.78 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Extended Follow-up: Day 8 | 4.3 breaths per min (breaths/min) | Standard Deviation 5.94 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Extended Follow-up: Day 22 | 4.9 breaths per min (breaths/min) | Standard Deviation 4.32 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: 8 hours | -0.5 breaths per min (breaths/min) | Standard Deviation 2.14 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Extended Follow-up: Day 29 | 3.5 breaths per min (breaths/min) | Standard Deviation 6.35 |
| SAGE-547 Standard Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: Loading - Pre-Dose | 0.3 breaths per min (breaths/min) | Standard Deviation 2.75 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Extended Follow-up: Day 29 | 5.6 breaths per min (breaths/min) | Standard Deviation 11.28 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: Loading - Pre-Dose | -2.0 breaths per min (breaths/min) | Standard Deviation 1.41 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: 1 hour | 0.2 breaths per min (breaths/min) | Standard Deviation 1.47 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Extended Follow-up: Day 8 | 0.6 breaths per min (breaths/min) | Standard Deviation 3.05 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Extended Follow-up: Day 15 | 5.0 breaths per min (breaths/min) | Standard Deviation 6.4 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | Baseline | 13.4 breaths per min (breaths/min) | Standard Deviation 3.58 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: Loading - 15 minutes | -0.6 breaths per min (breaths/min) | Standard Deviation 0.89 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: Loading - 30 minutes | -1.0 breaths per min (breaths/min) | Standard Deviation 1.41 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: Loading - 45 minutes | 1.0 breaths per min (breaths/min) | Standard Deviation 2.65 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: 2 hours | 0.8 breaths per min (breaths/min) | Standard Deviation 1.33 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: 4 hours | -0.2 breaths per min (breaths/min) | Standard Deviation 1.33 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: 8 hours | -0.3 breaths per min (breaths/min) | Standard Deviation 1.86 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 0-24 hours: 24 hours | 0.7 breaths per min (breaths/min) | Standard Deviation 1.51 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 25-48 hours: 48 hours | -0.8 breaths per min (breaths/min) | Standard Deviation 3.66 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 49-72 hours: 72 hours | 1.0 breaths per min (breaths/min) | Standard Deviation 6.96 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 73-96 hours: 96 hours | 1.2 breaths per min (breaths/min) | Standard Deviation 6.97 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Infusion: 97-120 hours: 120 hours | 1.0 breaths per min (breaths/min) | Standard Deviation 4.9 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Acute Follow-up: 121-144 hours | 1.4 breaths per min (breaths/min) | Standard Deviation 5.77 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Acute Follow-up: 145-168 hours | 6.0 breaths per min (breaths/min) | Standard Deviation 6.32 |
| SAGE-547 High Dose | Change From Baseline in Vital Sign Parameter: Respiratory Rate | CFB at Extended Follow-up: Day 22 | 3.0 breaths per min (breaths/min) | Standard Deviation 6 |
Primary
Number of Participants With Prior Anti-epileptic Drugs (AEDs) and Pressors Usage
Prior AEDs and Pressors are those medications that ended before the initiation of SAGE-547 infusion.
Time frame: Up to Day 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAGE-547 Standard Dose | Number of Participants With Prior Anti-epileptic Drugs (AEDs) and Pressors Usage | 16 Participants |
| SAGE-547 High Dose | Number of Participants With Prior Anti-epileptic Drugs (AEDs) and Pressors Usage | 4 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAEs are defined as those that begin on or after initiation of the infusion of SAGE-547.
Time frame: Up to Day 29
Population: Safety population included all participants who were initiated with an infusion of SAGE-547.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAGE-547 Standard Dose | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 17 Participants |
| SAGE-547 High Dose | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 6 Participants |
Secondary
Areas Under the Plasma SAGE-547 Concentration Time Curves From the Start of the Infusion Until the Time to the Last Sample (AUClast)
Time frame: Pre-dose (0 hours), 1, 2, 4, 8, 24, 48, 72, 96, 104, 112, 120 and 144 hours post-dose
Population: PK population included all participants who received the study drug and had at least one PK sample taken. Overall number of participants analyzed is the number of participants with data available for analysis at the given time point for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAGE-547 Standard Dose | Areas Under the Plasma SAGE-547 Concentration Time Curves From the Start of the Infusion Until the Time to the Last Sample (AUClast) | 7677.6 hour*nanograms per milliliter (h*ng/mL) | Standard Deviation 2668.06 |
| SAGE-547 High Dose | Areas Under the Plasma SAGE-547 Concentration Time Curves From the Start of the Infusion Until the Time to the Last Sample (AUClast) | 14260.0 hour*nanograms per milliliter (h*ng/mL) | Standard Deviation 5048.01 |
Secondary
Area Under the Plasma SAGE-547 Concentration-Time Curve (AUC1-96)
Time frame: Pre-dose (0 hours), 1, 2, 4, 8, 24, 48, 72 and 96 hours post-dose
Population: PK population included all participants who received the study drug and had at least one PK sample taken. Overall number of participants analyzed is the number of participants with data available for analysis at the given time point for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAGE-547 Standard Dose | Area Under the Plasma SAGE-547 Concentration-Time Curve (AUC1-96) | 6290.6 h*ng/mL | Standard Deviation 2080.04 |
| SAGE-547 High Dose | Area Under the Plasma SAGE-547 Concentration-Time Curve (AUC1-96) | 10801.7 h*ng/mL | Standard Deviation 4006.7 |
Secondary
Area Under the Plasma SAGE-547 Concentration-Time Curve in a 24 Hour Period (AUC24)
Time frame: Pre-dose (0 hours), 1, 2, 4, 8 and 24 hours post-dose
Population: PK population included all participants who received the study drug and had at least one PK sample taken. Overall number of participants analyzed is the number of participants with data available for analysis at the given time point for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAGE-547 Standard Dose | Area Under the Plasma SAGE-547 Concentration-Time Curve in a 24 Hour Period (AUC24) | 1590.3 h*ng/mL | Standard Deviation 524.58 |
| SAGE-547 High Dose | Area Under the Plasma SAGE-547 Concentration-Time Curve in a 24 Hour Period (AUC24) | 2728.3 h*ng/mL | Standard Deviation 1010.14 |
Secondary
Average Plasma Concentration (Cav) of SAGE-547
Time frame: Pre-dose (0 hours), 1, 2, 4, 8, 24, 48, 72 and 96 hours post-dose
Population: PK population included all participants who received the study drug and had at least one PK sample taken. Overall number of participants analyzed is the number of participants with data available for analysis at the given time point for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAGE-547 Standard Dose | Average Plasma Concentration (Cav) of SAGE-547 | 66.22 ng/mL | Standard Deviation 21.929 |
| SAGE-547 High Dose | Average Plasma Concentration (Cav) of SAGE-547 | 113.62 ng/mL | Standard Deviation 42.079 |
Secondary
Change From Baseline in Clinical Global Impression: Severity Scale (CGI-S)
The CGI-Severity (CGI-S) scale employs a 7-point Likert scale to assess the severity of participant's current illness state. Clinician responded to a question Considering your total clinical experience with this particular population, how mentally ill is your patient at this time? on the following scores: 1 = Normal, not at all ill, 2 = Borderline ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, and 7 = Among the most extremely ill, where higher score = more affected.
Time frame: Baseline (Screening), Extended follow-up at Days 8, 15, 22, and 29
Population: Efficacy population included all participants who completed the SAGE-547 infusion and who had at least one attempt to wean the third-line agent(s) before the start of the taper of the SAGE-547 infusion. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Clinical Global Impression: Severity Scale (CGI-S) | CFB at Extended Follow-up: Day 8 | -1.1 score on a scale | Standard Deviation 1.06 |
| SAGE-547 Standard Dose | Change From Baseline in Clinical Global Impression: Severity Scale (CGI-S) | CFB at Extended Follow-up: Day 22 | -2.7 score on a scale | Standard Deviation 1.63 |
| SAGE-547 Standard Dose | Change From Baseline in Clinical Global Impression: Severity Scale (CGI-S) | CFB at Extended Follow-up: Day 15 | -2.3 score on a scale | Standard Deviation 1.22 |
| SAGE-547 Standard Dose | Change From Baseline in Clinical Global Impression: Severity Scale (CGI-S) | CFB at Extended Follow-up: Day 29 | -3.0 score on a scale | Standard Deviation 1.96 |
| SAGE-547 Standard Dose | Change From Baseline in Clinical Global Impression: Severity Scale (CGI-S) | Baseline | 6.9 score on a scale | Standard Deviation 0.25 |
| SAGE-547 High Dose | Change From Baseline in Clinical Global Impression: Severity Scale (CGI-S) | CFB at Extended Follow-up: Day 29 | -2.8 score on a scale | Standard Deviation 2.39 |
| SAGE-547 High Dose | Change From Baseline in Clinical Global Impression: Severity Scale (CGI-S) | Baseline | 6.8 score on a scale | Standard Deviation 0.41 |
| SAGE-547 High Dose | Change From Baseline in Clinical Global Impression: Severity Scale (CGI-S) | CFB at Extended Follow-up: Day 8 | -1.2 score on a scale | Standard Deviation 1.3 |
| SAGE-547 High Dose | Change From Baseline in Clinical Global Impression: Severity Scale (CGI-S) | CFB at Extended Follow-up: Day 15 | -1.8 score on a scale | Standard Deviation 1.79 |
| SAGE-547 High Dose | Change From Baseline in Clinical Global Impression: Severity Scale (CGI-S) | CFB at Extended Follow-up: Day 22 | -2.4 score on a scale | Standard Deviation 1.82 |
Secondary
Change From Baseline in Glasgow Coma Scale (GCS) Scores
The Glasgow Coma Scale is divided into three components which are scored separately: ocular response (assessment 1-4 points), motor response (assessment 1-6 points), verbal response (evaluation of 1-5 points). Scores for each component are added together to get the total score that will range between a minimum of 3 points (which corresponds to a participant who does not open his/her eyes and no motor response to stimulation or verbal response) and a maximum value of 15 points (corresponding to a participant with open eyes, obeying orders and maintaining a consistent language). It has been considered that the GCS score between 15 and 13 points corresponds to a slight alteration of consciousness, a score of 12-9 points with moderate impairment and 8 points or less with a serious deterioration in level of consciousness.
Time frame: Baseline (Screening) to infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Efficacy population included all participants who completed the SAGE-547 infusion and who had at least one attempt to wean the third-line agent(s) before the start of the taper of the SAGE-547 infusion. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | Baseline | 3.9 score on a scale | Standard Deviation 1.88 |
| SAGE-547 Standard Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Acute Follow-up: 121-144 hours | 3.3 score on a scale | Standard Deviation 3.3 |
| SAGE-547 Standard Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Infusion: 25-48 hours | -0.6 score on a scale | Standard Deviation 1.63 |
| SAGE-547 Standard Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Acute Follow-up: 145-168 hours | 3.9 score on a scale | Standard Deviation 3.98 |
| SAGE-547 Standard Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Extended Follow-up: Day 22 | 6.9 score on a scale | Standard Deviation 4.99 |
| SAGE-547 Standard Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Extended Follow-up: Day 8 | 3.9 score on a scale | Standard Deviation 4.53 |
| SAGE-547 Standard Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Infusion: 49-72 hours | 0.9 score on a scale | Standard Deviation 2.21 |
| SAGE-547 Standard Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Extended Follow-up: Day 15 | 6.7 score on a scale | Standard Deviation 4.73 |
| SAGE-547 Standard Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Infusion: 73-96 hours | 1.1 score on a scale | Standard Deviation 2.16 |
| SAGE-547 Standard Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Infusion: 0-24 hours | -0.4 score on a scale | Standard Deviation 1.26 |
| SAGE-547 Standard Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Extended Follow-up: Day 29 | 6.1 score on a scale | Standard Deviation 5.7 |
| SAGE-547 Standard Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Infusion: 97-120 hours | 2.4 score on a scale | Standard Deviation 3.16 |
| SAGE-547 High Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Extended Follow-up: Day 29 | 7.4 score on a scale | Standard Deviation 4.67 |
| SAGE-547 High Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | Baseline | 3.5 score on a scale | Standard Deviation 1.22 |
| SAGE-547 High Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Infusion: 0-24 hours | -0.2 score on a scale | Standard Deviation 0.45 |
| SAGE-547 High Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Infusion: 25-48 hours | -0.5 score on a scale | Standard Deviation 1.22 |
| SAGE-547 High Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Infusion: 73-96 hours | 1.3 score on a scale | Standard Deviation 2.42 |
| SAGE-547 High Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Infusion: 97-120 hours | 3.0 score on a scale | Standard Deviation 3.69 |
| SAGE-547 High Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Acute Follow-up: 121-144 hours | 3.3 score on a scale | Standard Deviation 3.93 |
| SAGE-547 High Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Acute Follow-up: 145-168 hours | 5.0 score on a scale | Standard Deviation 4.9 |
| SAGE-547 High Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Extended Follow-up: Day 8 | 5.0 score on a scale | Standard Deviation 4.9 |
| SAGE-547 High Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Extended Follow-up: Day 15 | 5.4 score on a scale | Standard Deviation 5.27 |
| SAGE-547 High Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Extended Follow-up: Day 22 | 6.4 score on a scale | Standard Deviation 4.83 |
| SAGE-547 High Dose | Change From Baseline in Glasgow Coma Scale (GCS) Scores | CFB at Infusion: 49-72 hours | 1.4 score on a scale | Standard Deviation 1.34 |
Secondary
Change From Baseline in Modified Rankin Scale (mRS-9Q) Scores
The mRS-9Q is a commonly used scale to determine disability and functional dependence due to neurological insult such as a stroke. It is a shortened version consisting of 9 questions. The score was categorized on the scale of 0 to 5 (0 = No symptoms, 1 = No significant disability, able to carry out all usual activities, despite some symptoms, 2 = Slight disability, able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability, requires some help, but able to walk unassisted, 4 = Moderately severe disability, unable to attend to own bodily needs without assistance or unable to walk unassisted, and 5 = Severe disability, requires constant nursing care and attention, bedridden). Higher scores indicated worsening of symptoms.
Time frame: Baseline (Screening) to Infusion at 49-72 hour, 73-96 hour; Extended follow-up at Day 8, 15, 22 and 29
Population: Efficacy population included all participants who completed the SAGE-547 infusion and who had at least one attempt to wean the third-line agent(s) before the start of the taper of the SAGE-547 infusion. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Modified Rankin Scale (mRS-9Q) Scores | CFB at Extended Follow-up: Day 29 | -0.9 score on a scale | Standard Deviation 1.5 |
| SAGE-547 Standard Dose | Change From Baseline in Modified Rankin Scale (mRS-9Q) Scores | Baseline | 5.0 score on a scale | Standard Deviation 0 |
| SAGE-547 Standard Dose | Change From Baseline in Modified Rankin Scale (mRS-9Q) Scores | CBF at Infusion: 49-72 hours | 0.0 score on a scale | Standard Deviation 0 |
| SAGE-547 Standard Dose | Change From Baseline in Modified Rankin Scale (mRS-9Q) Scores | CFB at Infusion: 73-96 hours | 0.0 score on a scale | Standard Deviation 0 |
| SAGE-547 Standard Dose | Change From Baseline in Modified Rankin Scale (mRS-9Q) Scores | CFB at Extended Follow-up: Day 8 | -0.1 score on a scale | Standard Deviation 0.26 |
| SAGE-547 Standard Dose | Change From Baseline in Modified Rankin Scale (mRS-9Q) Scores | CFB at Extended Follow-up: Day 15 | -0.1 score on a scale | Standard Deviation 0.35 |
| SAGE-547 Standard Dose | Change From Baseline in Modified Rankin Scale (mRS-9Q) Scores | CFB at Extended Follow-up: Day 22 | -0.4 score on a scale | Standard Deviation 0.74 |
| SAGE-547 High Dose | Change From Baseline in Modified Rankin Scale (mRS-9Q) Scores | CFB at Infusion: 73-96 hours | 0.0 score on a scale | Standard Deviation 0 |
| SAGE-547 High Dose | Change From Baseline in Modified Rankin Scale (mRS-9Q) Scores | CFB at Extended Follow-up: Day 22 | -0.5 score on a scale | Standard Deviation 0.58 |
| SAGE-547 High Dose | Change From Baseline in Modified Rankin Scale (mRS-9Q) Scores | CFB at Extended Follow-up: Day 29 | -1.0 score on a scale | Standard Deviation 1.41 |
| SAGE-547 High Dose | Change From Baseline in Modified Rankin Scale (mRS-9Q) Scores | CFB at Extended Follow-up: Day 15 | -0.3 score on a scale | Standard Deviation 0.5 |
| SAGE-547 High Dose | Change From Baseline in Modified Rankin Scale (mRS-9Q) Scores | Baseline | 5.0 score on a scale | Standard Deviation 0 |
| SAGE-547 High Dose | Change From Baseline in Modified Rankin Scale (mRS-9Q) Scores | CFB at Extended Follow-up: Day 8 | 0.0 score on a scale | Standard Deviation 0 |
| SAGE-547 High Dose | Change From Baseline in Modified Rankin Scale (mRS-9Q) Scores | CBF at Infusion: 49-72 hours | 0.0 score on a scale | Standard Deviation 0 |
Secondary
Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score
The RASS was an assessment of agitation and sedation in hospitalized participants, using a 10 point scale (ranged from -5 to +4), where, -5 = Unarousable, -4 = Deep sedation, -3 = Moderate sedation, -2 = Light sedation, -1 = Drowsy, 0 = Alert and calm, +1 = Restless, +2 = Agitated, +3 = Very agitated and +4 = Combative. Lower scores signify higher levels of sedation and higher scores signify heightened agitation. Participant in a calm and alert state would score a 0.
Time frame: Baseline (Screening) to Infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Efficacy population included all participants who completed the SAGE-547 infusion and who had at least one attempt to wean the third-line agent(s) before the start of the taper of the SAGE-547 infusion. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | Baseline | -4.8 score on a scale | Standard Deviation 0.54 |
| SAGE-547 Standard Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Infusion: 0-24 hours | -0.1 score on a scale | Standard Deviation 0.25 |
| SAGE-547 Standard Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Infusion: 97-120 hours | 1.4 score on a scale | Standard Deviation 1.59 |
| SAGE-547 Standard Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Infusion: 25-48 hours | -0.1 score on a scale | Standard Deviation 0.44 |
| SAGE-547 Standard Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Infusion: 49-72 hours | 0.5 score on a scale | Standard Deviation 1.32 |
| SAGE-547 Standard Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Infusion: 73-96 hours | 0.9 score on a scale | Standard Deviation 1.41 |
| SAGE-547 Standard Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Acute Follow-up: 121-144 hours | 2.0 score on a scale | Standard Deviation 1.97 |
| SAGE-547 Standard Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Acute Follow-up: 145-168 hours | 2.3 score on a scale | Standard Deviation 2.24 |
| SAGE-547 Standard Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Extended Follow-up: Day 8 | 2.3 score on a scale | Standard Deviation 2.16 |
| SAGE-547 Standard Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Extended Follow-up: Day 15 | 3.3 score on a scale | Standard Deviation 1.79 |
| SAGE-547 Standard Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Extended Follow-up: Day 22 | 3.4 score on a scale | Standard Deviation 1.91 |
| SAGE-547 Standard Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Extended Follow-up: Day 29 | 3.0 score on a scale | Standard Deviation 2.22 |
| SAGE-547 High Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Extended Follow-up: Day 22 | 2.8 score on a scale | Standard Deviation 2.17 |
| SAGE-547 High Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Acute Follow-up: 121-144 hours | 1.3 score on a scale | Standard Deviation 1.97 |
| SAGE-547 High Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Infusion: 49-72 hours | 0.8 score on a scale | Standard Deviation 1.3 |
| SAGE-547 High Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Extended Follow-up: Day 15 | 2.2 score on a scale | Standard Deviation 1.92 |
| SAGE-547 High Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Infusion: 97-120 hours | 1.3 score on a scale | Standard Deviation 1.75 |
| SAGE-547 High Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | Baseline | -4.8 score on a scale | Standard Deviation 0.41 |
| SAGE-547 High Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Infusion: 0-24 hours | 0.0 score on a scale | Standard Deviation 0 |
| SAGE-547 High Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Acute Follow-up: 145-168 hours | 1.4 score on a scale | Standard Deviation 1.67 |
| SAGE-547 High Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Infusion: 25-48 hours | 0.0 score on a scale | Standard Deviation 0 |
| SAGE-547 High Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Extended Follow-up: Day 29 | 2.8 score on a scale | Standard Deviation 2.17 |
| SAGE-547 High Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Extended Follow-up: Day 8 | 2.4 score on a scale | Standard Deviation 2.61 |
| SAGE-547 High Dose | Change From Baseline in Richmond Agitation Sedation Scale (RASS) Score | CFB at Infusion: 73-96 hours | 0.7 score on a scale | Standard Deviation 1.21 |
Secondary
Clinical Global Impression: Improvement Scale (CGI-I) Scores
The CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved). CGI-I item employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse; where higher scores indicated worst outcomes. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions.
Time frame: Infusion at 0-24, 25-48, 49-72, 73-96, 97-120 hours; Acute follow-up at 121-144, 145-168 hours; Extended follow-up at Days 8, 15, 22 and 29
Population: Efficacy population included all participants who completed the SAGE-547 infusion and who had at least one attempt to wean the third-line agent(s) before the start of the taper of the SAGE-547 infusion. Number analyzed is the number of participants with data available for analyses at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAGE-547 Standard Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Infusion: 49-72 hours | 3.6 score on a scale | Standard Deviation 0.81 |
| SAGE-547 Standard Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Infusion: 25-48 hours | 4.0 score on a scale | Standard Deviation 0.52 |
| SAGE-547 Standard Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Acute Follow-up: 145-168 hours | 3.2 score on a scale | Standard Deviation 1.52 |
| SAGE-547 Standard Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Infusion: 73-96 hours | 3.1 score on a scale | Standard Deviation 0.81 |
| SAGE-547 Standard Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Extended Follow-up: Day 8 | 2.9 score on a scale | Standard Deviation 1.53 |
| SAGE-547 Standard Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Extended Follow-up: Day 15 | 2.2 score on a scale | Standard Deviation 1.21 |
| SAGE-547 Standard Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Infusion: 0-24 hours | 4.0 score on a scale | Standard Deviation 0.37 |
| SAGE-547 Standard Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Extended Follow-up: Day 22 | 2.3 score on a scale | Standard Deviation 1.58 |
| SAGE-547 Standard Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Infusion: 97-120 hours | 2.9 score on a scale | Standard Deviation 0.81 |
| SAGE-547 Standard Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Extended Follow-up: Day 29 | 2.6 score on a scale | Standard Deviation 1.89 |
| SAGE-547 Standard Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Acute Follow-up: 121-144 hours | 3.3 score on a scale | Standard Deviation 1.3 |
| SAGE-547 High Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Extended Follow-up: Day 29 | 2.4 score on a scale | Standard Deviation 2.61 |
| SAGE-547 High Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Extended Follow-up: Day 8 | 2.8 score on a scale | Standard Deviation 1.1 |
| SAGE-547 High Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Infusion: 0-24 hours | 4.0 score on a scale | Standard Deviation 0 |
| SAGE-547 High Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Infusion: 25-48 hours | 4.5 score on a scale | Standard Deviation 0.84 |
| SAGE-547 High Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Infusion: 49-72 hours | 3.6 score on a scale | Standard Deviation 0.89 |
| SAGE-547 High Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Infusion: 73-96 hours | 3.7 score on a scale | Standard Deviation 1.37 |
| SAGE-547 High Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Infusion: 97-120 hours | 3.0 score on a scale | Standard Deviation 1.1 |
| SAGE-547 High Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Acute Follow-up: 121-144 hours | 4.0 score on a scale | Standard Deviation 1.41 |
| SAGE-547 High Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Acute Follow-up: 145-168 hours | 3.2 score on a scale | Standard Deviation 1.92 |
| SAGE-547 High Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Extended Follow-up: Day 15 | 2.4 score on a scale | Standard Deviation 1.14 |
| SAGE-547 High Dose | Clinical Global Impression: Improvement Scale (CGI-I) Scores | Extended Follow-up: Day 22 | 2.6 score on a scale | Standard Deviation 1.95 |
Secondary
Duration of Response
Duration of response was defined as the time from the stop date/time of SAGE-547 maintenance to re-initiation of a third-line agent. If no re-initiation of a third-line agent was required, duration of response was not estimable and censored at Day 29 or death date, whichever occurred first. Kaplan-Meier method was used for the analysis.
Time frame: Up to Day 29
Population: Efficacy population included all participants who completed the SAGE-547 infusion and who had at least one attempt to wean the third-line agent(s) before the start of the taper of the SAGE-547 infusion.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SAGE-547 Standard Dose | Duration of Response | NA days |
| SAGE-547 High Dose | Duration of Response | NA days |
Secondary
Maximum Plasma Concentration (Cmax) of SAGE-547
Time frame: Pre-dose (0 hours), 1, 2, 4, 8, 24, 48, 72, 96, 104, 112, 120 and 144 hours post-dose
Population: Pharmacokinetic (PK) population included all participants who received the study drug and had at least one PK sample taken. Overall number of participants analyzed is the number of participants with data available for analysis at the given time point for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAGE-547 Standard Dose | Maximum Plasma Concentration (Cmax) of SAGE-547 | 144.24 nanograms per milliliter (ng/mL) | Standard Deviation 65.263 |
| SAGE-547 High Dose | Maximum Plasma Concentration (Cmax) of SAGE-547 | 200.82 nanograms per milliliter (ng/mL) | Standard Deviation 71 |
Secondary
Number of Participants Who Survived
Survival time was defined as duration of survival from screening up to Day 29.
Time frame: Up to Day 29
Population: Efficacy population included all participants who completed the SAGE-547 infusion and who had at least one attempt to wean the third-line agent(s) before the start of the taper of the SAGE-547 infusion.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAGE-547 Standard Dose | Number of Participants Who Survived | 13 Participants |
| SAGE-547 High Dose | Number of Participants Who Survived | 5 Participants |
Secondary
Number of Participants With Relapse - Re-Initiation of Third-Line Agent
Relapse of participants is defined as successfully weaning from a continuous IV third-line agent but subsequent requirement of re-initiation of a third-line agent following conclusion of SAGE-547 treatment.
Time frame: Up to Day 29
Population: Efficacy population included all participants who completed the SAGE-547 infusion and who had at least one attempt to wean the third-line agent(s) before the start of the taper of the SAGE-547 infusion.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAGE-547 Standard Dose | Number of Participants With Relapse - Re-Initiation of Third-Line Agent | 5 Participants |
| SAGE-547 High Dose | Number of Participants With Relapse - Re-Initiation of Third-Line Agent | 1 Participants |
Secondary
Number of Participants With Treatment Response (Treatment Responders)
A responder was defined as a participant for whom it was not required to re-initiate continuous IV third-line therapy for refractory seizure control during the administration of SAGE-547 at the maintenance dose (prior to SAGE-547 taper infusion).
Time frame: Up to 96 hours
Population: Efficacy population included all participants who completed the SAGE-547 infusion and who had at least one attempt to wean the third-line agent(s) before the start of the taper of the SAGE-547 infusion.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAGE-547 Standard Dose | Number of Participants With Treatment Response (Treatment Responders) | 13 Participants |
| SAGE-547 High Dose | Number of Participants With Treatment Response (Treatment Responders) | 4 Participants |
Secondary
Plasma Clearance (CL) of SAGE-547
Clearance is defined as the volume of plasma from which a substance is completely removed per unit time.
Time frame: Pre-dose (0 hours), 1, 2, 4, 8, 24, 48, 72, 96, 104, 112, 120 and 144 hours post-dose
Population: PK population included all participants who received the study drug and had at least one PK sample taken. Overall number of participants analyzed is the number of participants with data available for analysis at the given time point for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAGE-547 Standard Dose | Plasma Clearance (CL) of SAGE-547 | 1.3999 liters per hour per kilogram (L/h/kg) | Standard Deviation 0.54525 |
| SAGE-547 High Dose | Plasma Clearance (CL) of SAGE-547 | 1.2487 liters per hour per kilogram (L/h/kg) | Standard Deviation 0.65351 |
Secondary
Time to Attain Maximum Observed Plasma Concentration (Tmax) of SAGE-547
Time frame: Pre-dose (0 hours), 1, 2, 4, 8, 24, 48, 72, 96, 104, 112, 120 and 144 hours post-dose
Population: PK population included all participants who received the study drug and had at least one PK sample taken. Overall number of participants analyzed is the number of participants with data available for analysis at the given time point for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SAGE-547 Standard Dose | Time to Attain Maximum Observed Plasma Concentration (Tmax) of SAGE-547 | 1.010 hours |
| SAGE-547 High Dose | Time to Attain Maximum Observed Plasma Concentration (Tmax) of SAGE-547 | 60.150 hours |