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This is a two-part (open-label followed by double-blind) study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in 102 participants diagnosed with moderate to severe Major Depressive Disorder.
Part A of the study is an open-label design with dosing of SAGE-217 for 14 days.
Part B of the study is a randomized, double-blind, parallel-group, placebo-controlled design. Eligible participants were randomized to SAGE-217 or placebo for 14 days.
This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: SAGE-217 | Experimental | Participants received SAGE-217, 30 milligrams (mg), oral solution, once daily for 14 days, as tolerated. |
|
| Part B: Placebo | Placebo Comparator | Eligible participants received matching placebo capsules once daily for 14 days. |
|
| Part B: SAGE-217 | Experimental | Eligible participants received SAGE-217, 30 mg, oral capsules, once daily for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAGE-217 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part A | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was defined as an adverse event with onset after the start of study drug, or any worsening of a pre-existing medical condition/adverse event with onset after the start of study drug and until 7 days after the last dose. The analysis was performed in participants included in Part A of the study. | Day 1 up to Day 21 |
| Percentage of Participants With TEAEs, Graded by Severity - Part A | Severity was assessed according to the following scale: mild (awareness of sign or symptom, but easily tolerated); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with inability to perform normal activities). The analysis was performed in participants included in Part A of the study. | Day 1 up to Day 21 |
| Change From Baseline in Basophils - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Basophils to Leukocytes Ratio [Percentage (%)] - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as International System (SI) unit, percentage (%). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the HAM-D Total Score at Day 15 and All Other Time Points - Part A | The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicate a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sage Investigational Site | Garden Grove | California | 92845 | United States | ||
| Sage Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31483961 | Background | Gunduz-Bruce H, Silber C, Kaul I, Rothschild AJ, Riesenberg R, Sankoh AJ, Li H, Lasser R, Zorumski CF, Rubinow DR, Paul SM, Jonas J, Doherty JJ, Kanes SJ. Trial of SAGE-217 in Patients with Major Depressive Disorder. N Engl J Med. 2019 Sep 5;381(10):903-911. doi: 10.1056/NEJMoa1815981. | |
| 35378149 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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In Part A, 21 participants were screened; 13 received at least one dose of study drug. In Part B, 169 participants were screened; 89 received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: SAGE-217 | Participants received SAGE-217, 30 milligrams (mg), oral solution, once daily for 14 days, as tolerated. |
| FG001 | Part B: Placebo | Eligible participants received matching placebo capsules once daily for 14 days. |
| FG002 | Part B: SAGE-217 | Eligible participants received SAGE-217, 30 mg, oral capsules, once daily for 14 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The safety set included all participants who received at least one dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: SAGE-217 | Participants received SAGE-217, 30 mg, oral solution, once daily for 14 days, as tolerated. |
| BG001 | Part B: Placebo | Eligible participants received matching placebo capsules once daily for 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part A | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was defined as an adverse event with onset after the start of study drug, or any worsening of a pre-existing medical condition/adverse event with onset after the start of study drug and until 7 days after the last dose. The analysis was performed in participants included in Part A of the study. | The safety set included all participants who received at least one dose of the study drug. | Posted | Number | percentage of participants | Day 1 up to Day 21 |
|
Part A: Up to Day 21; Part B: Up to Day 21 and from Day 21 up to Day 42
AEs included TEAEs and AEs that occurred during post-TEAE period. TEAE was defined as adverse event with onset after the start of study drug, or any worsening of a pre-existing medical condition/adverse event with onset after the start of study drug and until 7 days after the last dose. Post-TEAE period was defined as 7 days after final study drug dose through last follow-up. The safety set included all participants who received at least one dose of the study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: SAGE-217 | Participants received SAGE-217, 30 mg, oral solution, once daily for 14 days, as tolerated. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| US Biogen Clinical Trial Center | Biogen | 866-633-4636 | clinicaltrials@biogen.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 13, 2017 | Sep 24, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 16, 2017 | Sep 24, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| C000634505 | zuranolone |
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| Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Eosinophils - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Hematocrit - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Hemoglobin - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Lymphocytes - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Monocytes - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Neutrophils - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Platelets - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Erythrocytes - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Reticulocytes - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Leukocytes - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Albumin - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Alkaline Phosphatase - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Alanine Aminotransferase - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Aspartate Aminotransferase - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Bilirubin - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Chloride - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Carbon Dioxide - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Creatinine - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Potassium - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Protein - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Sodium - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Urea Nitrogen - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Activated Partial Thromboplastin Time - Part A | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Prothrombin International Normalized Ratio (%) - Part A | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The data for prothrombin international normalized ratio are presented as SI unit, percentage (%). | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Prothrombin Time - Part A | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in pH - Part A | Urinalysis measures included pH and specific gravity. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline in Specific Gravity - Part A | Urinalysis measures included pH and specific gravity. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline (CFB) in Heart Rate - Part A | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline (CFB) in Respiratory Rate - Part A | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline (CFB) in Oral Temperature - Part A | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 |
| Change From Baseline (CFB) in Oxygen Saturation - Part A | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Day 8 (predose, 1 hour postdose) |
| Change From Baseline in QT Interval - Part A | Electrocardiogram (ECG) measures included QT interval, QTc based on Fridericia formula (QTcF interval), ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
| Change From Baseline in QTcF Interval - Part A | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
| Change From Baseline in ECG Mean Heart Rate - Part A | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
| Change From Baseline in RR Interval - Part A | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
| Change From Baseline in PR Interval - Part A | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
| Change From Baseline in QRS Interval - Part A | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
| Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Item - Part A | The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation (SI) and behavior and a postbaseline evaluation that focused on suicidality since the last study visit. The C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with specific plan. The analysis was performed in participants included in Part A of the study. | Day 1 up to Day 28 |
| Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 15 - Part A | The SSS was participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of one to seven, where the lowest score of 'one' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of 'seven' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. A negative change from baseline indicated less sleepiness. A positive change from baseline indicated more sleepiness. The analysis was performed in participants included in Part A of the study. | Baseline, Day 15 |
| Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 - Part B | The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study. | Baseline, Day 15 |
| Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 |
| Percentage of Participants With TEAEs - Part B | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an adverse event with onset after the start of study drug, or any worsening of a pre-existing medical condition/adverse event with onset after the start of study drug and until 7 days after the last dose. The analysis was performed in participants included in Part B of the study. | Day 1 up to Day 21 |
| Percentage of Participants With AEs During Post-TEAE Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAE was defined as an adverse event with onset after the start of study drug, or any worsening of a pre-existing medical condition/adverse event with onset after the start of study drug and until 7 days after the last dose. Post-TEAE period was defined as 7 days after final dose through last follow-up (Day 42). The analysis was performed in participants included in Part B of the study. | Day 21 up to Day 42 |
| Percentage of Participants With TEAEs, Graded by Severity - Part B | Severity was assessed according to the following scale: mild (awareness of sign or symptom, but easily tolerated); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with inability to perform normal activities). The analysis was performed in participants included in Part B of the study. | Day 1 up to Day 21 |
| Change From Baseline in Basophils - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Eosinophils - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Hematocrit - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Hemoglobin - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Lymphocytes - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Monocytes - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Neutrophils - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Platelets - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Erythrocytes - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Reticulocytes - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET |
| Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Leukocytes - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Albumin - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Alkaline Phosphatase - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Alanine Aminotransferase - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Aspartate Aminotransferase - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Bilirubin - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Calcium - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Chloride - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Carbon Dioxide - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Creatinine - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Glucose - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Potassium - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Magnesium - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Phosphate - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Protein - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Sodium - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Thyrotropin - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Urea Nitrogen - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Activated Partial Thromboplastin Time - Part B | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The data for prothrombin international normalized ratio are presented as SI unit, percentage (%). | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Prothrombin Time - Part B | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in pH - Part B | Urinalysis measures included pH and specific gravity. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline in Specific Gravity - Part B | Urinalysis measures included pH and specific gravity. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline (CFB) in Heart Rate - Part B | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline (CFB) in Respiratory Rate - Part B | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline (CFB) in Oral Temperature - Part B | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 |
| Change From Baseline (CFB) in Oxygen Saturation - Part B | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Day 8 (predose, 1 hour postdose) |
| Change From Baseline in QT Interval - Part B | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
| Change From Baseline in QTcF Interval - Part B | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
| Change From Baseline in ECG Mean Heart Rate - Part B | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
| Change From Baseline in RR Interval - Part B | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
| Change From Baseline in PR Interval - Part B | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
| Change From Baseline in QRS Duration - Part B | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
| Percentage of Participants With a Response of "Yes" to Any C-SSRS Suicidal Ideation (SI) Item - Part B | The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation and behavior and a postbaseline evaluation that focused on suicidality since the last study visit. The C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with specific plan. The analysis was performed in participants included in Part B of the study. SCLR = screening: lifetime recall. | Screening, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 15, 21, 28, 35 and 42 |
| Percentage of Participants With HAM-D Response - Part A | HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score. The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicate a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of the study. Data is reported for participants who had HAM-D response. | Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 |
| Percentage of Participants With HAM-D Remission - Part A | HAM-D remission was defined as having a HAM-D total score of ≤7. The HAM-D total score comprised a sum of the 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of the study. | Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 |
| Change From Baseline in the Montgomery and Ã…sberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part A | The MADRS was a ten-item diagnostic questionnaire which psychiatrists used to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicated more severe depression. A negative change from baseline indicated less severe depression. A positive change from baseline indicated more severe depression. The analysis was performed in participants included in Part A of the study. | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 |
| Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | HAM-D subscales were: Core, symptoms: depressed mood (DM), feelings of guilt (FG), suicide, work and activities (WA), and retardation (RE); Anxiety, symptoms: anxiety (psychic and somatic), somatic symptoms (SS) (gastrointestinal and general), hypochondriasis, and loss of weight; Bech-6, symptoms: DM, FG, WA, RE, anxiety psychic (AP), and SS general; and Maier, symptoms: DM, FG, WA, RE, agitation, and AP. Each item was scored in a range of 0 to 2 or 0 to 4. Higher scores indicated a greater degree of depression. Subscale scores were calculated as sum of individual rating scores related to each subscale, divided by total possible score within subscale, multiplied by 100, and rounded to a whole number. Therefore, subscale scores would be within range of 0-100 and might be larger than total score. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of study. | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 |
| Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | The HAM-D comprised individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms [gastrointestinal (GI) and general], genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of the study. | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 |
| Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points - Part A | The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms, and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scoring for HAM-A was calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56, where 0-13=Normal, 14-17 Mild Anxiety, 18-24 Moderate Anxiety, >=25 Severe Anxiety, per the Psych Congress Network. The HAM-A total score was calculated as the sum of the 14 individual item scores. A negative change from baseline indicated less anxiety. A positive change from baseline indicated more anxiety. The analysis was performed in participants included in Part A of the study. | Baseline, Days 2, 3, 8, 15, 21 and 28 |
| Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response - Part A | The CGI-I item employed 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. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions. CGI-I response was defined as having a CGI-I global improvement score of 1 (very much improved) or 2 (much improved). The analysis was performed in participants included in Part A of the study. Data is reported for participants who had CGI-I response. | Days 2, 3, 8, 15, 21 and 28 |
| Change From Baseline (CFB) in the SSS Score - Part B | The SSS was participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of one to seven, where the lowest score of 'one' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of 'seven' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. A negative change from baseline indicated less sleepiness. A positive change from baseline indicated more sleepiness. The analysis was performed in participants included in Part B of the study. H = Hour(s). | Baseline, Day 1 (0.25, 0.5, 1, 2 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15 |
| Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study. | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21, 28, 35 and 42 |
| Percentage of Participants With HAM-D Response - Part B | HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score. The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study. Data is reported for participants who had HAM-D response. | Days 2, 8, 15, 21, 28, 35 and 42 |
| Percentage of Participants With HAM-D Remission - Part B | HAM-D remission was defined as having a HAM-D total score of ≤7. The HAM-D total score comprised a sum of the 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study. | Days 2, 8, 15, 21, 28, 35 and 42 |
| Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B | The MADRS was a ten-item diagnostic questionnaire which psychiatrists used to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicated more severe depression. A negative change from baseline indicated less severe depression. A positive change from baseline indicated more severe depression. The analysis was performed in participants included in Part B of the study. | Baseline, Days 2, 8, 15, 21, 28, 35 and 42 |
| Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | HAM-D subscales were: Core, symptoms: depressed mood (DM), feelings of guilt (FG), suicide, work and activities (WA), and retardation (RE); Anxiety, symptoms: anxiety (psychic and somatic), somatic symptoms (SS) (gastrointestinal and general), hypochondriasis, and loss of weight; Bech-6, symptoms: DM, FG, WA, RE, anxiety psychic (AP), and SS general; and Maier, symptoms: DM, FG, WA, RE, agitation, and AP. Each item was scored in a range of 0 to 2 or 0 to 4. Higher scores indicated a greater degree of depression. Subscale scores were calculated as sum of individual rating scores related to each subscale, divided by total possible score within subscale, multiplied by 100, and rounded to a whole number. Therefore, subscale scores would be within range of 0-100 and might be larger than total score. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of study. | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21, 28, 35 and 42 |
| Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | The HAM-D comprised individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (GI and general), genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study. | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21, 28, 35 and 42 |
| Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B | The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms, and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scoring for HAM-A was calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56, where 0-13=Normal, 14-17 Mild Anxiety, 18-24 Moderate Anxiety, >=25 Severe Anxiety, per the Psych Congress Network. The HAM-A total score was calculated as the sum of the 14 individual item scores. A negative change from baseline indicated less anxiety. A positive change from baseline indicated more anxiety. The analysis was performed in participants included in Part B of the study. | Baseline, Days 2, 8, 15, 21, 28, 35 and 42 |
| Percentage of Participants With CGI-I Response - Part B | The CGI-I item employed 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. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions. CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved). The analysis was performed in participants included in Part B of the study. Data is reported for participants who had CGI-I response. | Days 2, 8, 15, 21, 28, 35 and 42 |
| Orlando |
| Florida |
| 32806 |
| United States |
| Sage Investigational Site | Atlanta | Georgia | 30331 | United States |
| Sage Investigational Site | Lake Charles | Louisiana | 70629 | United States |
| Sage Investigational Site | Berlin | New Jersey | 08009 | United States |
| Sage Investigational Site | Dayton | Ohio | 45417 | United States |
| Sage Investigational Site | Austin | Texas | 78754 | United States |
| Sage Investigational Site | Charlottesville | Virginia | 22908 | United States |
| Suthoff E, Kosinski M, Arnaud A, Hodgkins P, Gunduz-Bruce H, Lasser R, Silber C, Sankoh AJ, Li H, Werneburg B, Jonas J, Doherty J, Kanes SJ, Bonthapally V. Patient-reported health-related quality of life from a randomized, placebo-controlled phase 2 trial of zuranolone in adults with major depressive disorder. J Affect Disord. 2022 Jul 1;308:19-26. doi: 10.1016/j.jad.2022.03.068. Epub 2022 Apr 2. |
| Withdrawal by Subject |
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| BG002 | Part B: SAGE-217 | Eligible participants received SAGE-217, 30 mg, oral capsules, once daily for 14 days. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score - Part B | The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. | The efficacy set included all participants who were randomized and received at least one dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation in Part B. | Mean | Standard Deviation | score on a scale |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Percentage of Participants With TEAEs, Graded by Severity - Part A | Severity was assessed according to the following scale: mild (awareness of sign or symptom, but easily tolerated); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with inability to perform normal activities). The analysis was performed in participants included in Part A of the study. | The safety set included all participants who received at least one dose of the study drug. | Posted | Number | percentage of participants | Day 1 up to Day 21 |
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| Primary | Change From Baseline in Basophils - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | 10^9 cells per liter (10^9 cells/L) | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Basophils to Leukocytes Ratio [Percentage (%)] - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as International System (SI) unit, percentage (%). | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | percentage | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Eosinophils - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | percentage | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Hematocrit - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | fraction of one | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Hemoglobin - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | grams per liter (g/L) | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Lymphocytes - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | percentage | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Monocytes - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | percentage | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Neutrophils - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | percentage | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Platelets - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Erythrocytes - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | 10^12 cells per liter (10^12 cells/L) | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Reticulocytes - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Leukocytes - Part A | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Albumin - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | g/L | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Alkaline Phosphatase - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | units per liter (U/L) | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Alanine Aminotransferase - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | U/L | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Aspartate Aminotransferase - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | U/L | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Bilirubin - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | micro-moles per liter (umol/L) | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Chloride - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | milli-moles per liter (mmol/L) | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Carbon Dioxide - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Creatinine - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | umol/L | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Potassium - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Protein - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | g/L | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Sodium - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Urea Nitrogen - Part A | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Activated Partial Thromboplastin Time - Part A | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Median | Full Range | seconds | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part A | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The data for prothrombin international normalized ratio are presented as SI unit, percentage (%). | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | percentage | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Prothrombin Time - Part A | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Median | Full Range | seconds | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in pH - Part A | Urinalysis measures included pH and specific gravity. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | pH | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline in Specific Gravity - Part A | Urinalysis measures included pH and specific gravity. The analysis was performed in participants included in Part A of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | ratio | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit. | Posted | Mean | Standard Deviation | millimeter of mercury (mmHg) | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit. | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit. | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit. | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline (CFB) in Heart Rate - Part A | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit. | Posted | Mean | Standard Deviation | beats per minute (beats/min) | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline (CFB) in Respiratory Rate - Part A | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit. | Posted | Mean | Standard Deviation | breaths per minute (breaths/min) | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline (CFB) in Oral Temperature - Part A | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit. | Posted | Mean | Standard Deviation | degrees Celsius (degrees C) | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 |
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| Primary | Change From Baseline (CFB) in Oxygen Saturation - Part A | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit. | Posted | Mean | Standard Deviation | percentage of oxygen saturation | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Day 8 (predose, 1 hour postdose) |
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| Primary | Change From Baseline in QT Interval - Part A | Electrocardiogram (ECG) measures included QT interval, QTc based on Fridericia formula (QTcF interval), ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit. | Posted | Median | Full Range | milliseconds (msec) | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
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| Primary | Change From Baseline in QTcF Interval - Part A | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit. | Posted | Median | Full Range | msec | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
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| Primary | Change From Baseline in ECG Mean Heart Rate - Part A | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit. | Posted | Mean | Standard Deviation | beats/min | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
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| Primary | Change From Baseline in RR Interval - Part A | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit. | Posted | Median | Full Range | msec | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
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| Primary | Change From Baseline in PR Interval - Part A | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit. | Posted | Median | Full Range | msec | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
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| Primary | Change From Baseline in QRS Interval - Part A | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit. | Posted | Median | Full Range | msec | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
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| Primary | Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Item - Part A | The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation (SI) and behavior and a postbaseline evaluation that focused on suicidality since the last study visit. The C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with specific plan. The analysis was performed in participants included in Part A of the study. | The safety set included all participants who received at least one dose of the study drug. | Posted | Number | percentage of participants | Day 1 up to Day 28 |
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| Primary | Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 15 - Part A | The SSS was participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of one to seven, where the lowest score of 'one' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of 'seven' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. A negative change from baseline indicated less sleepiness. A positive change from baseline indicated more sleepiness. The analysis was performed in participants included in Part A of the study. | The safety set included all participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 15 |
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| Primary | Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 - Part B | The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study. | The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Day 15 |
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| Secondary | Change From Baseline in the HAM-D Total Score at Day 15 and All Other Time Points - Part A | The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicate a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of the study. | The efficacy set included all participants who received at least one dose of the study drug and had a baseline and at least one postbaseline efficacy evaluation. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 |
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| Secondary | Percentage of Participants With TEAEs - Part B | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an adverse event with onset after the start of study drug, or any worsening of a pre-existing medical condition/adverse event with onset after the start of study drug and until 7 days after the last dose. The analysis was performed in participants included in Part B of the study. | The safety set included all participants who received at least one dose of the study drug. | Posted | Number | percentage of participants | Day 1 up to Day 21 |
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| Secondary | Percentage of Participants With AEs During Post-TEAE Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAE was defined as an adverse event with onset after the start of study drug, or any worsening of a pre-existing medical condition/adverse event with onset after the start of study drug and until 7 days after the last dose. Post-TEAE period was defined as 7 days after final dose through last follow-up (Day 42). The analysis was performed in participants included in Part B of the study. | The safety set included all participants who received at least one dose of the study drug. | Posted | Number | percentage of participants | Day 21 up to Day 42 |
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| Secondary | Percentage of Participants With TEAEs, Graded by Severity - Part B | Severity was assessed according to the following scale: mild (awareness of sign or symptom, but easily tolerated); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with inability to perform normal activities). The analysis was performed in participants included in Part B of the study. | The safety set included all participants who received at least one dose of the study drug. | Posted | Number | percentage of participants | Day 1 up to Day 21 |
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| Secondary | Change From Baseline in Basophils - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | percentage | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Eosinophils - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | percentage | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Hematocrit - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | fraction of one | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Hemoglobin - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | g/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Lymphocytes - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | percentage | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Monocytes - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | percentage | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Neutrophils - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | percentage | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Platelets - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Erythrocytes - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | 10^12 cells/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Reticulocytes - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Overall number of participants analyzed: Number of participants analyzed in this outcome measure. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Day 8, Day 15/ET |
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| Secondary | Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | percentage | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Leukocytes - Part B | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Albumin - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | g/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Alkaline Phosphatase - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | U/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Alanine Aminotransferase - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | U/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Aspartate Aminotransferase - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | U/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Bilirubin - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | umol/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Calcium - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Chloride - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Carbon Dioxide - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Creatinine - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | umol/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Glucose - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Potassium - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Magnesium - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Phosphate - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Protein - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | g/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Sodium - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Thyrotropin - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | milli-international units per liter | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Urea Nitrogen - Part B | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Activated Partial Thromboplastin Time - Part B | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Median | Full Range | sec | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The data for prothrombin international normalized ratio are presented as SI unit, percentage (%). | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | percentage | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Prothrombin Time - Part B | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Median | Full Range | sec | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in pH - Part B | Urinalysis measures included pH and specific gravity. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | pH | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in Specific Gravity - Part B | Urinalysis measures included pH and specific gravity. The analysis was performed in participants included in Part B of the study. ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | ratio | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline (CFB) in Heart Rate - Part B | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | beats/min | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline (CFB) in Respiratory Rate - Part B | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | breaths/min | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline (CFB) in Oral Temperature - Part B | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | degrees C | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 |
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| Secondary | Change From Baseline (CFB) in Oxygen Saturation - Part B | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | percentage of oxygen saturation | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Day 8 (predose, 1 hour postdose) |
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| Secondary | Change From Baseline in QT Interval - Part B | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Median | Full Range | msec | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
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| Secondary | Change From Baseline in QTcF Interval - Part B | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Median | Full Range | msec | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
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| Secondary | Change From Baseline in ECG Mean Heart Rate - Part B | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | beats/min | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
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| Secondary | Change From Baseline in RR Interval - Part B | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Median | Full Range | msec | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
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| Secondary | Change From Baseline in PR Interval - Part B | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Median | Full Range | msec | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
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| Secondary | Change From Baseline in QRS Duration - Part B | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Median | Full Range | msec | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 |
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| Secondary | Percentage of Participants With a Response of "Yes" to Any C-SSRS Suicidal Ideation (SI) Item - Part B | The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation and behavior and a postbaseline evaluation that focused on suicidality since the last study visit. The C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with specific plan. The analysis was performed in participants included in Part B of the study. SCLR = screening: lifetime recall. | The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at the visit within each treatment group. | Posted | Number | percentage of participants | Screening, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 15, 21, 28, 35 and 42 |
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| Secondary | Percentage of Participants With HAM-D Response - Part A | HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score. The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicate a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of the study. Data is reported for participants who had HAM-D response. | The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. | Posted | Number | percentage of participants | Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 |
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| Secondary | Percentage of Participants With HAM-D Remission - Part A | HAM-D remission was defined as having a HAM-D total score of ≤7. The HAM-D total score comprised a sum of the 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of the study. | The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. | Posted | Number | percentage of participants | Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 |
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| Secondary | Change From Baseline in the Montgomery and Ã…sberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part A | The MADRS was a ten-item diagnostic questionnaire which psychiatrists used to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicated more severe depression. A negative change from baseline indicated less severe depression. A positive change from baseline indicated more severe depression. The analysis was performed in participants included in Part A of the study. | The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 |
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| Secondary | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | HAM-D subscales were: Core, symptoms: depressed mood (DM), feelings of guilt (FG), suicide, work and activities (WA), and retardation (RE); Anxiety, symptoms: anxiety (psychic and somatic), somatic symptoms (SS) (gastrointestinal and general), hypochondriasis, and loss of weight; Bech-6, symptoms: DM, FG, WA, RE, anxiety psychic (AP), and SS general; and Maier, symptoms: DM, FG, WA, RE, agitation, and AP. Each item was scored in a range of 0 to 2 or 0 to 4. Higher scores indicated a greater degree of depression. Subscale scores were calculated as sum of individual rating scores related to each subscale, divided by total possible score within subscale, multiplied by 100, and rounded to a whole number. Therefore, subscale scores would be within range of 0-100 and might be larger than total score. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of study. | The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 |
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| Secondary | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | The HAM-D comprised individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms [gastrointestinal (GI) and general], genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of the study. | The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 |
|
|
|
| Secondary | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points - Part A | The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms, and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scoring for HAM-A was calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56, where 0-13=Normal, 14-17 Mild Anxiety, 18-24 Moderate Anxiety, >=25 Severe Anxiety, per the Psych Congress Network. The HAM-A total score was calculated as the sum of the 14 individual item scores. A negative change from baseline indicated less anxiety. A positive change from baseline indicated more anxiety. The analysis was performed in participants included in Part A of the study. | The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Days 2, 3, 8, 15, 21 and 28 |
|
|
|
| Secondary | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response - Part A | The CGI-I item employed 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. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions. CGI-I response was defined as having a CGI-I global improvement score of 1 (very much improved) or 2 (much improved). The analysis was performed in participants included in Part A of the study. Data is reported for participants who had CGI-I response. | The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. | Posted | Number | percentage of participants | Days 2, 3, 8, 15, 21 and 28 |
|
|
|
| Secondary | Change From Baseline (CFB) in the SSS Score - Part B | The SSS was participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of one to seven, where the lowest score of 'one' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of 'seven' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. A negative change from baseline indicated less sleepiness. A positive change from baseline indicated more sleepiness. The analysis was performed in participants included in Part B of the study. H = Hour(s). | The safety set included all participants who received at least 1 dose of the double-blind study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 (0.25, 0.5, 1, 2 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15 |
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| Secondary | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study. | The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21, 28, 35 and 42 |
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|
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| Secondary | Percentage of Participants With HAM-D Response - Part B | HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score. The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study. Data is reported for participants who had HAM-D response. | The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. Number analyzed: Number of participants in the efficacy set ith a non-missing value at the visit within each treatment group. | Posted | Number | percentage of participants | Days 2, 8, 15, 21, 28, 35 and 42 |
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| Secondary | Percentage of Participants With HAM-D Remission - Part B | HAM-D remission was defined as having a HAM-D total score of ≤7. The HAM-D total score comprised a sum of the 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study. | The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. Number analyzed: Number of participants in efficacy set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Number | percentage of participants | Days 2, 8, 15, 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B | The MADRS was a ten-item diagnostic questionnaire which psychiatrists used to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicated more severe depression. A negative change from baseline indicated less severe depression. A positive change from baseline indicated more severe depression. The analysis was performed in participants included in Part B of the study. | The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Days 2, 8, 15, 21, 28, 35 and 42 |
|
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| Secondary | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | HAM-D subscales were: Core, symptoms: depressed mood (DM), feelings of guilt (FG), suicide, work and activities (WA), and retardation (RE); Anxiety, symptoms: anxiety (psychic and somatic), somatic symptoms (SS) (gastrointestinal and general), hypochondriasis, and loss of weight; Bech-6, symptoms: DM, FG, WA, RE, anxiety psychic (AP), and SS general; and Maier, symptoms: DM, FG, WA, RE, agitation, and AP. Each item was scored in a range of 0 to 2 or 0 to 4. Higher scores indicated a greater degree of depression. Subscale scores were calculated as sum of individual rating scores related to each subscale, divided by total possible score within subscale, multiplied by 100, and rounded to a whole number. Therefore, subscale scores would be within range of 0-100 and might be larger than total score. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of study. | The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. Number analyzed: Number of participants in efficacy set with a non-missing value at both baseline and visit within each treatment group. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21, 28, 35 and 42 |
|
|
|
| Secondary | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | The HAM-D comprised individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (GI and general), genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study. | The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. Number analyzed: Number of participants in efficacy set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21, 28, 35 and 42 |
|
|
|
| Secondary | Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B | The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms, and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scoring for HAM-A was calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56, where 0-13=Normal, 14-17 Mild Anxiety, 18-24 Moderate Anxiety, >=25 Severe Anxiety, per the Psych Congress Network. The HAM-A total score was calculated as the sum of the 14 individual item scores. A negative change from baseline indicated less anxiety. A positive change from baseline indicated more anxiety. The analysis was performed in participants included in Part B of the study. | The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Days 2, 8, 15, 21, 28, 35 and 42 |
|
|
|
|
| Secondary | Percentage of Participants With CGI-I Response - Part B | The CGI-I item employed 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. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions. CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved). The analysis was performed in participants included in Part B of the study. Data is reported for participants who had CGI-I response. | The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. Number analyzed: Number of participants in efficacy set with a non-missing value at both baseline and the visit within each treatment group. | Posted | Number | percentage of participants | Days 2, 8, 15, 21, 28, 35 and 42 |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 12 |
| 13 |
| EG001 | Part B: Placebo | Eligible participants received matching placebo capsules once daily for 14 days. | 0 | 44 | 0 | 44 | 12 | 44 |
| EG002 | Part B: SAGE-217 | Eligible participants received SAGE-217, 30 mg, oral capsules, once daily for 14 days. | 0 | 45 | 0 | 45 | 15 | 45 |
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| Muscle contractions involuntary | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
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| Euphoric mood | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| Libido increased | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| Vaginal discharge | Reproductive system and breast disorders | MedDRA (19.1) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Chromaturia | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
|
Our agreement is subject to confidentiality but generally the PI can publish, for non-commercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
| D001519 |
| Behavior |
| Male |
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| Black or African American |
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| White |
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| Other |
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| Not Hispanic or Latino |
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| Title | Measurements |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Title | Measurements |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 28 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 28 |
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| Title | Measurements |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 28 |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 28 |
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| Title | Measurements |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 28 |
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| Title | Measurements |
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| Change from Baseline at Follow-up Day 21 |
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| Change from Baseline at Follow-up Day 28 |
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| CFB at Day 1: 0.5 H Postdose |
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| CFB at Day 1: 1 H Postdose |
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| CFB at Day 1: 2 H Postdose |
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| CFB at Day 1: 12 H Postdose |
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| CFB at Day 2: Predose |
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| CFB at Day 2: 0.25 H Postdose |
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| CFB at Day 2: 0.5 H Postdose |
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| CFB at Day 2: 1 H Postdose |
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| CFB at Day 2: 2 H Postdose |
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| CFB at Day 2: 12 H Postdose |
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| CFB at Day 3: Predose |
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| CFB at Day 3: 0.25 H Postdose |
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| CFB at Day 3: 0.5 H Postdose |
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| CFB at Day 3: 1 H Postdose |
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| CFB at Day 3: 2 H Postdose |
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| CFB at Day 3: 12 H Postdose |
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| CFB at Day 4: Predose |
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| CFB at Day 4: 0.25 H Postdose |
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| CFB at Day 4: 0.5 H Postdose |
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| CFB at Day 4: 1 H Postdose |
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| CFB at Day 4: 2 H Postdose |
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| CFB at Day 4: 12 H Postdose |
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| CFB at Day 5: Predose |
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| CFB at Day 5: 0.25 H Postdose |
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| CFB at Day 5: 0.5 H Postdose |
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| CFB at Day 5: 1 H Postdose |
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| CFB at Day 5: 2 H Postdose |
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| CFB at Day 5: 12 H Postdose |
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| CFB at Day 6: Predose |
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| CFB at Day 6: 0.25 H Postdose |
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| CFB at Day 6: 0.5 H Postdose |
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| CFB at Day 6: 1 H Postdose |
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| CFB at Day 6: 2 H Postdose |
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| CFB at Day 6: 12 H Postdose |
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| CFB at Day 7: Predose |
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| CFB at Day 7: 0.25 H Postdose |
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| CFB at Day 7: 0.5 H Postdose |
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| CFB at Day 7: 1 H Postdose |
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| CFB at Day 7: 2 H Postdose |
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| CFB at Day 7: 12 H Postdose |
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| CFB at Day 8: Predose |
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| CFB at Day 8: 1 H Postdose |
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| CFB at Day 9: Predose |
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| CFB at Day 9: 1 H Postdose |
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| CFB at Day 10: Predose |
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| CFB at Day 10: 1 H Postdose |
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| CFB at Day 11: Predose |
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| CFB at Day 11: 1 H Postdose |
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| CFB at Day 12: Predose |
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| CFB at Day 12: 1 H Postdose |
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| CFB at Day 13: Predose |
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| CFB at Day 13: 1 H Postdose |
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| CFB at Day 14: Predose |
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| CFB at Day 14: 1 H Postdose |
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| CFB at Day 15/ET |
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| CFB at Follow-up Day 21 |
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| CFB at Follow-up Day 28 |
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| CFB at Day 1: 0.5 H Postdose |
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| CFB at Day 1: 1 H Postdose |
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| CFB at Day 1: 2 H Postdose |
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| CFB at Day 1: 12 H Postdose |
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| CFB at Day 2: Predose |
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| CFB at Day 2: 0.25 H Postdose |
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| CFB at Day 2: 0.5 H Postdose |
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| CFB at Day 2: 1 H Postdose |
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| CFB at Day 2: 2 H Postdose |
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| CFB at Day 2: 12 H Postdose |
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| CFB at Day 3: Predose |
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| CFB at Day 3: 0.25 H Postdose |
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| CFB at Day 3: 0.5 H Postdose |
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| CFB at Day 3: 1 H Postdose |
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| CFB at Day 3: 2 H Postdose |
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| CFB at Day 3: 12 H Postdose |
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| CFB at Day 4: Predose |
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| CFB at Day 4: 0.25 H Postdose |
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| CFB at Day 4: 0.5 H Postdose |
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| CFB at Day 4: 1 H Postdose |
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| CFB at Day 4: 2 H Postdose |
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| CFB at Day 4: 12 H Postdose |
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| CFB at Day 5: Predose |
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| CFB at Day 5: 0.25 H Postdose |
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| CFB at Day 5: 0.5 H Postdose |
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| CFB at Day 5: 1 H Postdose |
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| CFB at Day 5: 2 H Postdose |
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| CFB at Day 5: 12 H Postdose |
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| CFB at Day 6: Predose |
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| CFB at Day 6: 0.25 H Postdose |
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| CFB at Day 6: 0.5 H Postdose |
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| CFB at Day 6: 1 H Postdose |
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| CFB at Day 6: 2 H Postdose |
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| CFB at Day 6: 12 H Postdose |
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| CFB at Day 7: Predose |
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| CFB at Day 7: 0.25 H Postdose |
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| CFB at Day 7: 0.5 H Postdose |
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| CFB at Day 7: 1 H Postdose |
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| CFB at Day 7: 2 H Postdose |
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| CFB at Day 7: 12 H Postdose |
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| CFB at Day 8: Predose |
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| CFB at Day 8: 1 H Postdose |
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| CFB at Day 9: Predose |
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| CFB at Day 9: 1 H Postdose |
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| CFB at Day 10: Predose |
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| CFB at Day 10: 1 H Postdose |
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| CFB at Day 11: Predose |
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| CFB at Day 11: 1 H Postdose |
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| CFB at Day 12: Predose |
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| CFB at Day 12: 1 H Postdose |
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| CFB at Day 13: Predose |
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| CFB at Day 13: 1 H Postdose |
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| CFB at Day 14: Predose |
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| CFB at Day 14: 1 H Postdose |
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| CFB at Day 15/ET |
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| CFB at Follow-up Day 21 |
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| CFB at Follow-up Day 28 |
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|
|
| CFB at Day 1: 0.5 H Postdose |
|
|
| CFB at Day 1: 1 H Postdose |
|
|
| CFB at Day 1: 2 H Postdose |
|
|
| CFB at Day 1: 12 H Postdose |
|
|
| CFB at Day 2: Predose |
|
|
| CFB at Day 2: 0.25 H Postdose |
|
|
| CFB at Day 2: 0.5 H Postdose |
|
|
| CFB at Day 2: 1 H Postdose |
|
|
| CFB at Day 2: 2 H Postdose |
|
|
| CFB at Day 2: 12 H Postdose |
|
|
| CFB at Day 3: Predose |
|
|
| CFB at Day 3: 0.25 H Postdose |
|
|
| CFB at Day 3: 0.5 H Postdose |
|
|
| CFB at Day 3: 1 H Postdose |
|
|
| CFB at Day 3: 2 H Postdose |
|
|
| CFB at Day 3: 12 H Postdose |
|
|
| CFB at Day 4: Predose |
|
|
| CFB at Day 4: 0.25 H Postdose |
|
|
| CFB at Day 4: 0.5 H Postdose |
|
|
| CFB at Day 4: 1 H Postdose |
|
|
| CFB at Day 4: 2 H Postdose |
|
|
| CFB at Day 4: 12 H Postdose |
|
|
| CFB at Day 5: Predose |
|
|
| CFB at Day 5: 0.25 H Postdose |
|
|
| CFB at Day 5: 0.5 H Postdose |
|
|
| CFB at Day 5: 1 H Postdose |
|
|
| CFB at Day 5: 2 H Postdose |
|
|
| CFB at Day 5: 12 H Postdose |
|
|
| CFB at Day 6: Predose |
|
|
| CFB at Day 6: 0.25 H Postdose |
|
|
| CFB at Day 6: 0.5 H Postdose |
|
|
| CFB at Day 6: 1 H Postdose |
|
|
| CFB at Day 6: 2 H Postdose |
|
|
| CFB at Day 6: 12 H Postdose |
|
|
| CFB at Day 7: Predose |
|
|
| CFB at Day 7: 0.25 H Postdose |
|
|
| CFB at Day 7: 0.5 H Postdose |
|
|
| CFB at Day 7: 1 H Postdose |
|
|
| CFB at Day 7: 2 H Postdose |
|
|
| CFB at Day 7: 12 H Postdose |
|
|
| CFB at Day 8: Predose |
|
|
| CFB at Day 8: 1 H Postdose |
|
|
| CFB at Day 9: Predose |
|
|
| CFB at Day 9: 1 H Postdose |
|
|
| CFB at Day 10: Predose |
|
|
| CFB at Day 10: 1 H Postdose |
|
|
| CFB at Day 11: Predose |
|
|
| CFB at Day 11: 1 H Postdose |
|
|
| CFB at Day 12: Predose |
|
|
| CFB at Day 12: 1 H Postdose |
|
|
| CFB at Day 13: Predose |
|
|
| CFB at Day 13: 1 H Postdose |
|
|
| CFB at Day 14: Predose |
|
|
| CFB at Day 14: 1 H Postdose |
|
|
| CFB at Day 15/ET |
|
|
| CFB at Follow-up Day 21 |
|
|
| CFB at Follow-up Day 28 |
|
|
|
| CFB at Day 1: 0.5 H Postdose |
|
|
| CFB at Day 1: 1 H Postdose |
|
|
| CFB at Day 1: 2 H Postdose |
|
|
| CFB at Day 1: 12 H Postdose |
|
|
| CFB at Day 2: Predose |
|
|
| CFB at Day 2: 0.25 H Postdose |
|
|
| CFB at Day 2: 0.5 H Postdose |
|
|
| CFB at Day 2: 1 H Postdose |
|
|
| CFB at Day 2: 2 H Postdose |
|
|
| CFB at Day 2: 12 H Postdose |
|
|
| CFB at Day 3: Predose |
|
|
| CFB at Day 3: 0.25 H Postdose |
|
|
| CFB at Day 3: 0.5 H Postdose |
|
|
| CFB at Day 3: 1 H Postdose |
|
|
| CFB at Day 3: 2 H Postdose |
|
|
| CFB at Day 3: 12 H Postdose |
|
|
| CFB at Day 4: Predose |
|
|
| CFB at Day 4: 0.25 H Postdose |
|
|
| CFB at Day 4: 0.5 H Postdose |
|
|
| CFB at Day 4: 1 H Postdose |
|
|
| CFB at Day 4: 2 H Postdose |
|
|
| CFB at Day 4: 12 H Postdose |
|
|
| CFB at Day 5: Predose |
|
|
| CFB at Day 5: 0.25 H Postdose |
|
|
| CFB at Day 5: 0.5 H Postdose |
|
|
| CFB at Day 5: 1 H Postdose |
|
|
| CFB at Day 5: 2 H Postdose |
|
|
| CFB at Day 5: 12 H Postdose |
|
|
| CFB at Day 6: Predose |
|
|
| CFB at Day 6: 0.25 H Postdose |
|
|
| CFB at Day 6: 0.5 H Postdose |
|
|
| CFB at Day 6: 1 H Postdose |
|
|
| CFB at Day 6: 2 H Postdose |
|
|
| CFB at Day 6: 12 H Postdose |
|
|
| CFB at Day 7: Predose |
|
|
| CFB at Day 7: 0.25 H Postdose |
|
|
| CFB at Day 7: 0.5 H Postdose |
|
|
| CFB at Day 7: 1 H Postdose |
|
|
| CFB at Day 7: 2 H Postdose |
|
|
| CFB at Day 7: 12 H Postdose |
|
|
| CFB at Day 8: Predose |
|
|
| CFB at Day 8: 1 H Postdose |
|
|
| CFB at Day 9: Predose |
|
|
| CFB at Day 9: 1 H Postdose |
|
|
| CFB at Day 10: Predose |
|
|
| CFB at Day 10: 1 H Postdose |
|
|
| CFB at Day 11: Predose |
|
|
| CFB at Day 11: 1 H Postdose |
|
|
| CFB at Day 12: Predose |
|
|
| CFB at Day 12: 1 H Postdose |
|
|
| CFB at Day 13: Predose |
|
|
| CFB at Day 13: 1 H Postdose |
|
|
| CFB at Day 14: Predose |
|
|
| CFB at Day 14: 1 H Postdose |
|
|
| CFB at Day 15/ET |
|
|
| CFB at Follow-up Day 21 |
|
|
| CFB at Follow-up Day 28 |
|
|
|
| CFB at Day 1: 0.5 H Postdose |
|
|
| CFB at Day 1: 1 H Postdose |
|
|
| CFB at Day 1: 2 H Postdose |
|
|
| CFB at Day 1: 12 H Postdose |
|
|
| CFB at Day 2: Predose |
|
|
| CFB at Day 2: 0.25 H Postdose |
|
|
| CFB at Day 2: 0.5 H Postdose |
|
|
| CFB at Day 2: 1 H Postdose |
|
|
| CFB at Day 2: 2 H Postdose |
|
|
| CFB at Day 2: 12 H Postdose |
|
|
| CFB at Day 3: Predose |
|
|
| CFB at Day 3: 0.25 H Postdose |
|
|
| CFB at Day 3: 0.5 H Postdose |
|
|
| CFB at Day 3: 1 H Postdose |
|
|
| CFB at Day 3: 2 H Postdose |
|
|
| CFB at Day 3: 12 H Postdose |
|
|
| CFB at Day 4: Predose |
|
|
| CFB at Day 4: 0.25 H Postdose |
|
|
| CFB at Day 4: 0.5 H Postdose |
|
|
| CFB at Day 4: 1 H Postdose |
|
|
| CFB at Day 4: 2 H Postdose |
|
|
| CFB at Day 4: 12 H Postdose |
|
|
| CFB at Day 5: Predose |
|
|
| CFB at Day 5: 0.25 H Postdose |
|
|
| CFB at Day 5: 0.5 H Postdose |
|
|
| CFB at Day 5: 1 H Postdose |
|
|
| CFB at Day 5: 2 H Postdose |
|
|
| CFB at Day 5: 12 H Postdose |
|
|
| CFB at Day 6: Predose |
|
|
| CFB at Day 6: 0.25 H Postdose |
|
|
| CFB at Day 6: 0.5 H Postdose |
|
|
| CFB at Day 6: 1 H Postdose |
|
|
| CFB at Day 6: 2 H Postdose |
|
|
| CFB at Day 6: 12 H Postdose |
|
|
| CFB at Day 7: Predose |
|
|
| CFB at Day 7: 0.25 H Postdose |
|
|
| CFB at Day 7: 0.5 H Postdose |
|
|
| CFB at Day 7: 1 H Postdose |
|
|
| CFB at Day 7: 2 H Postdose |
|
|
| CFB at Day 7: 12 H Postdose |
|
|
| CFB at Day 8: Predose |
|
|
| CFB at Day 8: 1 H Postdose |
|
|
| CFB at Day 9: Predose |
|
|
| CFB at Day 9: 1 H Postdose |
|
|
| CFB at Day 10: Predose |
|
|
| CFB at Day 10: 1 H Postdose |
|
|
| CFB at Day 11: Predose |
|
|
| CFB at Day 11: 1 H Postdose |
|
|
| CFB at Day 12: Predose |
|
|
| CFB at Day 12: 1 H Postdose |
|
|
| CFB at Day 13: Predose |
|
|
| CFB at Day 13: 1 H Postdose |
|
|
| CFB at Day 14: Predose |
|
|
| CFB at Day 14: 1 H Postdose |
|
|
| CFB at Day 15/ET |
|
|
| CFB at Follow-up Day 21 |
|
|
| CFB at Follow-up Day 28 |
|
|
|
| CFB at Day 1: 0.5 H Postdose |
|
|
| CFB at Day 1: 1 H Postdose |
|
|
| CFB at Day 1: 2 H Postdose |
|
|
| CFB at Day 1: 12 H Postdose |
|
|
| CFB at Day 2: Predose |
|
|
| CFB at Day 2: 0.25 H Postdose |
|
|
| CFB at Day 2: 0.5 H Postdose |
|
|
| CFB at Day 2: 1 H Postdose |
|
|
| CFB at Day 2: 2 H Postdose |
|
|
| CFB at Day 2: 12 H Postdose |
|
|
| CFB at Day 3: Predose |
|
|
| CFB at Day 3: 0.25 H Postdose |
|
|
| CFB at Day 3: 0.5 H Postdose |
|
|
| CFB at Day 3: 1 H Postdose |
|
|
| CFB at Day 3: 2 H Postdose |
|
|
| CFB at Day 3: 12 H Postdose |
|
|
| CFB at Day 4: Predose |
|
|
| CFB at Day 4: 0.25 H Postdose |
|
|
| CFB at Day 4: 0.5 H Postdose |
|
|
| CFB at Day 4: 1 H Postdose |
|
|
| CFB at Day 4: 2 H Postdose |
|
|
| CFB at Day 4: 12 H Postdose |
|
|
| CFB at Day 5: Predose |
|
|
| CFB at Day 5: 0.25 H Postdose |
|
|
| CFB at Day 5: 0.5 H Postdose |
|
|
| CFB at Day 5: 1 H Postdose |
|
|
| CFB at Day 5: 2 H Postdose |
|
|
| CFB at Day 5: 12 H Postdose |
|
|
| CFB at Day 6: Predose |
|
|
| CFB at Day 6: 0.25 H Postdose |
|
|
| CFB at Day 6: 0.5 H Postdose |
|
|
| CFB at Day 6: 1 H Postdose |
|
|
| CFB at Day 6: 2 H Postdose |
|
|
| CFB at Day 6: 12 H Postdose |
|
|
| CFB at Day 7: Predose |
|
|
| CFB at Day 7: 0.25 H Postdose |
|
|
| CFB at Day 7: 0.5 H Postdose |
|
|
| CFB at Day 7: 1 H Postdose |
|
|
| CFB at Day 7: 2 H Postdose |
|
|
| CFB at Day 7: 12 H Postdose |
|
|
| CFB at Day 8: Predose |
|
|
| CFB at Day 8: 1 H Postdose |
|
|
| CFB at Day 9: Predose |
|
|
| CFB at Day 9: 1 H Postdose |
|
|
| CFB at Day 10: Predose |
|
|
| CFB at Day 10: 1 H Postdose |
|
|
| CFB at Day 11: Predose |
|
|
| CFB at Day 11: 1 H Postdose |
|
|
| CFB at Day 12: Predose |
|
|
| CFB at Day 12: 1 H Postdose |
|
|
| CFB at Day 13: Predose |
|
|
| CFB at Day 13: 1 H Postdose |
|
|
| CFB at Day 14: Predose |
|
|
| CFB at Day 14: 1 H Postdose |
|
|
| CFB at Day 15/ET |
|
|
| CFB at Follow-up Day 21 |
|
|
| CFB at Follow-up Day 28 |
|
|
|
| CFB at Day 1: 0.5 H Postdose |
|
|
| CFB at Day 1: 1 H Postdose |
|
|
| CFB at Day 1: 2 H Postdose |
|
|
| CFB at Day 1: 12 H Postdose |
|
|
| CFB at Day 2: Predose |
|
|
| CFB at Day 2: 0.25 H Postdose |
|
|
| CFB at Day 2: 0.5 H Postdose |
|
|
| CFB at Day 2: 1 H Postdose |
|
|
| CFB at Day 2: 2 H Postdose |
|
|
| CFB at Day 2: 12 H Postdose |
|
|
| CFB at Day 3: Predose |
|
|
| CFB at Day 3: 0.25 H Postdose |
|
|
| CFB at Day 3: 0.5 H Postdose |
|
|
| CFB at Day 3: 1 H Postdose |
|
|
| CFB at Day 3: 2 H Postdose |
|
|
| CFB at Day 3: 12 H Postdose |
|
|
| CFB at Day 4: Predose |
|
|
| CFB at Day 4: 0.25 H Postdose |
|
|
| CFB at Day 4: 0.5 H Postdose |
|
|
| CFB at Day 4: 1 H Postdose |
|
|
| CFB at Day 4: 2 H Postdose |
|
|
| CFB at Day 4: 12 H Postdose |
|
|
| CFB at Day 5: Predose |
|
|
| CFB at Day 5: 0.25 H Postdose |
|
|
| CFB at Day 5: 0.5 H Postdose |
|
|
| CFB at Day 5: 1 H Postdose |
|
|
| CFB at Day 5: 2 H Postdose |
|
|
| CFB at Day 5: 12 H Postdose |
|
|
| CFB at Day 6: Predose |
|
|
| CFB at Day 6: 0.25 H Postdose |
|
|
| CFB at Day 6: 0.5 H Postdose |
|
|
| CFB at Day 6: 1 H Postdose |
|
|
| CFB at Day 6: 2 H Postdose |
|
|
| CFB at Day 6: 12 H Postdose |
|
|
| CFB at Day 7: Predose |
|
|
| CFB at Day 7: 0.25 H Postdose |
|
|
| CFB at Day 7: 0.5 H Postdose |
|
|
| CFB at Day 7: 1 H Postdose |
|
|
| CFB at Day 7: 2 H Postdose |
|
|
| CFB at Day 7: 12 H Postdose |
|
|
| CFB at Day 8: Predose |
|
|
| CFB at Day 8: 1 H Postdose |
|
|
| CFB at Day 9: Predose |
|
|
| CFB at Day 9: 1 H Postdose |
|
|
| CFB at Day 10: Predose |
|
|
| CFB at Day 10: 1 H Postdose |
|
|
| CFB at Day 11: Predose |
|
|
| CFB at Day 11: 1 H Postdose |
|
|
| CFB at Day 12: Predose |
|
|
| CFB at Day 12: 1 H Postdose |
|
|
| CFB at Day 13: Predose |
|
|
| CFB at Day 13: 1 H Postdose |
|
|
| CFB at Day 14: Predose |
|
|
| CFB at Day 14: 1 H Postdose |
|
|
| CFB at Day 15/ET |
|
|
| CFB at Follow-up Day 21 |
|
|
| CFB at Follow-up Day 28 |
|
|
|
| CFB at Day 1: 0.5 H Postdose |
|
|
| CFB at Day 1: 1 H Postdose |
|
|
| CFB at Day 1: 2 H Postdose |
|
|
| CFB at Day 1: 12 H Postdose |
|
|
| CFB at Day 2: Predose |
|
|
| CFB at Day 2: 0.25 H Postdose |
|
|
| CFB at Day 2: 0.5 H Postdose |
|
|
| CFB at Day 2: 1 H Postdose |
|
|
| CFB at Day 2: 2 H Postdose |
|
|
| CFB at Day 2: 12 H Postdose |
|
|
| CFB at Day 3: Predose |
|
|
| CFB at Day 3: 0.25 H Postdose |
|
|
| CFB at Day 3: 0.5 H Postdose |
|
|
| CFB at Day 3: 1 H Postdose |
|
|
| CFB at Day 3: 2 H Postdose |
|
|
| CFB at Day 3: 12 H Postdose |
|
|
| CFB at Day 4: Predose |
|
|
| CFB at Day 4: 0.25 H Postdose |
|
|
| CFB at Day 4: 0.5 H Postdose |
|
|
| CFB at Day 4: 1 H Postdose |
|
|
| CFB at Day 4: 2 H Postdose |
|
|
| CFB at Day 4: 12 H Postdose |
|
|
| CFB at Day 5: Predose |
|
|
| CFB at Day 5: 0.25 H Postdose |
|
|
| CFB at Day 5: 0.5 H Postdose |
|
|
| CFB at Day 5: 1 H Postdose |
|
|
| CFB at Day 5: 2 H Postdose |
|
|
| CFB at Day 5: 12 H Postdose |
|
|
| CFB at Day 6: Predose |
|
|
| CFB at Day 6: 0.25 H Postdose |
|
|
| CFB at Day 6: 0.5 H Postdose |
|
|
| CFB at Day 6: 1 H Postdose |
|
|
| CFB at Day 6: 2 H Postdose |
|
|
| CFB at Day 6: 12 H Postdose |
|
|
| CFB at Day 7: Predose |
|
|
| CFB at Day 7: 0.25 H Postdose |
|
|
| CFB at Day 7: 0.5 H Postdose |
|
|
| CFB at Day 7: 1 H Postdose |
|
|
| CFB at Day 7: 2 H Postdose |
|
|
| CFB at Day 7: 12 H Postdose |
|
|
| CFB at Day 8: Predose |
|
|
| CFB at Day 8: 1 H Postdose |
|
|
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 7 |
|
|
| Change from Baseline at Day 14 |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 7 |
|
|
| Change from Baseline at Day 14 |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 7 |
|
|
| Change from Baseline at Day 14 |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 7 |
|
|
| Change from Baseline at Day 14 |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 7 |
|
|
| Change from Baseline at Day 14 |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 7 |
|
|
| Change from Baseline at Day 14 |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Title | Measurements |
|---|---|
|
| Change from Baseline at Day 4 |
|
| Change from Baseline at Day 5 |
|
| Change from Baseline at Day 6 |
|
| Change from Baseline at Day 7 |
|
| Change from Baseline at Day 8 |
|
| Change from Baseline at Day 15 |
|
| Change from Baseline at Day 21 |
|
| Change from Baseline at Day 28 |
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| Change from Baseline at Day 8 |
|
|
| Change from Baseline at Day 15/ET |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Follow-up Day 28 |
|
|
| Change from Baseline at Follow-up Day 35 |
|
|
| Change from Baseline at Follow-up Day 42 |
|
|
| CFB at Day 1: 0.25 H Postdose |
|
|
| CFB at Day 1: 0.5 H Postdose |
|
|
| CFB at Day 1: 1 H Postdose |
|
|
| CFB at Day 1: 2 H Postdose |
|
|
| CFB at Day 1: 12 H Postdose |
|
|
| CFB at Day 2: Predose |
|
|
| CFB at Day 2: 0.25 H Postdose |
|
|
| CFB at Day 2: 0.5 H Postdose |
|
|
| CFB at Day 2: 1 H Postdose |
|
|
| CFB at Day 2: 2 H Postdose |
|
|
| CFB at Day 2: 12 H Postdose |
|
|
| CFB at Day 3: Predose |
|
|
| CFB at Day 3: 0.25 H Postdose |
|
|
| CFB at Day 3: 0.5 H Postdose |
|
|
| CFB at Day 3: 1 H Postdose |
|
|
| CFB at Day 3: 2 H Postdose |
|
|
| CFB at Day 3: 12 H Postdose |
|
|
| CFB at Day 4: Predose |
|
|
| CFB at Day 4: 0.25 H Postdose |
|
|
| CFB at Day 4: 0.5 H Postdose |
|
|
| CFB at Day 4: 1 H Postdose |
|
|
| CFB at Day 4: 2 H Postdose |
|
|
| CFB at Day 4: 12 H Postdose |
|
|
| CFB at Day 5: Predose |
|
|
| CFB at Day 5: 0.25 H Postdose |
|
|
| CFB at Day 5: 0.5 H Postdose |
|
|
| CFB at Day 5: 1 H Postdose |
|
|
| CFB at Day 5: 2 H Postdose |
|
|
| CFB at Day 5: 12 H Postdose |
|
|
| CFB at Day 6: Predose |
|
|
| CFB at Day 6: 0.25 H Postdose |
|
|
| CFB at Day 6: 0.5 H Postdose |
|
|
| CFB at Day 6: 1 H Postdose |
|
|
| CFB at Day 6: 2 H Postdose |
|
|
| CFB at Day 6: 12 H Postdose |
|
|
| CFB at Day 7: Predose |
|
|
| CFB at Day 7: 0.25 H Postdose |
|
|
| CFB at Day 7: 0.5 H Postdose |
|
|
| CFB at Day 7: 1 H Postdose |
|
|
| CFB at Day 7: 2 H Postdose |
|
|
| CFB at Day 7: 12 H Postdose |
|
|
| CFB at Day 8: Predose |
|
|
| CFB at Day 8: 1 H Postdose |
|
|
| CFB at Day 9: Predose |
|
|
| CFB at Day 9: 1 H Postdose |
|
|
| CFB at Day 10: Predose |
|
|
| CFB at Day 10: 1 H Postdose |
|
|
| CFB at Day 11: Predose |
|
|
| CFB at Day 11: 1 H Postdose |
|
|
| CFB at Day 12: Predose |
|
|
| CFB at Day 12: 1 H Postdose |
|
|
| CFB at Day 13: Predose |
|
|
| CFB at Day 13: 1 H Postdose |
|
|
| CFB at Day 14: Predose |
|
|
| CFB at Day 14: 1 H Postdose |
|
|
| CFB at Day 15/ET |
|
|
| CFB at Follow-up Day 21 |
|
|
| CFB at Follow-up Day 28 |
|
|
| CFB at Follow-up Day 35 |
|
|
| CFB at Follow-up Day 42 |
|
|
| CFB at Day 1: 0.25 H Postdose |
|
|
| CFB at Day 1: 0.5 H Postdose |
|
|
| CFB at Day 1: 1 H Postdose |
|
|
| CFB at Day 1: 2 H Postdose |
|
|
| CFB at Day 1: 12 H Postdose |
|
|
| CFB at Day 2: Predose |
|
|
| CFB at Day 2: 0.25 H Postdose |
|
|
| CFB at Day 2: 0.5 H Postdose |
|
|
| CFB at Day 2: 1 H Postdose |
|
|
| CFB at Day 2: 2 H Postdose |
|
|
| CFB at Day 2: 12 H Postdose |
|
|
| CFB at Day 3: Predose |
|
|
| CFB at Day 3: 0.25 H Postdose |
|
|
| CFB at Day 3: 0.5 H Postdose |
|
|
| CFB at Day 3: 1 H Postdose |
|
|
| CFB at Day 3: 2 H Postdose |
|
|
| CFB at Day 3: 12 H Postdose |
|
|
| CFB at Day 4: Predose |
|
|
| CFB at Day 4: 0.25 H Postdose |
|
|
| CFB at Day 4: 0.5 H Postdose |
|
|
| CFB at Day 4: 1 H Postdose |
|
|
| CFB at Day 4: 2 H Postdose |
|
|
| CFB at Day 4: 12 H Postdose |
|
|
| CFB at Day 5: Predose |
|
|
| CFB at Day 5: 0.25 H Postdose |
|
|
| CFB at Day 5: 0.5 H Postdose |
|
|
| CFB at Day 5: 1 H Postdose |
|
|
| CFB at Day 5: 2 H Postdose |
|
|
| CFB at Day 5: 12 H Postdose |
|
|
| CFB at Day 6: Predose |
|
|
| CFB at Day 6: 0.25 H Postdose |
|
|
| CFB at Day 6: 0.5 H Postdose |
|
|
| CFB at Day 6: 1 H Postdose |
|
|
| CFB at Day 6: 2 H Postdose |
|
|
| CFB at Day 6: 12 H Postdose |
|
|
| CFB at Day 7: Predose |
|
|
| CFB at Day 7: 0.25 H Postdose |
|
|
| CFB at Day 7: 0.5 H Postdose |
|
|
| CFB at Day 7: 1 H Postdose |
|
|
| CFB at Day 7: 2 H Postdose |
|
|
| CFB at Day 7: 12 H Postdose |
|
|
| CFB at Day 8: Predose |
|
|
| CFB at Day 8: 1 H Postdose |
|
|
| CFB at Day 9: Predose |
|
|
| CFB at Day 9: 1 H Postdose |
|
|
| CFB at Day 10: Predose |
|
|
| CFB at Day 10: 1 H Postdose |
|
|
| CFB at Day 11: Predose |
|
|
| CFB at Day 11: 1 H Postdose |
|
|
| CFB at Day 12: Predose |
|
|
| CFB at Day 12: 1 H Postdose |
|
|
| CFB at Day 13: Predose |
|
|
| CFB at Day 13: 1 H Postdose |
|
|
| CFB at Day 14: Predose |
|
|
| CFB at Day 14: 1 H Postdose |
|
|
| CFB at Day 15/ET |
|
|
| CFB at Follow-up Day 21 |
|
|
| CFB at Follow-up Day 28 |
|
|
| CFB at Follow-up Day 35 |
|
|
| CFB at Follow-up Day 42 |
|
|
| CFB at Day 1: 0.25 H Postdose |
|
|
| CFB at Day 1: 0.5 H Postdose |
|
|
| CFB at Day 1: 1 H Postdose |
|
|
| CFB at Day 1: 2 H Postdose |
|
|
| CFB at Day 1: 12 H Postdose |
|
|
| CFB at Day 2: Predose |
|
|
| CFB at Day 2: 0.25 H Postdose |
|
|
| CFB at Day 2: 0.5 H Postdose |
|
|
| CFB at Day 2: 1 H Postdose |
|
|
| CFB at Day 2: 2 H Postdose |
|
|
| CFB at Day 2: 12 H Postdose |
|
|
| CFB at Day 3: Predose |
|
|
| CFB at Day 3: 0.25 H Postdose |
|
|
| CFB at Day 3: 0.5 H Postdose |
|
|
| CFB at Day 3: 1 H Postdose |
|
|
| CFB at Day 3: 2 H Postdose |
|
|
| CFB at Day 3: 12 H Postdose |
|
|
| CFB at Day 4: Predose |
|
|
| CFB at Day 4: 0.25 H Postdose |
|
|
| CFB at Day 4: 0.5 H Postdose |
|
|
| CFB at Day 4: 1 H Postdose |
|
|
| CFB at Day 4: 2 H Postdose |
|
|
| CFB at Day 4: 12 H Postdose |
|
|
| CFB at Day 5: Predose |
|
|
| CFB at Day 5: 0.25 H Postdose |
|
|
| CFB at Day 5: 0.5 H Postdose |
|
|
| CFB at Day 5: 1 H Postdose |
|
|
| CFB at Day 5: 2 H Postdose |
|
|
| CFB at Day 5: 12 H Postdose |
|
|
| CFB at Day 6: Predose |
|
|
| CFB at Day 6: 0.25 H Postdose |
|
|
| CFB at Day 6: 0.5 H Postdose |
|
|
| CFB at Day 6: 1 H Postdose |
|
|
| CFB at Day 6: 2 H Postdose |
|
|
| CFB at Day 6: 12 H Postdose |
|
|
| CFB at Day 7: Predose |
|
|
| CFB at Day 7: 0.25 H Postdose |
|
|
| CFB at Day 7: 0.5 H Postdose |
|
|
| CFB at Day 7: 1 H Postdose |
|
|
| CFB at Day 7: 2 H Postdose |
|
|
| CFB at Day 7: 12 H Postdose |
|
|
| CFB at Day 8: Predose |
|
|
| CFB at Day 8: 1 H Postdose |
|
|
| CFB at Day 9: Predose |
|
|
| CFB at Day 9: 1 H Postdose |
|
|
| CFB at Day 10: Predose |
|
|
| CFB at Day 10: 1 H Postdose |
|
|
| CFB at Day 11: Predose |
|
|
| CFB at Day 11: 1 H Postdose |
|
|
| CFB at Day 12: Predose |
|
|
| CFB at Day 12: 1 H Postdose |
|
|
| CFB at Day 13: Predose |
|
|
| CFB at Day 13: 1 H Postdose |
|
|
| CFB at Day 14: Predose |
|
|
| CFB at Day 14: 1 H Postdose |
|
|
| CFB at Day 15/ET |
|
|
| CFB at Follow-up Day 21 |
|
|
| CFB at Follow-up Day 28 |
|
|
| CFB at Follow-up Day 35 |
|
|
| CFB at Follow-up Day 42 |
|
|
| CFB at Day 1: 0.25 H Postdose |
|
|
| CFB at Day 1: 0.5 H Postdose |
|
|
| CFB at Day 1: 1 H Postdose |
|
|
| CFB at Day 1: 2 H Postdose |
|
|
| CFB at Day 1: 12 H Postdose |
|
|
| CFB at Day 2: Predose |
|
|
| CFB at Day 2: 0.25 H Postdose |
|
|
| CFB at Day 2: 0.5 H Postdose |
|
|
| CFB at Day 2: 1 H Postdose |
|
|
| CFB at Day 2: 2 H Postdose |
|
|
| CFB at Day 2: 12 H Postdose |
|
|
| CFB at Day 3: Predose |
|
|
| CFB at Day 3: 0.25 H Postdose |
|
|
| CFB at Day 3: 0.5 H Postdose |
|
|
| CFB at Day 3: 1 H Postdose |
|
|
| CFB at Day 3: 2 H Postdose |
|
|
| CFB at Day 3: 12 H Postdose |
|
|
| CFB at Day 4: Predose |
|
|
| CFB at Day 4: 0.25 H Postdose |
|
|
| CFB at Day 4: 0.5 H Postdose |
|
|
| CFB at Day 4: 1 H Postdose |
|
|
| CFB at Day 4: 2 H Postdose |
|
|
| CFB at Day 4: 12 H Postdose |
|
|
| CFB at Day 5: Predose |
|
|
| CFB at Day 5: 0.25 H Postdose |
|
|
| CFB at Day 5: 0.5 H Postdose |
|
|
| CFB at Day 5: 1 H Postdose |
|
|
| CFB at Day 5: 2 H Postdose |
|
|
| CFB at Day 5: 12 H Postdose |
|
|
| CFB at Day 6: Predose |
|
|
| CFB at Day 6: 0.25 H Postdose |
|
|
| CFB at Day 6: 0.5 H Postdose |
|
|
| CFB at Day 6: 1 H Postdose |
|
|
| CFB at Day 6: 2 H Postdose |
|
|
| CFB at Day 6: 12 H Postdose |
|
|
| CFB at Day 7: Predose |
|
|
| CFB at Day 7: 0.25 H Postdose |
|
|
| CFB at Day 7: 0.5 H Postdose |
|
|
| CFB at Day 7: 1 H Postdose |
|
|
| CFB at Day 7: 2 H Postdose |
|
|
| CFB at Day 7: 12 H Postdose |
|
|
| CFB at Day 8: Predose |
|
|
| CFB at Day 8: 1 H Postdose |
|
|
| CFB at Day 9: Predose |
|
|
| CFB at Day 9: 1 H Postdose |
|
|
| CFB at Day 10: Predose |
|
|
| CFB at Day 10: 1 H Postdose |
|
|
| CFB at Day 11: Predose |
|
|
| CFB at Day 11: 1 H Postdose |
|
|
| CFB at Day 12: Predose |
|
|
| CFB at Day 12: 1 H Postdose |
|
|
| CFB at Day 13: Predose |
|
|
| CFB at Day 13: 1 H Postdose |
|
|
| CFB at Day 14: Predose |
|
|
| CFB at Day 14: 1 H Postdose |
|
|
| CFB at Day 15/ET |
|
|
| CFB at Follow-up Day 21 |
|
|
| CFB at Follow-up Day 28 |
|
|
| CFB at Follow-up Day 35 |
|
|
| CFB at Follow-up Day 42 |
|
|
| CFB at Day 1: 0.25 H Postdose |
|
|
| CFB at Day 1: 0.5 H Postdose |
|
|
| CFB at Day 1: 1 H Postdose |
|
|
| CFB at Day 1: 2 H Postdose |
|
|
| CFB at Day 1: 12 H Postdose |
|
|
| CFB at Day 2: Predose |
|
|
| CFB at Day 2: 0.25 H Postdose |
|
|
| CFB at Day 2: 0.5 H Postdose |
|
|
| CFB at Day 2: 1 H Postdose |
|
|
| CFB at Day 2: 2 H Postdose |
|
|
| CFB at Day 2: 12 H Postdose |
|
|
| CFB at Day 3: Predose |
|
|
| CFB at Day 3: 0.25 H Postdose |
|
|
| CFB at Day 3: 0.5 H Postdose |
|
|
| CFB at Day 3: 1 H Postdose |
|
|
| CFB at Day 3: 2 H Postdose |
|
|
| CFB at Day 3: 12 H Postdose |
|
|
| CFB at Day 4: Predose |
|
|
| CFB at Day 4: 0.25 H Postdose |
|
|
| CFB at Day 4: 0.5 H Postdose |
|
|
| CFB at Day 4: 1 H Postdose |
|
|
| CFB at Day 4: 2 H Postdose |
|
|
| CFB at Day 4: 12 H Postdose |
|
|
| CFB at Day 5: Predose |
|
|
| CFB at Day 5: 0.25 H Postdose |
|
|
| CFB at Day 5: 0.5 H Postdose |
|
|
| CFB at Day 5: 1 H Postdose |
|
|
| CFB at Day 5: 2 H Postdose |
|
|
| CFB at Day 5: 12 H Postdose |
|
|
| CFB at Day 6: Predose |
|
|
| CFB at Day 6: 0.25 H Postdose |
|
|
| CFB at Day 6: 0.5 H Postdose |
|
|
| CFB at Day 6: 1 H Postdose |
|
|
| CFB at Day 6: 2 H Postdose |
|
|
| CFB at Day 6: 12 H Postdose |
|
|
| CFB at Day 7: Predose |
|
|
| CFB at Day 7: 0.25 H Postdose |
|
|
| CFB at Day 7: 0.5 H Postdose |
|
|
| CFB at Day 7: 1 H Postdose |
|
|
| CFB at Day 7: 2 H Postdose |
|
|
| CFB at Day 7: 12 H Postdose |
|
|
| CFB at Day 8: Predose |
|
|
| CFB at Day 8: 1 H Postdose |
|
|
| CFB at Day 9: Predose |
|
|
| CFB at Day 9: 1 H Postdose |
|
|
| CFB at Day 10: Predose |
|
|
| CFB at Day 10: 1 H Postdose |
|
|
| CFB at Day 11: Predose |
|
|
| CFB at Day 11: 1 H Postdose |
|
|
| CFB at Day 12: Predose |
|
|
| CFB at Day 12: 1 H Postdose |
|
|
| CFB at Day 13: Predose |
|
|
| CFB at Day 13: 1 H Postdose |
|
|
| CFB at Day 14: Predose |
|
|
| CFB at Day 14: 1 H Postdose |
|
|
| CFB at Day 15/ET |
|
|
| CFB at Follow-up Day 21 |
|
|
| CFB at Follow-up Day 28 |
|
|
| CFB at Follow-up Day 35 |
|
|
| CFB at Follow-up Day 42 |
|
|
| CFB at Day 1: 0.25 H Postdose |
|
|
| CFB at Day 1: 0.5 H Postdose |
|
|
| CFB at Day 1: 1 H Postdose |
|
|
| CFB at Day 1: 2 H Postdose |
|
|
| CFB at Day 1: 12 H Postdose |
|
|
| CFB at Day 2: Predose |
|
|
| CFB at Day 2: 0.25 H Postdose |
|
|
| CFB at Day 2: 0.5 H Postdose |
|
|
| CFB at Day 2: 1 H Postdose |
|
|
| CFB at Day 2: 2 H Postdose |
|
|
| CFB at Day 2: 12 H Postdose |
|
|
| CFB at Day 3: Predose |
|
|
| CFB at Day 3: 0.25 H Postdose |
|
|
| CFB at Day 3: 0.5 H Postdose |
|
|
| CFB at Day 3: 1 H Postdose |
|
|
| CFB at Day 3: 2 H Postdose |
|
|
| CFB at Day 3: 12 H Postdose |
|
|
| CFB at Day 4: Predose |
|
|
| CFB at Day 4: 0.25 H Postdose |
|
|
| CFB at Day 4: 0.5 H Postdose |
|
|
| CFB at Day 4: 1 H Postdose |
|
|
| CFB at Day 4: 2 H Postdose |
|
|
| CFB at Day 4: 12 H Postdose |
|
|
| CFB at Day 5: Predose |
|
|
| CFB at Day 5: 0.25 H Postdose |
|
|
| CFB at Day 5: 0.5 H Postdose |
|
|
| CFB at Day 5: 1 H Postdose |
|
|
| CFB at Day 5: 2 H Postdose |
|
|
| CFB at Day 5: 12 H Postdose |
|
|
| CFB at Day 6: Predose |
|
|
| CFB at Day 6: 0.25 H Postdose |
|
|
| CFB at Day 6: 0.5 H Postdose |
|
|
| CFB at Day 6: 1 H Postdose |
|
|
| CFB at Day 6: 2 H Postdose |
|
|
| CFB at Day 6: 12 H Postdose |
|
|
| CFB at Day 7: Predose |
|
|
| CFB at Day 7: 0.25 H Postdose |
|
|
| CFB at Day 7: 0.5 H Postdose |
|
|
| CFB at Day 7: 1 H Postdose |
|
|
| CFB at Day 7: 2 H Postdose |
|
|
| CFB at Day 7: 12 H Postdose |
|
|
| CFB at Day 8: Predose |
|
|
| CFB at Day 8: 1 H Postdose |
|
|
| CFB at Day 9: Predose |
|
|
| CFB at Day 9: 1 H Postdose |
|
|
| CFB at Day 10: Predose |
|
|
| CFB at Day 10: 1 H Postdose |
|
|
| CFB at Day 11: Predose |
|
|
| CFB at Day 11: 1 H Postdose |
|
|
| CFB at Day 12: Predose |
|
|
| CFB at Day 12: 1 H Postdose |
|
|
| CFB at Day 13: Predose |
|
|
| CFB at Day 13: 1 H Postdose |
|
|
| CFB at Day 14: Predose |
|
|
| CFB at Day 14: 1 H Postdose |
|
|
| CFB at Day 15/ET |
|
|
| CFB at Follow-up Day 21 |
|
|
| CFB at Follow-up Day 28 |
|
|
| CFB at Follow-up Day 35 |
|
|
| CFB at Follow-up Day 42 |
|
|
| CFB at Day 1: 0.25 H Postdose |
|
|
| CFB at Day 1: 0.5 H Postdose |
|
|
| CFB at Day 1: 1 H Postdose |
|
|
| CFB at Day 1: 2 H Postdose |
|
|
| CFB at Day 1: 12 H Postdose |
|
|
| CFB at Day 2: Predose |
|
|
| CFB at Day 2: 0.25 H Postdose |
|
|
| CFB at Day 2: 0.5 H Postdose |
|
|
| CFB at Day 2: 1 H Postdose |
|
|
| CFB at Day 2: 2 H Postdose |
|
|
| CFB at Day 2: 12 H Postdose |
|
|
| CFB at Day 3: Predose |
|
|
| CFB at Day 3: 0.25 H Postdose |
|
|
| CFB at Day 3: 0.5 H Postdose |
|
|
| CFB at Day 3: 1 H Postdose |
|
|
| CFB at Day 3: 2 H Postdose |
|
|
| CFB at Day 3: 12 H Postdose |
|
|
| CFB at Day 4: Predose |
|
|
| CFB at Day 4: 0.25 H Postdose |
|
|
| CFB at Day 4: 0.5 H Postdose |
|
|
| CFB at Day 4: 1 H Postdose |
|
|
| CFB at Day 4: 2 H Postdose |
|
|
| CFB at Day 4: 12 H Postdose |
|
|
| CFB at Day 5: Predose |
|
|
| CFB at Day 5: 0.25 H Postdose |
|
|
| CFB at Day 5: 0.5 H Postdose |
|
|
| CFB at Day 5: 1 H Postdose |
|
|
| CFB at Day 5: 2 H Postdose |
|
|
| CFB at Day 5: 12 H Postdose |
|
|
| CFB at Day 6: Predose |
|
|
| CFB at Day 6: 0.25 H Postdose |
|
|
| CFB at Day 6: 0.5 H Postdose |
|
|
| CFB at Day 6: 1 H Postdose |
|
|
| CFB at Day 6: 2 H Postdose |
|
|
| CFB at Day 6: 12 H Postdose |
|
|
| CFB at Day 7: Predose |
|
|
| CFB at Day 7: 0.25 H Postdose |
|
|
| CFB at Day 7: 0.5 H Postdose |
|
|
| CFB at Day 7: 1 H Postdose |
|
|
| CFB at Day 7: 2 H Postdose |
|
|
| CFB at Day 7: 12 H Postdose |
|
|
| CFB at Day 8: Predose |
|
|
| CFB at Day 8: 1 H Postdose |
|
|
| CFB at Day 9: Predose |
|
|
| CFB at Day 9: 1 H Postdose |
|
|
| CFB at Day 10: Predose |
|
|
| CFB at Day 10: 1 H Postdose |
|
|
| CFB at Day 11: Predose |
|
|
| CFB at Day 11: 1 H Postdose |
|
|
| CFB at Day 12: Predose |
|
|
| CFB at Day 12: 1 H Postdose |
|
|
| CFB at Day 13: Predose |
|
|
| CFB at Day 13: 1 H Postdose |
|
|
| CFB at Day 14: Predose |
|
|
| CFB at Day 14: 1 H Postdose |
|
|
| CFB at Day 15/ET |
|
|
| CFB at Follow-up Day 21 |
|
|
| CFB at Follow-up Day 28 |
|
|
| CFB at Follow-up Day 35 |
|
|
| CFB at Follow-up Day 42 |
|
|
| CFB at Day 1: 0.25 H Postdose |
|
|
| CFB at Day 1: 0.5 H Postdose |
|
|
| CFB at Day 1: 1 H Postdose |
|
|
| CFB at Day 1: 2 H Postdose |
|
|
| CFB at Day 1: 12 H Postdose |
|
|
| CFB at Day 2: Predose |
|
|
| CFB at Day 2: 0.25 H Postdose |
|
|
| CFB at Day 2: 0.5 H Postdose |
|
|
| CFB at Day 2: 1 H Postdose |
|
|
| CFB at Day 2: 2 H Postdose |
|
|
| CFB at Day 2: 12 H Postdose |
|
|
| CFB at Day 3: Predose |
|
|
| CFB at Day 3: 0.25 H Postdose |
|
|
| CFB at Day 3: 0.5 H Postdose |
|
|
| CFB at Day 3: 1 H Postdose |
|
|
| CFB at Day 3: 2 H Postdose |
|
|
| CFB at Day 3: 12 H Postdose |
|
|
| CFB at Day 4: Predose |
|
|
| CFB at Day 4: 0.25 H Postdose |
|
|
| CFB at Day 4: 0.5 H Postdose |
|
|
| CFB at Day 4: 1 H Postdose |
|
|
| CFB at Day 4: 2 H Postdose |
|
|
| CFB at Day 4: 12 H Postdose |
|
|
| CFB at Day 5: Predose |
|
|
| CFB at Day 5: 0.25 H Postdose |
|
|
| CFB at Day 5: 0.5 H Postdose |
|
|
| CFB at Day 5: 1 H Postdose |
|
|
| CFB at Day 5: 2 H Postdose |
|
|
| CFB at Day 5: 12 H Postdose |
|
|
| CFB at Day 6: Predose |
|
|
| CFB at Day 6: 0.25 H Postdose |
|
|
| CFB at Day 6: 0.5 H Postdose |
|
|
| CFB at Day 6: 1 H Postdose |
|
|
| CFB at Day 6: 2 H Postdose |
|
|
| CFB at Day 6: 12 H Postdose |
|
|
| CFB at Day 7: Predose |
|
|
| CFB at Day 7: 0.25 H Postdose |
|
|
| CFB at Day 7: 0.5 H Postdose |
|
|
| CFB at Day 7: 1 H Postdose |
|
|
| CFB at Day 7: 2 H Postdose |
|
|
| CFB at Day 7: 12 H Postdose |
|
|
| CFB at Day 8: Predose |
|
|
| CFB at Day 8: 1 H Postdose |
|
|
| Change from Baseline at Day 1 |
|
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 7 |
|
|
| Change from Baseline at Day 14 |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Day 1 |
|
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 7 |
|
|
| Change from Baseline at Day 14 |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Day 1 |
|
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 7 |
|
|
| Change from Baseline at Day 14 |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Day 1 |
|
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 7 |
|
|
| Change from Baseline at Day 14 |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Day 1 |
|
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 7 |
|
|
| Change from Baseline at Day 14 |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| Change from Baseline at Day 1 |
|
|
| Change from Baseline at Day 2 |
|
|
| Change from Baseline at Day 7 |
|
|
| Change from Baseline at Day 14 |
|
|
| Change from Baseline at Follow-up Day 21 |
|
|
| SCLR: Non-specific Active Suicidal Thoughts |
|
|
| SCLR: Active SI with Any Methods |
|
|
| SCLR: Active SI with Some Intent |
|
|
| Day 1: Wish to be Dead |
|
|
| Day 2: Wish to be Dead |
|
|
| Day 3: Wish to be Dead |
|
|
| Day 4: Wish to be Dead |
|
|
| Day 5: Wish to be Dead |
|
|
| Day 6: Wish to be Dead |
|
|
| Day 7: Wish to be Dead |
|
|
| Day 8: Wish to be Dead |
|
|
| Day 9: Wish to be Dead |
|
|
| Day 11: Wish to be Dead |
|
|
| Day 12: Wish to be Dead |
|
|
| Day 13: Wish to be Dead |
|
|
| Day 15: Wish to be Dead |
|
|
| Day 21: Wish to be Dead |
|
|
| Day 28: Wish to be Dead |
|
|
| Day 35: Wish to be Dead |
|
|
| Day 42: Wish to be Dead |
|
|
| Title | Measurements |
|---|
|
| Day 5 |
|
| Day 6 |
|
| Day 7 |
|
| Day 8 |
|
| Day 15 |
|
| Day 21 |
|
| Day 28 |
|
| Title | Measurements |
|---|
|
| Day 5 |
|
| Day 6 |
|
| Day 7 |
|
| Day 8 |
|
| Day 15 |
|
| Day 21 |
|
| Day 28 |
|
| Title | Measurements |
|---|---|
|
| Change from Baseline at Day 4 |
|
| Change from Baseline at Day 5 |
|
| Change from Baseline at Day 6 |
|
| Change from Baseline at Day 7 |
|
| Change from Baseline at Day 8 |
|
| Change from Baseline at Day 15 |
|
| Change from Baseline at Day 21 |
|
| Change from Baseline at Day 28 |
|
| Title | Measurements |
|---|---|
|
| Core: Change from Baseline at Day 4 |
|
| Core: Change from Baseline at Day 5 |
|
| Core: Change from Baseline at Day 6 |
|
| Core: Change from Baseline at Day 7 |
|
| Core: Change from Baseline at Day 8 |
|
| Core: Change from Baseline at Day 15 |
|
| Core: Change from Baseline at Day 21 |
|
| Core: Change from Baseline at Day 28 |
|
| Anxiety: Baseline |
|
| Anxiety: Change from Baseline at Day 2 |
|
| Anxiety: Change from Baseline at Day 3 |
|
| Anxiety: Change from Baseline at Day 4 |
|
| Anxiety: Change from Baseline at Day 5 |
|
| Anxiety: Change from Baseline at Day 6 |
|
| Anxiety: Change from Baseline at Day 7 |
|
| Anxiety: Change from Baseline at Day 8 |
|
| Anxiety: Change from Baseline at Day 15 |
|
| Anxiety: Change from Baseline at Day 21 |
|
| Anxiety: Change from Baseline at Day 28 |
|
| Bech-6: Baseline |
|
| Bech-6: Change from Baseline at Day 2 |
|
| Bech-6: Change from Baseline at Day 3 |
|
| Bech-6: Change from Baseline at Day 4 |
|
| Bech-6: Change from Baseline at Day 5 |
|
| Bech-6: Change from Baseline at Day 6 |
|
| Bech-6: Change from Baseline at Day 7 |
|
| Bech-6: Change from Baseline at Day 8 |
|
| Bech-6: Change from Baseline at Day 15 |
|
| Bech-6: Change from Baseline at Day 21 |
|
| Bech-6: Change from Baseline at Day 28 |
|
| Meier: Baseline |
|
| Meier: Change from Baseline at Day 2 |
|
| Meier: Change from Baseline at Day 3 |
|
| Meier: Change from Baseline at Day 4 |
|
| Meier: Change from Baseline at Day 5 |
|
| Meier: Change from Baseline at Day 6 |
|
| Meier: Change from Baseline at Day 7 |
|
| Meier: Change from Baseline at Day 8 |
|
| Meier: Change from Baseline at Day 15 |
|
| Meier: Change from Baseline at Day 21 |
|
| Meier: Change from Baseline at Day 28 |
|
| Title | Measurements |
|---|---|
|
| Depressed Mood: CFB at Day 4 |
|
| Depressed Mood: CFB at Day 5 |
|
| Depressed Mood: CFB at Day 6 |
|
| Depressed Mood: CFB at Day 7 |
|
| Depressed Mood: CFB at Day 8 |
|
| Depressed Mood: CFB at Day 15 |
|
| Depressed Mood: CFB at Day 21 |
|
| Depressed Mood: CFB at Day 28 |
|
| Work and Activities: Baseline |
|
| Work and Activities: CFB at Day 2 |
|
| Work and Activities: CFB at Day 3 |
|
| Work and Activities: CFB at Day 4 |
|
| Work and Activities: CFB at Day 5 |
|
| Work and Activities: CFB at Day 6 |
|
| Work and Activities: CFB at Day 7 |
|
| Work and Activities: CFB at Day 8 |
|
| Work and Activities: CFB at Day 15 |
|
| Work and Activities: CFB at Day 21 |
|
| Work and Activities: CFB at Day 28 |
|
| Insomnia Early: Baseline |
|
| Insomnia Early: CFB at Day 2 |
|
| Insomnia Early: CFB at Day 3 |
|
| Insomnia Early: CFB at Day 4 |
|
| Insomnia Early: CFB at Day 5 |
|
| Insomnia Early: CFB at Day 6 |
|
| Insomnia Early: CFB at Day 7 |
|
| Insomnia Early: CFB at Day 8 |
|
| Insomnia Early: CFB at Day 15 |
|
| Insomnia Early: CFB at Day 21 |
|
| Insomnia Early: CFB at Day 28 |
|
| Insomnia Middle: Baseline |
|
| Insomnia Middle: CFB at Day 2 |
|
| Insomnia Middle: CFB at Day 3 |
|
| Insomnia Middle: CFB at Day 4 |
|
| Insomnia Middle: CFB at Day 5 |
|
| Insomnia Middle: CFB at Day 6 |
|
| Insomnia Middle: CFB at Day 7 |
|
| Insomnia Middle: CFB at Day 8 |
|
| Insomnia Middle: CFB at Day 15 |
|
| Insomnia Middle: CFB at Day 21 |
|
| Insomnia Middle: CFB at Day 28 |
|
| Insomnia Late: Baseline |
|
| Insomnia Late: CFB at Day 2 |
|
| Insomnia Late: CFB at Day 3 |
|
| Insomnia Late: CFB at Day 4 |
|
| Insomnia Late: CFB at Day 5 |
|
| Insomnia Late: CFB at Day 6 |
|
| Insomnia Late: CFB at Day 7 |
|
| Insomnia Late: CFB at Day 8 |
|
| Insomnia Late: CFB at Day 15 |
|
| Insomnia Late: CFB at Day 21 |
|
| Insomnia Late: CFB at Day 28 |
|
| Genital Symptoms: Baseline |
|
| Genital Symptoms: CFB at Day 2 |
|
| Genital Symptoms: CFB at Day 3 |
|
| Genital Symptoms: CFB at Day 4 |
|
| Genital Symptoms: CFB at Day 5 |
|
| Genital Symptoms: CFB at Day 6 |
|
| Genital Symptoms: CFB at Day 7 |
|
| Genital Symptoms: CFB at Day 8 |
|
| Genital Symptoms: CFB at Day 15 |
|
| Genital Symptoms: CFB at Day 21 |
|
| Genital Symptoms: CFB at Day 28 |
|
| Somatic Symptoms GI: Baseline |
|
| Somatic Symptoms GI: CFB at Day 2 |
|
| Somatic Symptoms GI: CFB at Day 3 |
|
| Somatic Symptoms GI: CFB at Day 4 |
|
| Somatic Symptoms GI: CFB at Day 5 |
|
| Somatic Symptoms GI: CFB at Day 6 |
|
| Somatic Symptoms GI: CFB at Day 7 |
|
| Somatic Symptoms GI: CFB at Day 8 |
|
| Somatic Symptoms GI: CFB at Day 15 |
|
| Somatic Symptoms GI: CFB at Day 21 |
|
| Somatic Symptoms GI: CFB at Day 28 |
|
| Loss of Weight: Baseline |
|
| Loss of Weight: CFB at Day 2 |
|
| Loss of Weight: CFB at Day 3 |
|
| Loss of Weight: CFB at Day 4 |
|
| Loss of Weight: CFB at Day 5 |
|
| Loss of Weight: CFB at Day 6 |
|
| Loss of Weight: CFB at Day 7 |
|
| Loss of Weight: CFB at Day 8 |
|
| Loss of Weight: CFB at Day 15 |
|
| Loss of Weight: CFB at Day 21 |
|
| Loss of Weight: CFB at Day 28 |
|
| Somatic Symptoms General: Baseline |
|
| Somatic Symptoms General: CFB at Day 2 |
|
| Somatic Symptoms General: CFB at Day 3 |
|
| Somatic Symptoms General: CFB at Day 4 |
|
| Somatic Symptoms General: CFB at Day 5 |
|
| Somatic Symptoms General: CFB at Day 6 |
|
| Somatic Symptoms General: CFB at Day 7 |
|
| Somatic Symptoms General: CFB at Day 8 |
|
| Somatic Symptoms General: CFB at Day 15 |
|
| Somatic Symptoms General: CFB at Day 21 |
|
| Somatic Symptoms General: CFB at Day 28 |
|
| Feelings of Guilt: Baseline |
|
| Feelings of Guilt: CFB at Day 2 |
|
| Feelings of Guilt: CFB at Day 3 |
|
| Feelings of Guilt: CFB at Day 4 |
|
| Feelings of Guilt: CFB at Day 5 |
|
| Feelings of Guilt: CFB at Day 6 |
|
| Feelings of Guilt: CFB at Day 7 |
|
| Feelings of Guilt: CFB at Day 8 |
|
| Feelings of Guilt: CFB at Day 15 |
|
| Feelings of Guilt: CFB at Day 21 |
|
| Feelings of Guilt: CFB at Day 28 |
|
| Suicide: Baseline |
|
| Suicide: CFB at Day 2 |
|
| Suicide: CFB at Day 3 |
|
| Suicide: CFB at Day 4 |
|
| Suicide: CFB at Day 5 |
|
| Suicide: CFB at Day 6 |
|
| Suicide: CFB at Day 7 |
|
| Suicide: CFB at Day 8 |
|
| Suicide: CFB at Day 15 |
|
| Suicide: CFB at Day 21 |
|
| Suicide: CFB at Day 28 |
|
| Anxiety Psychic: Baseline |
|
| Anxiety Psychic: CFB at Day 2 |
|
| Anxiety Psychic: CFB at Day 3 |
|
| Anxiety Psychic: CFB at Day 4 |
|
| Anxiety Psychic: CFB at Day 5 |
|
| Anxiety Psychic: CFB at Day 6 |
|
| Anxiety Psychic: CFB at Day 7 |
|
| Anxiety Psychic: CFB at Day 8 |
|
| Anxiety Psychic: CFB at Day 15 |
|
| Anxiety Psychic: CFB at Day 21 |
|
| Anxiety Psychic: CFB at Day 28 |
|
| Anxiety Somatic: Baseline |
|
| Anxiety Somatic: CFB at Day 2 |
|
| Anxiety Somatic: CFB at Day 3 |
|
| Anxiety Somatic: CFB at Day 4 |
|
| Anxiety Somatic: CFB at Day 5 |
|
| Anxiety Somatic: CFB at Day 6 |
|
| Anxiety Somatic: CFB at Day 7 |
|
| Anxiety Somatic: CFB at Day 8 |
|
| Anxiety Somatic: CFB at Day 15 |
|
| Anxiety Somatic: CFB at Day 21 |
|
| Anxiety Somatic: CFB at Day 28 |
|
| Hypochondriasis: Baseline |
|
| Hypochondriasis: CFB at Day 2 |
|
| Hypochondriasis: CFB at Day 3 |
|
| Hypochondriasis: CFB at Day 4 |
|
| Hypochondriasis: CFB at Day 5 |
|
| Hypochondriasis: CFB at Day 6 |
|
| Hypochondriasis: CFB at Day 7 |
|
| Hypochondriasis: CFB at Day 8 |
|
| Hypochondriasis: CFB at Day 15 |
|
| Hypochondriasis: CFB at Day 21 |
|
| Hypochondriasis: CFB at Day 28 |
|
| Insight: Baseline |
|
| Insight: CFB at Day 2 |
|
| Insight: CFB at Day 3 |
|
| Insight: CFB at Day 4 |
|
| Insight: CFB at Day 5 |
|
| Insight: CFB at Day 6 |
|
| Insight: CFB at Day 7 |
|
| Insight: CFB at Day 8 |
|
| Insight: CFB at Day 15 |
|
| Insight: CFB at Day 21 |
|
| Insight: CFB at Day 28 |
|
| Agitation: Baseline |
|
| Agitation: CFB at Day 2 |
|
| Agitation: CFB at Day 3 |
|
| Agitation: CFB at Day 4 |
|
| Agitation: CFB at Day 5 |
|
| Agitation: CFB at Day 6 |
|
| Agitation: CFB at Day 7 |
|
| Agitation: CFB at Day 8 |
|
| Agitation: CFB at Day 15 |
|
| Agitation: CFB at Day 21 |
|
| Agitation: CFB at Day 28 |
|
| Retardation: Baseline |
|
| Retardation: CFB at Day 2 |
|
| Retardation: CFB at Day 3 |
|
| Retardation: CFB at Day 4 |
|
| Retardation: CFB at Day 5 |
|
| Retardation: CFB at Day 6 |
|
| Retardation: CFB at Day 7 |
|
| Retardation: CFB at Day 8 |
|
| Retardation: CFB at Day 15 |
|
| Retardation: CFB at Day 21 |
|
| Retardation: CFB at Day 28 |
|
| Title | Measurements |
|---|---|
|
| Change from Baseline at Day 8 |
|
| Change from Baseline at Day 15 |
|
| Change from Baseline at Day 21 |
|
| Change from Baseline at Day 28 |
|
| Title | Measurements |
|---|
|
| Day 15 |
|
| Day 21 |
|
| Day 28 |
|
| CFB at Day 1: 0.25 H Postdose |
|
|
| CFB at Day 1: 0.5 H Postdose |
|
|
| CFB at Day 1: 1 H Postdose |
|
|
| CFB at Day 1: 2 H Postdose |
|
|
| CFB at Day 2: Predose |
|
|
| CFB at Day 2: 0.25 H Postdose |
|
|
| CFB at Day 2: 0.5 H Postdose |
|
|
| CFB at Day 2: 1 H Postdose |
|
|
| CFB at Day 2: 2 H Postdose |
|
|
| CFB at Day 3: Predose |
|
|
| CFB at Day 3: 0.25 H Postdose |
|
|
| CFB at Day 3: 0.5 H Postdose |
|
|
| CFB at Day 3: 1 H Postdose |
|
|
| CFB at Day 3: 2 H Postdose |
|
|
| CFB at Day 4: Predose |
|
|
| CFB at Day 4: 0.25 H Postdose |
|
|
| CFB at Day 4: 0.5 H Postdose |
|
|
| CFB at Day 4: 1 H Postdose |
|
|
| CFB at Day 4: 2 H Postdose |
|
|
| CFB at Day 5: Predose |
|
|
| CFB at Day 5: 0.25 H Postdose |
|
|
| CFB at Day 5: 0.5 H Postdose |
|
|
| CFB at Day 5: 1 H Postdose |
|
|
| CFB at Day 5: 2 H Postdose |
|
|
| CFB at Day 6: Predose |
|
|
| CFB at Day 6: 0.25 H Postdose |
|
|
| CFB at Day 6: 0.5 H Postdose |
|
|
| CFB at Day 6: 1 H Postdose |
|
|
| CFB at Day 6: 2 H Postdose |
|
|
| CFB at Day 7: Predose |
|
|
| CFB at Day 7: 0.25 H Postdose |
|
|
| CFB at Day 7: 0.5 H Postdose |
|
|
| CFB at Day 7: 1 H Postdose |
|
|
| CFB at Day 7: 2 H Postdose |
|
|
| CFB at Day 8: Predose |
|
|
| CFB at Day 8: 1 H Postdose |
|
|
| CFB at Day 9: Predose |
|
|
| CFB at Day 9: 1 H Postdose |
|
|
| CFB at Day 10: Predose |
|
|
| CFB at Day 10: 1 H Postdose |
|
|
| CFB at Day 11: Predose |
|
|
| CFB at Day 11: 1 H Postdose |
|
|
| CFB at Day 12: Predose |
|
|
| CFB at Day 12: 1 H Postdose |
|
|
| CFB at Day 13: Predose |
|
|
| CFB at Day 13: 1 H Postdose |
|
|
| CFB at Day 14: Predose |
|
|
| CFB at Day 14: 1 H Postdose |
|
|
| CFB at Day 15 |
|
|
| Change from Baseline at Day 4 |
|
| Change from Baseline at Day 5 |
|
| Change from Baseline at Day 6 |
|
| Change from Baseline at Day 7 |
|
| Change from Baseline at Day 8 |
|
| Change from Baseline at Day 15 |
|
| Change from Baseline at Day 21 |
|
| Change from Baseline at Day 28 |
|
| Change from Baseline at Day 35 |
|
| Change from Baseline at Day 42 |
|
Day 3 |
| Mixed Effect Model for Repeated Measures |
The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables. |
| 0.0010 |
| Least Squares Mean Difference |
| -4.1 |
| Standard Error of the Mean |
| 1.18 |
| 2-Sided |
| 95 |
| -6.4 |
| -1.7 |
| Superiority |
| Day 4 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables. | 0.0233 | Least Squares Mean Difference | -2.9 | Standard Error of the Mean | 1.27 | 2-Sided | 95 | -5.5 | -0.4 | Superiority |
| Day 5 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables. | 0.0066 | Least Squares Mean Difference | -3.8 | Standard Error of the Mean | 1.37 | 2-Sided | 95 | -6.6 | -1.1 | Superiority |
| Day 6 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables. | 0.0019 | Least Squares Mean Difference | -4.5 | Standard Error of the Mean | 1.40 | 2-Sided | 95 | -7.3 | -1.7 | Superiority |
| Day 7 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables. | 0.0043 | Least Squares Mean Difference | -4.5 | Standard Error of the Mean | 1.53 | 2-Sided | 95 | -7.6 | -1.5 | Superiority |
| Day 8 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables. | 0.0318 | Least Squares Mean Difference | -3.4 | Standard Error of the Mean | 1.54 | 2-Sided | 95 | -6.4 | -0.3 | Superiority |
| Day 15 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables. | < 0.0001 | Least Squares Mean Difference | -7.0 | Standard Error of the Mean | 1.60 | 2-Sided | 95 | -10.2 | -3.9 | Superiority |
| Day 21 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables. | 0.0064 | Least Squares Mean Difference | -4.9 | Standard Error of the Mean | 1.76 | 2-Sided | 95 | -8.4 | -1.4 | Superiority |
| Day 28 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables. | 0.0243 | Least Squares Mean Difference | -4.1 | Standard Error of the Mean | 1.77 | 2-Sided | 95 | -7.6 | -0.5 | Superiority |
| Day 35 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables. | 0.2285 | Least Squares Mean Difference | -2.3 | Standard Error of the Mean | 1.86 | 2-Sided | 95 | -6.0 | 1.4 | Superiority |
| Day 42 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables. | 0.2120 | Least Squares Mean Difference | -2.3 | Standard Error of the Mean | 1.86 | 2-Sided | 95 | -6.0 | 1.4 | Superiority |
| Day 8 |
|
|
| Day 15 |
|
|
| Day 21 |
|
|
| Day 28 |
|
|
| Day 35 |
|
|
| Day 42 |
|
|
|
Day 8 |
| Generalized Estimating Equation |
Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables. |
| 0.0732 |
| Odds Ratio (OR) |
| 2.4 |
| 2-Sided |
| 95 |
| 0.9 |
| 6.4 |
For the model parameters estimation, the exchangeable working correlation structure was used. |
| Superiority |
| Day 15 | Generalized Estimating Equation | Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables. | 0.0002 | Odds Ratio (OR) | 9.6 | 2-Sided | 95 | 2.9 | 31.6 | For the model parameters estimation, the exchangeable working correlation structure was used. | Superiority |
| Day 21 | Generalized Estimating Equation | Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables. | 0.0006 | Odds Ratio (OR) | 6.7 | 2-Sided | 95 | 2.3 | 19.7 | For the model parameters estimation, the exchangeable working correlation structure was used. | Superiority |
| Day 28 | Generalized Estimating Equation | Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables. | 0.0379 | Odds Ratio (OR) | 3.1 | 2-Sided | 95 | 1.1 | 8.9 | For the model parameters estimation, the exchangeable working correlation structure was used. | Superiority |
| Day 35 | Generalized Estimating Equation | Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables. | 0.0468 | Odds Ratio (OR) | 3.0 | 2-Sided | 95 | 1.0 | 9.0 | For the model parameters estimation, the exchangeable working correlation structure was used. | Superiority |
| Day 42 | Generalized Estimating Equation | Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables. | 0.2208 | Odds Ratio (OR) | 1.9 | 2-Sided | 95 | 0.7 | 5.6 | For the model parameters estimation, the exchangeable working correlation structure was used. | Superiority |
| Day 8 |
|
|
| Day 15 |
|
|
| Day 21 |
|
|
| Day 28 |
|
|
| Day 35 |
|
|
| Day 42 |
|
|
Day 15 |
| Generalized Estimating Equation |
Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables. |
| 0.0005 |
| Odds Ratio (OR) |
| 5.3 |
| 2-Sided |
| 95 |
| 2.1 |
| 13.3 |
For the model parameters estimation, the exchangeable working correlation structure was used. |
| Superiority |
| Day 21 | Generalized Estimating Equation | Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables. | 0.0172 | Odds Ratio (OR) | 3.1 | 2-Sided | 95 | 1.2 | 8.0 | For the model parameters estimation, the exchangeable working correlation structure was used. | Superiority |
| Day 28 | Generalized Estimating Equation | Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables. | 0.0221 | Odds Ratio (OR) | 2.9 | 2-Sided | 95 | 1.2 | 7.3 | For the model parameters estimation, the exchangeable working correlation structure was used. | Superiority |
| Day 35 | Generalized Estimating Equation | Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables. | 0.4139 | Odds Ratio (OR) | 1.4 | 2-Sided | 95 | 0.6 | 3.5 | For the model parameters estimation, the exchangeable working correlation structure was used. | Superiority |
| Day 42 | Generalized Estimating Equation | Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables. | 0.2332 | Odds Ratio (OR) | 1.7 | 2-Sided | 95 | 0.7 | 4.3 | For the model parameters estimation, the exchangeable working correlation structure was used. | Superiority |
| Change from Baseline at Day 15 |
|
| Change from Baseline at Day 21 |
|
| Change from Baseline at Day 28 |
|
| Change from Baseline at Day 35 |
|
| Change from Baseline at Day 42 |
|
Day 8 |
| Mixed Effect Model for Repeated Measures |
The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable. |
| 0.0864 |
| Least Squares Mean Difference |
| -4.0 |
| Standard Error of the Mean |
| 2.32 |
| 2-Sided |
| 95 |
| -8.6 |
| 0.6 |
| Superiority |
| Day 15 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable. | 0.0021 | Least Squares Mean Difference | -7.6 | Standard Error of the Mean | 2.38 | 2-Sided | 95 | -12.3 | -2.8 | Superiority |
| Day 21 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable. | 0.0157 | Least Squares Mean Difference | -6.6 | Standard Error of the Mean | 2.69 | 2-Sided | 95 | -12.0 | -1.3 | Superiority |
| Day 28 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable. | 0.0533 | Least Squares Mean Difference | -5.3 | Standard Error of the Mean | 2.69 | 2-Sided | 95 | -10.6 | 0.1 | Superiority |
| Day 35 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable. | 0.2878 | Least Squares Mean Difference | -3.1 | Standard Error of the Mean | 2.87 | 2-Sided | 95 | -8.8 | 2.6 | Superiority |
| Day 42 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable. | 0.4664 | Least Squares Mean Difference | -2.0 | Standard Error of the Mean | 2.70 | 2-Sided | 95 | -7.4 | 3.4 | Superiority |
| Core: Change from Baseline at Day 2 |
|
|
| Core: Change from Baseline at Day 3 |
|
|
| Core: Change from Baseline at Day 4 |
|
|
| Core: Change from Baseline at Day 5 |
|
|
| Core: Change from Baseline at Day 6 |
|
|
| Core: Change from Baseline at Day 7 |
|
|
| Core: Change from Baseline at Day 8 |
|
|
| Core: Change from Baseline at Day 15 |
|
|
| Core: Change from Baseline at Day 21 |
|
|
| Core: Change from Baseline at Day 28 |
|
|
| Core: Change from Baseline at Day 35 |
|
|
| Core: Change from Baseline at Day 42 |
|
|
| Anxiety: Baseline |
|
|
| Anxiety: Change from Baseline at Day 2 |
|
|
| Anxiety: Change from Baseline at Day 3 |
|
|
| Anxiety: Change from Baseline at Day 4 |
|
|
| Anxiety: Change from Baseline at Day 5 |
|
|
| Anxiety: Change from Baseline at Day 6 |
|
|
| Anxiety: Change from Baseline at Day 7 |
|
|
| Anxiety: Change from Baseline at Day 8 |
|
|
| Anxiety: Change from Baseline at Day 15 |
|
|
| Anxiety: Change from Baseline at Day 21 |
|
|
| Anxiety: Change from Baseline at Day 28 |
|
|
| Anxiety: Change from Baseline at Day 35 |
|
|
| Anxiety: Change from Baseline at Day 42 |
|
|
| Bech-6: Baseline |
|
|
| Bech-6: Change from Baseline at Day 2 |
|
|
| Bech-6: Change from Baseline at Day 3 |
|
|
| Bech-6: Change from Baseline at Day 4 |
|
|
| Bech-6: Change from Baseline at Day 5 |
|
|
| Bech-6: Change from Baseline at Day 6 |
|
|
| Bech-6: Change from Baseline at Day 7 |
|
|
| Bech-6: Change from Baseline at Day 8 |
|
|
| Bech-6: Change from Baseline at Day 15 |
|
|
| Bech-6: Change from Baseline at Day 21 |
|
|
| Bech-6: Change from Baseline at Day 28 |
|
|
| Bech-6: Change from Baseline at Day 35 |
|
|
| Bech-6: Change from Baseline at Day 42 |
|
|
| Meier: Baseline |
|
|
| Meier: Change from Baseline at Day 2 |
|
|
| Meier: Change from Baseline at Day 3 |
|
|
| Meier: Change from Baseline at Day 4 |
|
|
| Meier: Change from Baseline at Day 5 |
|
|
| Meier: Change from Baseline at Day 6 |
|
|
| Meier: Change from Baseline at Day 7 |
|
|
| Meier: Change from Baseline at Day 8 |
|
|
| Meier: Change from Baseline at Day 15 |
|
|
| Meier: Change from Baseline at Day 21 |
|
|
| Meier: Change from Baseline at Day 28 |
|
|
| Meier: Change from Baseline at Day 35 |
|
|
| Meier: Change from Baseline at Day 42 |
|
|
| Depressed Mood: CFB at Day 2 |
|
|
| Depressed Mood: CFB at Day 3 |
|
|
| Depressed Mood: CFB at Day 4 |
|
|
| Depressed Mood: CFB at Day 5 |
|
|
| Depressed Mood: CFB at Day 6 |
|
|
| Depressed Mood: CFB at Day 7 |
|
|
| Depressed Mood: CFB at Day 8 |
|
|
| Depressed Mood: CFB at Day 15 |
|
|
| Depressed Mood: CFB at Day 21 |
|
|
| Depressed Mood: CFB at Day 28 |
|
|
| Depressed Mood: CFB at Day 35 |
|
|
| Depressed Mood: CFB at Day 42 |
|
|
| Work and Activities: Baseline |
|
|
| Work and Activities: CFB at Day 2 |
|
|
| Work and Activities: CFB at Day 3 |
|
|
| Work and Activities: CFB at Day 4 |
|
|
| Work and Activities: CFB at Day 5 |
|
|
| Work and Activities: CFB at Day 6 |
|
|
| Work and Activities: CFB at Day 7 |
|
|
| Work and Activities: CFB at Day 8 |
|
|
| Work and Activities: CFB at Day 15 |
|
|
| Work and Activities: CFB at Day 21 |
|
|
| Work and Activities: CFB at Day 28 |
|
|
| Work and Activities: CFB at Day 35 |
|
|
| Work and Activities: CFB at Day 42 |
|
|
| Insomnia Early: Baseline |
|
|
| Insomnia Early: CFB at Day 2 |
|
|
| Insomnia Early: CFB at Day 3 |
|
|
| Insomnia Early: CFB at Day 4 |
|
|
| Insomnia Early: CFB at Day 5 |
|
|
| Insomnia Early: CFB at Day 6 |
|
|
| Insomnia Early: CFB at Day 7 |
|
|
| Insomnia Early: CFB at Day 8 |
|
|
| Insomnia Early: CFB at Day 15 |
|
|
| Insomnia Early: CFB at Day 21 |
|
|
| Insomnia Early: CFB at Day 28 |
|
|
| Insomnia Early: CFB at Day 35 |
|
|
| Insomnia Early: CFB at Day 42 |
|
|
| Insomnia Middle: Baseline |
|
|
| Insomnia Middle: CFB at Day 2 |
|
|
| Insomnia Middle: CFB at Day 3 |
|
|
| Insomnia Middle: CFB at Day 4 |
|
|
| Insomnia Middle: CFB at Day 5 |
|
|
| Insomnia Middle: CFB at Day 6 |
|
|
| Insomnia Middle: CFB at Day 7 |
|
|
| Insomnia Middle: CFB at Day 8 |
|
|
| Insomnia Middle: CFB at Day 15 |
|
|
| Insomnia Middle: CFB at Day 21 |
|
|
| Insomnia Middle: CFB at Day 28 |
|
|
| Insomnia Middle: CFB at Day 35 |
|
|
| Insomnia Middle: CFB at Day 42 |
|
|
| Insomnia Late: Baseline |
|
|
| Insomnia Late: CFB at Day 2 |
|
|
| Insomnia Late: CFB at Day 3 |
|
|
| Insomnia Late: CFB at Day 4 |
|
|
| Insomnia Late: CFB at Day 5 |
|
|
| Insomnia Late: CFB at Day 6 |
|
|
| Insomnia Late: CFB at Day 7 |
|
|
| Insomnia Late: CFB at Day 8 |
|
|
| Insomnia Late: CFB at Day 15 |
|
|
| Insomnia Late: CFB at Day 21 |
|
|
| Insomnia Late: CFB at Day 28 |
|
|
| Insomnia Late: CFB at Day 35 |
|
|
| Insomnia Late: CFB at Day 42 |
|
|
| Genital Symptoms: Baseline |
|
|
| Genital Symptoms: CFB at Day 2 |
|
|
| Genital Symptoms: CFB at Day 3 |
|
|
| Genital Symptoms: CFB at Day 4 |
|
|
| Genital Symptoms: CFB at Day 5 |
|
|
| Genital Symptoms: CFB at Day 6 |
|
|
| Genital Symptoms: CFB at Day 7 |
|
|
| Genital Symptoms: CFB at Day 8 |
|
|
| Genital Symptoms: CFB at Day 15 |
|
|
| Genital Symptoms: CFB at Day 21 |
|
|
| Genital Symptoms: CFB at Day 28 |
|
|
| Genital Symptoms: CFB at Day 35 |
|
|
| Genital Symptoms: CFB at Day 42 |
|
|
| Somatic Symptoms GI: Baseline |
|
|
| Somatic Symptoms GI: CFB at Day 2 |
|
|
| Somatic Symptoms GI: CFB at Day 3 |
|
|
| Somatic Symptoms GI: CFB at Day 4 |
|
|
| Somatic Symptoms GI: CFB at Day 5 |
|
|
| Somatic Symptoms GI: CFB at Day 6 |
|
|
| Somatic Symptoms GI: CFB at Day 7 |
|
|
| Somatic Symptoms GI: CFB at Day 8 |
|
|
| Somatic Symptoms GI: CFB at Day 15 |
|
|
| Somatic Symptoms GI: CFB at Day 21 |
|
|
| Somatic Symptoms GI: CFB at Day 28 |
|
|
| Somatic Symptoms GI: CFB at Day 35 |
|
|
| Somatic Symptoms GI: CFB at Day 42 |
|
|
| Loss of Weight: Baseline |
|
|
| Loss of Weight: CFB at Day 2 |
|
|
| Loss of Weight: CFB at Day 3 |
|
|
| Loss of Weight: CFB at Day 4 |
|
|
| Loss of Weight: CFB at Day 5 |
|
|
| Loss of Weight: CFB at Day 6 |
|
|
| Loss of Weight: CFB at Day 7 |
|
|
| Loss of Weight: CFB at Day 8 |
|
|
| Loss of Weight: CFB at Day 15 |
|
|
| Loss of Weight: CFB at Day 21 |
|
|
| Loss of Weight: CFB at Day 28 |
|
|
| Loss of Weight: CFB at Day 35 |
|
|
| Loss of Weight: CFB at Day 42 |
|
|
| Somatic Symptoms General: Baseline |
|
|
| Somatic Symptoms General: CFB at Day 2 |
|
|
| Somatic Symptoms General: CFB at Day 3 |
|
|
| Somatic Symptoms General: CFB at Day 4 |
|
|
| Somatic Symptoms General: CFB at Day 5 |
|
|
| Somatic Symptoms General: CFB at Day 6 |
|
|
| Somatic Symptoms General: CFB at Day 7 |
|
|
| Somatic Symptoms General: CFB at Day 8 |
|
|
| Somatic Symptoms General: CFB at Day 15 |
|
|
| Somatic Symptoms General: CFB at Day 21 |
|
|
| Somatic Symptoms General: CFB at Day 28 |
|
|
| Somatic Symptoms General: CFB at Day 35 |
|
|
| Somatic Symptoms General: CFB at Day 42 |
|
|
| Feelings of Guilt: Baseline |
|
|
| Feelings of Guilt: CFB at Day 2 |
|
|
| Feelings of Guilt: CFB at Day 3 |
|
|
| Feelings of Guilt: CFB at Day 4 |
|
|
| Feelings of Guilt: CFB at Day 5 |
|
|
| Feelings of Guilt: CFB at Day 6 |
|
|
| Feelings of Guilt: CFB at Day 7 |
|
|
| Feelings of Guilt: CFB at Day 8 |
|
|
| Feelings of Guilt: CFB at Day 15 |
|
|
| Feelings of Guilt: CFB at Day 21 |
|
|
| Feelings of Guilt: CFB at Day 28 |
|
|
| Feelings of Guilt: CFB at Day 35 |
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| Feelings of Guilt: CFB at Day 42 |
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| Suicide: Baseline |
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| Suicide: CFB at Day 2 |
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| Suicide: CFB at Day 3 |
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| Suicide: CFB at Day 4 |
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| Suicide: CFB at Day 5 |
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| Suicide: CFB at Day 6 |
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| Suicide: CFB at Day 7 |
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| Suicide: CFB at Day 8 |
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| Suicide: CFB at Day 15 |
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| Suicide: CFB at Day 21 |
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| Suicide: CFB at Day 28 |
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| Suicide: CFB at Day 35 |
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| Suicide: CFB at Day 42 |
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| Anxiety Psychic: Baseline |
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| Anxiety Psychic: CFB at Day 2 |
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| Anxiety Psychic: CFB at Day 3 |
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| Anxiety Psychic: CFB at Day 4 |
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| Anxiety Psychic: CFB at Day 5 |
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| Anxiety Psychic: CFB at Day 6 |
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| Anxiety Psychic: CFB at Day 7 |
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| Anxiety Psychic: CFB at Day 8 |
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| Anxiety Psychic: CFB at Day 15 |
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| Anxiety Psychic: CFB at Day 21 |
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| Anxiety Psychic: CFB at Day 28 |
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| Anxiety Psychic: CFB at Day 35 |
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| Anxiety Psychic: CFB at Day 42 |
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| Anxiety Somatic: Baseline |
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| Anxiety Somatic: CFB at Day 2 |
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| Anxiety Somatic: CFB at Day 3 |
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| Anxiety Somatic: CFB at Day 4 |
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| Anxiety Somatic: CFB at Day 5 |
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| Anxiety Somatic: CFB at Day 6 |
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| Anxiety Somatic: CFB at Day 7 |
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| Anxiety Somatic: CFB at Day 8 |
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| Anxiety Somatic: CFB at Day 15 |
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| Anxiety Somatic: CFB at Day 21 |
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| Anxiety Somatic: CFB at Day 28 |
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| Anxiety Somatic: CFB at Day 35 |
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| Anxiety Somatic: CFB at Day 42 |
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| Hypochondriasis: Baseline |
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| Hypochondriasis: CFB at Day 2 |
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| Hypochondriasis: CFB at Day 3 |
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| Hypochondriasis: CFB at Day 4 |
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| Hypochondriasis: CFB at Day 5 |
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| Hypochondriasis: CFB at Day 6 |
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| Hypochondriasis: CFB at Day 7 |
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| Hypochondriasis: CFB at Day 8 |
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| Hypochondriasis: CFB at Day 15 |
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| Hypochondriasis: CFB at Day 21 |
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| Hypochondriasis: CFB at Day 28 |
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| Hypochondriasis: CFB at Day 35 |
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| Hypochondriasis: CFB at Day 42 |
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| Insight: Baseline |
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| Insight: CFB at Day 2 |
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| Insight: CFB at Day 3 |
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| Insight: CFB at Day 4 |
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| Insight: CFB at Day 5 |
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| Insight: CFB at Day 6 |
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| Insight: CFB at Day 7 |
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| Insight: CFB at Day 8 |
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| Insight: CFB at Day 15 |
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| Insight: CFB at Day 21 |
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| Insight: CFB at Day 28 |
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| Insight: CFB at Day 35 |
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| Insight: CFB at Day 42 |
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| Agitation: Baseline |
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| Agitation: CFB at Day 2 |
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| Agitation: CFB at Day 3 |
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| Agitation: CFB at Day 4 |
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| Agitation: CFB at Day 5 |
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| Agitation: CFB at Day 6 |
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| Agitation: CFB at Day 7 |
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| Agitation: CFB at Day 8 |
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| Agitation: CFB at Day 15 |
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| Agitation: CFB at Day 21 |
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| Agitation: CFB at Day 28 |
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| Agitation: CFB at Day 35 |
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| Agitation: CFB at Day 42 |
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| Retardation: Baseline |
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| Retardation: CFB at Day 2 |
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| Retardation: CFB at Day 3 |
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| Retardation: CFB at Day 4 |
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| Retardation: CFB at Day 5 |
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| Retardation: CFB at Day 6 |
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| Retardation: CFB at Day 7 |
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| Retardation: CFB at Day 8 |
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| Retardation: CFB at Day 15 |
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| Retardation: CFB at Day 21 |
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| Retardation: CFB at Day 28 |
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| Retardation: CFB at Day 35 |
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| Retardation: CFB at Day 42 |
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| Change from Baseline at Day 15 |
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| Change from Baseline at Day 21 |
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| Change from Baseline at Day 28 |
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| Change from Baseline at Day 35 |
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| Change from Baseline at Day 42 |
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Day 8 |
| Mixed Effect Model for Repeated Measures |
The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable. |
| 0.0516 |
| Least Squares Mean Difference |
| -2.5 |
| Standard Error of the Mean |
| 1.29 |
| 2-Sided |
| 95 |
| -5.1 |
| 0.0 |
| Superiority |
| Day 15 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable. | 0.0008 | Least Squares Mean Difference | -4.6 | Standard Error of the Mean | 1.32 | 2-Sided | 95 | -7.3 | -2.0 | Superiority |
| Day 21 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable. | 0.0282 | Least Squares Mean Difference | -3.4 | Standard Error of the Mean | 1.54 | 2-Sided | 95 | -6.5 | -0.4 | Superiority |
| Day 28 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable. | 0.1686 | Least Squares Mean Difference | -2.2 | Standard Error of the Mean | 1.56 | 2-Sided | 95 | -5.3 | 0.9 | Superiority |
| Day 35 | Mixed Effect Model for Repeated Measures | 0.2488 | Least Squares Mean Difference | -2.0 | Standard Error of the Mean | 1.75 | 2-Sided | 95 | -5.5 | 1.5 | Superiority |
| Day 42 | Mixed Effect Model for Repeated Measures | The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable. | 0.2037 | Least Squares Mean Difference | -2.3 | Standard Error of the Mean | 1.76 | 2-Sided | 95 | -5.7 | 1.2 | Superiority |
| Day 8 |
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| Day 15 |
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| Day 21 |
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| Day 28 |
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| Day 35 |
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| Day 42 |
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Day 15 |
| Generalized Estimating Equation |
Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable. |
| 0.0007 |
| Odds Ratio (OR) |
| 8.6 |
| 2-Sided |
| 95 |
| 2.5 |
| 29.5 |
For the model parameters estimation, the exchangeable working correlation structure was used. |
| Superiority |
| Day 21 | Generalized Estimating Equation | Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable. | 0.0113 | Odds Ratio (OR) | 4.4 | 2-Sided | 95 | 1.4 | 13.6 | For the model parameters estimation, the exchangeable working correlation structure was used. | Superiority |
| Day 28 | Generalized Estimating Equation | Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable. | 0.0227 | Odds Ratio (OR) | 3.9 | 2-Sided | 95 | 1.2 | 12.8 | For the model parameters estimation, the exchangeable working correlation structure was used. | Superiority |
| Day 35 | Generalized Estimating Equation | Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable. | 0.1516 | Odds Ratio (OR) | 2.3 | 2-Sided | 95 | 0.7 | 7.2 | For the model parameters estimation, the exchangeable working correlation structure was used. | Superiority |
| Day 42 | Generalized Estimating Equation | Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable. | 0.0793 | Odds Ratio (OR) | 2.7 | 2-Sided | 95 | 0.9 | 8.3 | For the model parameters estimation, the exchangeable working correlation structure was used. | Superiority |