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The purpose of this study is to evaluate the safety and efficacy in patients with major depressive disorder.
The screening phase is intended for diagnosing and assessing the patient for possible inclusion in the study and for providing an adequate washout period. The following study will be conducted in two parts. Part I is an open-label study, multiple center and dose escalation evaluation in twelve patients. Six subjects each will be evaluated for safety and efficacy assessments at 1 or 2 capsules TID dose for 28 days, sequentially. Each of them will be assessed twice in the first week after administration of PDC-1421 Capsules and once a week in the following treatment.
Part II is a randomized, double-blind, placebo-controlled, parallel-group study. 60 subjects will be randomly assigned on a 1:1:1 basis to one of the three arms (1 PDC-1421 Capsule plus 1 placebo TID, 2 PDC-1421 Capsules TID, 2 placebo TID) for 6 weeks and evaluated the safety and efficacy every two weeks during the treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I: 1 PDC-1421 Capsule | Experimental | 1 PDC-1421 Capsule TID, p.o. after meal for 28 days |
|
| Part I: 2 PDC-1421 Capsule | Experimental | 2 PDC-1421 Capsule TID, p.o. after meal for 28 days |
|
| Part II: 2 PDC-1421 Capsule | Experimental | 2 PDC-1421 Capsule TID, p.o. after meal for 42 days |
|
| Part II: 1 PDC-1421 Capsule plus 1 placebo | Experimental | 1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days |
|
| Part II: 2 placebo | Placebo Comparator | 2 placebo TID, p.o. after meal for 42 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDC-1421 Capsule | Drug | PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 Compared to Placebo for Part II. | The MADRS is a 10-item checklist of depressive symptoms. Each Item is rated on a scale of 0-6, with anchors at 2-point intervals; higher scores indicating more severity (i.e., ranging from 0 [no sadness] to 6 extremely despondent]). The total MADRS score was calculated by summing the ratings of all items. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity). | From Baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 2, 4 and 7 Part II. | The MADRS is a 10-item checklist of depressive symptoms. Each Item is rated on a scale of 0-6, with anchors at 2-point intervals; higher scores indicating more severity (i.e., ranging from 0 [no sadness] to 6 extremely despondent]). The total MADRS score was calculated by summing the ratings of all items. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard King, Ph.D. | American BriVision Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Depression Research Clinic | San Francisco | California | 94305 | United States | ||
| Taipei Veterans General Hospital |
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Subject were recruited over a 49-month period from April of 2015 to March of 2019 at 5 studies sites in Taiwan and 1 study site in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part I: 1 PDC-1421 Capsule | 1 PDC-1421 Capsule thrice daily (TID), oral administration (p.o.) after meal for 28 days |
| FG001 | Part I: 2 PDC-1421 Capsule | 2 PDC-1421 Capsule TID, p.o. after meal for 28 days |
| FG002 | Part II: 2 PDC-1421 Capsule | 2 PDC-1421 Capsule TID, p.o. after meal for 42 days PDC-1421 Capsule |
| FG003 | Part II: 1 PDC-1421 Capsule Plus 1 Placebo | 1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days PDC-1421 Capsule placebo |
| FG004 | Part II: 2 Placebo | 2 placebo TID, p.o. after meal for 42 days placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The ITT population included 12 subjects in Part I and 60 subjects in Part II. The PP population included 11 subjects in Part I and 44 subjects in Part II.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part I: 1 PDC-1421 Capsule | 1 PDC-1421 Capsule TID, p.o. after meal for 28 days |
| BG001 | Part I: 2 PDC-1421 Capsule | 2 PDC-1421 Capsule TID, p.o. after meal for 28 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 | Change of Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 Compared to Placebo for Part II. | The MADRS is a 10-item checklist of depressive symptoms. Each Item is rated on a scale of 0-6, with anchors at 2-point intervals; higher scores indicating more severity (i.e., ranging from 0 [no sadness] to 6 extremely despondent]). The total MADRS score was calculated by summing the ratings of all items. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity). | The Intention-To-Treat (ITT) population consisted of 60 randomized subjects. The Per-Protocol (PP) population consisted of 44 randomized subjects. This Outcome Measure was conducted for Part II only. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to Week 6 |
|
Part I: 5 weeks Part II: 7 weeks
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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 I: 1 PDC-1421 Capsule | 1 PDC-1421 Capsule TID, p.o. after meal for 28 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glaucoma | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hsien-Ming Wu | BioLite, Inc. | +886-6579631 | sonnywu@bioliteinc.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 | Mar 16, 2018 | Sep 3, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 14, 2019 | Aug 17, 2020 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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Part I is a open label, dose escalation with two dosage levels study. Part II is a randomized (1:1:1), double-blind, placebo-controlled, parallel groups with three treatment arms.
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|
| placebo | Drug | Placebo contained corn starch. |
|
| From Baseline to Week 2, 4, 7 |
| Change of Hamilton Depression Rating Scale (HAM-D-17) Total Score From Baseline to Week 2, 4, 6 and 7 for Part II. | HAM-D-17 scale is a clinician rated scale comprised of 17 items aimed at assessing depression severity among patients for treatment. Each item on the questionnaire is scored on a 3 point (8 items) or 5 point (9 items) scale, depending on the item. The total HAM-D-17 score was calculated by summing the ratings of all items. . The highest possible score was 52, which represented the most severe measure of depression; the lowest possible score was 0, which represented an absence of depression. | From Baseline to Week 2, 4, 6 and 7 |
| Change of Hamilton Anxiety Rating Scale (HAM-A) Total Score From Baseline to Week 2, 4, 6 and 7 for Part II. | HAM-A is a series of questions related to symptoms of anxiety. It rates the individual on a five-point scale (0~4) for each of the 14 items. Seven of the items specifically address psychic anxiety and the remaining seven items address somatic anxiety. The total HAM-A score was calculated by summing the ratings of all items. The total HAM-A score ranges from 0 to 56. The higher score represented a more severe measure of anxiety. | From Baseline to Week 2, 4, 6 and 7 |
| Change of Depression and Somatic Symptoms Scale (DSSS) From Baseline to Week 2, 4, 6 and 7 for Part II | DSSS includes a simultaneous measure of depression and somatic symptoms that two issues frequently co-occur. Consisting of 22 items, the DSSS includes 12 depression-related items (even items + item-21) and 10 somatic items (add items without item-21) - 5 of which query pain symptoms(item-1, 7, 11, 13, 17), forming a pain sub-scale. Each Item is rated on a scale of 0 (Absent) - 3 (Severe). DSSS Depression Sub-Score was calculated by summing the 12 depression-related items with ranges from 0 (absence of symptoms) to 36 (maximum severity). DSSS Somatic Sub-Score was calculated by summing the 10 somatin-related items with ranges from 0 (absence of symptoms) to 30 (maximum severity). DSSS Pain Sub-Score was calculated by summing the 5 pain-related items with ranges from 0 (absence of symptoms) to 15 (maximum severity). | From Baseline to Week 2, 4, 6 and 7 |
| Change of Clinical Global Impression Scale - Severity (CGI-S) From Baseline to Week 2, 4, 6 and 7 for Part II. | CGI-Severity (CGI-S) is a 7-point scale which rates illness severity of psychopathology from 1 (normal, not at all ill) to 7 (among the most extremely ill). | From Baseline to Week 2, 4, 6 and 7 |
| Percentage of Responders and Partial Responders in MADRS by Week 2, 4, 6 and 7 Weeks for Part II. | Responder defined as a participant with ≧50% decrease from baseline in total score. Partial responder defined as a participant with a ≧25 and <50% decrease from baseline in total score. | From Baseline to Week 2, 4, 6 and 7 |
| Number of Subjects With Suicidal Ideations Collected by Columbia-Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 2, 4, 6 and 7 for Part II. | The FDA has adopted the 11 categories defined in the C-SSRS (Category 1 to 5 for suicidal ideation , Category 6 to 10 for suicidal behavior, and Category 11 for self-injurious behavior without suicidal intent) as their standard. Number of subjects with Suicidal Ideation: The maximum suicidal ideation category (1-5 on the C-SSRS) present at the assessment. Assign a score of 0 if no ideation is present. | From screen to Week 2, 4, 6 and 7 |
| Number of Subjects With Suicidal Behaviors Collected by Columbia-Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 2, 4, 6 and 7 for Part II. | The FDA has adopted the 11 categories defined in the C-SSRS (Category 1 to 5 for suicidal ideation , Category 6 to 10 for suicidal behavior, and Category 11 for self-injurious behavior without suicidal intent) as their standard. Number of subjects with Suicidal Behavior: The maximum suicidal ideation category (6-10 on the C-SSRS) present at the assessment. Assign a score of 0 if no ideation is present. | From screen to Week 2, 4, 6 and 7 |
| Clinical Global Impression Scale -Improvement (CGI-I) From Baseline to Week 2, 4, 6 and 7 for Part II. | CGI-Improvement (CGI-I) is a 7-point scale which rates illness has improved or worsened relative to a baseline state from 1 (Very much improved) to 7 (Very much worse). | From Baseline to Week 2, 4, 6 and 7 |
| Taipei |
| Taiwan |
| Tri-Service General Hospital, Neihu Main Facility | Taipei | Taiwan |
| Wan Fang Hospital | Taipei | Taiwan |
| Linkou Chang Gung Memorial Hospital | Taoyuan | Taiwan |
| BG002 | Part II: 2 PDC-1421 Capsule | 2 PDC-1421 Capsule TID, p.o. after meal for 42 days PDC-1421 Capsule |
| BG003 | Part II: 1 PDC-1421 Capsule Plus 1 Placebo | 1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days PDC-1421 Capsule placebo |
| BG004 | Part II: 2 Placebo | 2 placebo TID, p.o. after meal for 42 days placebo |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Full Range | Kg |
|
| Height | Mean | Full Range | cm |
|
| OG001 | Part II: 1 PDC-1421 Capsule Plus 1 Placebo | 1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days PDC-1421 Capsule placebo |
| OG002 | Part II: 2 Placebo | 2 placebo TID, p.o. after meal for 42 days placebo |
|
|
|
| Secondary | Change of Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 2, 4 and 7 Part II. | The MADRS is a 10-item checklist of depressive symptoms. Each Item is rated on a scale of 0-6, with anchors at 2-point intervals; higher scores indicating more severity (i.e., ranging from 0 [no sadness] to 6 extremely despondent]). The total MADRS score was calculated by summing the ratings of all items. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity). | ITT population This Outcome Measure was conducted for Part II only. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to Week 2, 4, 7 |
|
|
|
| Secondary | Change of Hamilton Depression Rating Scale (HAM-D-17) Total Score From Baseline to Week 2, 4, 6 and 7 for Part II. | HAM-D-17 scale is a clinician rated scale comprised of 17 items aimed at assessing depression severity among patients for treatment. Each item on the questionnaire is scored on a 3 point (8 items) or 5 point (9 items) scale, depending on the item. The total HAM-D-17 score was calculated by summing the ratings of all items. . The highest possible score was 52, which represented the most severe measure of depression; the lowest possible score was 0, which represented an absence of depression. | ITT population This Outcome Measure was conducted for Part II only. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to Week 2, 4, 6 and 7 |
|
|
|
| Secondary | Change of Hamilton Anxiety Rating Scale (HAM-A) Total Score From Baseline to Week 2, 4, 6 and 7 for Part II. | HAM-A is a series of questions related to symptoms of anxiety. It rates the individual on a five-point scale (0~4) for each of the 14 items. Seven of the items specifically address psychic anxiety and the remaining seven items address somatic anxiety. The total HAM-A score was calculated by summing the ratings of all items. The total HAM-A score ranges from 0 to 56. The higher score represented a more severe measure of anxiety. | ITT population This Outcome Measure was conducted for Part II only. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to Week 2, 4, 6 and 7 |
|
|
|
| Secondary | Change of Depression and Somatic Symptoms Scale (DSSS) From Baseline to Week 2, 4, 6 and 7 for Part II | DSSS includes a simultaneous measure of depression and somatic symptoms that two issues frequently co-occur. Consisting of 22 items, the DSSS includes 12 depression-related items (even items + item-21) and 10 somatic items (add items without item-21) - 5 of which query pain symptoms(item-1, 7, 11, 13, 17), forming a pain sub-scale. Each Item is rated on a scale of 0 (Absent) - 3 (Severe). DSSS Depression Sub-Score was calculated by summing the 12 depression-related items with ranges from 0 (absence of symptoms) to 36 (maximum severity). DSSS Somatic Sub-Score was calculated by summing the 10 somatin-related items with ranges from 0 (absence of symptoms) to 30 (maximum severity). DSSS Pain Sub-Score was calculated by summing the 5 pain-related items with ranges from 0 (absence of symptoms) to 15 (maximum severity). | ITT population This Outcome Measure was conducted for Part II only. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to Week 2, 4, 6 and 7 |
|
|
|
| Secondary | Change of Clinical Global Impression Scale - Severity (CGI-S) From Baseline to Week 2, 4, 6 and 7 for Part II. | CGI-Severity (CGI-S) is a 7-point scale which rates illness severity of psychopathology from 1 (normal, not at all ill) to 7 (among the most extremely ill). | ITT population This Outcome Measure was conducted for Part II only. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to Week 2, 4, 6 and 7 |
|
|
|
| Secondary | Percentage of Responders and Partial Responders in MADRS by Week 2, 4, 6 and 7 Weeks for Part II. | Responder defined as a participant with ≧50% decrease from baseline in total score. Partial responder defined as a participant with a ≧25 and <50% decrease from baseline in total score. | ITT population This Outcome Measure was conducted for Part II only. | Posted | Count of Participants | Participants | From Baseline to Week 2, 4, 6 and 7 |
|
|
|
| Secondary | Number of Subjects With Suicidal Ideations Collected by Columbia-Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 2, 4, 6 and 7 for Part II. | The FDA has adopted the 11 categories defined in the C-SSRS (Category 1 to 5 for suicidal ideation , Category 6 to 10 for suicidal behavior, and Category 11 for self-injurious behavior without suicidal intent) as their standard. Number of subjects with Suicidal Ideation: The maximum suicidal ideation category (1-5 on the C-SSRS) present at the assessment. Assign a score of 0 if no ideation is present. | ITT population This Outcome Measure was conducted for Part II only. | Posted | Count of Participants | Participants | From screen to Week 2, 4, 6 and 7 |
|
|
|
| Secondary | Number of Subjects With Suicidal Behaviors Collected by Columbia-Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 2, 4, 6 and 7 for Part II. | The FDA has adopted the 11 categories defined in the C-SSRS (Category 1 to 5 for suicidal ideation , Category 6 to 10 for suicidal behavior, and Category 11 for self-injurious behavior without suicidal intent) as their standard. Number of subjects with Suicidal Behavior: The maximum suicidal ideation category (6-10 on the C-SSRS) present at the assessment. Assign a score of 0 if no ideation is present. | ITT population This Outcome Measure was conducted for Part II only. | Posted | Count of Participants | Participants | From screen to Week 2, 4, 6 and 7 |
|
|
|
| Secondary | Clinical Global Impression Scale -Improvement (CGI-I) From Baseline to Week 2, 4, 6 and 7 for Part II. | CGI-Improvement (CGI-I) is a 7-point scale which rates illness has improved or worsened relative to a baseline state from 1 (Very much improved) to 7 (Very much worse). | ITT population This Outcome Measure was conducted for Part II only. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to Week 2, 4, 6 and 7 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | Part I: 2 PDC-1421 Capsule | 2 PDC-1421 Capsule TID, p.o. after meal for 28 days | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | Part II: 2 PDC-1421 Capsule | 2 PDC-1421 Capsule TID, p.o. after meal for 42 days | 0 | 21 | 0 | 21 | 11 | 21 |
| EG003 | Part II: 1 PDC-1421 Capsule Plus 1 Placebo | 1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days | 0 | 19 | 0 | 19 | 12 | 19 |
| EG004 | Part II: 2 Placebo | 2 placebo TID, p.o. after meal for 42 days | 0 | 20 | 0 | 20 | 9 | 20 |
| Viral upper respirator tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Parlpitations | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Activated partial thromboplastin prolonged | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nuchal rigidity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
Not provided
Not provided
| Male |
|
|
|
| From baseline to Week 7 |
|
|
| From baseline to Week 6 |
|
| From baseline to Week 7 |
|
|
| From baseline to Week 6 |
|
| From baseline to Week 7 |
|
|
| DSSS Depression Sub-Score- From baseline to Week 6 |
|
| DSSS Depression Sub-Score- From baseline to Week 7 |
|
| DSSS Somatic Sub-Score- From baseline to Week 2 |
|
| DSSS Somatic Sub-Score- From baseline to Week 4 |
|
| DSSS Somatic Sub-Score- From baseline to Week 6 |
|
| DSSS Somatic Sub-Score- From baseline to Week 7 |
|
| DSSS Pain Sub-Score- From baseline to Week 2 |
|
| DSSS Pain Sub-Score- From baseline to Week 4 |
|
| DSSS Pain Sub-Score- From baseline to Week 6 |
|
| DSSS Pain Sub-Score- From baseline to Week 7 |
|
|
| From baseline to Week 6 |
|
| From baseline to Week 7 |
|
| No response |
|
| From baseline to Week 4 |
|
| From baseline to Week 6 |
|
| From baseline to Week 7 |
|
| Title | Measurements |
|---|---|
|
| Week 4 |
|
| Week 6 |
|
| Week 7 |
|
| Title | Measurements |
|---|---|
|
| Week 4 |
|
| Week 6 |
|
| Week 7 |
|
|
| From baseline to Week 6 |
|
| From baseline to Week 7 |
|