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| Name | Class |
|---|---|
| INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium | OTHER |
| U.S. Army Medical Research and Development Command | FED |
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This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, 15-week investigation of ganaxolone versus placebo for the treatment of Posttraumatic Stress Disorder (PTSD). Up to 120 participants will be enrolled and randomized to receive either ganaxolone or placebo for 6 weeks. After 6 weeks of randomized treatment all participants will continue for 6 weeks on ganaxolone. The aim of the study is to assess the efficacy of ganaxolone compared to placebo for the treatment of PTSD symptoms after 6 weeks of treatment using the Clinician-Administered PTSD Rating Scale (CAPS). The second aim of the study is to evaluate the safety and tolerability of ganaxolone in the PTSD population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ganaxolone | Experimental | active |
|
| Placebo | Placebo Comparator | non-active |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganaxolone | Drug | 200-600 mg bid, capsules, up to 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinician-Administered Posttrautamtic Stress Disorder (PTSD) Scale (CAPS) to Week 6 | The CAPS was a structured interview that queries participants about each of the 17 Diagnostic and Statistical manual of Mental Disorders IV (DSM-IV) criteria B, C, and D symptoms of PTSD. Each item has a frequency score (0-4) and intensity score (0-4). The CAPS total score is the sum of frequency and intensity ratings for each item and the score range was 0: no symptoms to 136: severe symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Week 0) and at Week 2, Week 4 and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in PTSD Re-Experience Score | The CAPS was a structured interview that queries participants about each of the 17 Diagnostic and Statistical manual of Mental Disorders IV (DSM-IV) criteria B, C, and D symptoms of PTSD. Each item has a frequency score (0-4) and intensity score (0-4). The Re-experience score is the sum of frequency and intensity ratings for items from cluster B and the score range was 0: no symptoms to 40: severe symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
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Key Inclusion Criteria:
Key Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Christine E Marx, MD, MA | Duke University Medical Center and Durham VA Medical Center | Principal Investigator |
| Ann Rasmusson, MD | Boston University School of Medicine Research Affiliate, National Center for PTSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System/ University of California, San Diego | San Diego | California | 92093 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28667510 | Derived | Rasmusson AM, Marx CE, Jain S, Farfel GM, Tsai J, Sun X, Geracioti TD, Hamner MB, Lohr J, Rosse R, Summerall L, Naylor JC, Cusin C, Lang AJ, Raman R, Stein MB. A randomized controlled trial of ganaxolone in posttraumatic stress disorder. Psychopharmacology (Berl). 2017 Aug;234(15):2245-2257. doi: 10.1007/s00213-017-4649-y. Epub 2017 Jul 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ganaxolone | active Ganaxolone: 200-600 milligram (mg) twice daily (bid), capsules, up to 12 weeks |
| FG001 | Placebo | non-active Placebo: capsules, bid, up to 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Modified Intent-to-treat (mITT) Population: Included randomized participants who had been dispensed study medication and had at least one post-Baseline data point during the 6-week placebo-controlled blinded phase of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ganaxolone | active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks |
| BG001 | Placebo | non-active Placebo: capsules, bid, up to 12 weeks |
| 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 From Baseline in Clinician-Administered Posttrautamtic Stress Disorder (PTSD) Scale (CAPS) to Week 6 | The CAPS was a structured interview that queries participants about each of the 17 Diagnostic and Statistical manual of Mental Disorders IV (DSM-IV) criteria B, C, and D symptoms of PTSD. Each item has a frequency score (0-4) and intensity score (0-4). The CAPS total score is the sum of frequency and intensity ratings for each item and the score range was 0: no symptoms to 136: severe symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | mITT Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 0) and at Week 2, Week 4 and Week 6 |
|
Up to Week 15
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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 | Ganaxolone | active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Splenomegaly | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marinus Clinical Trials Submission Manager | Marinus Pharmaceuticals, Inc. | 484-801-4670 | clinicaltrials@marinuspharma.com |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C105051 | ganaxolone |
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| Placebo | Drug | capsules, bid, up to 12 weeks |
|
|
| Baseline (Week 0) and at Week 2, Week 4 and Week 6 |
| Change From Baseline in PTSD Avoidance Score | The CAPS was a structured interview that queries participants about each of the 17 Diagnostic and Statistical manual of Mental Disorders IV (DSM-IV) criteria B, C, and D symptoms of PTSD. Each item has a frequency score (0-4) and intensity score (0-4). The Avoidance score is the sum of frequency and intensity ratings for items from cluster C.and the score range was 0: no symptoms to 56: severe symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Week 0) and at Week 2, Week 4 and Week 6 |
| Change From Baseline in PTSD Hyperarousal Score | The CAPS was a structured interview that queries participants about each of the 17 Diagnostic and Statistical manual of Mental Disorders IV (DSM-IV) criteria B, C, and D symptoms of PTSD. Each item has a frequency score (0-4) and intensity score (0-4). The Hyperarousal score is the sum of frequency and intensity ratings for items from cluster D and the score range was 0: no symptoms to 40: severe symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Week 0) and at Week 2, Week 4 and Week 6 |
| Number of Participants With Response to Clinical Global Impression - Improvement (Investigator) (CGI-II) Scale | The CGI-II scale is a 7-point scale where the investigator was required to assess how much the participant's illness has improved or worsened relative to a Baseline state at the beginning of the intervention, and rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Higher score indicated worse symptoms. The score was grouped into two categories for analysis: Responders=1 or 2, Non-responders=3-7. | Week 2, Week 4 and Week 6 |
| Number of Participants With Response to CGI-I Subject Scale Clinical Global Impression - Improvement (Subject) (CGI-IS) Scale | The CGI-IS scale is a 7-point scale where the participant assesses how much the illness has improved or worsened relative to a Baseline state at the beginning of the intervention, and rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Higher score indicated worse symptoms. The score was grouped into two categories for analysis: Responders=1 or 2, Non-responders=3-7. | Week 2, Week 4 and Week 6 |
| Change From Baseline in PTSD Checklist (PCL) Scores | The PCL is a 17-item self-report scale representing all DSM-IV criteria for PTSD, including re-experiencing, avoidance and numbing, and hyperarousal criteria. Each item is scored 1-5 (1=not at all; 2=a little bit; 3=moderately; 4=quite a bit; 5=extremely). The total score is the sum of 17 item scores and ranged from 17: no symptoms to 85: severe symptoms. Higher score indicated worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Week 0) and at Week 2, Week 4 and Week 6 |
| Change From Baseline in Profile of Mood States (POMS) Total Score | The POMS is a factor-analytically derived 65 item self-report inventory with 5-point measures of five dimensions of negative mood: anger/irritability, anxiety/tension, depression/dejection, confusion/bewilderment, and fatigue/inertia, as well as vigor/activity. Total score was calculated as Fatigue + Mood (sum [Confusion, anger, Anxiety/Tension, Depression])- Vigor. Score ranged from 0: no symptoms to 200: severe symptoms; higher score indicated worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Week 0) and Week 6 |
| Change From Baseline in Patient Health Questionnaire (PHQ-9) Score | The PHQ-9 is the nine-item depression scale of the Patient Health Questionnaire. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. Each item is scored 0-3 (0=not at all; 1=several days; 2=more than half the days; 3= nearly every day). The total score is the sum of 9 item scores and ranged 0: no depression to 27: severe depression. The higher the total score, the worse the depression. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Week 0) and Week 6 |
| Change From Baseline in Insomnia Severity Index (ISI) Score | The ISI is a self-rated questionnaire assessing the difficulty over the past two weeks with falling to sleep, awakening in the middle of the night, and early morning awakening, as well as the degree to which insomnia impairs daily function. It included 5 items (rst item has 3 sub-questions), so a total of 7 questions. Each question is scored 0-4 (0=none, 1=mild, 2=moderate, 3=severe, 4=very severe). The total score is the sum of 7 item scores and ranged from 0: no symptoms to 28: severe symptoms. Higher score indicated worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Week 0) and Week 6 |
| Change From Baseline in Connor-Davidson Resilience Scale (CD-RISC) Score | The CD-RISC comprises 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience that may be a target for treatment in stress disorders. The total score is the sum of 25 item scores and ranged from 0: no symptoms to 100: worse symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value | Baseline (Week 0) and Week 6 |
| Washington DC VA Medical Center/ Uniformed Services University of the Health Services |
| Washington D.C. |
| District of Columbia |
| 20422 |
| United States |
| VA Boston Healthcare Services/ Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02130 | United States |
| Manchester VA Medical Center/ Dartmouth College | Manchester | New Hampshire | 03104 | United States |
| Durham VA Medical Center /Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Cincinnati VA Medical Center/ University of Cincinnati | Cincinnati | Ohio | 45220 | United States |
| Charleston VA Medica Center/ Medical University of South Carolina | Charleston | South Carolina | 29401 | United States |
| White River Junction VA Medical Center/ Dartmouth College | White River Junction | Vermont | 05009 | United States |
| Withdrawal by Subject |
|
| Noncompliance |
|
| Relocated out of area |
|
| Other |
|
| multiple reasons |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
non-active Placebo: capsules, bid, up to 12 weeks |
| OG001 | Ganaxolone | active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks |
|
|
| Secondary | Change From Baseline in PTSD Re-Experience Score | The CAPS was a structured interview that queries participants about each of the 17 Diagnostic and Statistical manual of Mental Disorders IV (DSM-IV) criteria B, C, and D symptoms of PTSD. Each item has a frequency score (0-4) and intensity score (0-4). The Re-experience score is the sum of frequency and intensity ratings for items from cluster B and the score range was 0: no symptoms to 40: severe symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | mITT Population. Only those participants with data available at the specified data points were analyzed | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 0) and at Week 2, Week 4 and Week 6 |
|
|
|
| Secondary | Change From Baseline in PTSD Avoidance Score | The CAPS was a structured interview that queries participants about each of the 17 Diagnostic and Statistical manual of Mental Disorders IV (DSM-IV) criteria B, C, and D symptoms of PTSD. Each item has a frequency score (0-4) and intensity score (0-4). The Avoidance score is the sum of frequency and intensity ratings for items from cluster C.and the score range was 0: no symptoms to 56: severe symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | mITT Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 0) and at Week 2, Week 4 and Week 6 |
|
|
|
| Secondary | Change From Baseline in PTSD Hyperarousal Score | The CAPS was a structured interview that queries participants about each of the 17 Diagnostic and Statistical manual of Mental Disorders IV (DSM-IV) criteria B, C, and D symptoms of PTSD. Each item has a frequency score (0-4) and intensity score (0-4). The Hyperarousal score is the sum of frequency and intensity ratings for items from cluster D and the score range was 0: no symptoms to 40: severe symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | mITT Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 0) and at Week 2, Week 4 and Week 6 |
|
|
|
| Secondary | Number of Participants With Response to Clinical Global Impression - Improvement (Investigator) (CGI-II) Scale | The CGI-II scale is a 7-point scale where the investigator was required to assess how much the participant's illness has improved or worsened relative to a Baseline state at the beginning of the intervention, and rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Higher score indicated worse symptoms. The score was grouped into two categories for analysis: Responders=1 or 2, Non-responders=3-7. | mITT Population. Only those participants with data available at the specified data points were analyzed | Posted | Count of Participants | Participants | Week 2, Week 4 and Week 6 |
|
|
|
| Secondary | Number of Participants With Response to CGI-I Subject Scale Clinical Global Impression - Improvement (Subject) (CGI-IS) Scale | The CGI-IS scale is a 7-point scale where the participant assesses how much the illness has improved or worsened relative to a Baseline state at the beginning of the intervention, and rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Higher score indicated worse symptoms. The score was grouped into two categories for analysis: Responders=1 or 2, Non-responders=3-7. | mITT Population. Only those participants with data available at the specified data points were analyzed | Posted | Count of Participants | Participants | Week 2, Week 4 and Week 6 |
|
|
|
| Secondary | Change From Baseline in PTSD Checklist (PCL) Scores | The PCL is a 17-item self-report scale representing all DSM-IV criteria for PTSD, including re-experiencing, avoidance and numbing, and hyperarousal criteria. Each item is scored 1-5 (1=not at all; 2=a little bit; 3=moderately; 4=quite a bit; 5=extremely). The total score is the sum of 17 item scores and ranged from 17: no symptoms to 85: severe symptoms. Higher score indicated worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | mITT Population. Only those participants with data available at the specified data points were analyzed | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 0) and at Week 2, Week 4 and Week 6 |
|
|
|
| Secondary | Change From Baseline in Profile of Mood States (POMS) Total Score | The POMS is a factor-analytically derived 65 item self-report inventory with 5-point measures of five dimensions of negative mood: anger/irritability, anxiety/tension, depression/dejection, confusion/bewilderment, and fatigue/inertia, as well as vigor/activity. Total score was calculated as Fatigue + Mood (sum [Confusion, anger, Anxiety/Tension, Depression])- Vigor. Score ranged from 0: no symptoms to 200: severe symptoms; higher score indicated worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | mITT Population. Only those participants with data available at the specified data points were analyzed | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 0) and Week 6 |
|
|
|
| Secondary | Change From Baseline in Patient Health Questionnaire (PHQ-9) Score | The PHQ-9 is the nine-item depression scale of the Patient Health Questionnaire. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. Each item is scored 0-3 (0=not at all; 1=several days; 2=more than half the days; 3= nearly every day). The total score is the sum of 9 item scores and ranged 0: no depression to 27: severe depression. The higher the total score, the worse the depression. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | mITT Population. Only those participants with data available at the specified data points were analyzed | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 0) and Week 6 |
|
|
|
| Secondary | Change From Baseline in Insomnia Severity Index (ISI) Score | The ISI is a self-rated questionnaire assessing the difficulty over the past two weeks with falling to sleep, awakening in the middle of the night, and early morning awakening, as well as the degree to which insomnia impairs daily function. It included 5 items (rst item has 3 sub-questions), so a total of 7 questions. Each question is scored 0-4 (0=none, 1=mild, 2=moderate, 3=severe, 4=very severe). The total score is the sum of 7 item scores and ranged from 0: no symptoms to 28: severe symptoms. Higher score indicated worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | mITT Population. Only those participants with data available at the specified data points were analyzed | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 0) and Week 6 |
|
|
|
| Secondary | Change From Baseline in Connor-Davidson Resilience Scale (CD-RISC) Score | The CD-RISC comprises 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience that may be a target for treatment in stress disorders. The total score is the sum of 25 item scores and ranged from 0: no symptoms to 100: worse symptoms. Higher score indicates worse symptoms. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value | mITT Population. Only those participants with data available at the specified data points were analyzed | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 0) and Week 6 |
|
|
|
| 59 |
| 3 |
| 59 |
| 39 |
| 59 |
| EG001 | Placebo | non-active Placebo: capsules, bid, up to 12 weeks | 0 | 53 | 0 | 53 | 32 | 53 |
| Fever | General disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Confusion | Nervous system disorders | Systematic Assessment |
|
| Balance Issues | Nervous system disorders | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Dry Eye | Eye disorders | Systematic Assessment |
|
| Vision blurred | Eye disorders | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Chest discomfort | General disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Fatigue | Gastrointestinal disorders | Systematic Assessment |
|
| Feeling drunk | General disorders | Systematic Assessment |
|
| Influenza like illness | General disorders | Systematic Assessment |
|
| Irritability | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Sensation of pressure | General disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | Systematic Assessment |
|
| Rhinitis | Infections and infestations | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Vaginitis bacterial | Infections and infestations | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Inadequate analgesia | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood glucose increased | Investigations | Systematic Assessment |
|
| Blood urine present | Investigations | Systematic Assessment |
|
| Liver function test abnormal | Investigations | Systematic Assessment |
|
| Protein urine present | Investigations | Systematic Assessment |
|
| Tandem galt test abnormal | Investigations | Systematic Assessment |
|
| Weight increased | Investigations | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Ataxia | Nervous system disorders | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Lethargy | Nervous system disorders | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
| Motor dysfunction | Nervous system disorders | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
| Sedation | Nervous system disorders | Systematic Assessment |
|
| Slow speech | Nervous system disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | Systematic Assessment |
|
| Anger | Psychiatric disorders | Systematic Assessment |
|
| Anorgasmia | Psychiatric disorders | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | Systematic Assessment |
|
| Depressed | Psychiatric disorders | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | Systematic Assessment |
|
| Initial insomnia | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Nightmare | Psychiatric disorders | Systematic Assessment |
|
| Post-traumatic stress disorder | Psychiatric disorders | Systematic Assessment |
|
| Psychomotor retardation | Psychiatric disorders | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
|
| Tic | Psychiatric disorders | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Upper airway resistance syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Suicide of companion | Social circumstances | Systematic Assessment |
|
| Product used for unknown indication | Surgical and medical procedures | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| Week 4 |
|
|
| Week 6 |
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| Week 4 |
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| Week 6 |
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| Week 4 |
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| Week 6 |
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| Week 2 - Responder |
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| Week 4 - Non-Responder |
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| Week 4 - Responder |
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| Week 6 - Non-Responder |
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| Week 6 - Responder |
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| Week 2 - Responder |
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| Week 4 - Non-Responder |
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| Week 4 - Responder |
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| Week 6 - Non-Responder |
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| Week 6 - Responder |
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| Week 4 |
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| Week 6 |
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