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| Name | Class |
|---|---|
| University of California, Davis | 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, crossover study to investigate ganaxolone treatment in children with fragile x syndrome (FXS). The objective of the study is to assess the safety, tolerability and efficacy of ganaxolone in the treatment of anxiety and attention in subjects with FXS.
This is a single center study conducted at University of California Davis (UCD) MIND Institute. Children with FXS between the ages of 6-17 years, inclusive will be randomized at a 1:1 ratio to receive ganaxolone or placebo treatment for 6 weeks, discontinue treatment and washout for 2 weeks, and then cross over to the opposite treatment for another 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ganaxolone then Placebo | Experimental | Participants first received ganaxolone. They were first titrated up to the 12 milligram per kilogram (mg/kg) three times daily (tid) during a 2-week titration phase, then maintained on that dose for an additional 4 weeks. After a washout period of 2 weeks, participants received placebo for a duration of 6 weeks (from week 8 to 14). |
|
| Placebo then Ganaxolone | Experimental | Participants first received placebo. They were first titrated up to the 12 mg/kg tid during a 2-week titration phase, then maintained on that dose for an additional 4 weeks. After a washout period of 2 weeks, participants received ganaxolone for a duration of 6 weeks (from week 8 to 14). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganaxolone | Drug | oral suspension, given in 3 divided doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression-Improvement (CGI-I) Scale | The CGI-I scale is a clinician-rated 7-point scale used to assess how much the participant's illness had improved or worsened relative to a Baseline state at the beginning of the intervention. It was rated as: 1. "very much improved"; 2. "much improved"; 3. "minimally improved"; 4. "no change"; 5. "minimally worse"; 6. "much worse"; 7. "very much worse". Higher scores indicated worse condition. | Week 14 (End of Treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Anxiety Rating Scale (PARS) Total Score | Pediatric Anxiety Rating Scale (PARS) is a clinician administered measure of anxiety in children and adolescents. The PARS is comprised of a 50-item symptom checklist used to determine the presence or absence of specific anxiety symptoms during the prior week and 7 severity/impairment items, each scored from 0 to 5. The score on the 7 items allows the clinician to rate symptom severity and associated impairment on a range from 0 to 35, with higher scores reflecting greater symptom severity and associated impairment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M.I.N.D. Institute at University of California at Davis Medical Center | Sacramento | California | 95817 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28764646 | Derived | Ligsay A, Van Dijck A, Nguyen DV, Lozano R, Chen Y, Bickel ES, Hessl D, Schneider A, Angkustsiri K, Tassone F, Ceulemans B, Kooy RF, Hagerman RJ. A randomized double-blind, placebo-controlled trial of ganaxolone in children and adolescents with fragile X syndrome. J Neurodev Disord. 2017 Aug 2;9(1):26. doi: 10.1186/s11689-017-9207-8. |
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59 participants were randomized in the study.
A total of 48 participants from the University of California at Davis Medical Center site and 11 participants from a Belgium site between November 1, 2012 and November 1, 2016 were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ganaxolone, Then Placebo | Participants received ganaxolone were first titrated up to the 12 milligram per kilogram (mg/kg) three times daily (tid) during a 2-week titration phase, then maintained on that dose for an additional 4 weeks. After a washout period of 2 weeks, they received placebo for a duration of 6 weeks (from week 8 to 14). |
| FG001 | Placebo, Then Ganaxolone | Participants received placebo were first titrated up to the 12 mg/kg tid during a 2-week titration phase, then maintained on that dose for an additional 4 weeks. After a washout period of 2 weeks, they received ganaxolone for a duration of 6 weeks (from week 8 to 14). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (Week 1 to Week 6) |
|
| |||||||||||||||||||||
| Washout Period (2 Weeks) |
| ||||||||||||||||||||||
| Treatment Period 2 (Week 8 to Week 14) |
|
Safety Set included all participants who have taken at least one dose of study drug in Treatment period 1.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ganaxolone, Then Placebo | Participants received ganaxolone were first titrated up to the 12 mg/kg tid during a 2-week titration phase, then maintained on that dose for an additional 4 weeks. After a washout period of 2 weeks, they received placebo for a duration of 6 weeks (from week 8 to 14). |
| BG001 |
| 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 | Clinical Global Impression-Improvement (CGI-I) Scale | The CGI-I scale is a clinician-rated 7-point scale used to assess how much the participant's illness had improved or worsened relative to a Baseline state at the beginning of the intervention. It was rated as: 1. "very much improved"; 2. "much improved"; 3. "minimally improved"; 4. "no change"; 5. "minimally worse"; 6. "much worse"; 7. "very much worse". Higher scores indicated worse condition. | Intention-to-Treat (ITT) Population consisted of all participants who received medication and who had at least one post-Baseline assessment. Only those participants with data available at the specified data points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Week 14 (End of Treatment) |
|
Up to 14 Weeks
Safety Population included all participants who received at least one dose of intervention. One participant mistakenly did not cross over to receive placebo and remained on Ganaxolone during Period 2 as a result of a pharmacy error.
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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 | Participants who received Ganaxolone up to 12 mg/kg tid in the first 6 weeks or last 6 weeks of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marinus | Marinus Pharmaceuticals, Inc. | 484-801-4670 | clinicaltrials@marinuspharma.com |
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| ID | Term |
|---|---|
| D005600 | Fragile X Syndrome |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D038901 | X-Linked Intellectual Disability |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
Not provided
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| ID | Term |
|---|---|
| C105051 | ganaxolone |
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| Placebo | Drug | oral suspension, given in 3 divided doses |
|
| Week 14 (End of Treatment) |
| Visual Analogue Scale (VAS) | A semi-structured VAS design was employed, providing two of the three behaviors to be assessed as anxiety and attention, chosen by caregiver(s) of one additional behavior from a bank of five. This bank included sociability, attention, aggression, language, and hyperactivity/impulsivity. Parents mark on a visual line measuring 10 centimeters (cm) with "worst behavior" at 0 cm and "best behavior" at 10 cm. For each behavior the caregiver is instructed to mark their impression of behavior at Baseline visit and again at each visit. The calculated distance in cm between the baseline and each visit marks thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the least square mean distance and its corresponding standard error in cm from the "worst behavior" side, at baseline. Smaller the value, worser the behavior. | Week 14 (End of Treatment) |
| Anxiety, Depression, and Mood Scale (ADAMS) | The ADAMS is a 28-item behavior-based informant instrument rated by the parent(s), legal authorized guardian(s), or consistent caregiver(s). The scale is composed of 5 factors, which addresses Manic/Hyperactive Behavior, Depressed Mood, Social Avoidance, General Anxiety, and Obsessive/Compulsive Behavior. Items are scored on a 0-3 Likert scale that combines frequency and severity ratings (where 0=behavior has not occurred or is not a problem, 3=behavior occurs a lot or is a severe problem). Each subscale score is calculated separately; the scale range for Manic/Hyperactive Behavior is 0-15; for Depressed Mood, 0-21; for Social Avoidance, 0-21; for General Anxiety, 0-21; for Obsessive Behavior, 0-9. There is an overlapped item between Manic/Hypertension Behavior and General Anxiety; hence, the subscale ranges appear to reflect scores for 29 items instead of 28 items. | Week 14 (End of Treatment) |
| Aberrant Behavior Checklist (ABC) | The ABC is a 58-item parent rated from 0 (not at all a problem) to 3 (the problem is severe in degree with 6 subscales: Irritability (includes agitation, aggression, and self-injury, 15 items) with range of scores from 0-45; Social Withdrawal/Lethargy (16 items) with range of scores from 0-48; Stereotypy (7 items) with range of scores from 0-21; Hyperactivity (16 items) with range of scores from 0-48; Inappropriate Speech (4 items) with range of scores from 0-12 and Social avoidance (4 items) with range of scores from 0-12. Higher scores indicated greater severity. Social Withdrawal and Lethargy are reporting the same scale and Social Avoidance is a subscale of Social Withdrawal; hence, the subscale ranges appear to reflect scores for 62 items instead of 58 items. | Week 14 (End of Treatment) |
| Swanson, Nolan, and Pelham-IV Questionnaire (SNAP-IV) | The SNAP-IV is a revision of the Swanson, Nolan, and Pelham (SNAP) Questionnaire. The SNAP-IV: ADHD Inattention Subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). Possible scores ranged from 0-27; higher scores indicated a greater intensity. The SNAP-IV ADHD Hyperactivity/Impulsivity Subscale (items 10-18) scores the intensity of each item in the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). Possible scores ranged from 0-27; higher scores indicated a greater intensity. SNAP-IV ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranged from 0-54. A low score of 0 indicates less inattention + hyperactivity/impulsivity. A high score of 54 indicates more inattention + hyperactivity. | Week 14 (End of Treatment) |
| Antwerp University Hospital |
| Edegem |
| 2650 |
| Belgium |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
| Placebo, Then Ganaxolone |
Participants received placebo were first titrated up to the 12 mg/kg tid during a 2-week titration phase, then maintained on that dose for an additional 4 weeks. After a washout period of 2 weeks, they received ganaxolone for a duration of 6 weeks (from week 8 to 14). |
| 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 |
|
| OG001 | Placebo | Participants who received placebo (matching Ganaxolone) in the first 6 weeks or last 6 weeks of the study. |
|
|
|
| Secondary | Pediatric Anxiety Rating Scale (PARS) Total Score | Pediatric Anxiety Rating Scale (PARS) is a clinician administered measure of anxiety in children and adolescents. The PARS is comprised of a 50-item symptom checklist used to determine the presence or absence of specific anxiety symptoms during the prior week and 7 severity/impairment items, each scored from 0 to 5. The score on the 7 items allows the clinician to rate symptom severity and associated impairment on a range from 0 to 35, with higher scores reflecting greater symptom severity and associated impairment. | ITT Population. Only those participants with data available at the specified data points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Week 14 (End of Treatment) |
|
|
|
| Secondary | Visual Analogue Scale (VAS) | A semi-structured VAS design was employed, providing two of the three behaviors to be assessed as anxiety and attention, chosen by caregiver(s) of one additional behavior from a bank of five. This bank included sociability, attention, aggression, language, and hyperactivity/impulsivity. Parents mark on a visual line measuring 10 centimeters (cm) with "worst behavior" at 0 cm and "best behavior" at 10 cm. For each behavior the caregiver is instructed to mark their impression of behavior at Baseline visit and again at each visit. The calculated distance in cm between the baseline and each visit marks thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the least square mean distance and its corresponding standard error in cm from the "worst behavior" side, at baseline. Smaller the value, worser the behavior. | ITT Population. Only those participants with data available at the specified data points were analyzed | Posted | Least Squares Mean | Standard Error | Centimeters (cm) | Week 14 (End of Treatment) |
|
|
|
| Secondary | Anxiety, Depression, and Mood Scale (ADAMS) | The ADAMS is a 28-item behavior-based informant instrument rated by the parent(s), legal authorized guardian(s), or consistent caregiver(s). The scale is composed of 5 factors, which addresses Manic/Hyperactive Behavior, Depressed Mood, Social Avoidance, General Anxiety, and Obsessive/Compulsive Behavior. Items are scored on a 0-3 Likert scale that combines frequency and severity ratings (where 0=behavior has not occurred or is not a problem, 3=behavior occurs a lot or is a severe problem). Each subscale score is calculated separately; the scale range for Manic/Hyperactive Behavior is 0-15; for Depressed Mood, 0-21; for Social Avoidance, 0-21; for General Anxiety, 0-21; for Obsessive Behavior, 0-9. There is an overlapped item between Manic/Hypertension Behavior and General Anxiety; hence, the subscale ranges appear to reflect scores for 29 items instead of 28 items. | ITT Population. Only those participants with data available at the specified data points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Week 14 (End of Treatment) |
|
|
|
| Secondary | Aberrant Behavior Checklist (ABC) | The ABC is a 58-item parent rated from 0 (not at all a problem) to 3 (the problem is severe in degree with 6 subscales: Irritability (includes agitation, aggression, and self-injury, 15 items) with range of scores from 0-45; Social Withdrawal/Lethargy (16 items) with range of scores from 0-48; Stereotypy (7 items) with range of scores from 0-21; Hyperactivity (16 items) with range of scores from 0-48; Inappropriate Speech (4 items) with range of scores from 0-12 and Social avoidance (4 items) with range of scores from 0-12. Higher scores indicated greater severity. Social Withdrawal and Lethargy are reporting the same scale and Social Avoidance is a subscale of Social Withdrawal; hence, the subscale ranges appear to reflect scores for 62 items instead of 58 items. | ITT Population. Only those participants with data available at the specified data points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Week 14 (End of Treatment) |
|
|
|
| Secondary | Swanson, Nolan, and Pelham-IV Questionnaire (SNAP-IV) | The SNAP-IV is a revision of the Swanson, Nolan, and Pelham (SNAP) Questionnaire. The SNAP-IV: ADHD Inattention Subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). Possible scores ranged from 0-27; higher scores indicated a greater intensity. The SNAP-IV ADHD Hyperactivity/Impulsivity Subscale (items 10-18) scores the intensity of each item in the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). Possible scores ranged from 0-27; higher scores indicated a greater intensity. SNAP-IV ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranged from 0-54. A low score of 0 indicates less inattention + hyperactivity/impulsivity. A high score of 54 indicates more inattention + hyperactivity. | ITT Population. Only those participants with data available at the specified data points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Week 14 (End of Treatment) |
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 49 |
| 59 |
| EG001 | Placebo | Participants who received placebo (matching Ganaxolone) in the first 6 weeks or last 6 weeks of the study. | 0 | 54 | 0 | 54 | 46 | 54 |
| Condition aggravated | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperpyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Coordination abnormal | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Poor quality sleep | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Repetitive speech | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Drooling | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Petit mal epilepsy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Candida nappy rash | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Emotional disorder | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Self injurious behaviour | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Stereotypy | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Terminal insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tic | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Affect lability | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Binge eating | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysphemia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Negativism | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Obsessive thoughts | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sleep talking | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Staring | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Burns first degree | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Lip injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Tooth avulsion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ketonuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aortic dilatation | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nipple swelling | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tympanic membrane disorder | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Treatment noncompliance | Social circumstances | MedDRA 16.0 | Systematic Assessment |
|
| Dental operation | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D025064 | Sex Chromosome Disorders |
| D025063 | Chromosome Disorders |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D040181 | Genetic Diseases, X-Linked |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D001523 | Mental Disorders |
| Severity of Target Behavior 3 |
|
| Depress Mood Total |
|
|
| Social Avoidance Total |
|
|
| General Anxiety Total |
|
|
| Obsessive/Compulsive Behavior Total |
|
|
| Total - Subscale II (Social Withdrawal/Lethargy) |
|
|
| Total - Subscale III - (Stereotypy) |
|
|
| Total - Subscale IV (Hyperactivity) |
|
|
| Total - Subscale V (Inappropriate Speech) |
|
|
| Total - Subscale VI (Social Avoidance) |
|
|
| ADHD Combined |
|