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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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The primary objective of this study is to evaluate the effects of ASP8062, 25 mg once a day and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 2 weeks of daily dosing among subjects with moderate to severe alcohol use disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5â„¢). Secondary objectives include evaluation of ASP8062, 25 mg once a day, and matched placebo on reduction of alcohol consumption, alcohol craving, cigarette smoking (among smokers), mood, sleep, alcohol use negative consequences, study retention, and safety and tolerability throughout the last 4 weeks of the treatment phase of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP8062 (25 mg once daily) | Experimental |
| |
| Matching Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP8062 | Drug | ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Craving | Strength of alcohol craving Visual Analogue Scale (VAS) score; min=0, max=20; higher scores = more craving (worse outcome) | Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With no Heavy Drinking Days | Number of subjects that have no heavy drinking days during weeks 3 to 6 of the treatment phase. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men. | Weeks 3 to 6 of the treatment phase |
| Number of Subjects Abstinent From Alcohol |
Not provided
Inclusion Criteria:
Be at least 21 years of age.
Meet the DSM-5 criteria for AUD of at least moderate severity.
Be seeking treatment for AUD and desire a reduction or cessation of drinking.
Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control to at least 30 days post the last dose of study drug, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal (one year):
Agree (if female) to not donate ova for at least 30 days following the last ASP8062 administration.
Agree (if male) to use acceptable methods of contraception if the male participant's partner could become pregnant from the time of the first administration of the study drug until 90 days following the final administration of the study drug. One of the following acceptable methods of contraception must be utilized:
Agree (if male) to refrain from sperm donation from the randomization visit to at least 90 days after the last dose of study drug.
Be able to take oral medication and be willing to adhere to the medication regimen.
Complete all assessments required at screening and baseline.
Have a place to live in the 2 weeks prior to randomization and not be at risk that s/he will lose his/her housing in the next 2 months.
Not anticipate any significant problems with transportation arrangements or available time to travel to the study site over the next 2 months.
Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
Provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment.
Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document.
If taking a medication for depression or anxiety, must have been taking a stable dose in the 2-months prior to randomization and plan to continue during the study. This includes drugs such as the following:
Be someone who in the opinion of the investigator would be expected to complete the study protocol.
Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation.
Be willing to use a smartphone's video capability to record daily oral ingestion of tablets for the entire 6-week treatment period (subject's own smartphone or one provided by AiCure).
Have sitting (3 to 5 minutes) vital signs at the screening visit within the following limits:
Exclusion Criteria:
Current (past 12 months) substance use disorder of at least moderate severity (4 or more criteria) for any psychoactive substance other than alcohol and nicotine, including sedatives and hypnotics, or cocaine use disorder of any severity as defined by DSM-5 criteria.
Be mandated by the court to obtain treatment for alcohol-dependence, or has probation or parole requirements that might interfere with study participation.
Be anyone who in the opinion of the investigator could not be safely withdrawn from alcohol without medical detoxification.
Have any of the following, based on DSM-5 criteria as assessed using theMINI:
Contact site for additional exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Raye Litten, Ph.D. | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | 90095 | United States | ||
| University of Colorado |
Data and supporting information will be shared with the general research community upon request.
Data will be available approximately 6/25/2025 for an indefinite time period
Data users will be encouraged to complete a Data Use Agreement and obtain authorization for data use by the NIAAA Data Access Committee.
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| ID | Title | Description |
|---|---|---|
| FG000 | ASP8062 (25 mg Once Daily) | ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks |
| FG001 | Matching Placebo | Placebo: 1 x per day for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ASP8062 (25 mg Once Daily) | ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks |
| BG001 | Matching Placebo |
| 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 | Alcohol Craving | Strength of alcohol craving Visual Analogue Scale (VAS) score; min=0, max=20; higher scores = more craving (worse outcome) | Posted | Least Squares Mean | Standard Error | score on a scale | Week 3 |
|
6 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 | ASP8062 (25 mg Once Daily) | ASP8062: ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Falk | National Institute on Alcohol Abuse and Alcoholism | 3014430788 | falkde@mail.nih.gov |
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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 | Aug 12, 2022 | Jun 25, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 13, 2022 | Jun 25, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2022 | Jun 25, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000709210 | ASP8062 |
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| Placebo | Drug | 1 x per day for 6 weeks |
|
Number of subjects that have not drank alcohol during Weeks 3 to 6 of the treatment phase. |
| Weeks 3 to 6 of the treatment phase |
| WHO 1-level Decrease in Alcohol Consumption | The number of subjects experiencing at least a 1-level decrease in World Health Organization (WHO) levels of alcohol consumption from the level at baseline (the period including the 28 days before screening) to the level during Weeks 3 to 6 of the treatment phase. The WHO levels of average alcohol consumption per day are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate "Abstinent" category. | Weeks 3 to 6 of the treatment phase |
| WHO 2-level Decrease in Alcohol Consumption | The number of subjects experiencing at least a 2-level decrease in World Health Organization (WHO) levels of alcohol consumption from the level at baseline (the period including the 28 days before screening) to the level during Weeks 3 to 6 of the treatment phase. The WHO levels of average alcohol consumption per day are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate "Abstinent" category. | Weeks 3 to 6 of the treatment phase. |
| Percentage of Days Abstinent | The percentage of days abstinent from drinking alcohol | Weeks 3 to 6 of the treatment phase |
| Percentage of Heavy Drinking Days | Percentage of heavy drinking days where a heavy drinking day is 4 or more drinks on a day for women or 5 or more drinks on a day for men. | Weeks 3 to 6 of the treatment phase |
| Drinks Per Week | The number of drinks consumed per week | Weeks 3 to 6 of the treatment phase |
| Drinks Per Drinking Day | The number of drinks consumed on days where participants drank | Weeks 3 to 6 of the treatment phase |
| Penn Alcohol Craving Scale (PACS) | The amount of craving; higher numbers indicate more craving. There are 5 items each on a 0 to 6 scale. Items are summed to get to the total craving, resulting in scores having a min=0 and max=30. | Weeks 3 to 6 during the treatment phase, averaged |
| Pittsburgh Sleep Quality Index (PSQI) | A measure of sleep quality; the PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. | Weeks 4 & 6 of the treatment phase, averaged |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Alcohol Related Negative Consequences | A measure of alcohol-related negative consequences. There are 7 items scored on a 1 to 7 scale (a higher score indicative greater frequency of negative consequences). The items are summed and converted to a T-score to create a total score. The T-scores range from 0 to 100 (the population mean = 50 and standard deviation = 10). Higher T-scores are indicative of more negative consequences (worse outcome). | Week 6 of the treatment phase |
| Profile of Mood States (POMS) Total Disturbance | A measure of total mood disturbance. Total mood disturbance is the sum of depression, anger, fatigue, confusion, and tension subscales subtracting the vigor subscale items. The range of possible scores is from -32 to 200 with higher scores indicating greater mood disturbance. | Weeks 4 & 6 of the treatment phase, averaged |
| Cigarettes Smoked Per Day (Among Smokers) | The number of cigarettes smoked per day, computed among individuals who smoked at baseline | Weeks 3 to 6 of the treatment phase |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Brown University | Providence | Rhode Island | 02912 | United States |
Placebo: 1 x per day for 6 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Drinks per week | Mean | Standard Deviation | Standard drinks of alcohol/week |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Number of Subjects With no Heavy Drinking Days | Number of subjects that have no heavy drinking days during weeks 3 to 6 of the treatment phase. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men. | Posted | Count of Participants | Participants | Weeks 3 to 6 of the treatment phase |
|
|
|
| Secondary | Number of Subjects Abstinent From Alcohol | Number of subjects that have not drank alcohol during Weeks 3 to 6 of the treatment phase. | Posted | Count of Participants | Participants | Weeks 3 to 6 of the treatment phase |
|
|
|
| Secondary | WHO 1-level Decrease in Alcohol Consumption | The number of subjects experiencing at least a 1-level decrease in World Health Organization (WHO) levels of alcohol consumption from the level at baseline (the period including the 28 days before screening) to the level during Weeks 3 to 6 of the treatment phase. The WHO levels of average alcohol consumption per day are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate "Abstinent" category. | Posted | Count of Participants | Participants | Weeks 3 to 6 of the treatment phase |
|
|
|
| Secondary | WHO 2-level Decrease in Alcohol Consumption | The number of subjects experiencing at least a 2-level decrease in World Health Organization (WHO) levels of alcohol consumption from the level at baseline (the period including the 28 days before screening) to the level during Weeks 3 to 6 of the treatment phase. The WHO levels of average alcohol consumption per day are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate "Abstinent" category. | Posted | Count of Participants | Participants | Weeks 3 to 6 of the treatment phase. |
|
|
|
| Secondary | Percentage of Days Abstinent | The percentage of days abstinent from drinking alcohol | Posted | Least Squares Mean | Standard Error | percentage of days abstinent | Weeks 3 to 6 of the treatment phase |
|
|
|
| Secondary | Percentage of Heavy Drinking Days | Percentage of heavy drinking days where a heavy drinking day is 4 or more drinks on a day for women or 5 or more drinks on a day for men. | Posted | Least Squares Mean | Standard Error | percentage of heavy drinking days | Weeks 3 to 6 of the treatment phase |
|
|
|
| Secondary | Drinks Per Week | The number of drinks consumed per week | Posted | Least Squares Mean | Standard Error | standard drinks of alcohol/week | Weeks 3 to 6 of the treatment phase |
|
|
|
| Secondary | Drinks Per Drinking Day | The number of drinks consumed on days where participants drank | Posted | Least Squares Mean | Standard Error | standard drinks of alcohol/drinking day | Weeks 3 to 6 of the treatment phase |
|
|
|
| Secondary | Penn Alcohol Craving Scale (PACS) | The amount of craving; higher numbers indicate more craving. There are 5 items each on a 0 to 6 scale. Items are summed to get to the total craving, resulting in scores having a min=0 and max=30. | Posted | Least Squares Mean | Standard Error | score on a scale | Weeks 3 to 6 during the treatment phase, averaged |
|
|
|
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | A measure of sleep quality; the PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. | Posted | Least Squares Mean | Standard Error | score on a scale | Weeks 4 & 6 of the treatment phase, averaged |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Alcohol Related Negative Consequences | A measure of alcohol-related negative consequences. There are 7 items scored on a 1 to 7 scale (a higher score indicative greater frequency of negative consequences). The items are summed and converted to a T-score to create a total score. The T-scores range from 0 to 100 (the population mean = 50 and standard deviation = 10). Higher T-scores are indicative of more negative consequences (worse outcome). | Posted | Least Squares Mean | Standard Error | T-score | Week 6 of the treatment phase |
|
|
|
| Secondary | Profile of Mood States (POMS) Total Disturbance | A measure of total mood disturbance. Total mood disturbance is the sum of depression, anger, fatigue, confusion, and tension subscales subtracting the vigor subscale items. The range of possible scores is from -32 to 200 with higher scores indicating greater mood disturbance. | Posted | Least Squares Mean | Standard Error | score on a scale | Weeks 4 & 6 of the treatment phase, averaged |
|
|
|
| Secondary | Cigarettes Smoked Per Day (Among Smokers) | The number of cigarettes smoked per day, computed among individuals who smoked at baseline | Posted | Least Squares Mean | Standard Error | cigarettes smoked per day | Weeks 3 to 6 of the treatment phase |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 24 |
| 30 |
| EG001 | Matching Placebo | Placebo: 1 x per day for 6 weeks | 0 | 30 | 0 | 30 | 22 | 30 |
| Bundle branch block right | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Conduction disorder | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA | Systematic Assessment |
|
| Influenza like illness | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood albumin increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood alkaline phosphatase decreased | Investigations | MedDRA | Systematic Assessment |
|
| Blood bicarbonate decreased | Investigations | MedDRA | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood creatinine decreased | Investigations | MedDRA | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA | Systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA | Systematic Assessment |
|
| Protein urine | Investigations | MedDRA | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
|
| Red cell distribution width increased | Investigations | MedDRA | Systematic Assessment |
|
| Triglyceride analyses | Investigations | MedDRA | Systematic Assessment |
|
| Urine ketone body present | Investigations | MedDRA | Systematic Assessment |
|
| Urine leukocyte esterase positive | Investigations | MedDRA | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Blunted affect | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
Not provided
Not provided
| D004327 | Drinking Behavior |
| D001519 | Behavior |