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Primary: The primary objective of the study is to compare the efficacy of intranasal oxytocin in reducing the weekly percentage of heavy drinking days over the 10 weeks of maintenance treatment among subjects with moderate to severe Alcohol Use Disorder (AUD). A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.
Secondary: Secondary objectives include assessment of other measures of the effects of oxytocin compared with placebo on reduction of alcohol use as well as effects on psychological assessments, alcohol craving, alcohol-related consequences, cigarette smoking and other nicotine use, retention in the study, safety, and application site (nares) tolerability throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Oxytocin | Active Comparator | Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. |
|
| Instrasal Placebo | Placebo Comparator | Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Instranasal Oxytocin | Drug | Intranasal Oxytocin - concentrated formulation - 35 IU per dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weekly Percentage of Heavy Drinking Days | The primary efficacy endpoint is the weekly percentage of heavy drinking days during the 10-week maintenance treatment period. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men. Drinking data will be collected by the Timeline Followback (TLFB) method. | Weeks 3-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With no Heavy Drinking Days | Percentage of subjects with no heavy drinking days during the 10-week Maintenance period | weeks 3-12 |
| Percentage of Subjects Abstinent From Alcohol |
Not provided
Inclusion Criteria:
Be at least 21 years of age.
Have a current (past 12 months) DSM-5 diagnosis of AUD (4 or more symptoms) assessed using the MINI neuropsychiatric interview version 7.0.2 (at least moderate severity, ICD-10-CM Code F10.20 alcohol dependence, uncomplicated).
Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document (either just prior to or immediately after signing consent).
Be seeking treatment for problems with alcohol reduction in 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, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal:
Be able to take intranasal investigational products and be willing to adhere to the investigational product 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 by Study Week 14.
Not anticipate any significant problems with transportation arrangements or available time to travel to the study site by Study Week 14.
Not have any plans to move within Study Week 14 to a location which would make continued participation in the study impractical.
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.
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.
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:
Not currently taking oxytocin and agree not to take non-study oxytocin for the duration of the study.
Exclusion Criteria:
Contact study site for exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Raye Litten, PHD | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Los Angeles | California | 90095 | United States | ||
| Johns Hopkins School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intranasal Oxytocin | Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose |
| FG001 | Instrasal Placebo | Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline analysis includes randomized participants who received study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intranasal Oxytocin | Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose |
| 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 | Weekly Percentage of Heavy Drinking Days | The primary efficacy endpoint is the weekly percentage of heavy drinking days during the 10-week maintenance treatment period. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men. Drinking data will be collected by the Timeline Followback (TLFB) method. | Full Analysis Set - randomized and received study medication | Posted | Least Squares Mean | Standard Error | percentage of days per week | Weeks 3-12 |
|
AEs were assessed at study visits starting after the first administration of investigational product (Day 1) until the final follow-up visit (Week 15). However, SAEs were collected from the time of informed consent (Day -14) until Week 15.
General symptoms were collected via an open ended question: "How have you been feeling since your last clinic visit or phone contact?"?"
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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 | Intranasal Oxytocin | Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. The total daily dose of oxytocin will be 70 IU/mL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Falk | National Institute on Alcohol Abuse and Alcoholism | 301-443-0788 | 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 | Jul 5, 2022 | Jun 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 7, 2023 | Jun 16, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2022 | Jun 11, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Percentage of subjects abstinent from alcohol during the 10-week Maintenance period
| Weeks 3-12 |
| Percentage of Subjects With at Least a 1-level World Health Organization (WHO) Drinking Risk Category Decrease | Percentage of subjects with at least a 1-level World Health Organization (WHO) drinking risk category decrease from the baseline level to (the period including the 28 days before screening) to the level during the treatment phase (Study Weeks 3-12). The WHO levels of average alcohol consumption per day vary by Sex of participants and 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 3-12 |
| Percentage of Subjects With at Least a 2-level World Health Organization (WHO) Drinking Risk Category Decrease | Percentage of subjects with at least a 2-level World Health Organization (WHO) drinking risk category decrease from the baseline level to (the period including the 28 days before screening) to the level during the treatment phase (Study Weeks 3-12). The WHO levels of average alcohol consumption per day vary by Sex of participants and 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 3-12 |
| Percentage of Days Abstinent Per Week | Timeline Follow Back daily drinking data used to calculate the % of days abstinent per week during the 10-week Maintenance period. | weeks 3-12 |
| Weekly Mean Number of Drinks Per Week | Weekly mean number of drinks per week during the 10-week Maintenance period. | weeks 3-12 |
| Weekly Mean Drinks Per Drinking Day | Weekly mean drinks per drinking day during the 10-week Maintenance period. | weeks 3-12 |
| Number of Alcohol Use Disorder Symptoms (MINI) | The MINI (paper version 7.0.2) is a short structured diagnostic interview, developed jointly by psychiatrists and clinicians in the United States and Europe, for DSM-5 and ICD-10 psychiatric disorders (Sheehan-1998). This scale is a count of the number of alcohol use disorder symptoms. Minimum = 0 and maximum=11. Higher scores indicate worse outcome. | week 13 |
| Cigarettes Smoked Per Week Among Smokers | Cigarettes smoked per week among smokers during the 10-week Maintenance period. | weeks 3-12 |
| Abstinence From Cigarette Smoking Among Smokers | Abstinence from cigarette smoking among smokers during the 10-week Maintenance period. | weeks 3-12 |
| Other Nicotine Product Use - Days Per Week Among Other Nicotine Product Users | Other nicotine product use - days per week among other nicotine product users during the Maintenance period | weeks 3-12 |
| Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) Scores (Attachment-related Anxiety Subscale) | Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) scores (attachment-related anxiety subscale) during the 10-week Maintenance period. Minimum = 0 and maximum = 126. Higher scores are worse outcome. | weeks 3-12 |
| PROMIS Sleep Disturbances Score | PROMIS® (Patient-Reported Outcomes Measurement Information System) Sleep Disturbances score (Short Form 8b) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more sleep disturbance). | weeks 3-12 |
| PROMIS Alcohol-related Negative Consequences Score | PROMIS® (Patient-Reported Outcomes Measurement Information System) alcohol-related negative consequences score (Long Form) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more alcohol-related negative consequences). | weeks 3-12 |
| PROMIS Pain Interference Score | PROMIS® (Patient-Reported Outcomes Measurement Information System) Pain Interference score (Short Form 8a) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more pain interference). | weeks 3-12 |
| Profile of Moods States (POMS) - Total Mood Disturbance | Profile of Moods States (POMS) - Total Mood Disturbance during the 10-week Maintenance period. Minimum = -32 and maximum = 200. Higher scores are worse outcome. | weeks 3-12 |
| Urge to Drink Alcohol Craving Score | Urge to Drink alcohol craving score during the 10-week Maintenance period. Minimum = 0 and maximum = 35. Higher scores are worse outcome. | weeks 3-12 |
| Baltimore |
| Maryland |
| 21224 |
| United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| University of Virginia | Charlottesville | Virginia | 22904 | United States |
| BG001 | Instrasal Placebo | Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose |
| 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 |
|
| Region of Enrollment | Number | participants |
|
| Percentage of heavy drinking days | Mean | Standard Deviation | percentage of days |
|
| OG001 | Instrasal Placebo | Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose |
|
|
| Secondary | Percentage of Subjects With no Heavy Drinking Days | Percentage of subjects with no heavy drinking days during the 10-week Maintenance period | Full Analysis Set - randomized and received medication | Posted | Number | percentage of participants | weeks 3-12 |
|
|
|
| Secondary | Percentage of Subjects Abstinent From Alcohol | Percentage of subjects abstinent from alcohol during the 10-week Maintenance period | Full Analysis Set - randomized and received medication | Posted | Number | percentage of participants | Weeks 3-12 |
|
|
|
| Secondary | Percentage of Subjects With at Least a 1-level World Health Organization (WHO) Drinking Risk Category Decrease | Percentage of subjects with at least a 1-level World Health Organization (WHO) drinking risk category decrease from the baseline level to (the period including the 28 days before screening) to the level during the treatment phase (Study Weeks 3-12). The WHO levels of average alcohol consumption per day vary by Sex of participants and 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. | Full Analysis Set - randomized and received study medication | Posted | Number | percentage of participants | weeks 3-12 |
|
|
|
| Secondary | Percentage of Subjects With at Least a 2-level World Health Organization (WHO) Drinking Risk Category Decrease | Percentage of subjects with at least a 2-level World Health Organization (WHO) drinking risk category decrease from the baseline level to (the period including the 28 days before screening) to the level during the treatment phase (Study Weeks 3-12). The WHO levels of average alcohol consumption per day vary by Sex of participants and 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. | Full Analysis Set - randomized and received study medication | Posted | Number | percentage of participants | weeks 3-12 |
|
|
|
| Secondary | Percentage of Days Abstinent Per Week | Timeline Follow Back daily drinking data used to calculate the % of days abstinent per week during the 10-week Maintenance period. | Full Analysis Set - randomized and received study medication | Posted | Least Squares Mean | Standard Error | percentage of days per week | weeks 3-12 |
|
|
|
| Secondary | Weekly Mean Number of Drinks Per Week | Weekly mean number of drinks per week during the 10-week Maintenance period. | Full Analysis Set - randomized and received medication | Posted | Least Squares Mean | Standard Error | standard drinking units (SDUs) per week | weeks 3-12 |
|
|
|
| Secondary | Weekly Mean Drinks Per Drinking Day | Weekly mean drinks per drinking day during the 10-week Maintenance period. | Full Analysis Set - randomized and received medication | Posted | Least Squares Mean | Standard Error | standard drinking units (SDUs) per week | weeks 3-12 |
|
|
|
| Secondary | Number of Alcohol Use Disorder Symptoms (MINI) | The MINI (paper version 7.0.2) is a short structured diagnostic interview, developed jointly by psychiatrists and clinicians in the United States and Europe, for DSM-5 and ICD-10 psychiatric disorders (Sheehan-1998). This scale is a count of the number of alcohol use disorder symptoms. Minimum = 0 and maximum=11. Higher scores indicate worse outcome. | Full Analysis Set - randomized and received medication | Posted | Least Squares Mean | Standard Error | Number of alcohol use disorder symptoms | week 13 |
|
|
|
| Secondary | Cigarettes Smoked Per Week Among Smokers | Cigarettes smoked per week among smokers during the 10-week Maintenance period. | Full Analysis Set - randomized and received medication | Posted | Mean | Standard Deviation | number of cigarettes smoked per week | weeks 3-12 |
|
|
|
| Secondary | Abstinence From Cigarette Smoking Among Smokers | Abstinence from cigarette smoking among smokers during the 10-week Maintenance period. | Full Analysis Set - randomized and received medication | Posted | Number | percentage of participants | weeks 3-12 |
|
|
|
| Secondary | Other Nicotine Product Use - Days Per Week Among Other Nicotine Product Users | Other nicotine product use - days per week among other nicotine product users during the Maintenance period | Full Analysis Set - randomized and received medication | Posted | Mean | Standard Deviation | days per week | weeks 3-12 |
|
|
|
| Secondary | Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) Scores (Attachment-related Anxiety Subscale) | Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) scores (attachment-related anxiety subscale) during the 10-week Maintenance period. Minimum = 0 and maximum = 126. Higher scores are worse outcome. | Full Analysis Set - randomized and received medication | Posted | Least Squares Mean | Standard Error | score on a scale | weeks 3-12 |
|
|
|
| Secondary | PROMIS Sleep Disturbances Score | PROMIS® (Patient-Reported Outcomes Measurement Information System) Sleep Disturbances score (Short Form 8b) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more sleep disturbance). | Full Analysis Set - randomized and received study medication | Posted | Least Squares Mean | Standard Error | T-score | weeks 3-12 |
|
|
|
| Secondary | PROMIS Alcohol-related Negative Consequences Score | PROMIS® (Patient-Reported Outcomes Measurement Information System) alcohol-related negative consequences score (Long Form) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more alcohol-related negative consequences). | Full Analysis Set - randomized and received medication | Posted | Least Squares Mean | Standard Error | T-score | weeks 3-12 |
|
|
|
| Secondary | PROMIS Pain Interference Score | PROMIS® (Patient-Reported Outcomes Measurement Information System) Pain Interference score (Short Form 8a) during the 10-week Maintenance period. Scores are T-scores with a mean of 50 and standard deviation of 10. Minimum = 0 and maximum = 100. Higher scores are worse outcome (i.e., more pain interference). | Full Analysis Set - randomized and received medication | Posted | Least Squares Mean | Standard Error | T-score | weeks 3-12 |
|
|
|
| Secondary | Profile of Moods States (POMS) - Total Mood Disturbance | Profile of Moods States (POMS) - Total Mood Disturbance during the 10-week Maintenance period. Minimum = -32 and maximum = 200. Higher scores are worse outcome. | Full Analysis Set - randomized and received medication | Posted | Least Squares Mean | Standard Error | score on a scale | weeks 3-12 |
|
|
|
| Secondary | Urge to Drink Alcohol Craving Score | Urge to Drink alcohol craving score during the 10-week Maintenance period. Minimum = 0 and maximum = 35. Higher scores are worse outcome. | Full Analysis Set - randomized and received medication | Posted | Least Squares Mean | Standard Error | score on a scale | weeks 3-12 |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 44 |
| 49 |
| EG001 | Instrasal Placebo | Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 μL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 μL. Instranasal Oxytocin: Intranasal Oxytocin - concentrated formulation - 35 IU per dose | 0 | 48 | 0 | 48 | 45 | 48 |
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal hernia | 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 |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA | Systematic Assessment |
|
| Chills | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Mucosal haemorrhage | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Pain and discomfort NEC | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Secretion discharge | General disorders | MedDRA | Systematic Assessment |
|
| Sensation of foreign body | General disorders | MedDRA | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood creatinine decreased | Investigations | MedDRA | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Food craving | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyponatraemia | 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 |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hyposmia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasal crusting | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasal septum disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Upper respiratory tract signs and symptoms | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Endodontic procedure | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Arteriosclerosis | Vascular disorders | MedDRA | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
Not provided
Not provided