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| Name | Class |
|---|---|
| Genome Protection, Inc. | INDUSTRY |
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Researchers are evaluating the safety and effectiveness of a single administration of entolimod when administered at the same time as the influenza vaccine (flu vaccine).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entolimod 1 mcg | Experimental | Subjects will receive entolimod as a single dose administered intramuscularly (1mcg) |
|
| Entolimod 3 mcg | Experimental | Subjects will receive entolimod as a single dose administered intramuscularly (3mcg) |
|
| Entolimod 10 mcg | Experimental | Subjects will receive entolimod as a single dose administered intramuscularly (10mcg) |
|
| Placebo | Placebo Comparator | Subjects will receive a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entolimod | Drug | Intramuscular (IM) single dose administration. Entolimod is provided as a sterile, clear, colorless or slightly yellow liquid for IM injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anti- A/H1N1 Antibody Titer | Change of the anti- A/H1N1 influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month. | Baseline, 1 month |
| Change in Anti-A/H3N2 Antibody Titer | Change of the anti-A/H3N2 influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month. | Baseline, 1 month |
| Change in Anti-B Antibody Titer | Change of the anti-B influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month.. | Baseline, 1 month |
| Adverse Events | The number of adverse events (AEs) related to dose limiting toxicities (DLTs); laboratory abnormalities; oxygen saturation and vital sign changes, and adverse electrocardiogram (ECG) findings for 1 year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Onset for Upper-respiratory Infections | Subject self-reporting of the number of days to develop an upper-respiratory infection | 1 year |
| Upper Respiratory Infections | The total number of subjects to self-report an upper-respiratory infection |
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Inclusion:
Exclusion:
Receipt of any other vaccines within the past 30 days prior to enrollment
Acute illness within the last 7 days
History of hypersensitivity to the flu vaccine or its components (including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein).
History of Guillain Barré syndrome (GBS)
History of bleeding disorders
Medical contraindication to treatment with vaccine as indicated by a history of autoimmune disease, immune deficiency, or hypersensitivity to other vaccines.
Unstable major cardiovascular, renal, endocrine, immunological or hepatic disorder
Systolic blood pressure (SBP) < 110 mmHg or orthostatic hypotension [>20 mmHg fall in SBP or >10 mmHg fall in diastolic blood pressure (DBP) with standing] at the time of screening.
Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) (within 14 days prior to entolimod administration). Note: Subjects with localized fungal infections of skin or nails are eligible.
Clinical signs of febrile illness (temperature >99.5oF)
Baseline vital signs with ≥Grade 2 abnormalities
Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism, venous thromboembolism) within 6 months prior to study drug administration; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; or uncontrolled Grade ≥3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg) despite antihypertensive therapy.
o Significant screening ECG abnormalities, including unstable cardiac arrhythmia requiring medication, atrial fibrillation, 2nd-degree atrioventricular (AV) block type II, 3rd degree AV block, or Grade ≥2 bradycardia (within 14 days prior to entolimod administration).
Inadequate hepatic function (within 14 days prior to entolimod administration):
Serum bilirubin ≥1.5 × ULN (Grade ≥1)
Positive antiviral serology:
Positive human immunodeficiency virus (HIV) antibody.
Use of medication that might interact with the flu vaccine including (but not limited to) specifically: aminopyrine, phenytoin sodium, theophylline, and warfarin sodium.
Any ongoing treatment with immunosuppressive or immune-stimulant therapy
Ongoing use of systemic corticosteroids.
Blood or blood products given within the three months prior to vaccination and two months after vaccination
Current and/or expected receipt of chemotherapy, radiation therapy or any other cytotoxic or immunosuppressive therapy [i.e. more than 10 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 3 months]
Receipt of another investigational pharmaceutical product within 60 days of treatment
Diagnosis of Parkinson's Disease, previous stroke, or significant cognitive impairment (defined as MMSE <20)
Other concerns that in the opinion of the PI would preclude a subject from participating in study procedures or from completing the study.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Pignolo, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Entolimod 1 mcg | Subjects received entolimod as a single dose administered intramuscularly (1mcg) Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection. Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur |
| FG001 | Entolimod 3 mcg | Subjects received entolimod as a single dose administered intramuscularly (3mcg) Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection. Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur |
| FG002 | Entolimod 10 mcg | Subjects received entolimod as a single dose administered intramuscularly (10mcg) Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection. Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur |
| FG003 | Placebo | Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient. Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug. Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entolimod 1 mcg | Subjects received entolimod as a single dose administered intramuscularly (1mcg) Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection. Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur |
| 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 in Anti- A/H1N1 Antibody Titer | Change of the anti- A/H1N1 influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month. | Posted | Mean | Standard Deviation | titer | Baseline, 1 month |
|
Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
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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 | Entolimod 1 mcg | Subjects received entolimod as a single dose administered intramuscularly (1mcg) Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection. Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert J. Pignolo, MD, PhD | Mayo Clinic | 507-255-8716 | Pignolo.Robert@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 18, 2020 | Apr 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C528306 | CBLB502 |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Placebo | Drug | Intramuscular (IM) single dose administration, no active ingredient. A matching placebo is provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug. |
|
| Influenza vaccine | Drug | Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur |
|
|
| 1 year |
| Change in Frailty | Change in self-reported 5 items frail scale. Frail scale scores range from 0-5, 1 point for each component, 0 = best 5 = worst (robust=0 points; pre-frail=0-1 points; frail 3-5 points) | baseline, 2 months |
| Change in 6-minute Walk Test | Distance a subject is able to walk over 6 minutes over a hard flat surface | baseline, 2 months |
| Change in Grip Strength | Measured by a grip dynamometer as reported in units of pounds. | baseline, 2 months |
| Change in Body Mass Index (BMI) | Subject's BMI calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions) | baseline, 2 months |
| BG001 | Entolimod 3 mcg | Subjects received entolimod as a single dose administered intramuscularly (3mcg) Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection. Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur |
| BG002 | Entolimod 10 mcg | Subjects received entolimod as a single dose administered intramuscularly (10mcg) Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection. Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur |
| BG003 | Placebo | Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient. Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug. Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur |
| BG004 | 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 |
|
Subjects received entolimod as a single dose administered intramuscularly (3mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
| OG002 | Entolimod 10 mcg | Subjects received entolimod as a single dose administered intramuscularly (10mcg) Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection. Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur |
| OG003 | Placebo | Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient. Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug. Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur |
|
|
| Primary | Change in Anti-A/H3N2 Antibody Titer | Change of the anti-A/H3N2 influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month. | Posted | Mean | Standard Deviation | titer | Baseline, 1 month |
|
|
|
| Primary | Change in Anti-B Antibody Titer | Change of the anti-B influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month.. | Posted | Mean | Standard Deviation | titer | Baseline, 1 month |
|
|
|
| Primary | Adverse Events | The number of adverse events (AEs) related to dose limiting toxicities (DLTs); laboratory abnormalities; oxygen saturation and vital sign changes, and adverse electrocardiogram (ECG) findings for 1 year | Posted | Number | adverse event | 1 year |
|
|
|
| Secondary | Time of Onset for Upper-respiratory Infections | Subject self-reporting of the number of days to develop an upper-respiratory infection | The number of subjects to develop upper-respiratory infections were analyzed for each arm | Posted | Mean | Standard Deviation | days | 1 year |
|
|
|
| Secondary | Upper Respiratory Infections | The total number of subjects to self-report an upper-respiratory infection | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Change in Frailty | Change in self-reported 5 items frail scale. Frail scale scores range from 0-5, 1 point for each component, 0 = best 5 = worst (robust=0 points; pre-frail=0-1 points; frail 3-5 points) | Posted | Mean | Standard Deviation | score on a scale | baseline, 2 months |
|
|
|
| Secondary | Change in 6-minute Walk Test | Distance a subject is able to walk over 6 minutes over a hard flat surface | Posted | Mean | Standard Deviation | meters | baseline, 2 months |
|
|
|
| Secondary | Change in Grip Strength | Measured by a grip dynamometer as reported in units of pounds. | Posted | Mean | Standard Deviation | pounds | baseline, 2 months |
|
|
|
| Secondary | Change in Body Mass Index (BMI) | Subject's BMI calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions) | Posted | Mean | Standard Deviation | kg/m^2 | baseline, 2 months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 20 |
| 20 |
| EG001 | Entolimod 3 mcg | Subjects received entolimod as a single dose administered intramuscularly (3mcg) Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection. Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur | 0 | 19 | 0 | 19 | 19 | 19 |
| EG002 | Entolimod 10 mcg | Subjects received entolimod as a single dose administered intramuscularly (10mcg) Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection. Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur | 0 | 6 | 0 | 6 | 6 | 6 |
| EG003 | Placebo | Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient. Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug. Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur | 0 | 16 | 1 | 16 | 16 | 16 |
| Alkaline phosphatase increased | Investigations | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Ankle fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Anosmia | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | Systematic Assessment |
|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cardiac disorders | Cardiac disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dysgeusia | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspareunia | Reproductive system and breast disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Edema limbs | General disorders | Systematic Assessment |
|
| Eye disorders | Eye disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Flu like symptoms | General disorders | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hematoma | Vascular disorders | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Hemoglobinuria | Renal and urinary disorders | Systematic Assessment |
|
| Hot flashes | Vascular disorders | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | Systematic Assessment |
|
| Injection site reaction | General disorders | Systematic Assessment |
|
| Injury and poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Localized edema | General disorders | Systematic Assessment |
|
| Lymphocyte count decreased | Blood and lymphatic system disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Muscle cramp | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Prostatic obstruction | Reproductive system and breast disorders | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Reproductive system and breast disorders | Reproductive system and breast disorders | Systematic Assessment |
|
| Respiratory and thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Retinal tear | Eye disorders | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin infection | Infections and infestations | Systematic Assessment |
|
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Vaccination complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Wrist fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Electrocardiogram T wave abnormal | Cardiac disorders | Systematic Assessment |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |