Study: NCT03185546

Adverse event: Bradycardia (slow heart rate)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Ear Pain (ache/fullness)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 6 at risk

Adverse event: Tingling sensation left ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 6 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Dyspepsia (upset stomach)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Irritability (frustration)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Sinusitis - sinus infection (incl. bacterial, fungal, viral)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Headache (incl. migraine)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: CES-D Score, elevated
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Depressed (sad) mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Insomnia (change/disturbance in sleep)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nightmare/terror
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypertension (high BP)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Ear Pain (ache/fullness)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dyspepsia (upset stomach)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypoglycemia (low blood sugar)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 7 at risk

Adverse event: Myalgia (muscle aches/pain/spasms)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Arthralgia (joint aches)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Exposed Jaw Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dizziness/Lightheadedness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 7 at risk

Adverse event: Headache (incl. migraine)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 7 at risk

Adverse event: Sinus pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Anxiety, clinical diagnosis
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

Adverse event: CES-D Score, elevated
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 7 at risk

Adverse event: Depressed (sad) mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

Adverse event: Worsened Kidney Disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nasal congestion (incl. runny nose)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Sore throat (incl. itchy/irritated throat)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 7 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 7 at risk

Adverse event: Hypertension (high BP)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: torn hamstring tendon
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 7 at risk

Adverse event: elevated potassium (hyperkalemia)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Myalgia (muscle aches/pain/spasms)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness/Lightheadedness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache (incl. migraine)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Paresthesia (numbness/tingling)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Depressed (sad) mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Allergic rhinitis (incl. seasonal allergies)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Nasal congestion (incl. runny nose)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Myalgia (muscle aches/pain/spasms)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness/Lightheadedness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache (incl. migraine)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 4 affected / 6 at risk

Adverse event: Nasal congestion (incl. runny nose)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Sore throat (incl. itchy/irritated throat)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 6 at risk

Adverse event: Hypertension (high BP)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: stiffness thumb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dental caries
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Oral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Sinusitis - sinus infection (incl. bacterial, fungal, viral)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 5 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dizziness/Lightheadedness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 5 at risk

Adverse event: Intracranial Vascular Event (stroke/aneurysm)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk

Adverse event: Anxiety/Panic Attack
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: CES-D Score, elevated
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 5 at risk

Adverse event: Allergic rhinitis (incl. seasonal allergies)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 3 affected / 5 at risk

Adverse event: Cough, Productive (lung 'fullness')
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Nasal congestion (incl. runny nose)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Nosebleed / Dry nasal membrane
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hyperhidrosis (excessive sweating)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cut/Abrasion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: CES-D Score, elevated
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 5 at risk

Adverse event: Depressed (sad) mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Nasal congestion (incl. runny nose)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Sore throat (incl. itchy/irritated throat)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Lymph Node, pain (swollen)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Sinusitis - sinus infection (incl. bacterial, fungal, viral)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Appetite, Increase/hunger
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia (muscle aches/pain/spasms)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Dizziness/Lightheadedness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 10 at risk

Adverse event: Headache (incl. migraine)
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 10 at risk

Adverse event: Anxious (nervous) mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: CES-D Score, elevated
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 10 at risk

Adverse event: Insomnia (change/disturbance in sleep)
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 10 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Cough, Productive (lung 'fullness')
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Nasal congestion (incl. runny nose)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Sore throat (incl. itchy/irritated throat)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 10 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 10 at risk

Adverse event: methicillin-resistant Staphylococcus aureus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Cut/Abrasion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Gastroesophageal Reflux (GERD/heartburn/acid)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Myalgia (muscle aches/pain/spasms)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Headache (incl. migraine)
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 5 at risk

Adverse event: Sinus pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: CES-D Score, elevated
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 3 affected / 5 at risk

Adverse event: Nasal congestion (incl. runny nose)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 5 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Sore throat (incl. itchy/irritated throat)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 106 at risk

Adverse event: Headache (incl. migraine)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 106 at risk

Adverse event: CES-D Score, elevated
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 106 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 106 at risk

Adverse event: Nasal congestion (incl. runny nose)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 106 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 106 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 106 at risk

Adverse event: Hypertension (high BP)
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 106 at risk