Study: NCT04432376

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Acute kidney injury on Chronic Kidney Disease (CKD)
Frequency: 1 affected / 89 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Hypotension
Frequency: 1 affected / 89 at risk

Adverse event: Ear discomfort
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 89 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 89 at risk

Adverse event: Ear infection fungal
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 89 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Otitis externa fungal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 89 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 89 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 7 affected / 89 at risk

Adverse event: Exposure to SARS-CoV-2
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 89 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 89 at risk

Adverse event: Hypovolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 89 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Ear discomfort
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 9 affected / 90 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 90 at risk

Adverse event: Tympanic membrane perforation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 90 at risk

Adverse event: Ear infection fungal
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 90 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Otitis externa bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 90 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 8 affected / 90 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Paranasal cyst
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 203 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 203 at risk

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 203 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 3 affected / 203 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 203 at risk