Study: NCT03081117

Adverse event: Kidney obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cardiac event
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hospitalization for syncope/hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 10 at risk

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

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 10 at risk

Adverse event: Congestion/Runny Nose
Serious: no
Organ System: General disorders
Frequency: 4 affected / 10 at risk

Adverse event: Nasal Irritation or Reaction (during administration of investigational product)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 10 at risk

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

Adverse event: Odor/Taste (during administration of investigational product)
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 10 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 10 at risk

Adverse event: Upper Gastrointestinal Pain or Discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Infection (other than upper respiratory infection)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Creatinine, High Blood
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 10 at risk

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

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

Adverse event: Glucose, High Blood
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 10 at risk

Adverse event: Amylase, High Blood
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 10 at risk

Adverse event: Major depressive episode
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 11 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 11 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Congestion/Runny Nose
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Nasal Irritation or Reaction (during administration of investigational product)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 11 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 11 at risk

Adverse event: Odor/Taste (during administration of investigational product)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 11 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Creatinine, High Blood
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 11 at risk

Adverse event: Blood Pressure, High (acute)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Edema, Lower Extremity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk