Study: NCT02503501

Adverse event: Hospitalisation
Serious: yes
Organ System: Renal and urinary disorders
Notes: Dizziness secondary to dehydration and hyponatremia secondary to vomiting + hydrochlorothiazide
Frequency: 1 affected / 16 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 19 at risk

Adverse event: Respiratory/Sinus symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 19 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 19 at risk

Adverse event: Imbalance/falls
Serious: no
Organ System: General disorders
Frequency: 4 affected / 19 at risk

Adverse event: Dental
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 19 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 19 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Opthalmic
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hematologic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 19 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 19 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 16 at risk

Adverse event: Respiratory/Sinus symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 16 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 16 at risk

Adverse event: Imbalance/falls
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Injury related to falls
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Dental
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 16 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 16 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Opthalmic
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk