Study: NCT01629823

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: Stroke
Frequency: 1 affected / 66 at risk

Adverse event: Pyleonephritis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Kidney infection
Frequency: 1 affected / 66 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 15 affected / 50 at risk

Adverse event: Increased work breathing
Serious: no
Organ System: Social circumstances
Frequency: 3 affected / 55 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 58 at risk

Adverse event: Drying of nose, mouth, and/or throat
Serious: no
Organ System: General disorders
Frequency: 10 affected / 55 at risk

Adverse event: Nose irritation
Serious: no
Organ System: General disorders
Frequency: 6 affected / 57 at risk

Adverse event: Ear or sinus discomfort
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 57 at risk

Adverse event: Congestion, runny nose, sneezing
Serious: no
Organ System: General disorders
Frequency: 21 affected / 52 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 56 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Hospitalization due to chronic blood loss and fatigue
Frequency: 1 affected / 69 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 55 at risk

Adverse event: Increased work breathing
Serious: no
Organ System: Social circumstances
Frequency: 7 affected / 60 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 62 at risk

Adverse event: Drying of nose, mouth, and/or throat
Serious: no
Organ System: General disorders
Frequency: 13 affected / 59 at risk

Adverse event: Nose irritation
Serious: no
Organ System: General disorders
Frequency: 9 affected / 61 at risk

Adverse event: Ear or sinus discomfort
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 60 at risk

Adverse event: Congestion, runny nose, sneezing
Serious: no
Organ System: General disorders
Frequency: 25 affected / 52 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 14 affected / 46 at risk

Adverse event: Increased work breathing
Serious: no
Organ System: Social circumstances
Frequency: 3 affected / 56 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 57 at risk

Adverse event: Drying of nose, mouth, and/or throat
Serious: no
Organ System: General disorders
Frequency: 8 affected / 55 at risk

Adverse event: Nose irritation
Serious: no
Organ System: General disorders
Frequency: 7 affected / 56 at risk

Adverse event: Ear or sinus discomfort
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 56 at risk

Adverse event: Congestion, runny nose, sneezing
Serious: no
Organ System: General disorders
Frequency: 14 affected / 46 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 51 at risk