Study: NCT01027143

Adverse event: asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalized for asthma exacerbation; respiratory distress
Frequency: 2 affected / 77 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: hematemesis requiring urgent care
Frequency: 1 affected / 77 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Notes: Painful sensation in any part of the head
Frequency: 39 affected / 77 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Immune system disorders
Notes: Salivary Glands are not making enough saliva in the mouth
Frequency: 14 affected / 77 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Feeling of queasiness or wooziness or need to vomit
Frequency: 21 affected / 77 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Intestinal organs are being stretched or distended
Frequency: 11 affected / 77 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Liquid form of feces discharged from the bowels
Frequency: 11 affected / 77 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Difficulty emptying the bowels; harden feces
Frequency: 8 affected / 77 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Accumulation of gas in the stomach
Frequency: 14 affected / 77 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 77 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Infection of the upper respiratory system
Frequency: 31 affected / 77 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pain and/or inflammation of the throat
Frequency: 20 affected / 77 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Inflamed cavities around the nasal passages
Frequency: 9 affected / 77 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Notes: Painful sensation in any part of the head
Frequency: 8 affected / 21 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Immune system disorders
Notes: Salivary Glands are not making enough saliva in the mouth
Frequency: 5 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Feeling of queasiness or wooziness or need to vomit
Frequency: 4 affected / 21 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Intestinal organs are being stretched or distended
Frequency: 2 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Liquid form of feces discharged from the bowels
Frequency: 5 affected / 21 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Difficulty emptying the bowels; harden feces
Frequency: 2 affected / 21 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Accumulation of gas in the stomach
Frequency: 5 affected / 21 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Infection of the upper respiratory system
Frequency: 8 affected / 21 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pain and/or inflammation of the throat
Frequency: 8 affected / 21 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Inflamed cavities around the nasal passages
Frequency: 1 affected / 21 at risk