Study: NCT00332644

Adverse event: hospitalization: cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 262 at risk

Adverse event: hospitalization: surgical
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 262 at risk

Adverse event: hospitalization: general
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 262 at risk

Adverse event: Skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 92 affected / 262 at risk

Adverse event: Cough
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 262 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 262 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 262 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 262 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 26 affected / 262 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 262 at risk

Adverse event: Nausea
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 262 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 85 affected / 262 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 67 affected / 262 at risk

Adverse event: Throat irritation
Serious: no
Organ System: General disorders
Frequency: 7 affected / 262 at risk

Adverse event: hospitalization: cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 260 at risk

Adverse event: hospitalization: general
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 260 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 102 affected / 260 at risk

Adverse event: Cough
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 260 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 260 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 260 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 260 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 29 affected / 260 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 35 affected / 260 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 260 at risk

Adverse event: Nausea
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 260 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 260 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 18 affected / 260 at risk

Adverse event: Throat irritation
Serious: no
Organ System: General disorders
Frequency: 18 affected / 260 at risk

Adverse event: hospitalization: cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 267 at risk

Adverse event: hospitalization: surgical
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 267 at risk

Adverse event: hospitalization: respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 88 affected / 267 at risk

Adverse event: Cough
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 267 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 267 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 267 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 267 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 267 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 34 affected / 267 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 22 affected / 267 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 267 at risk

Adverse event: Nausea
Serious: no
Organ System: Infections and infestations
Frequency: 55 affected / 267 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 63 affected / 267 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 63 affected / 267 at risk

Adverse event: Throat irritation
Serious: no
Organ System: General disorders
Frequency: 21 affected / 267 at risk

Adverse event: hospitalization: cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 264 at risk

Adverse event: hospitalization: respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Hopitalization: abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Hospitalization: psychiatric and alcohol
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 264 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Pregnancy
Frequency: 1 affected / 264 at risk

Adverse event: hospitalization: general
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 264 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 74 affected / 264 at risk

Adverse event: Cough
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 264 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 264 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 20 affected / 264 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 264 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 23 affected / 264 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 264 at risk

Adverse event: Nausea
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 264 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 264 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 88 affected / 264 at risk

Adverse event: Throat irritation
Serious: no
Organ System: General disorders
Frequency: 6 affected / 264 at risk

Adverse event: hospitalization: surgical
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 262 at risk

Adverse event: hospitalization: general
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 262 at risk

Adverse event: Death: COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 65 affected / 262 at risk

Adverse event: Cough
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 262 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 15 affected / 262 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 25 affected / 262 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 262 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 262 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 30 affected / 262 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 7 affected / 262 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 262 at risk

Adverse event: Nausea
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 262 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 262 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 69 affected / 262 at risk

Adverse event: Throat irritation
Serious: no
Organ System: General disorders
Frequency: 16 affected / 262 at risk

Adverse event: hospitalization: cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 189 at risk

Adverse event: hospitalization: respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 189 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Pregnancy
Frequency: 1 affected / 189 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 57 affected / 189 at risk

Adverse event: Cough
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 189 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 189 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 189 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 189 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 189 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 24 affected / 189 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 1 affected / 189 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: Nausea
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 189 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 189 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 20 affected / 189 at risk

Adverse event: Throat irritation
Serious: no
Organ System: General disorders
Frequency: 5 affected / 189 at risk