Study: NCT01118312

Adverse event: Depression (hospitalized)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 189 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 189 at risk

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 45 affected / 140 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 22 affected / 174 at risk

Adverse event: Nasal bleed
Serious: no
Organ System: General disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 10 affected / 176 at risk

Adverse event: Rhinalgia
Serious: no
Organ System: General disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 25 affected / 162 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 7 affected / 172 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 17 affected / 157 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 9 affected / 172 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 27 affected / 178 at risk

Adverse event: Trouble breathing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 42 affected / 136 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 10 affected / 175 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 39 affected / 133 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 10 affected / 116 at risk

Adverse event: Depression (hospitalized)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 199 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 199 at risk

Adverse event: Headache and high blood pressure
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 199 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 199 at risk

Adverse event: asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 199 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 199 at risk

Adverse event: Fungus ball of the sinus requiring surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 199 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 199 at risk

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 56 affected / 148 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 34 affected / 175 at risk

Adverse event: Nasal bleed
Serious: no
Organ System: General disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 15 affected / 184 at risk

Adverse event: Rhinalgia
Serious: no
Organ System: General disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 44 affected / 168 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 18 affected / 180 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 23 affected / 165 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 17 affected / 181 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 28 affected / 184 at risk

Adverse event: Trouble breathing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 55 affected / 152 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 19 affected / 183 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 44 affected / 157 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
Frequency: 14 affected / 112 at risk