Study: NCT01052116

Adverse event: Pulmonary including asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 193 at risk

Adverse event: Renal/urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 193 at risk

Adverse event: Reproductive
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 193 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 193 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 193 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 40 affected / 160 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 45 affected / 139 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 47 affected / 77 at risk

Adverse event: Difficulty swallowing
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 179 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 182 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 180 at risk

Adverse event: Change in menstrual symptoms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 33 affected / 62 at risk

Adverse event: Pulmonary including asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 193 at risk

Adverse event: Cardiovascular, circulatory, and lymphatic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 193 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 193 at risk

Adverse event: Neuropsychiatric
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 193 at risk

Adverse event: Reproductive
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 193 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 193 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 167 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 47 affected / 147 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 48 affected / 81 at risk

Adverse event: Difficulty swallowing
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 171 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 180 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 175 at risk

Adverse event: Change in menstrual symptoms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 43 affected / 71 at risk