Study: NCT01248065

Adverse event: Asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 207 at risk

Adverse event: Initial diagnosis of breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 207 at risk

Adverse event: Severe leg pain
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 207 at risk

Adverse event: Sigmoid diverticulitis with abscess
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Major depression disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 207 at risk

Adverse event: Allergic reaction/rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 207 at risk

Adverse event: Limb edema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 207 at risk

Adverse event: Diseases of the digestive system
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 207 at risk

Adverse event: Diseases of the genitourinary system
Serious: no
Organ System: Renal and urinary disorders
Frequency: 18 affected / 207 at risk

Adverse event: Diseases of the musculoskeletal system and connective tissue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 207 at risk

Adverse event: Diseases of the nervous system and sense organs
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 207 at risk

Adverse event: Diseases of the respiratory system
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 122 affected / 207 at risk

Adverse event: Infectious and parasitic diseases
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 207 at risk

Adverse event: Injury and poisoning
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 23 affected / 207 at risk

Adverse event: Symptoms, signs, and ill-defined conditions
Serious: no
Organ System: General disorders
Frequency: 60 affected / 207 at risk

Adverse event: Asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 201 at risk

Adverse event: Gastric volvulus causing gastric outlet obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 201 at risk

Adverse event: Post-traumatic stress disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 201 at risk

Adverse event: Benign fibroid tumor surgery
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 201 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 201 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 201 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 201 at risk

Adverse event: Diseases of the digestive system
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 201 at risk

Adverse event: Diseases of the genitourinary system
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 201 at risk

Adverse event: Diseases of the musculoskeletal system and connective tissue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 201 at risk

Adverse event: Diseases of the nervous system and sense organs
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 201 at risk

Adverse event: Diseases of the respiratory system
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 137 affected / 201 at risk

Adverse event: Infectious and parasitic diseases
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 201 at risk

Adverse event: Injury and poisoning
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 28 affected / 201 at risk

Adverse event: Symptoms, signs, and ill-defined conditions
Serious: no
Organ System: General disorders
Frequency: 59 affected / 201 at risk