Study: NCT01151098

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Hernia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Angiopathy
Serious: yes
Organ System: Vascular disorders
Notes: Systematic and nonsystematic assessments
Frequency: 2 affected / 189 at risk

Adverse event: Cardiovascular disorder
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Pseudolymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Cachexia - Death
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: DEATH - Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 189 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Systematic and nonsystematic assessments
Frequency: 16 affected / 189 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 16 affected / 189 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Systematic and nonsystematic assessments
Frequency: 12 affected / 189 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 12 affected / 189 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Systematic and nonsystematic assessments
Frequency: 10 affected / 189 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 13 affected / 189 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 29 affected / 189 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Systematic and nonsystematic assessments
Frequency: 13 affected / 189 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 12 affected / 189 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 15 affected / 189 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 17 affected / 189 at risk

Adverse event: Erythema at site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 61 affected / 189 at risk

Adverse event: Pruritus at site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 42 affected / 189 at risk

Adverse event: Rash at site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 33 affected / 189 at risk

Adverse event: Other site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 17 affected / 189 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 10 affected / 189 at risk