Study: NCT01286207

Adverse event: Malignant melanoma
Serious: yes
Organ System: General disorders
Notes: Body as a whole/site unspecific (SOC)
Frequency: 1 affected / 711 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Notes: Body as a whole/site unspecific (SOC)
Frequency: 1 affected / 711 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 711 at risk

Adverse event: Rectocele
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 711 at risk

Adverse event: Neoplasm, thyroid, malignant
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 711 at risk

Adverse event: Fracture, hip, right
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 711 at risk

Adverse event: Pain, knee
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 711 at risk

Adverse event: Pain, neck
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 711 at risk

Adverse event: Trauma, cartilage
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 711 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 1 affected / 711 at risk

Adverse event: Depression
Serious: yes
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 1 affected / 711 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 1 affected / 711 at risk

Adverse event: Neoplasm, breast, malignant
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Urogenital System (SOC)
Frequency: 1 affected / 711 at risk

Adverse event: Neoplasm, uterine, benign
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Urogenital System (SOC)
Frequency: 1 affected / 711 at risk

Adverse event: Asthenia/fatigue
Serious: no
Organ System: General disorders
Notes: Body as a Whole/Site Unspecific (SOC)
Frequency: 70 affected / 711 at risk

Adverse event: Pain, abdominal
Serious: no
Organ System: General disorders
Notes: Body as a Whole/Site Unspecific (SOC)
Frequency: 24 affected / 711 at risk

Adverse event: Pain, chest
Serious: no
Organ System: General disorders
Notes: Body as a Whole/Site Unspecific (SOC)
Frequency: 34 affected / 711 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 711 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 117 affected / 711 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 711 at risk

Adverse event: Pain, back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 711 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 69 affected / 711 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 62 affected / 711 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 21 affected / 711 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 34 affected / 711 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 50 affected / 711 at risk

Adverse event: Infection, respiratory, upper
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 78 affected / 711 at risk

Adverse event: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 711 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 711 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 711 at risk

Adverse event: Pain, abdominal
Serious: yes
Organ System: General disorders
Notes: Body as a whole/site unspecific (SOC)
Frequency: 1 affected / 834 at risk

Adverse event: Pain, chest
Serious: yes
Organ System: General disorders
Notes: Body as a whole/site unspecific (SOC)
Frequency: 1 affected / 834 at risk

Adverse event: Embolism/infarction, pulmonary
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 834 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 834 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 834 at risk

Adverse event: Hemorrhage, anal/rectal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 834 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 834 at risk

Adverse event: Agranulocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 834 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 834 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Metabolic/Nutritional/Immune (SOC)
Frequency: 1 affected / 834 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Metabolic/Nutritional/Immune (SOC)
Frequency: 1 affected / 834 at risk

Adverse event: Fracture, elbow, right
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 834 at risk

Adverse event: Pain, back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 834 at risk

Adverse event: Pain, neck
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 834 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 1 affected / 834 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 3 affected / 834 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 834 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 834 at risk

Adverse event: Neoplasm, skin, malignant
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 834 at risk

Adverse event: Abortion
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Urogenital System (SOC)
Frequency: 1 affected / 834 at risk

Adverse event: Hypertrophy, uterine
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Urogenital System (SOC)
Frequency: 1 affected / 834 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Urogenital System (SOC)
Frequency: 1 affected / 834 at risk

Adverse event: Prostatitis
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Urogenital System (SOC)
Frequency: 1 affected / 834 at risk

Adverse event: Asthenia/fatigue
Serious: no
Organ System: General disorders
Notes: Body as a Whole/Site Unspecific (SOC)
Frequency: 111 affected / 834 at risk

Adverse event: Pain, abdominal
Serious: no
Organ System: General disorders
Notes: Body as a Whole/Site Unspecific (SOC)
Frequency: 27 affected / 834 at risk

Adverse event: Pain, chest
Serious: no
Organ System: General disorders
Notes: Body as a Whole/Site Unspecific (SOC)
Frequency: 61 affected / 834 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 834 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 178 affected / 834 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 72 affected / 834 at risk

Adverse event: Pain, back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 48 affected / 834 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 135 affected / 834 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 100 affected / 834 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 31 affected / 834 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 63 affected / 834 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 127 affected / 834 at risk

Adverse event: Infection, respiratory, upper
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 114 affected / 834 at risk

Adverse event: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 52 affected / 834 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 47 affected / 834 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 72 affected / 834 at risk

Adverse event: Hernia, inguinal
Serious: yes
Organ System: General disorders
Notes: Body as a whole/site unspecific (SOC)
Frequency: 1 affected / 334 at risk

Adverse event: Pain, abdominal
Serious: yes
Organ System: General disorders
Notes: Body as a whole/site unspecific (SOC)
Frequency: 2 affected / 334 at risk

Adverse event: Septicimea
Serious: yes
Organ System: General disorders
Notes: Body as a whole/site unspecific (SOC)
Frequency: 1 affected / 334 at risk

Adverse event: Surgery, abdominal
Serious: yes
Organ System: General disorders
Notes: Body as a whole/site unspecific (SOC)
Frequency: 1 affected / 334 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 334 at risk

Adverse event: Depression
Serious: yes
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 1 affected / 334 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 1 affected / 334 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 3 affected / 334 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Urogenital System (SOC)
Frequency: 1 affected / 334 at risk

Adverse event: Asthenia/fatigue
Serious: no
Organ System: General disorders
Notes: Body as a Whole/Site Unspecific (SOC)
Frequency: 44 affected / 334 at risk

Adverse event: Pain, abdominal
Serious: no
Organ System: General disorders
Notes: Body as a Whole/Site Unspecific (SOC)
Frequency: 18 affected / 334 at risk

Adverse event: Pain, chest
Serious: no
Organ System: General disorders
Notes: Body as a Whole/Site Unspecific (SOC)
Frequency: 28 affected / 334 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 334 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 86 affected / 334 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 334 at risk

Adverse event: Pain, back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 334 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 35 affected / 334 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 42 affected / 334 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 17 affected / 334 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 24 affected / 334 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Nervous System and Psychiatric (SOC)
Frequency: 30 affected / 334 at risk

Adverse event: Infection, respiratory, upper
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 334 at risk

Adverse event: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 334 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 334 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 334 at risk