Study: NCT00660010

Adverse event: Adverse reaction
Serious: yes
Organ System: General disorders
Notes: COSTART body system is body as a whole
Frequency: 1 affected / 55 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: COSTART body system is body as a whole
Frequency: 1 affected / 55 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: COSTART body system is body as a whole
Frequency: 1 affected / 55 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: COSTART body system is cardiovascular system
Frequency: 1 affected / 55 at risk

Adverse event: Bone disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: COSTART body system is musculoskeletal system
Frequency: 1 affected / 55 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: COSTART body system is musculoskeletal system
Frequency: 1 affected / 55 at risk

Adverse event: Personality disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: COSTART body system is nervous system
Frequency: 1 affected / 55 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: COSTART body system is respiratory system
Frequency: 1 affected / 55 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: COSTART body system is respiratory system
Frequency: 1 affected / 55 at risk

Adverse event: Repair of ventriculoperitoneal shunt
Serious: yes
Organ System: Surgical and medical procedures
Notes: COSTART body system was not classified since it was a surgical repair.
Frequency: 1 affected / 55 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: COSTART body system is body as a whole
Frequency: 16 affected / 55 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: COSTART body system is body as a whole
Frequency: 16 affected / 55 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: COSTART body system is body as a whole
Frequency: 6 affected / 55 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: COSTART body system is body as a whole
Frequency: 6 affected / 55 at risk

Adverse event: Skin odour abnormal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: COSTART body system is body as a whole
Frequency: 3 affected / 55 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: COSTART body system is body as a whole
Frequency: 14 affected / 55 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: COSTART body system is body as a whole
Frequency: 19 affected / 55 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: COSTART body system is body as a whole
Frequency: 25 affected / 55 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: COSTART body system is body as a whole
Frequency: 13 affected / 55 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: COSTART body system is body as a whole
Frequency: 8 affected / 55 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: COSTART body system is body as a whole
Frequency: 3 affected / 55 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: COSTART body system is body as a whole
Frequency: 12 affected / 55 at risk

Adverse event: Unevaluable event
Serious: no
Organ System: General disorders
Notes: COSTART body system is body as a whole
Frequency: 5 affected / 55 at risk

Adverse event: Vasodilatation
Serious: no
Organ System: Vascular disorders
Notes: COSTART body system is cardiovascular system
Frequency: 6 affected / 55 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: COSTART body system is digestive system
Frequency: 9 affected / 55 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: COSTART body system is digestive system
Frequency: 5 affected / 55 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: COSTART body system is digestive system
Frequency: 5 affected / 55 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: COSTART body system is digestive system
Frequency: 7 affected / 55 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: COSTART body system is digestive system
Frequency: 13 affected / 55 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: COSTART body system is hemic and lymphatic system
Frequency: 3 affected / 55 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: COSTART body system is metabolic and nutritional disorders
Frequency: 4 affected / 55 at risk

Adverse event: Growth retardation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: COSTART body system is metabolic and nutritional disorders
Frequency: 6 affected / 55 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: COSTART body system is metabolic and nutritional disorders
Frequency: 9 affected / 55 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: COSTART body system is metabolic and nutritional disorders
Frequency: 3 affected / 55 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: COSTART body system is musculoskeletal system
Frequency: 3 affected / 55 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: COSTART body system is musculoskeletal system
Frequency: 4 affected / 55 at risk

Adverse event: Pathological fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: COSTART body system is musculoskeletal system
Frequency: 4 affected / 55 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: COSTART body system is nervous system
Frequency: 3 affected / 55 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: COSTART body system is nervous system
Frequency: 4 affected / 55 at risk

Adverse event: Affect lability
Serious: no
Organ System: Psychiatric disorders
Notes: COSTART body system is nervous system
Frequency: 15 affected / 55 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Notes: COSTART body system is nervous system
Frequency: 4 affected / 55 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: COSTART body system is respiratory system
Frequency: 17 affected / 55 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: COSTART body system is respiratory system
Frequency: 6 affected / 55 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: COSTART body system is respiratory system
Frequency: 29 affected / 55 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: COSTART body system is respiratory system
Frequency: 14 affected / 55 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: COSTART body system is respiratory system
Frequency: 11 affected / 55 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: COSTART body system is skin and appendages
Frequency: 15 affected / 55 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: COSTART body system is skin and appendages
Frequency: 8 affected / 55 at risk

Adverse event: Hirsutism
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: COSTART body system is skin and appendages
Frequency: 3 affected / 55 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: COSTART body system is skin and appendages
Frequency: 3 affected / 55 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: COSTART body system is skin and appendages
Frequency: 18 affected / 55 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: COSTART body system is skin and appendages
Frequency: 6 affected / 55 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: COSTART body system is skin and appendages
Frequency: 4 affected / 55 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: COSTART body system is special senses
Frequency: 4 affected / 55 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Notes: COSTART body system is special senses
Frequency: 3 affected / 55 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: COSTART body system is special senses
Frequency: 15 affected / 55 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: COSTART body system is urogenital system
Frequency: 4 affected / 55 at risk

Adverse event: Menstrual disorder
Serious: no
Organ System: Reproductive system and breast disorders
Notes: COSTART body system is urogenital system
Frequency: 3 affected / 55 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: COSTART body system is urogenital system
Frequency: 4 affected / 55 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Notes: COSTART body system is urogenital system
Frequency: 11 affected / 55 at risk