Study: NCT00085631

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 101 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 101 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Pelvic pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 101 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 101 at risk

Adverse event: "Cardiac disorders - Other, specify: Valvular heart disease"
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 101 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 101 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 101 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 101 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 101 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 101 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 101 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 101 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 101 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: "Infections and infestations - Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Cervix"
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: "Infections and infestations - Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Vulva"
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 101 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 101 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 101 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 101 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 101 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 101 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 101 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 101 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 101 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 101 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 101 at risk

Adverse event: Urinary tract obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 101 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 101 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 101 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 101 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 101 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: "Skin and subcutaneous tissue disorders - Other, specify"
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 101 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 101 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 101 at risk