Study: NCT00760513

Adverse event: Anaemia and disorientation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: cellulitis on right lateral malleolus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: severe chest pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Tonsillectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 51 at risk

Adverse event: dermatological disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 51 at risk

Adverse event: Nausea and vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 51 at risk

Adverse event: anxiety and depression
Serious: no
Organ System: General disorders
Frequency: 4 affected / 51 at risk

Adverse event: asthma and breathing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: back pain and sciatica
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 51 at risk

Adverse event: urological disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 51 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 51 at risk

Adverse event: chest pain and ecg alterations
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 51 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 51 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 51 at risk

Adverse event: fall and fracture
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: fertility problems
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 51 at risk

Adverse event: Fibromyalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: flu, cough and sore throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 51 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 51 at risk

Adverse event: gynecological disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 51 at risk

Adverse event: headache and dizziness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 51 at risk

Adverse event: hyperglycaemia & hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 51 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 5 affected / 51 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 51 at risk

Adverse event: knee surgery
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 51 at risk

Adverse event: Biopsy liver
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 51 at risk

Adverse event: neurological disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 51 at risk

Adverse event: onset diabetes
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 51 at risk

Adverse event: other drug overdose
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 51 at risk

Adverse event: other drug reaction
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 51 at risk

Adverse event: otolaryngological disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 10 affected / 51 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 51 at risk

Adverse event: proctological disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Seminoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 52 at risk

Adverse event: Acute asthma attack
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: stabilisation of her diabetes
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 52 at risk

Adverse event: Laparoscopy and appendectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 52 at risk

Adverse event: chest pain radiating to the neck with tingling to left arm
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Adhesiolysis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 52 at risk

Adverse event: elective hysterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 52 at risk

Adverse event: removal of myxoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 52 at risk

Adverse event: dermatological disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 52 at risk

Adverse event: Nausea and vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 52 at risk

Adverse event: accidental fall
Serious: no
Organ System: General disorders
Frequency: 2 affected / 52 at risk

Adverse event: achile's heel and foot problems
Serious: no
Organ System: General disorders
Frequency: 2 affected / 52 at risk

Adverse event: anxiety and depression
Serious: no
Organ System: General disorders
Frequency: 2 affected / 52 at risk

Adverse event: back pain and sciatica
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 52 at risk

Adverse event: carpal disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: urological disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 52 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 52 at risk

Adverse event: chest pain and ecg alterations
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 52 at risk

Adverse event: dental disorders
Serious: no
Organ System: General disorders
Frequency: 2 affected / 52 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 52 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 52 at risk

Adverse event: flu, cough and sore throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 52 at risk

Adverse event: fluid retention and oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 52 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 52 at risk

Adverse event: gynecological disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 52 at risk

Adverse event: headache and dizziness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 52 at risk

Adverse event: hepatological disorder
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 52 at risk

Adverse event: hyperglycaemia & hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 52 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 52 at risk

Adverse event: onset diabetes
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 52 at risk

Adverse event: ophtalmological disorders
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 52 at risk

Adverse event: orthopedic disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: otolaryngological disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 52 at risk

Adverse event: proctological disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 52 at risk