Study: NCT00195507

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 357 at risk

Adverse event: Abscess
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 357 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 357 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 357 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 357 at risk

Adverse event: Laboratory test abnormal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 357 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 357 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 357 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 357 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 357 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 357 at risk

Adverse event: Varicose vein
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 357 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 357 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Anorectal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Oedema
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 357 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 357 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 357 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 357 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 357 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 357 at risk

Adverse event: Nasal septum disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 357 at risk

Adverse event: Psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 357 at risk

Adverse event: Skin cancer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 357 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 357 at risk

Adverse event: Renal pain
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 357 at risk

Adverse event: Testicular disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 357 at risk

Adverse event: Unintended pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 357 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 357 at risk

Adverse event: Injury
Serious: no
Organ System: General disorders
Frequency: 28 affected / 357 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 27 affected / 357 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 26 affected / 357 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 37 affected / 357 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 63 affected / 357 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 22 affected / 357 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 21 affected / 357 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 25 affected / 357 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 357 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 357 at risk

Adverse event: Metabolic and nutritional
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 357 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 357 at risk

Adverse event: Nervousness
Serious: no
Organ System: Nervous system disorders
Frequency: 48 affected / 357 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 357 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 357 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 357 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 64 affected / 357 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 357 at risk

Adverse event: Special senses
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 29 affected / 357 at risk

Adverse event: Urogenital
Serious: no
Organ System: Renal and urinary disorders
Frequency: 20 affected / 357 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 363 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 363 at risk

Adverse event: Anaphylactoid reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 363 at risk

Adverse event: Back pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 363 at risk

Adverse event: Hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 363 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 363 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 363 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 363 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 363 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 363 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 363 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 363 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 363 at risk

Adverse event: Gastrointestinal carcinoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 363 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 363 at risk

Adverse event: Bone disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 363 at risk

Adverse event: Synovitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 363 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 363 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 363 at risk

Adverse event: Coordination abnormal
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 363 at risk

Adverse event: Speech disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 363 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 363 at risk

Adverse event: Erythema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 363 at risk

Adverse event: Psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 363 at risk

Adverse event: Skin cancer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 363 at risk

Adverse event: Abortion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 363 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 363 at risk

Adverse event: Unintended pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 363 at risk

Adverse event: Urogenital disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 363 at risk

Adverse event: Injury
Serious: no
Organ System: General disorders
Frequency: 33 affected / 363 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 363 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 363 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 34 affected / 363 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 47 affected / 363 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 21 affected / 363 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 24 affected / 363 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 17 affected / 363 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 363 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 363 at risk

Adverse event: Metabolic and nutritional
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 363 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 363 at risk

Adverse event: Nervousness
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 363 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 363 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 363 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 363 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 63 affected / 363 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 363 at risk

Adverse event: Special senses
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 20 affected / 363 at risk

Adverse event: Urogenital
Serious: no
Organ System: Renal and urinary disorders
Frequency: 27 affected / 363 at risk