Study: NCT01166438

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 121 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 121 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 121 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 121 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 121 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 121 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 121 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 121 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 121 at risk

Adverse event: Any Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 121 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 12 affected / 121 at risk

Adverse event: Influenza-like illness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 121 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 34 affected / 121 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 121 at risk

Adverse event: Any General Disorders and Administration Site Conditions
Serious: no
Organ System: General disorders
Frequency: 49 affected / 121 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 28 affected / 121 at risk

Adverse event: Urine abnormality
Serious: no
Organ System: Renal and urinary disorders
Frequency: 17 affected / 121 at risk

Adverse event: Urine odour abnormal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 121 at risk

Adverse event: Any Renal and Urinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 49 affected / 121 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 32 affected / 121 at risk

Adverse event: Any Eye Disorders
Serious: no
Organ System: Eye disorders
Frequency: 34 affected / 121 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 121 at risk

Adverse event: Any Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 121 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 121 at risk

Adverse event: Any Musculoskeletal and Connective Tissue Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 121 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 121 at risk

Adverse event: Any Skin and Subcutaneous Tissue Disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 121 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 121 at risk

Adverse event: Any Immune System Disorders
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 121 at risk

Adverse event: Cardiac septal hypertrophy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 126 at risk

Adverse event: Endometrial adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 126 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 126 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 126 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 64 affected / 126 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 126 at risk

Adverse event: Any Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 74 affected / 126 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 12 affected / 126 at risk

Adverse event: Influenza-like illness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 126 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 36 affected / 126 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 126 at risk

Adverse event: Any General Disorders and Administration Site Conditions
Serious: no
Organ System: General disorders
Frequency: 41 affected / 126 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 23 affected / 126 at risk

Adverse event: Urine abnormality
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 126 at risk

Adverse event: Urine odour abnormal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 126 at risk

Adverse event: Any Renal and Urinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 38 affected / 126 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 31 affected / 126 at risk

Adverse event: Any Eye Disorders
Serious: no
Organ System: Eye disorders
Frequency: 31 affected / 126 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 126 at risk

Adverse event: Any Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 126 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 126 at risk

Adverse event: Any Musculoskeletal and Connective Tissue Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 126 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 126 at risk

Adverse event: Any Skin and Subcutaneous Tissue Disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 126 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Any Immune System Disorders
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 126 at risk