Study: NCT02643849

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 107 at risk

Adverse event: Clostridium difficile toxin test positive and E. coli urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 107 at risk

Adverse event: Flank discomfort and dysuria
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 107 at risk

Adverse event: Intervertebral disc operation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Malignant and unspecified neoplasms gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: Hypotension and dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Shortness of breath and fever
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Fever, flu and mental state abnormal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Fatigue and fever
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Bacteriuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 25 affected / 107 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 107 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 107 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 107 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 107 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 107 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 107 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 107 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 107 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 107 at risk

Adverse event: Penile pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 107 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 107 at risk