Study: NCT03527589

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 487 at risk

Adverse event: Blood urine present
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 487 at risk

Adverse event: Dizziness upon walking
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 487 at risk

Adverse event: Dyspnea and congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 487 at risk

Adverse event: Emergency admission with abdominal pain and vomiting
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 487 at risk

Adverse event: False aneurysm at point of puncture
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 487 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 487 at risk

Adverse event: Prostatitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 487 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 487 at risk

Adverse event: Urinary tract infection and hypotension
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 487 at risk

Adverse event: Abdominal rigidity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 487 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 487 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 487 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 487 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 487 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 487 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 20 affected / 487 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 487 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 487 at risk

Adverse event: Pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 487 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 487 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 487 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 487 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 487 at risk

Adverse event: Bladder spasm
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 487 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 29 affected / 487 at risk

Adverse event: Contracted bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 487 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 487 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 487 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 487 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 31 affected / 487 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 487 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 487 at risk

Adverse event: Urinary catheterization
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 487 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 487 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 487 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 487 at risk

Adverse event: Haematospermia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 487 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 13 affected / 487 at risk

Adverse event: Penile pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 487 at risk

Adverse event: Rectoprostatic fistula
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 487 at risk

Adverse event: Penile ulceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 487 at risk