Study: NCT02943070

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject had preexisting Congestive Heart Failure which deteriorated into symptomatic pulmonary edema, subject was hospitalized and treated.
Frequency: 1 affected / 50 at risk

Adverse event: Cardiac Event
Serious: yes
Organ System: Cardiac disorders
Notes: Subject with medical history of Hypertension, arrhythmia and diabetes, experienced a myocardial infarction and was hospitalized. A percutaneous transluminal coronary angiogram was done and subject was discharged home.
Frequency: 1 affected / 50 at risk

Adverse event: Pain/Discomfort - Pelvic
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Subject reported pain and discomfort in his right hip, and was hospitalized for a surgical revision of right hip endoprothesis coxae due to pain, and restricted, limited motion. The event was resolved after the revision procedure.
Frequency: 1 affected / 50 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Notes: Due to worsening urinary retention subject underwent TURP.
Frequency: 3 affected / 50 at risk

Adverse event: Pollakiuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: At one month follow up catheter was removed and subject voided, but later that day had a re-catheterization due to to urinary retention. Subject underwent cystoscopy and a prostatic median lobe was identified. Subject then had a TURP procedure.
Frequency: 1 affected / 50 at risk

Adverse event: Weakness or Fatigue
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The subject reported having fatigue, weakness and diarrhea, and was hospitalized. The subject was diagnosed with Salmonella enteritis and treated with antibiotics.
Frequency: 1 affected / 50 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The subject reported having fatigue, weakness and diarrhea, and was hospitalized. The subject was diagnosed with Salmonella enteritis and treated with antibiotics.
Frequency: 1 affected / 50 at risk

Adverse event: Cancer -Other
Serious: yes
Organ System: Renal and urinary disorders
Notes: The subject reported undergoing a routine preventive colonoscopy and a tumor of the hepatic flexure in the colon was detected. Subject had a right hemi colectomy performed.
Frequency: 1 affected / 50 at risk

Adverse event: Urinary Tract Infection-Proven
Serious: yes
Organ System: Renal and urinary disorders
Notes: Subject reported sudden onset of fever (40C) and voided grayish appearing material. Subject hospitalized and was diagnosed with urosepsis. Subject was treated with Ciprofloxacin and event resolved.
Frequency: 1 affected / 50 at risk

Adverse event: Poor Stream
Serious: yes
Organ System: Renal and urinary disorders
Notes: At one month follow up catheter was removed and subject voided, but later that day had a re-catheterization due to to urinary retention. Subject underwent cystoscopy and a prostatic median lobe was identified. Subject then had a TURP procedure.
Frequency: 1 affected / 50 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: 002-005: Pain/Discomfort-Pelvic; R hip prosthesis revision; Gonarthrosis-subject underwent planned implantation of left knee endoptrothesis.

002-008: L arm pain (surgical repair of joint); Death due to previously unreported metastatic cancer
Frequency: 2 affected / 50 at risk

Adverse event: Infection Other than UTI
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 50 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 50 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 50 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 4 affected / 50 at risk

Adverse event: Poor Stream
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 50 at risk

Adverse event: UTI - Suspected
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 50 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 50 at risk

Adverse event: Pain/Discomfort
Serious: no
Organ System: General disorders
Frequency: 7 affected / 50 at risk

Adverse event: Hematuria - Gross
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 50 at risk

Adverse event: Urinary Incontinence - Urge
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 50 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 50 at risk

Adverse event: Urinary hesitation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 50 at risk

Adverse event: Pain/Discomfort - Pelvic
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Urethral Secretion w/o Hematuria or Stones
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 50 at risk

Adverse event: Pain/Discomfort with Scrotum
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 50 at risk

Adverse event: Abdominal Bloating with Gas
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Bladder Spasms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cancer - Prostate
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Epididymitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Injury - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain/Discomfort - Back
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain/Discomfort - Perineum
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Prostatic Cyst De Novo
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Terminal dribbling
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Urinary Incontinence - Not Specified
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk