Study: NCT03366220

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Ascending colon perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Congestive heart failure exacerbation/flash pulmonary edema
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Worsening acute kidney injury requiring continuous renal replacement therapy to be restarted
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Traumatic brain injury (tracheostomy & percutaneous endoscopic gastrostomy)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: atrial fibrillation requiring multiple cardioversions
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: acute renal failure requiring intermittent hemodialysis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Enterocutaneous fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: acute renal failure requiring continuous renal replacement therapy/intermittent hemodialysis
Serious: yes
Organ System: Renal and urinary disorders
Notes: (resolved)
Frequency: 1 affected / 4 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4 at risk

Adverse event: medication induced blindness
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Deep vein thrombosis with persistent anemia requiring inferior vena cava filter
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk

Adverse event: anemia requiring Inferior vena cava filter
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Chylothorax
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: multiple episodes of severe sepsis secondary to urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk