Table 2

Reportable adverse events

Adverse eventsSerious adverse events
Disease relatedCVC and renal replacement therapy (RRT) related
  • Death caused by underlying diseases (eg, severe sepsis/septic shock).

  • Cardiovascular events: aggravation of known congestive heart failure, new myocardial infarction after known acute myocardial infarction.

  • Neurological events: aggravation of intracerebral bleeding, rupture of known intracerebral aneurysm.

  • Respiratory events: deterioration of the Horowitz index, mechanical ventilation, hypoxia, ARDS, acute pulmonary dysfunction.

  • Hepatic events: liver failure or liver dysfunction with an acute increase in serum bilirubin from baseline.

  • Haematological events not related to anticoagulation method: DIC, thrombocytosis.

  • SIRS criteria: tachypnoea, hypopnoea, leucocytosis, hypothermia, hyperthermia, tachycardia or bradycardia.

  • CVC-related adverse events:

    • Haemorrhage at the site orCVC insertion with requiring of transfusion >1 unit of packed red blood cells and/or surgical intervention within 12 hours following insertion.

    • CVC-associated bloodstream infection (bacteraemia and culture-positive confirmation of the same organism from the dialysis catheter on removal).

    • Ultrasonographically confirmed thrombus attributed to CVC.

    • Pneumothorax (for catheters placed in the internal jugular or subclavian position).

    • Haemothorax (for catheters placed in the internal jugular or subclavian position).

    • Air embolism.

    • Inadvertent arterial puncture at time of CVC insertion.

  • RRT-associated hypotension: drop in blood pressure requiring

    • Initiation of vasopressor during RRT session.

    • Need to escalate dose of vasopressor during RRT session.

    • Premature discontinuation of RRT session.

    • Any other intervention to stabilise blood pressure.

  • Severe hypophosphataemia <0.5 mmol/L.

  • Severe hypokalaemia <3.0 mmol/L.

  • New arrhythmia developed during dialysis and was not present prior to dialysis:

    • Atrial arrhythmia (excluding sinus arrhythmia or sinus tachycardia).

    • Ventricular arrhythmia.

  • New onset of seizures (not present/known prior to dialysis).

  • Clinical results or typical events in connection with CVC or RRT, as defined above, if the investigator suspects a reasonable causal relationship to the investigational product.

  • All other serious adverse events, regardless of whether or not the investigator suspects a reasonable causal relationship to the investigational product.

  • ARDS, acute respiratory distress syndrome; CVC, central venous catheter; DIC, disseminated intravascular coagulation; SIRS, systemic inflammatory response syndrome.