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Table 1 Adverse events reported day 1 to 7 in the ICU

From: Detailed statistical analysis plan for the target temperature management after out-of-hospital cardiac arrest trial

Adverse event

Definition

Renal replacement therapy

Continuous or intermittent

Seizures

Myoclonic and tonic-clonic

Bleeding

Uncontrolled bleeding (defined as the need for transfusion with 1 unit of blood per 10 kg/h), intracranial, intraspinal, intraocular, intra-articular, pericardial, gastrointestinal, tracheal, oral cavity, nose, genital, and bleeding from insertion sites

Infection

Pneumonia, severe sepsis, septic shock, and other serious infection

Cardiac arrhythmia

Atrial fibrillation, atrial flutter, tachycardia, bradycardia, ventricular tachycardia, ventricular fibrillation, and cardiac arrest mandating cardiopulmonary resuscitation (CPR)

Electrolyte and metabolic disorders

Hypokalemia (<3.0 mmol/L), hypomagnesemia (<0.7 mmol/L), hypophosphatemia (<0.7 mmol/L), and hypoglycemia (<3.0 mmol/L)