Definitions of adverse events and safety outcomes
| Label | Description |
| Serious Adverse Events (SAE) | Hyperglycaemia: Blood glucose >300 mg/dL or new insulin infusion occurring in the first 120 hours after enrolment. Hypernatraemia: Serum sodium (>150 mmol/L) occurring in the first 120 hours after enrolment. New Infection: As determined by the site principal investigator at each site. Should be a new organism or site of infection and believed to be unrelated to the initial presenting infectious source. Many will have the initiation of new antibiotics or a change in antibiotics. Serious allergic reaction: Anaphylaxis or other allergic reaction requiring systemic corticosteroids. Renal calculus: Development of a renal calculus between enrolment and 30-day follow-up. Others/unexpected: Any other SAE possibly related to study drug or study participation. |
| Related to Study? | Definitely related: No other potential cause of SAE is identified. Investigator certain or near certain the hyperglycaemia is related to study drug. Possibly related: Other potential causes of SAE exist. There is at least a 50% chance the hyperglycaemia is related to the study drug. Unlikely related: A clear alternative reason for SAE exists. The investigators believe that there is a <50% change the SAE is related to study drug. |
| Other SAE severity grading | Grade I: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade II: Moderate; minimal, local or noninvasive intervention indicated. Grade III: Severe or medically significant BUT not immediately life-threatening. Grade IV: Life-threatening consequences; urgent intervention indicated. Grade V: Death related to adverse event. |
The following definitions will be used:.
Adverse event: any untoward medical occurrence in a participant to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment.
SAE: any untoward medical occurrence that at any dose requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, results in a congenital anomaly or birth defect, is life-threatening, or results in death.
Suspected unexpected serious adverse event: a serious adverse reaction, the nature, severity or outcome of which is not consistent with the reference safety information.