Table 1 Sepsis-related clinical events, possible side effects of the trial drug, and classification of severity of adverse events (AEs)

Sepsis-related clinical events

 ◦ Death caused by severe sepsis or septic shock

 ◦ Cardiovascular event requiring the administration of vasoactive substances

 ◦ Respiratory event: e.g. decrease in PaO2/FiO2 ratio, hypoxia, ARDS, acute pulmonary dysfunction, and mechanical ventilation

 ◦ Hepatic event: e.g. Liver failure or liver dysfunction

 ◦ Renal event: e.g. Kidney failure, renal insufficiency

 ◦ Haematological event: e.g. coagulopathy, thrombocytopaenia, thrombocytosis

 ◦ Neurological event: e.g. delirium, confusion

Possible side effects of the trial drug

 ◦ Flush

 ◦ Urticaria

 ◦ Fever

 ◦ Nausea

 ◦ Anaphylactic shock

 ◦ Hypervolaemia

 ◦ Pulmonary oedema

 ◦ Transmission of infection (in addition to sepsis, see corresponding section of the valid information brochure).

Classification of AEs according to severity

 ◦ Mild: a clinical symptom or sign that is well/easily tolerated and usually requires no intervention.

 ◦ Moderate: clinical symptom or sign sufficient to interfere with normal/daily activity, intervention may be required.

 ◦ Severe: a clinical symptom or sign that results in severe disability, inability to work or inability to perform everyday activities or daily activities/work not possible, treatment or intervention usually required.