Table 3 Adverse events classification

 Mild

An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities

 Moderate

An event that causes sufficient discomfort as to interfere with normal everyday activities

 Severe

An event that prevents normal everyday activities

 Serious

Any untoward medical occurrence that:

o Results in death

o Is life threating (an event in which the subject was at risk of death at the time of the event)

o Requires hospitalization or prolongation of an existing hospitalization

o Results in disability or permanent damage as defined as a substantial disruption of a person’s ability to conduct normal life functions

o Is a congenital anomaly/birth defect

o Other adverse events that may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes

 Unrelated

Where an event is not considered related to the investigational medicinal product

 Unlikely

Although the relationship to investigational medicinal product cannot be completely ruled out, the nature of the event, the underlying disease, concomitant medication or temporal relationship make other explanations more likely

 Possibly related

The temporal relationship and the absence of a more likely explanation suggest the event could be related to the investigational medicinal product

 Probably related

The known effects of the investigational medicinal product or its therapeutic class, or based on challenge testing, suggest the investigational medicinal product is the most likely cause

 Definitely related

This category applies to those AEs that are clearly a consequence of administration of the drug. It is likely that such events will be widely documented and generally accepted as having association with the study medication.