Table 1 Classification of adverse events [14, 29]

Mild

Asymptomatic or mild symptoms, requiring self-care only to alleviate symptoms (e.g. ice/heat, over-the-counter analgesic).

Moderate

Limiting age-appropriate activities of daily living (e.g. work, school) OR sought care from a medical doctor.

Severe

Medically significant but not immediately life-threatening; temporarily limits self-care (e.g. bathing, dressing, eating); OR urgent or emergency room assessment sought.

Serious

Results in death OR a life-threatening adverse event OR an adverse event resulting in inpatient hospitalization or prolongation of existing hospitalization for more than 24 h; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.

Indirect harms

The use of intervention may cause a delay in diagnosis or treatment and the delay itself carries the potential harm.