Table 1 Definitions of terminology for study protocol [20]
Adverse event (AE) | Any unfavorable sign, symptom or disease temporally associated with the treatment, whether or not caused by the treatment. Specifically, any new symptom of moderate severity or a pre-existing symptom that is worse after treatment |
Seriousness | Mild: asymptomatic or mild symptoms, self-care only (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 physician | |
Severe: medically significant but not immediately life-threatening; temporarily limits self-care (e.g., bathing, dressing, eating) (for 5 years of age and older); 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; a congenital anomaly/birth defect | |
Causality (i.e., relatedness) | Certain: a clinical event occurring in a plausible time relationship to treatment, and which cannot be explained by concurrent disease or other drugs or therapies |
Probable/likely: a clinical event with a reasonable time sequence to treatment, unlikely to be attributed to concurrent disease or other drugs or therapies | |
Possible: a clinical event with a reasonable time sequence to treatment, but which could also be explained by concurrent disease or other drugs or therapies | |
Unlikely: a clinical event with a temporal relationship to treatment which makes a causal relationship improbable, and in which drugs, other therapies or underlying disease provide plausible explanations | |
Preventability | 1: Virtually no evidence of preventability |
2: Slight to modest evidence of preventability | |
3: Preventability not quite likely (less than 50/50, but “close call”) | |
4: Preventability more than likely (more than 50/50, but “close call”) | |
5: Strong evidence of preventability | |
6: Virtually certain evidence of preventability | |
Patient disposition | 1: Resolved, no sequelae |
2: AE still present – no treatment | |
3: AE still present – being treated | |
4: Residual effects present – no treatment | |
5: Residual effects present – treated | |
6: Death | |
7: Unknown |