Table 4 Severity categories of adverse events
Severity | Description |
|---|---|
Mild | Event may be noticeable to patient; does not influence daily activities; usually does not require intervention |
Moderate | Event may be of sufficient severity to make patient uncomfortable; performance of daily activities may be influenced; intervention may be required |
Severe | Event may cause severe discomfort; usually interferes with daily activities; patient may not be able to continue in the study; treatment or other intervention usually required |
Serious | Results in death or life-threatening situation; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; or congenital anomaly/birth defect or important medical event |