Table 3 Classification of disease severity
Classification | Features |
|---|---|
1. Mild | Participants can continue to participate in the trial without medical treatment and impact on the health. |
2. Moderate | Participants could not tolerate the drug or need medical treatment. Such events partially affect the participants’ functional activity without threat to life safety. |
3. Severe | The events pose threat the life of participants, leading to death or disability, which requires immediate withdrawal of medicine or emergency monitoring treatment. |