Table 4 Classification of the correlation between adverse events and drugs

1. Definite

Use of the experimental drug has a definite relationship with time.

The event is consistent with the known adverse reactions of Chinese herbal medicine.

Adverse events disappear after drug withdrawal and reappear after repeated administration.

2. Probable

Use of the experimental drug has a reasonable relationship with time.

Adverse events are partially in line with the known adverse reactions of Chinese herbal medicine.

It is difficult to identify a cause owing to disease or other reasons.

3. Possible

Use of the experimental drug has a reasonable relationship with time.

Adverse events do not conform to adverse reactions of Chinese herbal medicine.

The adverse events are likely to be caused by diseases or other reasons.

4. Remote

There is a possible connection between time and experimental drug.

It is easily explained and verified through the disease or other reasons.

5. Unrelated

There is no connection between time and the test drug.

Adverse events are definitely caused by the disease or the main cause of the disease