Skip to main content

Table 5 Classification of adverse events

From: Efficacy and safety of Ban-Lan-Gen granules in the treatment of seasonal influenza: study protocol for a randomized controlled trial

Classification

Feature

1. Definite

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

Similar pharmacologic effects of the drug or experimental drug are well known.

There is no other plausible cause owing to disease or other explanations.

2. Probable

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

Similar pharmacologic effects of the drug or experimental drug are well known.

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

3. Possible

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

The adverse event may be caused by disease or other explanations.

4. Remote

There is a connection between time and test drug.

It is easy to explain through disease or the main causes of a disease.

5. Unrelated

There is no connection between time and the test drug.

The adverse event is definitely caused by other reasons, and not the test drug.