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. |