|
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.
|
