Table 5 Determining the relationship between adverse events and the study drug
Relationship | Description |
|---|---|
Certain | An adverse event, including laboratory test abnormality, occurring in a plausible time relationship to drug administration, which cannot be explained by concurrent disease or other drugs or chemicals |
Probable/likely | An adverse event, including laboratory test abnormality, with a reasonable time sequence to administration of the drug that is unlikely to be attributed to a plausible response on withdrawal |
Possible | An adverse event, including laboratory test abnormality, with a reasonable time sequence to administration of the drug, which could also be explained by concurrent disease or other drugs or chemicals. Information on drug withdrawal may be lacking or unclear |
Unlikely | An adverse event, including laboratory test abnormality, with a temporal relationship to drug administration which makes a causal relationship improbable, in which other drugs, chemicals, or underlying disease provide plausible explanations |
Not related | An adverse event which is judged to be clearly due to extraneous causes (e.g., disease and environment) |