Unlikely Related definition
Unlikely Related. This relationship suggests that the temporal sequence of the event with study drug administration makes a causal relationship improbable and/or other factors also provide plausible explanations.
Unlikely Related. This category applies to an AE that could reasonably be considered caused by something else, and where there is no known or expected response pattern to the suspected study drug.
Unlikely Related. A potential relationship between study drug and the AE could exist (ie, the possibility cannot be excluded), but the AE is most likely explained by causes other than the study drug (eg, could readily have been produced by the subject’s clinical state or could have been due to environmental or other interventions). • Not Related: The AE is clearly due to extraneous causes (eg, underlying disease, environment) or exposure to the study drug has not occurred. Such events MUST have an alternative, definitive etiology documented in the subject’s medical record.
Examples of Unlikely Related in a sentence
Unlikely Related A clinical event, including laboratory test abnormality, with a temporal relationship to study drug administration which makes a causal relationship improbable, and in which other drugs, chemicals or underlying disease provide plausible explanations.
More Definitions of Unlikely Related
Unlikely Related. The AE is most likely due to a non-study drug-related cause. Unrelated: Another cause of the AE is most plausible and a clinically plausible temporal sequence is inconsistent with the onset of the AE and study drug administration and/or a causal relationship is considered biologically implausible.