Probable Sample Clauses

Probable. The temporal relationship of the clinical event to study treatment (drug related or device related) makes a causal relationship probable, and other drugs, therapeutic interventions or underlying conditions do not provide a definitive explanation for the observed event.

Probable. An adverse event that might be due to the use of the drug. The relationship in time is suggestive (e.g., confirmed by dechallenge). An alternative explanation is less likely, e.g., concomitant drug(s), concomitant disease(s). · Very likely An adverse event that is listed as a possible adverse reaction and cannot be reasonably explained by an alternative explanation, e.g., concomitant drug(s), concomitant disease(s). The relationship in time is very suggestive (e.g., it is confirmed by dechallenge and rechallenge).

Probable. The event follows a reasonable temporal sequence from the time of drug administration, and follows a known response pattern to the study drug. The event cannot be reasonably explained by other factors such as the participant’s clinical state, therapeutic interventions, or concomitant drugs.

Probable. The relationship with the use of the investigational device or comparator, or the relationship with procedures, seems relevant and/or the event cannot be reasonably explained by another cause.

Probable. There is a temporal coincidence between intake of study medication and occurrence of the adverse event. A contribution of the study medication is probable (e.g. due to the pharmacological properties of the study medication). Improvement or recovery is noted after withdrawal of study medication. Specific findings (e.g. positive allergy testing or antibodies against the study medication) definitely indicate a contribution by the study medication. NOT ASSESSABLE: The available information is insufficient to assess causality.