Relationship to Study Drug. Relationship to Drug Comment Definitely Previously known toxicity of agent; or an event that follows a reasonable temporal sequence from administration of the drug; that follows a known or expected response pattern to the suspected drug; that is confirmed by stopping or reducing the dosage of the drug; and that is not explained by any other reasonable hypothesis. Probably An event that follows a reasonable temporal sequence from administration of the drug; that follows a known or expected response pattern to the suspected drug; that is confirmed by stopping or reducing the dosage of the drug; and that is unlikely to be explained by the known characteristics of the subject’s clinical state or by other interventions. Possibly An event that follows a reasonable temporal sequence from administration of the drug; that follows a known or expected response pattern to that suspected drug; but that could readily have been produced by a number of other factors. Unrelated An event that can be determined with certainty to have no relationship to the study drug.
Relationship to Study Drug. The relationship of an AE to the study drug should be assessed using the following the guidelines in Table 2.
Relationship to Study Drug. An investigator who is qualified in medicine must make the determination of relationship to the investigational product, when appropriate, for each AE (unrelated, possibly related or probably related). The investigator should decide whether, in his or her medical judgment, there is a reasonable possibility that the event may have been caused by the investigational product. If no valid reason exists for suggesting a relationship, then the AE should be classified as “unrelated.” If there is any valid reason, even if undetermined, for suspecting a possible cause and effect relationship between the investigational product and the occurrence of the AE, then the AE should be considered “related.” If the relationship between the AE/SAE and the investigational product is determined to be “possible” or “probable” the event will be considered to be related to the investigational product for the purposes of expedited regulatory reporting.
Relationship to Study Drug. An Investigator who is qualified in medicine must make the determination of relationship to the investigational product for each adverse event (not related, possibly related or probably related). The Investigator should decide whether, in his or her medical judgment, there is a reasonable possibility that the event may have been caused by the investigational product. If no valid reason exists for suggesting a relationship, then the adverse event should be classified as “not related.” If there is any valid reason, even if undetermined, for suspecting a possible cause-and-effect relationship between the investigational product and the occurrence of the adverse event, then the adverse event should be considered “related.” Not Related: No relationship between the experience and the administration of study drug; related to other etiologies such as concomitant medications or subject’s clinical state. Possibly Related: A reaction that follows a plausible temporal sequence from administration of the study drug and follows a known response pattern to the suspected study drug. The reaction might have been produced by the subject’s clinical state or other modes of therapy administered to the subject, but this is not known for sure. Probably Related: A reaction that follows a plausible temporal sequence from administration of the study drug and follows a known response pattern to the suspected study drug. The reaction cannot be reasonably explained by the known characteristics of the subject’s clinical state or other modes of therapy administered to the subject. If the relationship between the adverse event/serious adverse event and the investigational product is determined to be “possible” or “probable”, the event will be considered to be related to the investigational product for the purposes of expedited regulatory reporting.
Relationship to Study Drug. The investigator will determine if there is a reasonable causal relationship between the study medication and an AE or not. The investigator will use her/his best medical judgment and consider all relevant factors (e.g., temporal relationship, location of the event, the subject’s relevant medical history, concomitant therapies and concurrent conditions) to determine the relationship of the AE to the study medication. The investigator will define the relationship of an AE to the study medication by selecting one of the following categories: Related – There is a reasonable possibility that there is a causal relationship between the study medication and the AE. Not Related – There is not a reasonable possibility that there is a causal relationship between the study medication and the AE.
