DEFINITE. Whenever used in this Agreement, the following terms shall have the meaning ascribed to them below :
DEFINITE. The temporal relationship of the clinical event to study treatment (drug related or device related) makes a causal relationship definite, and other drugs, therapeutic interventions or underlying conditions can provide a definitive explanation for the observed event.
DEFINITE must be certain and clear, not vague or speculative so that the liability (or rights) of the parties may be exactly fixed because it is necessary that the acceptance be identical with the offer to create a contract without any further act on the part of the offeror (De Xxxx, 511);
DEFINITE. An AE that follows a reasonable temporal sequence from administration of a marketed drug (including the course after withdrawal of the drug) and that satisfies any of the following: • Reappearance of a similar reaction by repeated exposure (rechallenge) • Positive results in drug sensitivity tests (skin test, etc.) • Toxic level of the drug revealed by measurement of drug concentrations in blood or another bodily fluid Probable An AE that follows a reasonable temporal sequence from administration of the drug (including the course after withdrawal of the drug) and for which involvement of factors other than the drug, such as underlying diseases, complications, concomitant drugs or concurrent treatments, can reasonably be excluded. Possible An AE that follows a reasonable temporal sequence from administration of the drug (including the course after withdrawal of the drug) and for which possible involvement of the drug can be argued*, although factors other than the drug, such as underlying diseases, complications, concomitant drugs or concurrent treatments, may also be responsible. * For example, there have been similar reports in the past, including reports on its analogues, or the occurrence of the event could be predicted from the pharmacological actions/chemical structure of the drug. Not related An AE that does not follow a reasonable temporal sequence from administration of the drug or that can be reasonably explained by other factors, including underlying diseases, complications, concomitant drugs or concurrent treatments. Lack of data Lack of data, such as temporal sequence of an AE from administration of the drug (including the course after withdrawal of the drug), underlying diseases, complications, concomitant drugs or concurrent treatments, considered necessary for evaluation. As regards the causal relationship between an investigational drug and an adverse event, assessment shall be made using a four-category (Definite, Probable, Possible or Not Related) system. Attachment 3 Causal Relationship Between an AE and a Marketed Drug YES Terms such as possibly, probably, definitely, or most likely will be interpreted and reported as “possibly related.” NO Terms such as remotely, unlikely, doubtfully related, will be interpreted and reported as “not related.” Unassessed (or Unknown) The reporter’s assessment is actively sought in each case, however, where not provided, or unknown, the general principle of suspected causality by the reporter is adopted ...
DEFINITE. The event follows a reasonable temporal sequence from the time of drug administration, follows a known response pattern to the study drug, cannot be reasonably explained by other factors such as the participant’s condition, therapeutic interventions, or concomitant drugs, AND occurs immediately following study drug administration, improves upon stopping the drug, or reappears on re-exposure.
DEFINITE. There is a clinically plausible time sequence between the onset of the AE and the administration of investigational product; when the event responds to withdrawal of investigational product and/or recurs with re-administration of investigational product • Probable: There is a clinically plausible time sequence between the onset of the AE and the administration of investigational product; the AE is unlikely to be caused by the concurrent/underlying illness, other drugs or procedures • Possible: There may or may not be a clinically plausible time sequence between the onset of the AE and the administration of investigational product and a cause cannot be ruled out • Unrelated: There is not a temporal or causal relationship to investigational product administration
