Table 1.
Safety reporting definitions.a
| Term | Definition |
|---|---|
| Adverse event (AE) | Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. |
| Adverse reaction | Any adverse event caused by a drug. |
| Suspected adverse reaction | Any AE for which there is a reasonable possibility that the drug caused the adverse event. For the purposes of investigational new drug (IND) safety reporting, “reasonable possibility” means there is evidence to suggest a causal relationship between the drug and the adverse event. A suspected adverse reaction implies a lesser degree of certainty than an adverse reaction. |
| Unexpected | An AE or suspected adverse reaction is considered “unexpected” if it is not listed in the investigator brochure, is not listed at the specificity or severity that has been observed, or, if an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended. |
| Anticipated | For the purposes of IND safety reporting, anticipated serious AEs are serious AEs that the sponsor can foresee occurring with some frequency, independent of investigational drug exposure, in the general patient population under study, in patients with the disease under study, or both. |
| Serious | An AE or suspected adverse reaction that results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. |
| Analysis of similar events | The sponsor must identify in each IND safety report all IND safety reports previously submitted to Food and Drug Administration (FDA) concerning a similar suspected adverse reaction and must analyze the significance of the suspected adverse reaction in light of previous, similar reports or any other relevant information. |