Definition: This is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization (>24 hours), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.
Reporting: All SAEs must be reported by fax or email to Dr. Siskin (fax: 518-262-4210; e-mail: sisking@mail.amc.edu) by the investigator within 24 hours of the first awareness of the event. An initial SAE CRF must be completed as soon as possible. Copies of all relevant hospital records, lab and imaging reports, discharge summaries, notes, and other materials relating to the SAE should be forwarded to Dr. Siskin as well. The investigator must also report any SAE to the IRB. The patient should be observed and monitored carefully until the condition resolves or stabilizes or its cause is defined.
Assessment: Investigators are required to assess whether there is a reasonable possibility that the product and/or procedure being evaluated in this clinical trial caused or contributed to an SAE. A determination of whether there is a reasonable possibility that a product or procedure caused or contributed to the SAE includes assessing temporal relationships, biologic plausibility, association (or lack of association) with underlying disease, and presence (or absence) or a more likely cause. We will be asking you to the determine the relationship of the SAE to the study treatment by selecting one of the following:
- Not Related: Exposure to the investigational product or procedure has not occurred, OR the occurrence of the adverse event is not reasonably related in time, OR the AE is considered unlikely to be related to the investigational product or procedure (biologically implausible).
- Remote: The investigational product or procedure, and the AE are considered reasonably related in time AND the AE could also be explained by causes other than the exposure to the investigational product or procedure (concurrent illness/underlying disease, other drugs or procedures).
- Possible: Exposure to the investigational product or procedure and the adverse event are reasonably related in time AND the investigational product or procedure is more likely than other causes to be responsible for the adverse event, OR is the most likely cause of the adverse event.
- Definite: Exposure to the investigational product or procedure is clearly determined to be the cause of the adverse event.
Follow-Up: An SAE must be followed up after the initial report has been sent to Dr. Siskin until it is resolved or a stable clinical endpoint is reached. Follow-up may include further investigation as medically indicated to identify the nature and/or cause of the adverse event. An updated SAE CRF should be completed, including all missing information from the initial report, as appropriate. Any information from the initial report that is no longer accurate should be updated on the CRF. In addition, new/updated copies of any relevant hospital records, labs, imaging reports, discharge summaries, or comments on the status of these documents should be included in a follow-up report. All patients who withdraw from the study due to an SAE will be followed up until the effects of the adverse event are resolved or until a stable clinical endpoint is reached. If appropriate, subjects who withdraw prior to completion of the study due to an SAE will be asked to complete the UFS-QoL questionnaire at the time of their final visit.