Serious adverse event

The nurse encourages the parents or guardians to report any adverse reactions or serious adverse events occurring after administration of a vaccine It may be necessary to report the event to VAERS. 

Report SERIOUS adverse events. An event is serious when the patient outcome is ... 

If your report Involves a serious adverse event With a device and It occurred in a facility outside a doctor s office, that facility may be legally required to report to FDA and/or the manufacturer. Please notify the person in that facility who would handle such reporting. 

The USP Practitioners Reporting Network is a partner in mf.dWatcm, the FDA s medical products reporting program. As a partner, USP PRN contributes to the FDA s efforts to protect the public health by helping to identify serious adverse events for the agency. This means that your reported information is shared with the FDA on a daily basis, or immediately if necessary. 

Please detail how safety data will be collected. Safety data should be collected according to the definitions of an adverse event and a serious adverse event as outlined in ICHE2A... 

PROCEDURES FOR MONITORING AND RECORDING ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS... 

Notification by originating investigator to sponsor of serious adverse events and related reports... 

Aleatory uncertainty —the roll of the die—describes risks that cannot practicably be predicted within the research process, for example, new failure modes, or modes that can only be detected in late stages of work, for example, humans. An example of aleatory uncertainty is the withdrawal in the UK of Bextra on the basis of two serious adverse events out of 40,000 patients this could only be discovered after launch [2]. This, without hindsight, was an uncontrollable risk. ... 

Just as there is an adverse event form, there is usually a serious adverse event (SAE) form. Note here that serious as defined by the FDA is different from severe on the adverse event form. A patient can have a severe headache that may not be considered serious. The ICH guideline (also in ICH E3) entitled Clinical Safety Data Management Definitions and Standards for Expedited Reporting defines serious adverse events as follows ... 

A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. 

Usually a separate CRF is used to capture serious adverse events, as those must be reported to the FDA within 24 hours. That often means that the serious adverse events CRF data and the regular trial CRF adverse events are collected in different data tables, if not entirely different software systems. Pharmaceutical companies often want to reconcile the two databases to ensure that all serious adverse events appear in the regular-trial CRF adverse events database and that any event in the serious adverse events database is flagged properly as serious in the regular CRF adverse events database. 

The problem is that the regular-trial adverse events database and the serious adverse events database do not join well if at all programmatically. You can attempt to join or merge the two databases by event start date and coded term, and that will join many regular-trial adverse events to the serious events. However, this is far from foolproof, because of mismatches in adverse event start dates and because the adverse events may have been coded slightly differently in the two systems. The best way to link the serious adverse events and adverse events databases is to have the clinical data management system create a linking variable key for you. In lieu of that, the only way to reliably link the two data sources is manually. 

A large open-label flexible dose study (Sanchez-Lacay etal, 2001) utilizing nefa-zodone in the treatment of major depression in a predominantly monolingual, Hispanic Caribbean population (Dominican Republic, Puerto Rico, and Cuba) revealed similar response rates and an endpoint mean dosage when compared to previous nefazodone trials with non-Hispanic patients. No serious adverse events were reported, but 42% of the subjects did not complete the study for various reasons including side effects, family, or work responsibilities. 

Herbal, natural, and food-supplement products are often used to promote weight loss (Table 59-3). The FDA does not strictly regulate these products, so the ingredients may be inactive and present in variable concentrations. After more than 800 reports of serious adverse events (e.g., seizures, stroke, and death) were attributed to ephedrine alkaloids, the FDA decided to exclude them from dietary supplements. 

Postmarketing surveillance is critical to ensuring the safety of medications because of the limitations of Phase 2 and 3 studies to identify rare, serious adverse events. Typically, these studies are too short and the study population is fairly healthy. Once a drug is marketed, the population of patients using the drug expands to include sicker patients, older patients, and other populations. 

Furthermore, instead of just identifying a signal, the additional data and DNA samples enable scientists to rapidly study groups of patients that develop the adverse event and compare them with groups of patients who do not develop the event. Once a rare, serious adverse event has been identified, a genome-wide SNP scan could be performed on samples from patients with the serious, rare adverse event and compared with patients without the event, thus identifying the SNP markers associated with the rare adverse event. 

Drug-drug interactions have always been major concerns to the pharmaceutical industry. Several prominent drugs were withdrawn from the market because of serious adverse events related to drug-drug interactions. These interactions create problems for clinicians and patients and economic losses for pharmaceutical manufacturers. For this reason, pharmaceutical companies screen for enzyme inhibition and induction at the discovery stage. 

Serious adverse event A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose ... 

An Investigator, not an employee of the Sponsor, is appointed to be responsible for the conduct of a trial. An appropriate quality system is followed and deviations from trial protocols are reported. Serious adverse events have to be reported to regulatory authorities within a specified time. 

All these studies indicate that the incidence of serious adverse events in such studies is very low and is comparable with the normal hazards of everyday life. Nevertheless, it must always be remembered that the volunteer is placing his or her welfare in the trust of the research physician, who therefore bears an enormous responsibility. 

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