Adverse events probability

In patients treated with pegaptanib sodium alone, ocular adverse events considered likely to be associated with intravitreal injection of pegaptanib sodium included vitreous floaters or haze, mild transient anterior chamber inflammation, ocular irritation, increased IOP, intraocular air, subconjunctival hemorrhage, eye pain, lid edema/ erythema, dry eye, and conjunctival injection. In patients treated with pegaptanib sodium and PDT, adverse events probably associated included ptosis (due to the contact lens), mild anterior chamber inflammation, corneal abrasion, eye pain, foreign body sensation, chemosis, subconjunctival hemorrhage, and vitreous prolapse. 

The adverse event for a patient may indicate a medical condition such as hypercholestimia, so there may be a request to ensure that there are elevated cholesterol laboratory data to verify such a claim. You can sometimes make this kind of verification with programming if you know precisely which lab tests are involved and what level indicates a probable adverse event. 

The quantitative or qualitative expression of possible loss that considers both the probability that a hazard will result in an adverse event and the consequences of that event. 

An adverse drug event (ADE) can be defined as An injury related to the use of a drug, although the causality of this relationship may not be proven (Leape 1995). Medications are the most frequent cause of adverse event. In a review it was reported that ADEs are common in most clinical settings included adult inpatients (reported incidences of 6.5%), adult outpatients (27.4%), and a paediatric inpatients (2.3%) (Morimoto et al. 2004). No data on the elderly was reported but it is probably even higher than in adult settings. 

Decisions have to be made by pharmaceutical companies and regulatory authorities about whether a drug can cause a particular adverse event (AE) so that an appropriate action can be taken. What does can cause mean Does it imply certainty In many cases to wait for certainty before taking action would entail many patients suffering unnecessarily. The degree of certainty or probability required will vary according to the situation. 

Adverse events are rare and mostly allergic reactions such as urticaria and acneiform eruptions that probably can be attributed to impurities and preservatives in the preparations. 

In conclusion, although it is difficult to quantify discomfort, the adverse effects of antipsychotics most often experienced are less severe than symptoms associated with the common cold. Serious adverse events are much less common. There is a risk to every treatment, but it is erroneous to suggest that because a serious event may occur, it is likely to occur. One of the most dangerous activities we engage in, for example, is driving or riding in an automobile, yet that does not mean that every time we drive to work there is a high probability that we will experience a serious injury or death. 

In a 2-year study of the tolerability and safety of acarbose in 2035 patients the incidence of adverse effects was 7.5% and of withdrawals 2.5% (11). Of 1907 patients, 444 (23%) reported one or more adverse events. In 143 patients the physician considered that there was a probable or possible relation between the adverse event (all gastrointestinal) and acarbose. There were 77 deaths, but none was considered to be related to acarbose 52 stopped taking acarbose because of an adverse event and 45 were considered to be related to acarbose. Laboratory analyses were all within the reference ranges. HbAlc fell by 1.92%. 

Intranasal calcitonin is associated with fewer adverse effects than parenteral formulations, probably because of low systemic availability. However, a meta-analysis has confirmed that adverse events are poorly reported in clinical trials (21). The pooled relative risk for rhinitis from four trials (n = 1663) was 1.72, but this did not reach statistical significance. 

According to the researchers, nearly half of the adverse events definitely, probably, or possibly caused by ephedra were cardiovascular side effects. The most common cardiovascular side effect was hypertension, or high blood pressure. Other reported cardiovascular events were palpitations, tachycardia (an abnormally fast heartbeat), stroke, and seizures. The researchers stated that 10 of the adverse events definitely, probably, or possibly caused by ephedra resulted in death, and 13 of the events caused permanent disability. In one-fifth of the cases, there was not enough evidence or information about the incident, and the remaining complications were not related to ephedra. 

The Mitre Model. With the assistance of the Mitre Corporation, EPA has developed a model for assessing the risk and ranking superfund sites by Section 108. The Mitre Model is a simple, straightforward model which will rank sites largely on the basis of easily obtainable information. Five pathways of exposure (ground water, surface water, air, direct contact, and explosion) will be considered. The probability and magnitude of an adverse event will be estimated for each pathway to arrive at an overall risk estimate. 

The IND application allows the FDA to determine whether it is probably safe to administer a particular drug product to humans and whether the anticipated specified therapeutic action is likely to outweigh anticipated adverse reactions. Probability and likelihood are the province of the statistician. It is not possible for statistical manipulations of recorded events to prove absolutely that any predicted event will actually occur. Statistics can provide an estimation of the likelihood that a particular treatment previously administered in a particular dosage form at a particular level will continue to yield similar therapeutic effects and side effects in a similar population. 

The safety and tolerability of once-daily oral metrifonate has been evaluated in patients with probable mild to moderate Alzheimer s disease in a randomized, doubleblind, placebo-controlled, parallel-group study (9). Metrifonate was given to 29 patients as a loading dose (2.5 mg/kg) for 2 weeks, followed by maintenance dose (1 mg/kg) for 4 weeks 10 patients received placebo. The proportion of patients who had at least one adverse event was comparable in the two groups metrifonate 76%, placebo 80%. Selected adverse events, defined as those for which the incidence in the metrifonate and placebo group differed by at least 10%, were diarrhea, nausea, leg cramps, and accidental injury. The adverse events were predominantly mild and transient. Those who took metrifonate had a significantly lower heart rate. Metrifonate had no clinically important effect on laboratory tests, such as liver function tests, and did not affect exercise tolerance or pulmonary function. 

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