Adverse events rates

Initiate therapy with 20 mg orally once daily, then increase by 10 mg/week, or longer intervals, to attain adequate control of blood pressure. The usual maintenance dosage is 20 to 40 mg once daily. BP response increases over the 10 to 60 mg/day dose range, but adverse event rates also increase. Doses more than 60 mg once daily are not recommended. 

Pooling the data gives an overall adverse event rate on treatment A of 5.7 per cent, compared to 6.0 per cent on treatment, a pooled difference (A — B) of —0.3 per cent. This is clearly misleading and a more appropriate measure of the treatment difference is given by the average absolute difference of 1.75 per cent. 

Intranasal estradiol gives results comparable to transdermal estradiol, but substantially higher doses are needed. In 300 postmenopausal women, 17-P-estradiol 300 micro-grams/day was as effective as two patches per week delivering 50 micrograms/day (220). Adverse events rates were similar but moderate, and severe mastalgia was significantly less frequent with intranasal estradiol (7.2%) than with the patch (15.5%) 66% of the patients chose to continue the intranasal therapy and 34% the transdermal therapy. 

The analytical approach to safety data is limited but growing (Dubey et al., 2006). Some suitable statistical techniques that can be employed include Fisher s exact test, the Mantel-Haenszel test, and the adapted Cochran-Mantel-Haenszel test, all of which can be used to compare adverse event rates between treatment groups (see Chow and Liu, 2004, for further details). 

Rheumatoid arthritis Double-blind randomized controlled trial 24 weeks Leflunomide 100 mg/day for 2 days, then 10 mg/day (n = 130) versus placebo (n = 133), both with methotrexate 10-25 mg/day American College of Rheumatology 20 rates at 24 weeks leflunomide -i- methotrexate 46% versus placebo -i- methotrexate 20% similar drug withdrawal and adverse events rates (18)... 

The adverse effects rates of levofloxacin are 1.3% for nausea, 0.1% for anxiety, 0.3% for insomnia, and 0.1% for headache. No levofloxacin-related adverse events were reported at a rate higher than 1.3%, and most were less common. High-dose levofloxacin (750 mg) was also well tolerated. Surveillance data reported low adverse event rates nausea 0.8%, rash 0.5%, abdominal pain 0.4%, and diarrhea, dizziness, and vomiting 0.3%. The adverse drug reactions rate for levofloxacin is stiU one of the lowest of any fluoroquinolone, at 2% compared with 2-10% for other fluoroquinolones (6-9). 

The safety and efficacy of topical ofloxacin ear-drops 0.3% (0.25 ml bd) have been compared with that of co-amoxiclav oral suspension (40 mg/kg/day) for acute otitis media in 286 children aged 1-12 years with tympanostomy tubes in place. Topical ofloxacin was as effective as and better tolerated than systemic therapy with co-amoxiclav. Treatment-related adverse event rates were 31% for co-amoxiclav and 6% for ofloxacin (1). 

Oral ibandronate has also been investigated in patients with metastatic bone disease. In 2 pooled Phase III studies, 564 patients with metastatic bone disease from breast cancer were randomised to receive 50 mg oral ibandronate or placebo once daily for up to 96 weeks [84]. Oral ibandronate significantly reduced the mean rate of new skeletal complications by almost 20% compared with placebo (P=0.004). The incidence of mild treatment-related upper gastrointestinal adverse events was slightly higher for oral ibandronate compared with the placebo group, whereas the renal adverse event rate was comparable between the 2 groups (ibandronate, 5.2% placebo, 4.7%) with no report of renal failure [84]. 

Trimethoprim-sulfamethoxazole is used frequently for preventive or active treatment of Pneumocystis carinii pneumonia in patients with the AIDS. Adverse reactions to trimethoprim-sulfamethoxazole have been observed to occur much more frequently in these patients compared with those without AIDS. Adverse effects to trimethoprim-sulfamethoxazole occur in 50% to 80% of AIDS patients compared with 10% of other immunocompromised patients. Trimethoprim-sulfamethoxazole was associated with an adverse-event rate of 26.3 per 100 person-years and hypersensitivity events at 22 per 100 person-years. Adverse-event rate was related to lower CD4+ cell count. When the CD4+ cell count was less than 100/mm , the adverse drug event rate was 31 per 100 person-years. ... 

Health care providers must report all events requiring medical attention within 30 days of vaccination to the Vaccine Adverse Event Reporting System (VAERS), which serves as a central depot for vaccine-related adverse effects. Only a temporal association between the adverse event and vaccine administration needs to be made. No adverse event rates can be determined because only the number of adverse events reported is known the number of vaccines administered is not known. This database can be used to determine changes in adverse-event frequencies, to evaluate risk factors for adverse events, and to find rare adverse events VAERS report forms can be obtained by calling 1-800-822-7967, or reports can be made online at www.vaers.com. 

CAPTURE has reported outcomes on 2,500 high-surgical-risk patients treated using the Guidant filter and stent system at 137 centers across the United States, 90.7% of whom were asymptomatic (49). The 30-day major adverse event rate (death, stroke, myocardial infarction) for asymptomatic patients (n = 2268) was 4.9% and for asymptomatic patients under the age of 80 years (n = 1741) was 4.2%. Moreover, if only the 30-day rate of stroke and death is considered the event rate fell to 3.6% in asymptomatic patients under the age of 80 years. Lastly, CASES-PMS enrolled 974 asymptomatic high-surgical risk patients who were treated with Cordis/Johnson 8c Johnson stent and filter system (50). The 30-day risk of stroke and death in the entire asymptomatic group was 4.2% (the breakout for patients under 80 years of age is unavailable). 

American or Japanese physicians are frequently surprised at European drug labels. The brevity and (usually) the absence of quantitative data (such as adverse event rates or statistical analyses of efficacy end-points) reflects a very different philosophy. Such labels arise from a regulatory milieu which itself has a different philosophy, expecting product manufacturers to assume responsibilities that would be accepted by the regulatory authorities in the USA and Japan. There is no European equivalent of the worldwide enforcement arm of the FDA. 

Important Note Statistical information about smallpox vaccine adverse reactions is ba.sed on data from two studies conducted in 1968. Adverse event rates in the United States today may be higher because there may be more people at risk from immune suppression (from cancer, cancer therapy, organ transplants, and illnesses such as HIV/AIDS) and eczema or atopic dermatitis. The outcome a.ssociated with adverse events may be less severe than previously reported because of advances in medical care. Rates may be lower for persons previously vaccinated. 

A systematic review of adverse events reported in clinical trials of St. John s wort indicated that data from 35 doubleblind randomized trials showed that dropout and adverse event rates in patients receiving St. John s wort extracts were similar to placebo, lower than with older antidepressants, and somewhat lower than with SSRI antidepressants. Dropout rates due to adverse events ranged from 0 to 5.7% in 17 observational studies that included 35,562 patients. No serious adverse events were reported in any of the studies (Knuppel and Linde 2004). 

In the present studies, the parameters measured varied because of differences in hearf size, anatomy, species movement artifacts, and equipment used. However, certain parameters are constant across the studies, and these are used for comparative purposes. Two of these parameters (or surrogate) are also those used in the Common Terminology Criteria for Adverse Events (CTCAE), version 3 (v3), an adverse event rating, which is used for assessing adverse evenfs during clinical trials. These parameters include an assessment of left ventricular ejection fraction and fractional shortening of the left ventricle. 

At the time of writing the impact of SPI on patient outcomes is not clear. There has been some evaluation of the clinical indices on the first four sites, but conflicting views on the effectiveness of the programme. Some have claimed that the adverse event rate, as measured by the global trigger tool, has reduced... 

Like all other research, patient safety research involves some methodological issues. There are important factors that may cause both under- and overestimation of the number of medical accidents in the U.S. health care system. Some methodological concerns focus on the reliability of clinicians judgments about the events themselves (Brennan, 2000) and their failure to account for the morbidity of hospitalized patients before calculating adverse event rates (Leape, 2000). When studies have not been able to address these issues, they may have overestimated the extent of medical accidents. 

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