Adverse events incidence

Coney P, Washenik K, Langley RG, DiGiovanna JJ, Harrison DD. Weight change and adverse event incidence with a low-dose oral contraceptive two randomized, placebo-controlled trials. Contraception 2001 63(6) 297-302. 

Olsen, S., Neale, G., Schwab, K. et al. (2007) Hospital staff should use more than one method to detect adverse events and potential adverse events incident reporting, pharmacist surveillance and local real-time record review may all have a place. Quality and Safety in Health Care, 16(1), 40-44. 

Observational studies In a phase III, open, multicenter study, 169 children with partial seizures were treated with divalproex sodium sprinkle capsules as monotherapy or add-on treatment [338. The most common treatment-emergent adverse events were vomiting (14%), tremor (9%), somnolence (8%), and diarrhea (8%). Patients had similar overall adverse event incidence rates whether they received polytherapy at any time during the study or monotherapy (83% and 80% respectively). However, patients taking polytherapy were more likely to have gastrointestinal disorders (36% versus 21%), diarrhea (11% versus 5%), vomiting (17% versus 10%), and increased weight (4% versus 2%). Nine patients (5.3%) prematurely withdrew because of an adverse event. Ammonia concentrations were increased in 31 patients and there was a mean increase in uric acid concentrations and fall in... 

An extension study for patients completing a 52-week core study with olanzapine or asenapine continued until study blind was broken [19 ]. Adverse event incidence was lower during the extension than during the core study and weight gain and incidence of extrapyramidal symptoms were negligible in both groups. 

In patients having Parkinson s disease, both entacapone and tolcapone potentiate the therapeutic effect of L-dopa and prolong the daily ON time by 1-2 h. In the clinic, COMT inhibitors have been well tolerated, and the number of premature terminations has been low. In general, the incidence of adverse events has been higher in tolcapone-treated patients than in entacapone-treated patients. The main events have comprised of dopaminergic and gastrointestinal problems [2,3]. 

A/-acetyltransferase 2 Low activity in about 60% of Caucasian populations. High incidence of adverse events from the drug isoniazide in slow acetylators. 

Thiopurine S methyltransferase Low activity in about 10% of Caucasians and deficient activity in about 0.4%. High incidence of severe adverse events from azathioprine and 6-mercaptopurine in carriers of low activity. 

Ezetimibe 1 0 mg tablet 10 mg once daily The overall incidence of adverse events reported with ezetimibe alone was similar to that reported with placebo and generally similar between ezetimibe with a statin and statin alone. The frequency of increased transaminases was slightly higher in patients receiving ezetimibe plus a statin compared with those receiving statin monotherapy (1.3% versus 0.4%). 

Corticosteroids induce a non-specific immunosuppresion. Owing to their overwhelming incidence of adverse events, many practitioners attempt to use low-dose maintenance therapy or, in some cases, complete steroid withdrawal. Corticosteroids are also effective in reversing acute rejection. 

The incidence of chemotherapy extravasation generally is reported to be between 0.5% and 6% of all chemotherapy-related adverse events.35 A number of risk factors have been identified for chemotherapy extravasation (Table 96-13). 

Table 11. Eradication rate and incidence of adverse events following administration of rifaximin and different rifaximin-based eradication regimens in H. pylori-positive patients (from Pretolani et al. [174])... 

Table 14. Adverse events with an incidence >2% among patients receiving rifaximin (600 mg daily) or placebo in placebo-controlled studies (from rifaximin FDA label [34])... 

As a result of these findings, a scheduled standard pelvic exploration is now an obligatory procedure in clinical trials with new SERMs. It is important to note that this adverse effect has not been associated with tamoxifen or toremifene therapy (Maenpaa et al. 1997 Fisher et al. 1998), and in the case of raloxifene, a post hoc metaanalysis of 6926 nonhysterectomized postmenopausal women participating in clinical trials for 3 years or more showed a significant 50% reduction in the incidence of surgery for repairing pelvic floor relaxation, reported as an adverse event, compared with placebo (Goldstein et al. 2001). 

Specialized risk consultants and even insurance risk offices can now offer a variety of software products or services to conduct mathematical consequence modeling of most hydrocarbon adverse events. The primarily advantage of these tools is that some estimate can be provided on the possible effects of an explosion or fire incident where previously these effects were rough guesses or unavailable Although these models are effective in providing estimate they still should be used with caution and consideration of other physical features that may alter the real incident outcome. 

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. 

IVIVC studies are normally conducted in the fasted state. Where a product is not tolerated in the fasted state, studies may be conducted in the fed state (1). Some drugs are labeled to be administered with food, either to take advantage of greater bioavailability or lessen the incidence of adverse events. For such formulations, it could be argued that the IVIVC model should be developed using in vivo data obtained under fed conditions, so that the model predicts the in vivo performance under the intended condition of administration. We have had recent experience in successfully correlating... 

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