Descargar Plm 2010 Def 55 Pfizer

Descargar Plm 2010 Def 55 Pfizer

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The aggregate nausea rate reported in the medication label for mitoxantrone (55%) was higher than that reported in PLM (20.3%). A more detailed examination of the medication label data suggests that the expected difference may be even more striking than the observed difference. The median medication label nausea rate of 55% is based on data collected over the course of three clinical trials, one with a nausea rate of 76% (n = 62, dose = 12 mg/m2), the second with a rate of 55% (n = 65, dose = 5 mg/m2), and a third trial where mitoxantrone was administered concurrently with methylprednisolone and had a nausea rate of 29% (n = 21) (Novantrone [package insert], 2012). The current recommended daily dose of mitoxantrone is 12 mg/m2, which is more than double the dose administered in the cohort of patients whose reported nausea rate was 55% (Marriott et al., 2010). Furthermore, administration of mitoxantrone in combination with an anti-emetic medication, such as methylprednisolone, would likely result in lower overall reported rates of nausea. It seems that the median medication label nausea rate (55%) may actually be an underestimate of the nausea rate observed during a clinical trial that more closely mirrors real-world prescribing practices (76%), leading to an even greater discrepancy between the nausea rates reported in PLM and those reported in the medication label. 153554b96e

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