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Results from the adjuvant trial bone substudy, at 12 24 months demonstrated that patients receiving anastrozole had a mean decrease in both lumbar spine total hip bone mineral density (BMD) compared to baseline. Patients receiving NOLVADEX (tamoxifen citrate) had a mean increase in both lumbar spine total hip BMD compared to baseline. Ductal Carcinoma in Situ (DCIS) The type frequency of adverse events in the NSABP B-24 trial were consistent with those observed in the other adjuvant trials conducted with NOLVADEX (tamoxifen citrate). Reduction in Breast Cancer Incidence in High Risk Women. In the NSABP P-1 Trial, there was an increase in five serious adverse effects in the NOLVADEX (tamoxifen citrate) group: endometrial cancer (33 cases in the NOLVADEX (tamoxifen citrate) group vs. The following table presents the adverse events observed in NSABP P-1 by treatment arm. Only adverse events more common on NOLVADEX (tamoxifen citrate) than placebo are shown. NSABP P-1 Trial: All Adverse Events % of Women NOLVADEX N=6681 PLACEBO N=6707 Self Reported Symptoms N=6441 1 N=6469 1 Hot Flashes 80 68 Vaginal Discharges 55 35 Vaginal Bleeding 23 22 Laboratory Abnormalities N=6520 2 N=6535 2 Platelets decreased 0. In the NSABP P-1 trial, 15. The following are the medical reasons withdrawing from NOLVADEX (tamoxifen citrate) placebo therapy, respectively: Hot flashes (3. In the NSABP P-1 trial, 8. On the NSABP P-1 trial, hot flashes of any severity occurred in 68% of women on placebo in 80% of women on NOLVADEX (tamoxifen citrate). Severe hot flashes occurred in 28% of women on placebo 45% of women on NOLVADEX (tamoxifen citrate). Vaginal discharge occurred in 35% 55% of women on placebo NOLVADEX (tamoxifen citrate) respectively; was severe in 4. There was no difference in the incidence of vaginal bleeding between treatment arms. Pediatric Patients – McCune-Albright Syndrome. Mean uterine volume increased after 6 months of treatment doubled at the end of the one-year study. A causal relationship has not been established; however, as an increase in the incidence of endometrial adenocarcinoma uterine sarcoma has been noted in adults treated with NOLVADEX (see BOXED WARNING ), continued monitoring of McCune-Albright patients treated with NOLVADEX (tamoxifen citrate) long-term effects is recommended, steroids legal buy. The safety efficacy of NOLVADEX (tamoxifen citrate) girls aged two to 10 years with McCune-Albright Syndrome precocious puberty have not been studied beyond one year of treatment. The long-term effects of NOLVADEX (tamoxifen citrate) therapy in girls have not been established. Less frequently reported adverse reactions are vaginal bleeding, vaginal discharge, menstrual irregularities, skin rash headaches. Usually these have not been of sufficient severity to require dosage reduction or discontinuation of treatment. Very rare reports of erythema multiforme, Stevens-Johnson syndrome, bullous pemphigoid, interstitial pneumonitis, rare reports of hypersensitivity reactions including angioedema have been reported with NOLVADEX (tamoxifen citrate) therapy. In some of these cases, the time to onset was more than one year. Rarely, elevation of serum triglyceride levels, in some cases with pancreatitis, may be associated with the use of NOLVADEX (tamoxifen citrate) (see PRECAUTIONS- Drug/Laboratory Testing Interactions section).
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