Toxicity study evaluation statistical significance

Developmental Toxicity. Occupational exposure to metallic mercury in males did not result in statistically significant effects on malformations or the number of children bom (Alcser et al. 1989 Lauwerys et al. 1985). The results from an inhalation developmental rat study (Baranski and Szymczyk 1973) suggest that metallic mercury vapors may cause a higher incidence of fetal malformations, resorptions, and deaths. Dermal studies on metallic mercury in humans and animals were not available. Additional well-conducted inhalation and dermal studies on metallic mercury in animals are needed to evaluate the potential for adverse developmental effects to humans from mercury. 

Idoxifene has been evaluated as a breast cancer treatment for postmenopausal patients [296, 297]. In one study, 321 postmenopausal patients with unknown receptor status or hormone receptor-positive metastatic breast cancer were randomized to receive either tamoxifen or idoxifene as first-line endocrine therapy for their advanced disease. Complete plus partial response rates were 9 and 13% for tamoxifen and idoxifene, respectively. The median time to progression was slightly higher for idoxifene (140 versus 166 days), but these differences were not statistically significant. Morbidity was similar for both groups. The authors concluded that in postmenopausal women with metastatic breast cancer idoxifene had similar efficacy and toxicity to tamoxifen [298]. However, idoxifene has not been developed further because of concerns about uterine prolapse [299]. This side-effect is not seen with tamoxifen. 

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