Errata for FDA ODAC Briefing Document for Evista for the July 24, 2007 ODAC Meeting

NDA 22042

 

 

The following changes should be made to the FDA briefing document for Evista:

 

 

Page 4 in 4^th paragraph:  replace “5057 women” with “5044 women”

 

Page 10 in 2^nd paragraph:  add “endometrial cancer” to secondary endpoints

 

Page 13 next to last paragraph:  replace “172 cases” with “173 cases”

 

Page 14 in Table 10:  replace “Tamoxifen 9736” with “Tamoxifen 4010”

                                   replace “Placebo 9751” with “placebo 4008”

 

Page 15 in 1^st paragraph:  replace “54 deaths” with “5 deaths”

                                          replace “56 deaths” with “7 deaths”

 

Page 15 in 2^nd paragraph 4^th line:  replace “99” with “92”

 

Page 16 in Table 12: “*” indicates Stage II patients lacking information to classify as IIA

                                   or IIB

 

Page 26 in Table 18:  ovarian cancer replace placebo denominator “1999” with “2576”

                                    endometrial cancer absolute risk difference replace +0.15

                                    with -0.15

 

Page 35 in Table 24:  replace “Placebo N=44” with “Placebo N=22”, “Raloxifene N=17”

                                    with “Raloxifene N=24” and “Total N=61” with “Total N=46”