^Mantel-Haenszel risk difference stratified by study. Example Listing 12.6 Listing of Deaths by Study and Treatment: Integrated Database Safety Population Study XXXX Treatment = <<Treatment 1>> Subject Date of First Study Date of Last Study Drug Date of Death Preferred Term Verbatim Term of ID Age Sex Race Drug Administration Administration (Study Day) (Study Day) of Fatal Event Fatal Event Example Table 12.7 Summary of Serious Adverse Events: Integrated Database Safety Population TRT PL (N=XX) (N=XX) Risk Difference^ Study Size- Study Size- TRT-PL Preferred Term n (%) Adjusted % n (%) Adjusted % (95% CI) Number of subjects reporting at least xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) one serious adverse event [Preferred Term #1] xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) [Preferred Term #2] xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x)
^Mantel-Haenszel risk difference stratified by study. Example Listing 12.6 Listing of Deaths by Study and Treatment: Integrated Database Safety Population Study XXXX Treatment = <<Treatment 1>> Subject ID Age Sex Race Date of First Study Drug Administration Date of Last Study Drug Administration (Study Day) Date of Death (Study Day) Preferred Term of Fatal Event Verbatim Term of Fatal Event Example Table 12.7 Summary of Serious Adverse Events: Integrated Database Safety Population TRT (N=XX) PL (N=XX) Preferred Term n (%) Study Size- Adjusted % n (%) Study Size- Adjusted % Risk Difference^ TRT-PL (95% CI) Number of subjects reporting at least one serious adverse event xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) [Preferred Term #1] xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) [Preferred Term #2] xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x)
Phuse_AE_August2016_ForPublicReview.docx