[Preferred Term #2] Grade 1 xx (xx.x) xx.x xx (xx.x) xx.x -- Grade 2 xx (xx.x) xx.x xx (xx.x) xx.x -- Grade 3 xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) Grade 4 xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) Grade 5 xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) Grade ≥ 3 xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) Any Grade xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) Footnotes: N=number of patients; n=number of patients with at least one row event. Percentages are calculated relative to the treatment group N. Patients may be counted in more than one row. aMantel-Haenszel risk difference stratified by study. bDenominator adjusted because sex-specific event for males: N=XX (Treatment 1), N=XX (Treatment 2), N=XX (Placebo) [For applicable PTs]. cDenominator adjusted because sex-specific event for females: N=XX (Treatment 1), N=XX (Treatment 2), N=XX(Placebo) [For applicable PTs]. Listing 12.. Listing of Deaths by Study and Treatment: Integrated Database Safety Population Study XXXX Treatment = <<Treatment 1>> Patient Study Day of Last Study Study Day of Preferred Term Verbatim Term of ID Age Sex Race Drug Administration Death of Fatal Event Fatal Event Table 12.. Summary of Serious Adverse Events by Preferred Term in Descending Frequency of TRT: Integrated Database Safety Population TRT PL (N=XX) (N=XX)
[Preferred Term #2] Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Grade ≥ 3 xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx.x xx.x xx.x xx.x xx.x xx.x xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx (xx.x) xx.x xx.x xx.x xx.x xx.x xx.x -- -- xx.x (xx.x, xx.x) xx.x (xx.x, xx.x) xx.x (xx.x, xx.x) xx.x (xx.x, xx.x) Any Grade xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) Footnotes: N=number of patients; n=number of patients with at least one row event. Percentages are calculated relative to the treatment group N. Patients may be counted in more than one row. aMantel-Haenszel risk difference stratified by study. bDenominator adjusted because sex-specific event for males: N=XX (Treatment 1), N=XX (Treatment 2), N=XX (Placebo) [For applicable PTs]. cDenominator adjusted because sex-specific event for females: N=XX (Treatment 1), N=XX (Treatment 2), N=XX(Placebo) [For applicable PTs]. Listing 12.. Listing of Deaths by Study and Treatment: Integrated Database Safety Population Study XXXX Treatment = <<Treatment 1>> Patient ID Age Sex Race Study Day of Last Study Drug Administration Study Day of Death Preferred Term of Fatal Event Verbatim Term of Fatal Event Table 12.. Summary of Serious Adverse Events by Preferred Term in Descending Frequency of TRT: Integrated Database Safety Population TRT (N=XX) PL (N=XX)
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