Table 12.. Overview of Adverse Events During the Treatment Phase: Integrated Database Safety Population TRT PL (N=XX) (N=XX) Risk Differencea Study Size- Study Size- TRT-PL n (%) Adjusted % n (%) Adjusted % (95% CI) Treatment-Emergent Adverse Events xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) Serious Adverse Events xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) Adverse Events leading to xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) Discontinuation of Investigational Product Fatal Adverse Events 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. Serious Adverse Events are counted regardless of whether severity increases relative to baseline. aMantel-Haenszel risk difference stratified by study. Table 12.. Summary of Treatment-Emergent Adverse Events by Preferred Term in Descending Frequency of TRT within System Organ Class: Integrated Database Safety Population TRT PL (N=XX) (N=XX) Risk Differencea System Organ Class Study Size- Study Size- TRT-PL Preferred Term n (%) Adjusted % n (%) Adjusted % (95% CI) Number of patients reporting at least one xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) treatment-emergent adverse event [System Organ Class #1] xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x)
Table 12.. Overview of Adverse Events During the Treatment Phase: Integrated Database Safety Population TRT (N=XX) PL (N=XX) n (%) Study Size- Adjusted % n (%) Study Size- Adjusted % Risk Differencea TRT-PL (95% CI) Treatment-Emergent Adverse Events xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) Serious Adverse Events xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) Adverse Events leading to Discontinuation of Investigational Product xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) Fatal Adverse Events 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. Serious Adverse Events are counted regardless of whether severity increases relative to baseline. aMantel-Haenszel risk difference stratified by study. Table 12.. Summary of Treatment-Emergent Adverse Events by Preferred Term in Descending Frequency of TRT within System Organ Class: Integrated Database Safety Population System Organ Class Preferred Term TRT (N=XX) PL (N=XX) n (%) Study Size- Adjusted % n (%) Study Size- Adjusted % Risk Differencea TRT-PL (95% CI) Number of patients reporting at least one treatment-emergent adverse event xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x) [System Organ Class #1] xx (xx.x) xx.x xx (xx.x) xx.x xx.x (xx.x, xx.x)
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