Benefit Risk Charts

Composite Outcome (Stacked Bar Chart)

stacked_barchart(
  data = comp_outcome,
  chartcolors = colfun()$fig12_colors,
  xlabel = "Study Week"
)

How to read

  • This visualization is comprised of a separate chart for each dose level placebo, low dose and high dose.

  • The Y-axis displays the percentage of subjects 0 to 100%.

  • The X-axis displays the study visits by study week.

  • Each stacked bar in the display area is comprised of five bars representing the five possible outcomes defined in the legend above the graph.

  • The five ordinal outcomes range from best scenario (e.g. dark blue = benefit without AE) to worst scenario (e.g., dark red = withdrew).

  • The outcome category is determined for each subject at each study week. Once subjects withdraw, they continued to be counted in the “Withdrew” category at subsequent visits.

  • The visualization compares the distribution of the five ordinal outcomes within a visit, across visits, and across doses.

Key Conclusions:

  • In this hypothetical example, the placebo control group has more subjects with “No Benefit No AE.” The proportion of subjects with benefits is the highest in the high-dose group.

  • The most favorable outcome of “Benefit-No AE” is not only sustainable but the percentage of subjects is increasing.

  • It is expected that the percentage of subjects withdrawing increase over time, due to placebo subjects receiving no benefit and other subjects experiencing adverse events.