FDA Figure 3

Figure 3. Time to Adverse Event Leading to Treatment Discontinuation, Safety Population, Trial X

# Load Libraries & Data
library(cardinal)

adsl <- random.cdisc.data::cadsl

# Output Figure
make_fig_03(df = adsl, dcsreas_var = "DCSREAS")

make_fig_03()

Required variables:

  • df: The variables specified by arm_var, id_var, saffl_var, trtsdtm_var, trtedtm_var and dcsreas_var.
Argument Description Default
df (data.frame) Dataset (typically ADSL) required to build figure. No default
arm_var (character) Arm variable used to split table into columns. "ARM"
saffl_var (character) Flag variable used to indicate inclusion in safety population. "SAFFL"
id_var (character) Identifier variable used to count the participants within each flag. "USUBJID"
trtsdtm_var (character) Treatment start datetime variable in df. "TRTSDTM"
trtedtm_var (character) Treatment end datetime variable in df. "TRTEDTM"
u_trtdur (character) Unit for duration of treatment. Options are "days", "weeks", "months" and "years". "days"
dcsreas_var (character) Reason for treatment discontinuation variable used to split figure into lines. "DCSREAS"
x_lab (character) x-axis label. paste0("Time from first dose (", u_trtdur, ")")
y_lab (character) y-axis label. "Percent of Patients (%)"
xticks (vector of numeric) x-axis tick positions. If NA (default), tick mark positions are automatically calculated. NA
add_table (flag) whether “Number of Patients” table should be printed under the plot. TRUE
annotations (named list of character) List of annotations to add to the figure. Valid annotation types are title, subtitles, and caption. Each name-value pair should use the annotation type as name and the desired string as value. NULL

Source code for this function is available here.