FDA Table 5

Duration of Treatment Exposure, Safety Population, Pooled Analyses

                                           A: Drug X                    B: Placebo                 C: Combination         Risk Difference (%) (95% CI)
Parameter                                   (N=134)                      (N=134)                      (N=132)                       (N=268)           
——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
Duration of Treatment, days                                                                                                                           
  Mean (SD)                             961.49 (208.62)              949.45 (223.73)              984.71 (200.08)                      NA             
  Median (min - max)               1095.75 (392.79 - 1095.75)   1095.75 (387.34 - 1095.75)   1095.75 (368.91 - 1095.75)                NA             
  Interquartile range                   859.95 - 1095.75             781.56 - 1095.75             960.34 - 1095.75                     NA             
  Total exposure (person years)        105763.56 (289.56)           100641.30 (275.54)           109302.29 (299.25)                    NA             
Patients Treated, by duration                                                                                                                         
  Any duration (at least 1 dose)          110 (82.1%)                  106 (79.1%)                  111 (84.1%)                -3.0 (-12.4 - 6.5)     
  <1 month                                     0                            0                            0                      0.0 (0.0 - 0.0)       
  >=1 month                               110 (82.1%)                  106 (79.1%)                  111 (84.1%)                -3.0 (-12.4 - 6.5)     
  >=3 months                              110 (82.1%)                  106 (79.1%)                  111 (84.1%)                -3.0 (-12.4 - 6.5)     
  >=6 months                              110 (82.1%)                  106 (79.1%)                  111 (84.1%)                -3.0 (-12.4 - 6.5)     
  >=12 months                             110 (82.1%)                  106 (79.1%)                  111 (84.1%)                -3.0 (-12.4 - 6.5)     
# Load Libraries & Data
library(cardinal)

adsl <- random.cdisc.data::cadsl

# Output Table
risk_diff <- list(arm_x = "B: Placebo", arm_y = "A: Drug X") # optional
make_table_05(df = adsl, risk_diff = risk_diff)

make_table_05()

Required variables:

  • df: The variables specified by vars, arm_var, and saffl_var.
  • alt_counts_df (if specified): USUBJID and the variables specified by arm_var and saffl_var.
Argument Description Default
df (data.frame) Dataset (typically ADSL) required to build table. No default
alt_counts_df (character) Alternative dataset used only to calculate column counts. NULL
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"
lbl_trtdur (character) Label for treatment duration variable u_trtdur. paste("Duration of Treatment,", u_trtdur)
lbl_overall (character) If specified, an overall column will be added to the table with the given value as the column label. NULL
risk_diff

(named list) List of settings to apply to add a risk difference column to the table. See tern::add_riskdiff() for more details. List should contain the following elements:

  • arm_x: (required) the name of reference arm.

  • arm_y: (required) the name of the arm to compare to the reference arm.

  • col_label: (optional) label to use for the risk difference column. Defaults to "Risk Difference (%) (95% CI)".

  • pct: (optional) whether the output should be returned as percentages. Defaults to TRUE.

 NULL
prune_0 (flag) Whether all-zero rows should be removed from the table. TRUE
annotations (named list of character) List of annotations to add to the table. Valid annotation types are title, subtitles, main_footer, and prov_footer. 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.