FDA Table 35

Patients With Adverse Events by System Organ Class, Safety Population, Pooled Analysis (or Trial X)

                             A: Drug X    B: Placebo   C: Combination   Risk Difference (%) (95% CI)
Primary System Organ Class    (N=134)      (N=134)        (N=132)                 (N=268)           
————————————————————————————————————————————————————————————————————————————————————————————————————
cl D                         96 (71.6%)   90 (67.2%)     98 (74.2%)          -4.5 (-15.5 - 6.5)     
cl B                         96 (71.6%)   89 (66.4%)     97 (73.5%)          -5.2 (-16.3 - 5.8)     
cl A                         78 (58.2%)   75 (56.0%)     89 (67.4%)          -2.2 (-14.1 - 9.6)     
cl C                         67 (50.0%)   75 (56.0%)     79 (59.8%)          6.0 (-6.0 - 17.9)      
# Load Libraries & Data
library(random.cdisc.data)
library(cardinal)

adsl <- random.cdisc.data::cadsl
adae <- random.cdisc.data::cadae

# Output Table
risk_diff <- list(arm_x = "B: Placebo", arm_y = "A: Drug X") # optional
make_table_35(adae = adae, alt_counts_df = adsl, risk_diff = risk_diff)

make_table_35()

Required variables:

  • adae: USUBJID and the variables specified by arm_var, saffl_var and soc_var.
  • alt_counts_df (if specified): USUBJID and the variables specified by arm_var and saffl_var.
Argument Description Default
adae (data.frame) Dataset (typically ADAE) required to build table. No default
alt_counts_df (character) Alternative dataset (typically ADSL) used only to calculate column counts. NULL
show_colcounts (flag) Whether column counts should be printed. TRUE
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"
soc_var (character) SOC variable from adae to include in the table. "AEDECOD"
lbl_soc_var (character) Label corresponding to SOC variable soc_var to print in the table. formatters::var_labels(adae, fill = TRUE)[soc_var]
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. FALSE
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.