FDA Table 21

Overview of Serious Adverse Events1 by Demographic Subgroup, Safety Population, Pooled Analysis (or Trial X)

                                               A: Drug X    B: Placebo    C: Combination
Characteristic                                  (N=134)       (N=134)        (N=132)    
————————————————————————————————————————————————————————————————————————————————————————
Any SAE                                       104 (77.6%)   101 (75.4%)     99 (75.0%)  
SEX                                                                                     
  F                                           61 (77.2%)     64 (78%)       50 (71.4%)  
  M                                           43 (78.2%)    37 (71.2%)       49 (79%)   
Age Group, years                                                                        
  >=17 to <65                                 104 (77.6%)   101 (75.4%)     98 (74.8%)  
  >=65                                             0             0           1 (100%)   
RACE                                                                                    
  ASIAN                                       52 (76.5%)    46 (68.7%)      51 (69.9%)  
  BLACK OR AFRICAN AMERICAN                   23 (74.2%)    23 (82.1%)      26 (81.2%)  
  WHITE                                       22 (81.5%)    22 (84.6%)       17 (81%)   
  AMERICAN INDIAN OR ALASKA NATIVE             7 (87.5%)     8 (72.7%)      5 (83.3%)   
  MULTIPLE                                         0         1 (100%)           0       
  NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER        0         1 (100%)           0       
  OTHER                                            0             0              0       
  UNKNOWN                                          0             0              0       
ETHNIC                                                                                  
  HISPANIC OR LATINO                          11 (73.3%)    13 (72.2%)      11 (73.3%)  
  NOT HISPANIC OR LATINO                      81 (77.9%)    80 (77.7%)      78 (77.2%)  
  NOT REPORTED                                 6 (100%)       7 (70%)       7 (63.6%)   
  UNKNOWN                                      6 (66.7%)     1 (33.3%)       3 (60%)    
# Load Libraries & Data
library(dplyr)
library(cardinal)

adsl <- random.cdisc.data::cadsl %>%
  mutate(AGEGR1 = as.factor(case_when(
    AGE >= 17 & AGE < 65 ~ ">=17 to <65",
    AGE >= 65 ~ ">=65",
    AGE >= 65 & AGE < 75 ~ ">=65 to <75",
    AGE >= 75 ~ ">=75"
  )) %>% formatters::with_label("Age Group, years")) %>%
  formatters::var_relabel(
    AGE = "Age, years"
  )

adae <- random.cdisc.data::cadae
adae$ASER <- adae$AESER

df <- left_join(adsl, adae, by = intersect(names(adsl), names(adae)))

# Output Table
make_table_21(df = df, alt_counts_df = adsl, denom = "N_s")

make_table_21()

Required variables:

  • df: USUBJID, ASER, and the variables specified by arm_var and saffl_var.
  • alt_counts_df (if specified): USUBJID and the variables specified by arm_var and saffl_var.

make_table_21() inherits from cardinal::a_count_occurrences_ser_ae() function.

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
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"
vars (character) Variables from df to include in the table. c("SEX", "AGE", "AGEGR1", "RACE", "ETHNIC", "COUNTRY")
denom (character) Denominator choice (N_col to get the total column, n to have the total number of “Any SAE” in the column, or N_s to have the total number of participants of the category in the column as denominator). c("N_s", "N_col", "n")
lbl_vars (character) Labels corresponding to variables in vars to print in the table. Labels should be ordered according to the order of variables in vars. formatters::var_labels(df, fill = TRUE)[vars]
lbl_overall (character) If specified, an overall column will be added to the table with the given value as the column label. 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.