FDA Table 20

Adverse Events of Special Interest Assessment, Safety Population, Pooled Analysis (or Trial X)

                                A: Drug X    B: Placebo    C: Combination   Risk Difference (%) (95% CI)
AESI Assessment                  (N=134)       (N=134)        (N=132)                 (N=268)           
————————————————————————————————————————————————————————————————————————————————————————————————————————
AE grouping related to AESI    107 (79.9%)   112 (83.6%)    113 (85.6%)          3.7 (-5.5 - 13.0)      
  dcd A.1.1.1.1                50 (37.3%)    45 (33.6%)      63 (47.7%)          -3.7 (-15.2 - 7.7)     
  dcd A.1.1.1.2                48 (35.8%)    48 (35.8%)      50 (37.9%)          0.0 (-11.5 - 11.5)     
  dcd D.1.1.1.1                50 (37.3%)    42 (31.3%)      51 (38.6%)          -6.0 (-17.3 - 5.4)     
  dcd D.1.1.4.2                48 (35.8%)    42 (31.3%)      50 (37.9%)          -4.5 (-15.8 - 6.8)     
  dcd D.2.1.5.3                47 (35.1%)    58 (43.3%)      57 (43.2%)          8.2 (-3.4 - 19.9)      
Maximum severity                                                                                        
  MILD                         16 (11.9%)    19 (14.2%)      17 (12.9%)          2.2 (-5.8 - 10.3)      
  MODERATE                     41 (30.6%)    51 (38.1%)      45 (34.1%)          7.5 (-3.9 - 18.8)      
  SEVERE                       50 (37.3%)    42 (31.3%)      51 (38.6%)          -6.0 (-17.3 - 5.4)     
Serious                        75 (70.1%)    77 (68.8%)      83 (73.5%)          1.5 (-10.4 - 13.4)     
  Deaths                       50 (46.7%)    42 (37.5%)      51 (45.1%)          -6.0 (-17.3 - 5.4)     
Resulting in discontinuation   35 (32.7%)    34 (30.4%)      33 (29.2%)          -0.7 (-11.2 - 9.7)     
Relatedness                    74 (69.2%)    74 (66.1%)      84 (74.3%)          0.0 (-11.9 - 11.9)     
Laboratory Assessment          89 (66.4%)    86 (64.2%)      90 (68.2%)          -2.2 (-13.6 - 9.2)     
# Load Libraries & Data
library(cardinal)

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

# Pre-Processing - Add/create any required variables in adae
set.seed(1)
adae$AESIFL <- ifelse(adae$AESOC %in% c("cl A", "cl D"), "Y", "N")
adae$AELABFL <- sample(c("Y", "N"), nrow(adae), replace = TRUE)

# Select Preferred Term Variable
pref_var <- "AEDECOD"

# Output Table
risk_diff <- list(arm_x = "B: Placebo", arm_y = "A: Drug X") # optional
make_table_20(
  adae = adae, alt_counts_df = adsl, pref_var = pref_var, aesifl_var = "AESIFL",
  aelabfl_var = "AELABFL", risk_diff = risk_diff
)

make_table_20()

Required variables:

  • adae: USUBJID, AESEV, AESER, AESDTH, EOSSTT, AEREL, and the variables specified by pref_var, aesifl_var, aelabfl_var, arm_var, and saffl_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"
pref_var (character) Preferred term variable from adae to include in the table. "AEDECOD"
aesifl_var (character) Variable from adae that indicates adverse events of special interest. "AESIFL"
aelabfl_var (character) Variable from adae that indicates a laboratory assessment. "AELABFL"
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.