FDA Table 36

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

Spec. Screenshot

Table

                             A: Drug X    B: Placebo   C: Combination   Risk Difference (%) (95% CI)
Primary System Organ Class    (N=134)      (N=134)        (N=132)                 (N=268)           
————————————————————————————————————————————————————————————————————————————————————————————————————
cl A                         78 (58.2%)   75 (56.0%)     89 (67.4%)          -2.2 (-14.1 - 9.6)     
  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)     
cl B                         96 (71.6%)   89 (66.4%)     97 (73.5%)          -5.2 (-16.3 - 5.8)     
  dcd B.1.1.1.1              47 (35.1%)   49 (36.6%)     43 (32.6%)          1.5 (-10.0 - 13.0)     
  dcd B.2.1.2.1              49 (36.6%)   44 (32.8%)     52 (39.4%)          -3.7 (-15.1 - 7.7)     
  dcd B.2.2.3.1              48 (35.8%)   54 (40.3%)     51 (38.6%)          4.5 (-7.1 - 16.1)      
cl C                         67 (50.0%)   75 (56.0%)     79 (59.8%)          6.0 (-6.0 - 17.9)      
  dcd C.1.1.1.3              43 (32.1%)   46 (34.3%)     43 (32.6%)          2.2 (-9.0 - 13.5)      
  dcd C.2.1.2.1              35 (26.1%)   48 (35.8%)     55 (41.7%)          9.7 (-1.3 - 20.7)      
cl D                         96 (71.6%)   90 (67.2%)     98 (74.2%)          -4.5 (-15.5 - 6.5)     
  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)      

Table Setup

# 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_36(adae = adae, alt_counts_df = adsl, risk_diff = risk_diff, prune_0 = TRUE)

Function Details

make_table_36()

---

Required variables:

• adae: The variables specified by id_var, arm_var, saffl_var, soc_var, and pref_var.
• alt_counts_df (if specified): The variables specified by id_var, 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.	"AESOC"
pref_var	(character) Preferred term 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.