FDA Table 33

Percentage of Patients Meeting Specific Hypotension Levels Postbaseline, Safety Population, Pooled Analysis

Blood Pressure    A: Drug X    B: Placebo   C: Combination   Risk Difference (%) (95% CI)
(Pa)               (N=134)      (N=134)        (N=132)                 (N=268)           
—————————————————————————————————————————————————————————————————————————————————————————
SBP <90          85 (63.4%)    84 (62.7%)     90 (68.2%)         -0.7 (-12.3 - 10.8)     
DBP <60          133 (99.3%)   134 (100%)     132 (100%)           0.7 (-0.7 - 2.2)      
# Load Libraries & Data
library(cardinal)

adsl <- random.cdisc.data::cadsl
advs <- random.cdisc.data::cadvs
advs$AVAL <- advs$AVAL - 100

# Output Table
risk_diff <- list(arm_x = "B: Placebo", arm_y = "A: Drug X") # optional
make_table_33(advs = advs, alt_counts_df = adsl, risk_diff = risk_diff)

make_table_33()

Required variables:

  • advs: USUBJID, AVISITN, PARAMCD, AVAL, AVALU, 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.
Argument Description Default
advs (data.frame) Dataset (typically ADVS) 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"
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.

Blood Pressure (Pa)

A: Drug X
N = 134

B: Placebo
N = 134

C: Combination
N = 132
SBP <90 85 (63.4%) 84 (62.7%) 90 (68.2%)
DBP <60 133 (99.3%) 134 (100.0%) 132 (100.0%) 
# Load Libraries & Data
library(cardinal)

adsl <- random.cdisc.data::cadsl
advs <- random.cdisc.data::cadvs
advs$AVAL <- advs$AVAL - 100

# Output table
tbl <- make_table_33_gtsum(advs = advs)
tbl

make_table_33_gtsum()

Required variables:

  • advs: USUBJID, AVISITN, PARAMCD, AVAL, AVALU, and the variables specified by arm_var and saffl_var.
Argument Description Default
advs (data.frame) Dataset (typically ADVS) required to build table. No default
alt_counts_df (character) Alternative dataset (typically ADSL) 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"
lbl_overall (character) If specified, an overall column will be added to the table with the given value as the column label. "Total Population"

Source code for this function is available here.