FDA Table 32

Percentage of Patients With Maximum Diastolic Blood Pressure by Category of Blood Pressure Postbaseline, Safety Population, Pooled Analysis

Diastolic Blood Pressure    A: Drug X    B: Placebo    C: Combination   Risk Difference (%) (95% CI)
(Pa)                         (N=134)       (N=134)        (N=132)                 (N=268)           
————————————————————————————————————————————————————————————————————————————————————————————————————
<60                             0             0              0                0.0 (0.0 - 0.0)       
>60                        134 (100%)    134 (100%)      132 (100%)           0.0 (0.0 - 0.0)       
>90                        134 (100%)    134 (100%)     131 (99.2%)           0.0 (0.0 - 0.0)       
>110                       123 (91.8%)   111 (82.8%)    107 (81.1%)         -9.0 (-16.9 - -1.1)     
>=120                      88 (65.7%)    70 (52.2%)      76 (57.6%)         -13.4 (-25.1 - -1.8)

# Load Libraries & Data
library(cardinal)

adsl <- random.cdisc.data::cadsl
advs <- random.cdisc.data::cadvs

# Output Table
risk_diff <- list(arm_x = "B: Placebo", arm_y = "A: Drug X") # optional
make_table_32(advs = advs, alt_counts_df = adsl, risk_diff = risk_diff)

`make_table_32()`

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.

Diastolic Blood Pressure (Pa)	A: Drug X N = 134	B: Placebo N = 134	C: Combination N = 132
<60	0 (0.0%)	0 (0.0%)	0 (0.0%)
>60	134 (100.0%)	134 (100.0%)	132 (100.0%)
>90	134 (100.0%)	134 (100.0%)	131 (99.2%)
>110	123 (91.8%)	111 (82.8%)	107 (81.1%)
>=120	88 (65.7%)	70 (52.2%)	76 (57.6%)

# Load Libraries & Data
library(cardinal)

adsl <- random.cdisc.data::cadsl
advs <- random.cdisc.data::cadvs

# Output table
tbl <- make_table_32_gtsum(advs = advs)
tbl

`make_table_32_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.

--- title: FDA Table 32 subtitle: Percentage of Patients With Maximum Diastolic Blood Pressure by Category of Blood Pressure Postbaseline, Safety Population, Pooled Analysis format: html --- ::: panel-tabset ## Spec. Screenshot ![](../assets/images/screenshots/table_32.png){fig-align="center" width="70%"} ## rtables Table ```{r tbl, message=FALSE, warning=FALSE} # Load Libraries & Data library(cardinal) adsl <- random.cdisc.data::cadsl advs <- random.cdisc.data::cadvs # Output Table risk_diff <- list(arm_x = "B: Placebo", arm_y = "A: Drug X") # optional make_table_32(advs = advs, alt_counts_df = adsl, risk_diff = risk_diff) ``` ## rtables Table Setup ```{r tbl, eval=FALSE, echo=TRUE} ``` ## Function Details ### `make_table_32()` ------------------------------------------------------------------------ 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()`](https://insightsengineering.github.io/tern/main/reference/add_riskdiff.html) for more details. List should contain the following elements: | `NULL` | | | | | | | - `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`. | | +------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+--------------+ | `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](https://github.com/pharmaverse/cardinal/blob/main/R/fda-table_32.R#L31). ## gtsummary Table ```{r tbl_gtsum, message=FALSE, warning=FALSE} # Load Libraries & Data library(cardinal) adsl <- random.cdisc.data::cadsl advs <- random.cdisc.data::cadvs # Output table tbl <- make_table_32_gtsum(advs = advs) tbl ``` ## gtsummary Table Setup ```{r tbl_gtsum, eval=FALSE, echo=TRUE} ``` ## Function Details: `make_table_32_gtsum` ### `make_table_32_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](https://github.com/pharmaverse/cardinal/blob/main/R/fda-table_32.R#L91). :::