Package {crane}

Title:	Supplements the 'gtsummary' Package for Pharmaceutical Reporting
Version:	0.3.2
Description:	Tables summarizing clinical trial results are often complex and require detailed tailoring prior to submission to a health authority. The 'crane' package supplements the functionality of the 'gtsummary' package for creating these often highly bespoke tables in the pharmaceutical industry.
License:	Apache License 2.0
URL:	https://github.com/insightsengineering/crane, https://insightsengineering.github.io/crane/
BugReports:	https://github.com/insightsengineering/crane/issues
Depends:	gtsummary (≥ 2.5.1), R (≥ 4.2)
Imports:	broom (≥ 1.0.8), cards (≥ 0.8.0), cardx (≥ 0.3.3), cli (≥ 3.6.4), cowplot (≥ 1.2.0), dplyr (≥ 1.2.0), flextable (≥ 0.9.7), ggplot2 (≥ 4.0.0), glue (≥ 1.8.0), gt (≥ 0.11.1), labeling, lifecycle, rlang (≥ 1.1.5), scales, scales (≥ 1.3.0), survival (≥ 3.6-4), tibble, tidyr (≥ 1.3.0)
Suggests:	broom.helpers (≥ 1.20.0), coin (≥ 1.4.3), emmeans, labelled, magick, mmrm, parameters, pharmaverseadam, testthat (≥ 3.0.0), tidyselect, withr (≥ 3.0.1), yaml
Config/Needs/check:	hms
Config/Needs/website:	rmarkdown, yaml
Config/testthat/edition:	3
Config/testthat/parallel:	true
Encoding:	UTF-8
Language:	en-US
RoxygenNote:	8.0.0
NeedsCompilation:	no
Packaged:	2026-06-03 08:01:07 UTC; sanchosl
Author:	Daniel D. Sjoberg [aut] (note: Original creator of the package), Emily de la Rua [aut], Davide Garolini [aut], Chi Zhang [aut], Abinaya Yogasekaram [ctb], Joe Zhu [cre], Jan Szczypiński [aut], F. Hoffmann-La Roche AG [cph, fnd]
Maintainer:	Joe Zhu <joe.zhu@roche.com>
Repository:	CRAN
Date/Publication:	2026-06-03 09:00:02 UTC

crane: Supplements the 'gtsummary' Package for Pharmaceutical Reporting

Description

Tables summarizing clinical trial results are often complex and require detailed tailoring prior to submission to a health authority. The 'crane' package supplements the functionality of the 'gtsummary' package for creating these often highly bespoke tables in the pharmaceutical industry.

Author(s)

Maintainer: Joe Zhu joe.zhu@roche.com (ORCID)

Authors:

• Daniel D. Sjoberg danield.sjoberg@gmail.com (ORCID) (note: Original creator of the package)

• Emily de la Rua emilydelarua@gmail.com (ORCID)

• Davide Garolini davide.garolini@roche.com (ORCID)

• Chi Zhang chi.zhang.cz7@roche.com (ORCID)

• Jan Szczypiński jan.szczypinski@external.roche.com (ORCID)

Other contributors:

• Abinaya Yogasekaram ayogasek@gmail.com (ORCID) [contributor]

• F. Hoffmann-La Roche AG [copyright holder, funder]

See Also

Useful links:

• https://github.com/insightsengineering/crane

• https://insightsengineering.github.io/crane/

• Report bugs at https://github.com/insightsengineering/crane/issues

Calculate Error Bar Statistics

Description

Computes central tendency and dispersion metrics for a given numeric vector. This serves as the computational engine for gg_add_error_bars.

Usage

.calc_stats(x, stat, variability, conf_level)

Arguments

Value

A data.frame with columns y, ymin, and ymax.

Examples

## Not run: 
# Calculate the mean and 95% Confidence Interval for a numeric vector
mpg_data <- mtcars$mpg
mean_ci_stats <- calc_error_bars(
  x = mpg_data,
  stat = "mean",
  variability = "ci",
  conf_level = 0.95
)

## End(Not run)

Format p-values for display

Description

Numeric values below 0.0001 are shown as "<0.0001", others are formatted to four decimal places. Character input is returned as-is, allowing users to pre-format the p-value column in pairwise_df before calling tbl_coxph().

Usage

.format_pvalue(x)

Arguments

Value

A character vector of formatted p-values.

Examples

crane:::.format_pvalue(0.000156)

Build Single Comparison Table for Cox PH

Description

Internal helper function to build a formatted gtsummary table for a single comparison arm. It conditionally extracts available statistics from the subsetted data and stacks them into rows for the final display.

Usage

.get_single_comp_table(data_subset, pval_label = NULL)

Arguments

Value

A gtsummary object containing the stacked summary statistics.

Examples

tbl <- tibble::tibble(
  comparison_label = "A-B",
  hr_formatted = "5.21",
  ci_formatted = "0.25-0.35",
  pval_formatted = 0.005
)
crane:::.get_single_comp_table(tbl, pval_label = "p-val")

Add Blank Row

Description

Add a blank row below each variable group defined by variables or below each specified row_numbers. A blank row will not be added to the bottom of the table.

NOTE: For HTML flextable output (which includes the RStudio IDE Viewer), the blank rows do not render. But they will appear when the table is rendered to Word.

Usage

add_blank_rows(x, variables = NULL, row_numbers = NULL, variable_level = NULL)

Arguments

Value

updated 'gtsummary' table.

Examples

# Example 1 ----------------------------------
# Default to every variable used
trial |>
  tbl_roche_summary(
    by = trt,
    include = c(age, marker, grade),
    nonmissing = "always"
  ) |>
  add_blank_rows(variables = everything())

# Example 2 ----------------------------------
trial |>
  tbl_roche_summary(
    by = trt,
    include = c(age, marker, grade),
    nonmissing = "always"
  ) |>
  add_blank_rows(variables = age)

Add a Forest Plot Column to a gtsummary Table

Description

This function adds a forest plot column to a gtsummary table, typically produced by tbl_roche_subgroups(). The forest plot visualizes estimates and confidence intervals for each subgroup in the table. The function supports rendering with either the gt or flextable engines, making it suitable for different outputs.

Usage

add_forest(
  x,
  estimate = starts_with("estimate"),
  conf_low = starts_with("conf.low"),
  conf_high = starts_with("conf.high"),
  pvalue = starts_with("p.value"),
  after = starts_with("p.value"),
  header_spaces = 20,
  table_engine = c("flextable", "gt")
)

Arguments

Details

Both gt and flextable outputs could produce issues in line continuity between rows if there are wrapping in the statistical cells.

Value

a gt table or flextable object with an added forest plot column.

Examples

# Simple example ------------------------------------------------------------
trial |>
  select(age, marker, grade, response) |>
  tbl_uvregression(
    y = response,
    method = glm,
    method.args = list(family = binomial),
    exponentiate = TRUE,
    hide_n = TRUE
  ) |>
  modify_column_merge(
    pattern = "{estimate} (95% CI {ci}; {p.value})",
    rows = !is.na(estimate)
  ) |>
  modify_header(estimate = "**Odds Ratio**") |>
  add_forest(table_engine = "gt")

# Realistic example ---------------------------------------------------------

if (requireNamespace("broom.helpers", quietly = TRUE)) {
  trial |>
    tbl_roche_subgroups(
      rsp = "response",
      by = "trt",
      subgroups = c("grade"),
      ~ glm(response ~ trt, data = .x) |>
        gtsummary::tbl_regression(
          show_single_row = trt,
          exponentiate = TRUE # , tidy_fun = broom.helpers::tidy_parameters
        )
    ) |>
    add_forest(pvalue = starts_with("p.value"), table_engine = "flextable") |>
    flextable::set_header_labels(ggplot = "---------")
}

Add row with counts

Description

Typically used to add a row with overall AE counts to a table that primarily displays AE rates.

Usage

add_hierarchical_count_row(
  x,
  label = "Overall total number of events",
  .before = NULL,
  .after = NULL,
  data_preprocess = identity
)

Arguments

Value

gtsummary table

Examples

# Example 1 ----------------------------------
cards::ADAE |>
  # subset the data for a shorter example table
  dplyr::slice(1:10) |>
  tbl_hierarchical(
    by = "TRTA",
    variables = AEDECOD,
    denominator = cards::ADSL,
    id = "USUBJID",
    overall_row = TRUE
  ) |>
  add_hierarchical_count_row(.after = 1L)

Adjust Statistics Columns Wrapping

Description

Toggles standard whitespace to non-breaking spaces (⁠\u00A0⁠) dynamically in all visible statistics columns of a gtsummary table's body (or vice versa). This forces the layout engine to keep statistics (e.g., "12.5 ( 95%)") on a single line when protected. Column headers and labels remain unaffected. For the rare cases when protecting creates ugly squashed label column protection can be reversed using the same function.

Usage

adjust_stat_columns_wrap(tbl, mode = c("protect", "unprotect"))

Arguments

Value

A modified gtsummary object.

Examples

tbl <- gtsummary::tbl_summary(
  trial,
  by = trt,
  include = c(age, grade)
)
adjust_stat_columns_wrap(tbl, "protect")

Annotate Kaplan-Meier Plot

Description

These functions provide capabilities to annotate Kaplan-Meier plots (gg_km()) with additional summary tables, including median survival times, numbers at risk, and cox proportional hazards results. The annotations are added using the cowplot package for flexible placement.

Usage

annotate_riskdf(
  gg_plt,
  fit_km,
  title = "Patients at Risk:",
  rel_height_plot = 0.75,
  xlab = "Days",
  ...
)

annotate_surv_med(
  gg_plt,
  fit_km,
  table_position = c(x = 0.8, y = 0.85, w = 0.32, h = 0.16),
  ...
)

annotate_coxph(
  gg_plt,
  coxph_tbl,
  table_position = c(x = 0.29, y = 0.51, w = 0.4, h = 0.125),
  ...
)

Arguments

Value

The function annotate_riskdf returns a cowplot object combining the KM plot and the 'Numbers at Risk' table.

The function annotate_surv_med returns a cowplot object
with the median survival table annotation added.

The function annotate_coxph returns a cowplot object
with the Cox-PH table annotation added.

Functions

• annotate_riskdf(): The function annotate_riskdf adds a "Numbers at Risk" table below a Kaplan-Meier plot using patchwork.
  Note: For this specific function, gg_plt must be a pure ggplot2 object (not a combined cowplot object) because it requires exact X-axis extraction.

• annotate_surv_med(): The annotate_surv_med function adds a median survival time summary table as an annotation box.

• annotate_coxph(): The function annotate_coxph() adds a Cox Proportional Hazards summary table as an annotation box.

See Also

gg_km(), process_survfit(), and get_cox_pairwise_df() for related functionalities.

Examples

# Preparing the Kaplan-Meier Plot
library(survival)
use_lung <- lung
use_lung$arm <- factor(sample(c("A", "B", "C"), nrow(use_lung), replace = TRUE))
use_lung$status <- use_lung$status - 1 # Convert status to 0/1
use_lung <- na.omit(use_lung)

formula <- Surv(time, status) ~ arm
fit_kmg01 <- survfit(formula, use_lung)
surv_plot_data <- process_survfit(fit_kmg01)

plt_kmg01 <- gg_km(surv_plot_data)

# Annotate Plot with Numbers at Risk Table
annotate_riskdf(plt_kmg01, fit_kmg01)

# Change order of y-axis (arm)
use_lung2 <- use_lung
use_lung2$arm <- factor(use_lung2$arm, levels = c("C", "B", "A"))
fit_kmg01 <- survival::survfit(formula, use_lung2)
annotate_riskdf(plt_kmg01, fit_kmg01) # rerun gg_km to change legend order

# Annotate Kaplan-Meier Plot with Median Survival Table
annotate_surv_med(plt_kmg01, fit_kmg01)

# Annotate Kaplan-Meier Plot with Cox-PH Table
coxph_tbl <- get_cox_pairwise_df(
  formula,
  data = use_lung, arm = "arm", ref_group = "A"
)
result <- annotate_coxph(plt_kmg01, coxph_tbl)

# Extract original plots from any annotated result
attr(result, "plotlist")$main

Annotate Line Plot with Summary Table

Description

These functions provide capabilities to annotate lineplot (gg_lineplot()) with additional summary statistics table. The annotations are added using the cowplot package for flexible placement.

Usage

annotate_lineplot_df(
  gg_plt,
  data,
  x = NULL,
  y = NULL,
  group = NULL,
  summary_stats = c("n", "mean", "sd"),
  digits = NULL,
  rel_height_plot = 0.75
)

Arguments

Value

A cowplot object.

See Also

gg_lineplot() for related functionalities.

Examples

# 1. Create a mock dataset
set.seed(123)
mock_adlb <- data.frame(
  ARM = rep(c("Treatment A", "Treatment B"), each = 30),
  AVISIT = rep(c(0, 4, 8), 20),
  AVAL = rnorm(60, mean = 10, sd = 2)
)

# 2. Generate the base line plot
p_base <- gg_lineplot(
  data = mock_adlb,
  x = AVISIT,
  y = AVAL,
  group = ARM
)

# 3. Annotate with default stats (auto-extracts variables from p_base)
annotate_lineplot_df(gg_plt = p_base, data = mock_adlb)

# 4. Annotate with custom statistics and exactly 2 decimal places
annotate_lineplot_df(
  gg_plt = p_base,
  data = mock_adlb,
  summary_stats = c("n", "median", "iqr"),
  digits = c(0, 2, 2)
)

Annotate PK Plot with Summary Table

Description

These functions provide capabilities to annotate Pharmacokinetics plot (gg_pkc_lineplot()) with additional summary statistics table. The annotations are added using the cowplot package for flexible placement.

Usage

annotate_pkc_df(
  gg_plt,
  data,
  time_var = NULL,
  analyte_var = NULL,
  group = NULL,
  summary_stats = c("n", "mean", "sd"),
  digits = NULL,
  text_size = 3.5,
  rel_height_plot = 0.75
)

Arguments

Value

A ggplot2 object: a plot with a table at the bottom.

See Also

gg_pkc_lineplot() for related functionalities.

Examples

# Prepare PK Data using the built-in Theoph dataset
df_pk <- Theoph
df_pk$Time_Nominal <- round(df_pk$Time)
# Filter to specific timepoints to keep the table clean
df_pk <- df_pk[df_pk$Time_Nominal %in% c(0, 2, 4, 8, 24), ]
# Create a mock treatment group based on Dose
df_pk$Dose_Group <- ifelse(df_pk$Dose > 4.5, "High Dose", "Low Dose")

# Create the Base Plot using actual Theoph column names
p_pk <- gg_pkc_lineplot(
  data = df_pk,
  time_var = Time_Nominal,
  analyte_var = conc,
  group = Dose_Group,
  stat = "mean",
  variability = "sd",
  log_y = FALSE
)

# Annotate the Plot (Auto-detects variables from aesthetic mapping)
annotate_pkc_df(
  data = df_pk,
  gg_plt = p_pk
)

# Annotate with specific statistics, explicit variable names, and explicit digits
annotate_pkc_df(
  data = df_pk,
  gg_plt = p_pk,
  time_var = "Time_Nominal",
  analyte_var = "conc",
  group = "Dose_Group",
  summary_stats = c("n", "median", "iqr"),
  digits = c(0, 2, 2)
)

ARD Tabulate Abnormality by Baseline Status

Description

This function creates an Analysis Results Data (ARD) object counting participants with abnormal assessments, stratified by their baseline status. For each abnormality (e.g., "Low", "High"), it calculates statistics for three tiers:

1. Patients Not Abnormal at baseline.

2. Patients Abnormal at baseline.

3. Total (all patients with a post-baseline assessment).

Usage

ard_tabulate_abnormal_by_baseline(
  data,
  postbaseline,
  baseline,
  abnormal,
  id = "USUBJID",
  by = NULL,
  strata = NULL
)

Arguments

Value

An ARD data frame of class 'card'.

Examples

# Example usage with ADLB-like data
adlb <- cards::ADLB
ard_tabulate_abnormal_by_baseline(
  data = adlb,
  postbaseline = LBNRIND,
  baseline = BNRIND,
  abnormal = list(Low = "LOW", High = "HIGH"),
  by = TRTA
) %>% tbl_ard_summary(by = TRTA)

Deprecated functions

Description

Some functions have been deprecated and are no longer being actively supported.

Usage

tbl_demographics(..., nonmissing = "always")

g_lineplot(...)

g_lineplot_table(...)

preprocess_lineplot_data(...)

Value

Warnings

Examples

NULL

Create and Stack an X-Axis Aligned Table

Description

Generates a text table from a dataframe, perfectly aligns its X-axis to match a provided ggplot, and seamlessly stacks them vertically. Allow annotation of general "GEN" plots and more specific plots such as Pharmacokinetic ("PK") or Kaplan-Meier ("KM"). Supports both continuous and discrete X-axes.

Usage

df2gg_aligned(
  df,
  gg_plt,
  type = c("GEN", "PK", "KM"),
  y_labels = NULL,
  title = NULL,
  xlab = NULL,
  show_xaxis = FALSE,
  text_size = 3.5,
  label_size = 10,
  rel_height_plot = 0.75
)

Arguments

Details

The original plots are stored in attr(result, "plotlist") as a named list (main and table) for downstream data extraction.

Value

A combined cowplot object.

Examples

## Not run: 
# 1. Create a base plot with a continuous X-axis
p_base <- ggplot(mtcars, aes(x = mpg, y = disp)) +
  geom_point() +
  scale_x_continuous(limits = c(10, 35), breaks = c(10, 20, 30))

# 2. Create a mock summary table matching the X-axis breaks
mock_df <- data.frame(
  `10` = c("15", "12"),
  `20` = c("10", "8"),
  `30` = c("5", "3"),
  check.names = FALSE
)
rownames(mock_df) <- c("Group A", "Group B")

# 3. Align and stack the table under the plot using the "KM" engine
result <- df2gg_aligned(
  df = mock_df,
  gg_plt = p_base,
  type = "KM",
  title = "Subjects at Risk",
  show_xaxis = TRUE
)

# 4. Extract the original plots and data
plist <- attr(result, "plotlist")
plist$main$data # original dataframe from the base plot
plist$table # the table ggplot object

## End(Not run)

Convert Data Frame to Floating ggplot2 Table Graphic

Description

Creates a standalone ggplot2 table and overlays it onto a base plot using cowplot at specified coordinates.

Usage

df2gg_floating(
  df,
  gg_plt,
  x = 0.8,
  y = 0.8,
  w = 0.3,
  h = 0.2,
  colwidths = NULL,
  font_size = 10,
  col_labels = TRUE,
  col_lab_fontface = "bold",
  hline = TRUE,
  bg_fill = NULL
)

Arguments

Details

The original plots are stored in attr(result, "plotlist") as a named list (main and table) for downstream data extraction.

Value

A cowplot object representing the combined plot and table.

Examples

## Not run: 

# 1. Create a base plot
p_base <- ggplot(mtcars, aes(x = wt, y = mpg)) +
  geom_point() +
  theme_classic()

# 2. Create a mock summary table
mock_df <- data.frame(
  Statistic = c("N", "Median", "Mean"),
  Value = c("32", "19.2", "20.1")
)

# 3. Float the table on the plot
result <- df2gg_floating(
  df = mock_df,
  gg_plt = p_base,
  x = 0.75,
  y = 0.75,
  w = 0.35,
  h = 0.25,
  bg_fill = "white"
)

# 4. Extract the original plots and data
plist <- attr(result, "plotlist")
plist$main$data # original dataframe from the base plot
plist$table # the floating table ggplot object

## End(Not run)

Add custom pooling to an ADaM dataset list - see DISCLAIMER

Description

DISCLAIMER: this is a risky function. Please consider using tbl_with_pools() instead. This function allows you to create new pooled groups in your ADaM datasets based on specified arm values. You can choose to keep the original unpooled rows or not. Important Note: If you choose to keep the original rows and also add a pool that includes all patients (using the "all" keyword), you will end up with duplicate rows in your dataset. This can lead to incorrect patient counts if you later add a total column. Use this option with caution and ensure that you do not add a standard total column later to avoid double-counting.

Usage

df_add_poolings(adam_db, pools, arm_var = "TRT01A", keep_original = TRUE)

Arguments

Value

Updated list of ADaM datasets.

See Also

tbl_with_pools() for a safer alternative that creates pooled summaries without modifying the underlying datasets.

Examples

# Create a minimal dummy adam_db
adsl <- data.frame(
  USUBJID = c("001", "002", "003", "004", "005"),
  TRT01A = c("Drug A", "Drug A", "Drug B", "Drug C", "Drug C"),
  FLAG = c("Y", "N", "Y", "N", "Y"),
  stringsAsFactors = FALSE
)
adam_db <- list(adsl = adsl)

# Define the requested pools
my_pools <- list(
  "Drugs A and B" = c("Drug A", "Drug B"),
  "All Patients"  = "all"
)

# Example A: Safe pooling (keep_original = FALSE, no "all" pool) -----------------
safe_pools <- list("Drugs A and B" = c("Drug A", "Drug B"))
adam_db_safe <- df_add_poolings(adam_db, pools = safe_pools, keep_original = FALSE)
print(adam_db_safe$adsl)

# Example B: Triggering the warnings (keep_original = TRUE and "all" pool) -------
# This will throw two warnings: one for duplicates, one for the "all" pool.
adam_db_warnings <- df_add_poolings(adam_db, pools = my_pools, keep_original = TRUE)
print(adam_db_warnings$adsl)

# Example C: Complex pooling using logical expressions ---------------------------
complex_pools <- list(
  "Flagged Patients" = rlang::expr(FLAG == "Y"),
  "Drug A Flagged"   = rlang::expr(TRT01A == "Drug A" & FLAG == "Y")
)

adam_db_complex <- df_add_poolings(adam_db, pools = complex_pools, keep_original = FALSE)
print(adam_db_complex$adsl)


# Example D: Use yaml to define the pools config and run the function ------------
# Creating Dummy Data
adex <- data.frame(
  USUBJID = c("001", "002", "003", "004"),
  AEDECOD = c("Headache", "Nausea", "Fatigue", "Dizziness"),
  stringsAsFactors = FALSE
)
adam_db <- list(adsl = adsl, adex = adex, adsl2 = adsl)

# Define the config as a standard R list
config_to_write <- list(
  df_add_poolings_config = list(
    keep_original = FALSE,
    arm_var = "TRT01A",
    pools = list(
      "Drug A + B" = c("Drug A", "Drug B"),
      "Drug C + B" = c("Drug C", "Drug B"),
      "All Patients" = "all"
    )
  )
)

# Write it to a file (using a temp file for this example)
yaml_path <- tempfile(fileext = ".yaml")
yaml::write_yaml(config_to_write, yaml_path)

# Print out what the physical YAML file looks like
cat("--- Contents of the generated YAML file ---\n")
cat(readLines(yaml_path), sep = "\n")
cat("-------------------------------------------\n\n")

# Read the YAML file back into R
arg_specs <- yaml::read_yaml(yaml_path)

# Extract just the poolings config block
pool_args <- arg_specs$df_add_poolings_config

# Run the function
if (!is.null(pool_args)) {
  adam_db_pooled <- df_add_poolings(
    adam_db       = adam_db,
    pools         = pool_args$pools,
    arm_var       = pool_args$arm_var,
    keep_original = pool_args$keep_original
  )
}

# View the result
adam_db_pooled$adsl2

Generate Table of Pairwise Cox-PH and Log-Rank Results

Description

This function performs pairwise comparisons of treatment arms using the Cox Proportional Hazards model and calculates the corresponding log-rank p-value. Each comparison tests a non-reference group against a specified reference group.

Usage

get_cox_pairwise_df(
  model_formula,
  data,
  arm,
  ref_group = NULL,
  ties = c("exact", "efron", "breslow"),
  test = c("log-rank", "gehan-breslow", "tarone", "peto", "prentice",
    "fleming-harrington", "likelihood-ratio"),
  ...
)

Arguments

Details

The function iterates through each non-reference arm, subsets the data to the current arm and the reference arm, and then:

• Fits a Cox model using survival::coxph().

• Computes a p-value, which dispatches to coin::logrank_test() for weighted log-rank variants or to a nested survival::coxph() LRT for the likelihood-ratio test.

Value

A data.frame with one row per comparison arm (stored as rownames). The columns are:

• HR: The Hazard Ratio formatted to two decimal places.

• conf.int (default 0.95): Adjusts the confidence interval level. Note: Changing this value dynamically updates the corresponding column name in the output (e.g., passing 0.99 renames the column to "99% CI").

• ⁠p-value (<test>)⁠: The p-value from the selected test, where ⁠<test>⁠ is the title-cased test name (e.g., "p-value (log-rank)").

Note

When robust = TRUE is specified, the Hazard Ratio and Confidence Intervals are computed using robust sandwich standard errors. However, the p-values across all tests (including the likelihood-ratio test) are calculated using standard, non-robust model variances.

See Also

annotate_gg_km(), gg_km(), survival::coxph(), coin::logrank_test().

Examples

# Example data setup (assuming 'time' is event time, 'status'
# is event indicator (1=event), and 'arm' is the treatment group)
# for data handling
library(dplyr)
library(survival)
# Prepare data in a modern dplyr-friendly way
surv_data <- lung |>
  mutate(
    arm = factor(sample(c("A", "B", "C"), n(), replace = TRUE)),
    status = status - 1 # Convert status to 0/1
  ) |>
  filter(if_all(everything(), ~ !is.na(.)))

formula <- Surv(time, status) ~ arm

# Example 1: Default usage (ties = "exact", test = "log-rank")
results_default <- get_cox_pairwise_df(
  model_formula = formula,
  data = surv_data,
  arm = "arm",
  ref_group = "A"
)
print(results_default)

# Example 2: Using Breslow ties and the Gehan-Breslow test
results_wilcoxon <- get_cox_pairwise_df(
  model_formula = formula,
  data = surv_data,
  arm = "arm",
  ref_group = "A",
  ties = "breslow",
  test = "gehan-breslow"
)
print(results_wilcoxon)

# Example 3: Using Efron ties and the Likelihood-Ratio test
results_lr <- get_cox_pairwise_df(
  model_formula = formula,
  data = surv_data,
  arm = "arm",
  ref_group = "A",
  ties = "efron",
  test = "likelihood-ratio"
)
print(results_lr)

Add Error Bars to a ggplot2 Object

Description

Enhances an existing ggplot2 object by adding a stat_summary layer that displays a central tendency (mean or median) alongside a specified measure of dispersion.

Usage

gg_add_stats(
  gg_plt,
  stat = c("mean", "median"),
  variability = c("sd", "se", "ci", "iqr", "none"),
  conf_level = 0.95
)

Arguments

Value

A modified ggplot2 object with an added error bar layer.

Examples

## Not run: 
# Create a base plot with realistic data
p <- ggplot(mtcars, aes(x = factor(cyl), y = mpg)) +
  geom_point(alpha = 0.5)

# Add mean and 95% CI error bars
gg_add_stats(
  gg_plt = p,
  stat = "mean",
  variability = "ci"
)

## End(Not run)

Kaplan-Meier Plot

Description

This set of functions facilitates the creation of Kaplan-Meier survival plots using ggplot2. Use process_survfit() to prepare the survival data from a fitted survfit object, and then gg_km() to generate the Kaplan-Meier plot with various customization options. Additional functions like annot_surv_med(), annot_cox_ph(), and annotate_riskdf() allow for adding summary tables and annotations to the plot.

Usage

process_survfit(fit_km, strata_levels = "All", max_time = NULL)

gg_km(
  surv_plot_data,
  lty = NULL,
  lwd = 0.5,
  censor_show = TRUE,
  size = 2,
  max_time = NULL,
  xticks = NULL,
  yval = c("Survival", "Failure"),
  ylim = NULL,
  font_size = 10,
  legend_pos = NULL
)

Arguments

Details

Data setup assumes "time" is event time, "status" is event indicator (1 represents an event), while "arm" is the treatment group.

Value

The function process_survfit returns a data frame containing the survival curve steps, confidence intervals, and censoring info.

The function gg_km returns a ggplot2 object of the KM plot.

Functions

• process_survfit(): takes a fitted survfit object and processes it into a data frame suitable for plotting a Kaplan-Meier curve with ggplot2. Time zero is also added to the data.

• gg_km(): creates a Kaplan-Meier survival curve, with support for various customizations like censoring marks, Confidence Intervals (CIs), and axis control.

Examples

# Data preparation for KM plot
library(survival)
use_lung <- lung
use_lung$arm <- factor(sample(c("A", "B", "C"), nrow(use_lung), replace = TRUE))
use_lung$status <- use_lung$status - 1 # Convert status to 0/1
use_lung <- na.omit(use_lung)

# Fit Kaplan-Meier model
formula <- Surv(time, status) ~ arm
fit_kmg01 <- survfit(formula, use_lung)

# Process survfit data for plotting
surv_plot_data <- process_survfit(fit_kmg01)
head(surv_plot_data)

# Example of making the KM plot
plt_kmg01 <- gg_km(surv_plot_data)

# Confidence Interval as Ribbon
plt_kmg01 +
  ggplot2::geom_ribbon(alpha = 0.3, lty = 0, na.rm = TRUE)

# Adding Title and Footnotes
plt_kmg01 +
  ggplot2::labs(title = "title", caption = "footnotes")

# Changing xlab and ylab
plt_kmg01 +
  ggplot2::xlab("Another Day") +
  ggplot2::ylab("THE Survival Probability")

Generate a Summary Line Plot from Raw Data

Description

Calculates summary statistics inline using ggplot2::stat_summary(), generating a line plot directly from raw data. Supports configurable central tendencies and dispersion metrics.

Usage

gg_lineplot(
  data,
  x,
  y,
  group = NULL,
  stat = c("mean", "median"),
  variability = c("ci", "sd", "se", "iqr", "none"),
  conf_level = 0.95
)

Arguments

Value

A ggplot object of class crane_gg_line.

See Also

annotate_lineplot_df() for related functionalities.

Examples

set.seed(123)
mock_adlb <- data.frame(
  ARM = rep(c("Treatment A", "Treatment B"), each = 30),
  AVISIT = rep(c(0, 4, 8), 20),
  AVAL = rnorm(60, mean = 10, sd = 2)
)

# 1. Default Plot: Mean with 95% Confidence Intervals
gg_lineplot(
  data = mock_adlb,
  x = AVISIT,
  y = AVAL,
  group = ARM
)

# 2. Median with Interquartile Range (IQR)
gg_lineplot(
  data = mock_adlb,
  x = AVISIT,
  y = AVAL,
  group = ARM,
  stat = "median",
  variability = "iqr"
)

# 3. Ungrouped data with Mean and Standard Deviation +
# Change legend position to top and add horizontal reference line
gg_lineplot(
  data = mock_adlb,
  x = AVISIT,
  y = AVAL,
  group = ARM,
  stat = "mean",
  variability = "sd"
) +
  ggplot2::theme(legend.position = "top") +
  ggplot2::geom_hline(
    yintercept = 30,
    linetype = "dashed",
    color = "gray50"
  )

Create MMRM Line Plot

Description

Generates a standardized line plot for Mixed-Effect Repeated Measures Model (MMRM) analysis. It displays adjusted means (change from baseline) along with either 95% Confidence Intervals (CI) or Standard Errors (SE) over time.

Usage

gg_mmrm_lineplot(
  mmrm_df,
  arm,
  visit,
  error_bar = c("ci", "se"),
  dodge_width = 0.15,
  hline = 0,
  legend_pos = c(0.02, 0.02)
)

Arguments

Value

A ggplot object.

See Also

get_mmrm_results() to get the MMRM results, and tbl_mmrm() for a summary table of the MMRM results.

Examples

library(mmrm)
fv_dt <- mmrm::fev_data |>
  dplyr::mutate(
    ARMCD = factor(ARMCD)
  )
# Fit an MMRM model using the FEV data
fit_mmrm <- mmrm::mmrm(
  formula = FEV1 ~ RACE + SEX + ARMCD * AVISIT + us(AVISIT | USUBJID),
  data = fv_dt
)
mmrm_results <- get_mmrm_results(fit_mmrm, arm = "ARMCD", visit = "AVISIT", conf_level = 0.95)

# Create a plot with SE bars, jittered by 0.2, legend inside bottom-left
my_plot <- gg_mmrm_lineplot(
  mmrm_df = mmrm_results,
  arm = "ARMCD",
  visit = "AVISIT",
  error_bar = "se", # Switch to "ci" for Confidence Intervals
  dodge_width = 0.2, # Jitters the x-axis to prevent overlap
  legend_pos = c(0.02, 0.02)
)

print(my_plot)

Plot Pharmacokinetic Concentration Time Profile

Description

Creates a standard Pharmacokinetic (PK) concentration-time profile plot. This function wraps ggplot2 calls to consistently format PK profiles, handling log transformations, various summary statistics, and variability measures.

Usage

gg_pkc_lineplot(
  data,
  time_var,
  analyte_var,
  group,
  stat = c("mean", "median"),
  variability = c("sd", "se", "ci", "iqr", "none"),
  conf_level = 0.95,
  log_y = TRUE,
  lloq = NA_real_
)

Arguments

Value

A ggplot object.

See Also

annotate_pkc_df() for related functionalities.

Examples

# Prepare PK Data using the built-in Theoph dataset
df_pk <- Theoph
df_pk$Time_Nominal <- round(df_pk$Time)
# Filter to specific timepoints to keep the table clean
df_pk <- df_pk[df_pk$Time_Nominal %in% c(0, 2, 4, 8, 24), ]
# Create a mock treatment group based on Dose
df_pk$Dose_Group <- ifelse(df_pk$Dose > 4.5, "High Dose", "Low Dose")

# Linear Scale Example (Baseline 0 is included)
gg_pkc_lineplot(
  data = df_pk,
  time_var = Time_Nominal,
  analyte_var = conc,
  group = Dose_Group,
  stat = "mean",
  variability = "sd",
  log_y = FALSE
)

# Log Scale Example (Filter out 0s first to avoid log(0) warnings)
df_pk |>
  dplyr::filter(conc > 0) |>
  gg_pkc_lineplot(
    time_var = Time_Nominal,
    analyte_var = conc,
    group = Dose_Group,
    stat = "mean",
    variability = "se",
    log_y = TRUE,
    lloq = 2.0
  )

# Title, subtitle, axes labels and legend position customization
gg_pkc_lineplot(
  data = df_pk,
  time_var = Time_Nominal,
  analyte_var = conc,
  group = Dose_Group,
  stat = "mean",
  variability = "sd",
  log_y = FALSE
) +
  ggplot2::labs(
    x = "Nominal time (hr)",
    y = "Concentration (ng/mL)",
    title = "Title",
    subtitle = "Subtitle"
  ) +
  ggplot2::theme(
    legend.position = "top"
  )

Extract Variable Names from ggplot2 Aesthetic Mappings

Description

This internal helper function safely extracts variable names as character strings from ggplot2 aesthetic mappings (quosures). It is designed to handle both simple symbols (e.g., aes(x = TIME)) and .data pronouns (e.g., aes(x = .data[["TIME"]])). Complex expressions or mathematical operations (e.g., aes(x = TIME / 24)) will safely fall back to returning NULL.

Usage

gg_varname_extraction(mapping_quo)

Arguments

Value

A single character string containing the extracted variable name, or NULL if the variable cannot be safely extracted or is missing.

Examples

## Not run: 

# Create a plot with both standard and .data pronoun mappings
p <- ggplot(mtcars, aes(x = mpg, y = .data[["wt"]]))

# Extracts "mpg"
gg_varname_extraction(p$mapping$x)

# Extracts "wt"
gg_varname_extraction(p$mapping$y)

## End(Not run)

Median Survival Summary Table

Description

Extracts and formats the median survival time and its confidence interval from a fitted Kaplan-Meier object.

Usage

h_tbl_median_surv(fit_km, strata_levels = "All")

Arguments

Value

A data frame with columns "N", "Median", and the confidence interval label.

Examples

NULL

Calculate X-axis Ticks

Description

Determines the positions for x-axis ticks based on the data and user input.

Usage

h_xticks(data, xticks = NULL, max_time = NULL)

Arguments

Value

A numeric vector of x-axis tick positions.

Examples

NULL

Formatting percent and p-values

Description

• label_roche_pvalue() returns formatted p-values.

• label_roche_percent() returns formatted percent values. This function only formats percentages between 0 and 1.

• label_roche_ratio() returns formatted ratios with values below and above a threshold being returned as ⁠< 0.1⁠ and ⁠> 999.9⁠, for example, when digits=1.

• label_roche_number() returns formatted numbers.

Usage

style_roche_pvalue(
  x,
  big.mark = ifelse(decimal.mark == ",", " ", ","),
  decimal.mark = getOption("OutDec"),
  ...
)

label_roche_pvalue(
  big.mark = ifelse(decimal.mark == ",", " ", ","),
  decimal.mark = getOption("OutDec"),
  ...
)

style_roche_percent(
  x,
  digits = 1,
  prefix = "",
  suffix = "",
  scale = 100,
  big.mark = ifelse(decimal.mark == ",", " ", ","),
  decimal.mark = getOption("OutDec"),
  ...
)

label_roche_percent(
  digits = 1,
  suffix = "",
  scale = 100,
  big.mark = ifelse(decimal.mark == ",", " ", ","),
  decimal.mark = getOption("OutDec"),
  ...
)

style_roche_ratio(
  x,
  digits = 2,
  prefix = "",
  suffix = "",
  scale = 1,
  big.mark = ifelse(decimal.mark == ",", " ", ","),
  decimal.mark = getOption("OutDec"),
  ...
)

label_roche_ratio(
  digits = 2,
  prefix = "",
  suffix = "",
  scale = 1,
  big.mark = ifelse(decimal.mark == ",", " ", ","),
  decimal.mark = getOption("OutDec"),
  ...
)

style_roche_number(
  x,
  digits = 0,
  big.mark = ifelse(decimal.mark == ",", " ", ","),
  decimal.mark = getOption("OutDec"),
  scale = 1,
  prefix = "",
  suffix = "",
  na = "NE",
  inf = "NE",
  nan = "NE",
  ...
)

label_roche_number(
  digits = 0,
  big.mark = ifelse(decimal.mark == ",", " ", ","),
  decimal.mark = getOption("OutDec"),
  scale = 1,
  prefix = "",
  suffix = "",
  na = "NE",
  inf = "NE",
  nan = "NE",
  ...
)

Arguments

Value

A character vector of rounded p-values

Examples

# p-value formatting
x <- c(0.0000001, 0.123456)

style_roche_pvalue(x)
label_roche_pvalue()(x)

# percent formatting
x <- c(0.0008, 0.9998)

style_roche_percent(x)
label_roche_percent()(x)

# ratio formatting
x <- c(0.0008, 0.8234, 2.123, 1000)

style_roche_ratio(x)
label_roche_ratio()(x)

# number formatting
x <- c(0.0008, 0.8234, 2.123, 1000, NA, Inf, -Inf)

style_roche_number(x)
label_roche_number()(x)

Remove Markdown Syntax from Header

Description

Remove markdown syntax (e.g. double star for bold, underscore for italic, etc) from the headers and spanning headers of a gtsummary table.

Usage

modify_header_rm_md(x, md = "bold", type = "star")

Arguments

Value

gtsummary table

Examples

tbl_roche_summary(
  data = cards::ADSL,
  include = AGE,
  by = ARM,
  nonmissing = "always"
) |>
  modify_header_rm_md()

Zero Count Recode

Description

Removes the percentage from cells with zero counts. Handles both regular spaces and non-breaking spaces (⁠\u00A0⁠, the HTML ⁠ ⁠ equivalent) that some formatting engines insert.

0 (0.0%)      -->  0
0 (0%)        -->  0
0 (NA%)       -->  0
0 / nn (0%)   -->  0 / nn
0/nn (0.0%)   -->  0/nn
0 / 0 (NA%)   -->  0 / 0

Usage

modify_zero_recode(x)

Arguments

Details

The function is a wrapper for gtsummary::modify_post_fmt_fun().

gtsummary::modify_post_fmt_fun(
  x,
  fmt_fun = \(x) {
    dplyr::case_when(
      # convert "0 (0%)" OR "0 (0.0%)" OR 0 (NA%) to "0"
      str_detect(x, "^0\\s\\((?:0(?:\\.0)?|NA)%\\)$") ~ str_remove(x, pattern = "\\s\\((?:0(?:\\.0)?|NA)%\\)$"),
      # convert "0 / nn (0%)" OR "0/nn (0.0%)" OR 0/0 (NA%) to "0 / nn" OR "0/nn" OR "0/0"
      str_detect(x, pattern = "^(0 ?/) ?\\d+[^()]* \\((?:0(?:\\.0)?|NA)%\\)$") ~ str_remove(x, pattern = "\\s\\((?:0(?:\\.0)?|NA)%\\)$"),
      .default = x
    )
  },
  columns = gtsummary::all_stat_cols()
)

Value

a gtsummary table

Examples

trial |>
  dplyr::mutate(trt = factor(trt, levels = c("Drug A", "Drug B", "Drug C"))) |>
  tbl_summary(include = trt) |>
  modify_zero_recode()

Objects exported from other packages

Description

These objects are imported from other packages. Follow the links below to see their documentation.

dplyr

%>%

gtsummary

add_difference_row(), add_overall(), filter_hierarchical(), sort_hierarchical()

Reverse Confidence Interval

Description

Negates and swaps confidence interval bounds. Takes a CI string in the format "(lower%, upper%)" and returns "(-upper%, -lower%)". This is useful when gtsummary::add_difference_row() computes reference - arm but you need arm - reference.

Usage

reverse_ci(x)

Arguments

Value

A character vector with negated and swapped CI bounds.

See Also

reverse_rate_difference() for reversing rate difference values.

Examples

# Basic usage - negates values and swaps order
reverse_ci(c("(2.5%, 10.0%)", "(-5.0%, 3.0%)"))

# Handles NA and empty strings
reverse_ci(c("(1.0%, 5.0%)", NA, ""))

# Handles negative bounds
reverse_ci("(-8.0%, -2.0%)")

# Example: Reversing direction in a gtsummary table
# When add_difference_row() computes "reference - arm" but you need "arm - reference"
library(gtsummary)

tbl <- trial |>
  tbl_summary(
    by = trt,
    include = response,
    missing = "no"
  ) |>
  add_difference_row(
    include = response,
    reference = "Drug A",
    statistic = response ~ c("{estimate}", "({conf.low}, {conf.high})"),
    estimate_fun = response ~ label_style_number(digits = 1, scale = 100, suffix = "%")
  )

# Reverse the direction using modify_table_body
tbl |>
  modify_table_body(
    ~ .x |>
      dplyr::mutate(
        dplyr::across(
          dplyr::starts_with("stat_"),
          ~ ifelse(variable == "response-row_difference" & label == "Rate Difference",
            reverse_rate_difference(.x), .x
          )
        )
      ) |>
      dplyr::mutate(
        dplyr::across(
          dplyr::starts_with("stat_"),
          ~ ifelse(variable == "response-row_difference" &
            label == "(CI Lower Bound, CI Upper Bound)",
          reverse_ci(.x), .x
          )
        )
      )
  )

Reverse Rate Difference

Description

Negates numeric rate difference values while preserving any suffix (e.g., "%"). This is useful when gtsummary::add_difference_row() computes reference - arm but you need arm - reference.

Usage

reverse_rate_difference(x)

Arguments

Value

A character vector with negated numeric values.

See Also

Usually used together with reverse_ci() for reversing confidence intervals; see examples there for usage with gtsummary::modify_table_body().

Examples

# Basic usage with percentage suffix
reverse_rate_difference(c("5.0%", "-3.2%", "0.0%"))

# Handles NA and empty strings
reverse_rate_difference(c("2.5%", NA, "", "-1.0%"))

# Works with values without suffix
reverse_rate_difference(c("10.0", "-5.5"))

Change from Baseline

Description

Typical use is tabulating changes from baseline measurement of an Analysis Variable.

Usage

tbl_baseline_chg(
  data,
  baseline_level,
  denominator,
  by = NULL,
  digits = NULL,
  statistic = gtsummary::all_continuous() ~ c("{mean} ({sd})", "{median}",
    "{min} - {max}"),
  id = "USUBJID",
  visit = "AVISIT",
  visit_number = "AVISITN",
  analysis_variable = "AVAL",
  change_variable = "CHG"
)

## S3 method for class 'tbl_baseline_chg'
add_overall(
  x,
  last = FALSE,
  col_label = "All Participants  \n(N = {style_roche_number(n)})",
  ...
)

Arguments

Value

A gtsummary table.

Examples

theme_gtsummary_roche()

df <- cards::ADLB |>
  dplyr::mutate(AVISIT = trimws(AVISIT)) |>
  dplyr::filter(
    AVISIT != "End of Treatment",
    PARAMCD %in% c("SODIUM", "K")
  )

tbl_baseline_chg(
  data = df |> dplyr::filter(PARAMCD == "SODIUM"),
  baseline_level = "Baseline",
  by = "TRTA",
  denominator = cards::ADSL,
  statistic = everything() ~ c("{mean} ({sd})", "{median} ({p25}, {p75})")
)

tbl_baseline_chg(
  data = df |> dplyr::filter(PARAMCD == "K"),
  baseline_level = "Baseline",
  by = "TRTA",
  denominator = cards::ADSL
) |>
  add_overall(last = TRUE, col_label = "All Participants")

# Split by PARAM
tbl_strata(
  data = df,
  strata = PARAMCD,
  .tbl_fun = ~ tbl_baseline_chg(
    data = .x,
    baseline_level = "Baseline",
    by = "TRTA",
    denominator = cards::ADSL
  ),
  .combine_with = "tbl_stack",
  .combine_args = list(group_header = NULL, quiet = TRUE)
) |>
  tbl_split_by_rows(variable_level = ends_with("lbl"))

Pairwise Cox Proportional Hazards Table

Description

Generates a gtsummary table from the pairwise comparison results created by get_cox_pairwise_df(). The table splits the results by comparison arms, presenting the p-value, Hazard Ratio, and 95% Confidence Interval in a stacked layout where statistics form the rows of the table.

Usage

tbl_coxph(pairwise_df)

Arguments

Value

A gtsummary object with additional class tbl_coxph.

See Also

get_cox_pairwise_df().

Examples

# Setup sample survival data
library(survival)
surv_data <- lung |>
  dplyr::mutate(
    arm = factor(sample(c("A", "B", "C"), dplyr::n(), replace = TRUE)),
    status = status - 1
  ) |>
  dplyr::filter(dplyr::if_all(dplyr::everything(), ~ !is.na(.)))

formula <- Surv(time, status) ~ arm

# Generate the pairwise statistics data.frame
pairwise_results <- get_cox_pairwise_df(
  model_formula = formula,
  data = surv_data,
  arm = "arm",
  ref_group = "A"
)

# Example 1: Full table
tbl_coxph(pairwise_df = pairwise_results)

# Example 2: Table with only HR and CI (p-value removed)
pairwise_no_pval <- pairwise_results[, c("HR", "95% CI"), drop = FALSE]
tbl_coxph(pairwise_df = pairwise_no_pval)

# Example 3: Table with only p-values
pairwise_only_pval <- pairwise_results[, 3, drop = FALSE]
tbl_coxph(pairwise_df = pairwise_only_pval)

# Example 4: Customize p-value precision
# Pre-format the p-value column as character before passing to tbl_coxph().
# Character values are displayed as-is (no further formatting applied).
pval_col <- grep("p-value", names(pairwise_results), value = TRUE)
custom <- pairwise_results
custom[[pval_col]] <- ifelse(
  custom[[pval_col]] < 0.001, "<0.001",
  sprintf("%.3f", custom[[pval_col]])
)
tbl_coxph(pairwise_df = custom)

Hierarchical Exposure-Adjusted Incidence Rates

Description

A wrapper function for gtsummary::tbl_hierarchical() to calculate exposure-adjusted incidence rates of adverse events (or other clinical events) across a hierarchy.

The function calculates the incidence rate per specified person-time dynamically. For subjects experiencing an event, Person-Years is calculated from start_date to event_date. For subjects without an event, it is calculated from start_date to end_date.

Usage

tbl_hierarchical_incidence_rate(
  data,
  denominator,
  variables,
  by = NULL,
  id = "USUBJID",
  start_date = "TRTSDT",
  end_date = "TRTEDT",
  event_date = "AESTDTC",
  event_type = c("first_event", "all"),
  n_person_time = 100,
  unit_label = "years",
  conf.level = 0.95,
  conf.type = "normal",
  digits = 2,
  label = NULL
)

Arguments

Value

a gtsummary table of class "tbl_hierarchical_incidence_rate".

Examples

# Dummy denominator dataset with treatment start and end dates
adsl <- data.frame(
  USUBJID = paste0("PT", sprintf("%02d", 1:5)),
  ARM = c("Treatment", "Treatment", "Placebo", "Placebo", "Placebo"),
  TRTSDT = as.Date(rep("2023-01-01", 5)),
  TRTEDT = as.Date(c(
    "2023-12-31", "2023-06-30", "2023-12-31", "2023-08-15", "2023-10-31"
  ))
)

# Dummy AE dataset with onset dates (subset to first occurrences)
adae <- data.frame(
  USUBJID = c("PT02", "PT05", "PT05"),
  AESOC = c("Cardiac", "Nervous", "Cardiac"),
  ARM = c("Treatment", "Placebo", "Placebo"),
  AEDECOD = c("Tachycardia", "Headache", "Palpitations"),
  AESTDTC = c("2023-04-15", "2023-09-10", "2023-10-01")
)

# Build the hierarchical incidence rate table
tbl_hierarchical_incidence_rate(
  data = adae,
  denominator = adsl,
  variables = c(AESOC, AEDECOD),
  by = ARM,
  start_date = TRTSDT,
  end_date = TRTEDT,
  event_date = AESTDTC,
  n_person_time = 100,
  unit_label = "years",
  label = list(
    AESOC = "MedDRA System Organ Class",
    AEDECOD = "MedDRA Preferred Term",
    "..ard_hierarchical_overall.." = "All Adverse Events"
  )
)

Hierarchical Rates and Counts

Description

A mix of adverse event rates (from gtsummary::tbl_hierarchical()) and counts (from gtsummary::tbl_hierarchical_count()). The function produces additional summary rows for the higher level nesting variables providing both rates and counts.

When a hierarchical summary is filtered, the summary rows no longer provide useful/consistent information. When creating a filtered summary, use gtsummary::tbl_hierarchical() or gtsummary::tbl_hierarchical_count() directly, followed by a call to gtsummary::filter_hierarchical().

Usage

tbl_hierarchical_rate_and_count(
  data,
  variables,
  denominator,
  by = NULL,
  id = "USUBJID",
  label = NULL,
  digits = NULL,
  sort = NULL,
  label_overall_rate = "Total number of participants with at least one adverse event",
  label_overall_count = "Overall total number of events",
  label_rate = "Total number of participants with at least one adverse event",
  label_count = "Total number of events"
)

## S3 method for class 'tbl_hierarchical_rate_and_count'
add_overall(
  x,
  last = FALSE,
  col_label = "All Participants  \n(N = {style_roche_number(N)})",
  ...
)

Arguments

Details

Factor levels and zero-rows

When the first variable in variables is a factor, the function respects its levels and emits zero-rows for any levels not observed in the data. Each unobserved level gets a header row (with NA stats), a rate summary row ("0"), and a count summary row ("0").

This is useful when the set of expected categories is predefined but some may not be present in the data. To exclude categories with no observations, drop unused levels before calling the function (e.g., droplevels()).

Ensures consistent output structure for empty datasets, removing the need for manual workarounds in reporting templates.

Value

a gtsummary table

Examples

# Example 1 ----------------------------------
cards::ADAE[c(1, 2, 3, 8, 16), ] |>
  tbl_hierarchical_rate_and_count(
    variables = c(AEBODSYS, AEDECOD),
    denominator = cards::ADSL,
    by = TRTA
  ) |>
  add_overall(last = TRUE)

# Example 2: factor with unobserved levels ----------------------------------
# Adding an unobserved SOC level produces zero-rows automatically
cards::ADAE[c(1, 2, 3, 8, 16), ] |>
  dplyr::mutate(
    AEBODSYS = factor(AEBODSYS, levels = c(unique(AEBODSYS), "UNOBSERVED SOC"))
  ) |>
  tbl_hierarchical_rate_and_count(
    variables = c(AEBODSYS, AEDECOD),
    denominator = cards::ADSL,
    by = TRTA
  )

AE Rates by Highest Toxicity Grade

Description

A wrapper function for gtsummary::tbl_hierarchical() to calculate rates of highest toxicity grades with the options to add rows for grade groups and additional summary sections at each variable level.

Only the highest grade level recorded for each subject will be analyzed. Prior to running the function, ensure that the toxicity grade variable (grade) is a factor variable, with factor levels ordered lowest to highest.

Grades will appear in rows in the order of the factor levels given, with each grade group appearing prior to the first level in its group.

Usage

tbl_hierarchical_rate_by_grade(
  data,
  variables,
  denominator,
  by = NULL,
  id = "USUBJID",
  include_overall = everything(),
  statistic = everything() ~ "{n} ({p}%)",
  label = NULL,
  digits = NULL,
  sort = "alphanumeric",
  filter = NULL,
  grade_groups = list(),
  grades_exclude = NULL,
  keep_zero_rows = FALSE
)

## S3 method for class 'tbl_hierarchical_rate_by_grade'
add_overall(
  x,
  last = FALSE,
  col_label = "**Overall**  \nN = {style_number(N)}",
  statistic = NULL,
  digits = NULL,
  ...
)

add_grade_column(x)

Arguments

Details

This function returns a structurally pristine table where the label column retains unique grade text (e.g., "1", "2", "Grade 1-2"). This preserves row uniqueness required by gtsummary::tbl_merge() and tbl_with_pools(). To apply visual formatting (grade column, label blanking, header styling), pipe the result through add_grade_column() after any merging operations.

When using the filter argument, the filter will be applied to the second variable from variables, i.e. the adverse event terms variable. If an AE does not meet the filtering criteria, the AE overall row as well as all grade and grade group rows within an AE section will be excluded from the table. Filtering out AEs does not exclude the records corresponding to these filtered out rows from being included in rate calculations for overall sections. If all AEs for a given SOC have been filtered out, the SOC will be excluded from the table. If all AEs are filtered out and the SOC variable is included in include_overall the ⁠- Any adverse events -⁠ section will still be kept.

See gtsummary::filter_hierarchical() for more details and examples.

add_grade_column()

Post-processing function that applies visual formatting to tables generated by tbl_hierarchical_rate_by_grade(). Must be called after any merging (e.g., via tbl_with_pools()) to avoid Cartesian join explosions caused by blanking the label column prior to merge.

The function extracts metadata injected by tbl_hierarchical_rate_by_grade() via x$custom_info (standalone tables) or the first sub-table's custom_info (merged tables). If no metadata is found, the function aborts with an informative error.

add_grade_column() only works on tables produced by tbl_hierarchical_rate_by_grade() — it reads the custom_info metadata that function stores. They share a help page because they are designed to be used together: build the table first, optionally merge with gtsummary::tbl_merge() or tbl_with_pools(), then call add_grade_column() as the final step.

Value

a gtsummary table of class "tbl_hierarchical_rate_by_grade".

Examples

theme_gtsummary_roche()
ADSL <- cards::ADSL
ADAE_subset <- cards::ADAE |>
  dplyr::filter(
    AESOC %in% unique(cards::ADAE$AESOC)[1:5],
    AETERM %in% unique(cards::ADAE$AETERM)[1:10]
  )

grade_groups <- list(
  "Grade 1-2" = c("1", "2"),
  "Grade 3-4" = c("3", "4"),
  "Grade 5" = "5"
)

# Example 1 ----------------------------------
tbl_hierarchical_rate_by_grade(
  ADAE_subset,
  variables = c(AEBODSYS, AEDECOD, AETOXGR),
  denominator = ADSL,
  by = TRTA,
  label = list(
    AEBODSYS = "MedDRA System Organ Class",
    AEDECOD = "MedDRA Preferred Term",
    AETOXGR = "Grade"
  ),
  grade_groups = grade_groups,
  grades_exclude = "5"
) |>
  add_grade_column()

# Example 2 ----------------------------------
# Filter: Keep AEs with an overall prevalence of greater than 10%
tbl_hierarchical_rate_by_grade(
  ADAE_subset,
  variables = c(AEBODSYS, AEDECOD, AETOXGR),
  denominator = ADSL,
  by = TRTA,
  grade_groups = list("Grades 1-2" = c("1", "2"), "Grades 3-5" = c("3", "4", "5")),
  filter = sum(n) / sum(N) > 0.10
) |>
  add_overall(last = TRUE) |>
  add_grade_column()

Create listings from a data frame

Description

This function creates a listing from a data frame. Common uses rely on few pre-processing steps, such as ensuring unique values in key columns or split by rows or columns. They are described in the note section.

Usage

tbl_listing(
  data,
  split_by_rows = list(),
  split_by_columns = list(),
  add_blank_rows = list()
)

remove_duplicate_keys(x, keys = NULL, value = NA)

Arguments

Value

A table listing of class "tbl_listing".

Note

Common pre-processing steps for the data frame that may be common:

• Unique values - this should be enforced in pre-processing by users.

• NA values - they are not printed by default in {gtsummary}. You can make them explicit if they need to be displayed in the listing. See example 3.

• Sorting key columns and moving them to the front. See the examples pre-processing.

Splitting the listing

• Split by rows - you can split the data frame by rows by using split_by_rows parameter. You can use the same parameters used in gtsummary::tbl_split_by_rows(). See example 4.

• Split by columns - you can split the data frame by columns by using split_by_columns parameter. Use the same parameters from gtsummary::tbl_split_by_rows(). See example 5.

Examples

# Load the trial dataset
trial_data <- trial |>
  dplyr::select(trt, age, marker, stage) |>
  dplyr::filter(stage %in% c("T2", "T3")) |>
  dplyr::slice_head(n = 2, by = c(trt, stage)) |> # downsampling
  dplyr::arrange(trt, stage) |> # key columns should be sorted
  dplyr::relocate(trt, stage) # key columns should be first

# Example 1 --------------------------------
out <- tbl_listing(trial_data)
out
out |> remove_duplicate_keys(keys = "trt")

# Example 2 --------------------------------
# make NAs explicit
trial_data_na <- trial_data |>
  mutate(across(everything(), ~ tidyr::replace_na(labelled::to_character(.), "-")))
tbl_listing(trial_data_na)

# Example 3 --------------------------------
# Add blank rows for first key column
lst <- tbl_listing(trial_data_na, add_blank_rows = list(variable_level = "trt"))
lst

# Can add them also manually in post-processing
lst |> add_blank_rows(row_numbers = seq(2))

# Example 4 --------------------------------
# Split by rows
list_lst <- tbl_listing(trial_data, split_by_rows = list(row_numbers = c(2, 3, 4)))
list_lst[[2]]

# Example 5 --------------------------------
# Split by columns
show_header_names(lst)
grps <- list(c("trt", "stage", "age"), c("trt", "stage", "marker"))
list_lst <- tbl_listing(trial_data, split_by_columns = list(groups = grps))
list_lst[[2]]

# Example 6 --------------------------------
# Split by rows and columns
list_lst <- tbl_listing(trial_data,
  split_by_rows = list(row_numbers = c(2, 3, 4)), split_by_columns = list(groups = grps)
)
length(list_lst) # 8 tables are flatten out
list_lst[[2]]

# Example 7 --------------------------------
# Hide duplicate columns in post-processing
out <- list_lst |>
  remove_duplicate_keys(keys = c("trt", "stage"))
out[[2]]

Get and display MMRM Results in a Formatted Table

Description

These functions take a fitted MMRM model object and creates a formatted table, following the style of the MMRM template. It combines baseline summary statistics (if available) with the MMRM results, presenting them in a clear and organized manner.

Usage

get_mmrm_results(fit_mmrm, arm, visit, conf_level = 0.95)

tbl_mmrm(
  mmrm_df,
  base_df = NULL,
  arm,
  visit,
  baseline_aval = NULL,
  digits = c(2, 3, 4)
)

Arguments

Value

A data.frame containing the estimated marginal means (adjusted means) and contrasts (differences in adjusted means) for each visit and arm, along with their standard errors, confidence intervals, degrees of freedom, and sample sizes. This data frame is structured to facilitate the creation of a formatted table using tbl_mmrm().

tbl_mmrm returns a 'gtsummary' table object.

See Also

gg_mmrm_lineplot() for visualizing MMRM results.

Examples

library(mmrm)
fv_dt <- mmrm::fev_data |>
  dplyr::mutate(
    ARMCD = sprintf(
      "%s\n(N = %d)", ARMCD,
      table(mmrm::fev_data$ARMCD)[ARMCD]
    ),
    ARMCD = factor(ARMCD)
  )


# Fit an MMRM model using the FEV data
fit_mmrm <- mmrm::mmrm(
  # us -> unstructured cov structure
  formula = FEV1 ~ RACE + SEX + ARMCD * AVISIT + us(AVISIT | USUBJID),
  data = fv_dt
)
mmrm_results <- get_mmrm_results(fit_mmrm, arm = "ARMCD", visit = "AVISIT", conf_level = 0.95)


tbl_mmrm(
  mmrm_results,
  fv_dt |> dplyr::mutate(AVISIT = "Baseline"),
  arm = "ARMCD", visit = "AVISIT", baseline_aval = "FEV1"
)

Creates null report

Description

This function creates a null report for tables or listings without any statistics.

Usage

tbl_null_report(
  label = "No observations met the reporting criteria for this output."
)

Arguments

Value

A gtsummary object of class tbl_null_report.

Examples

tbl_null_report(label = "No data available for the selected criteria.")

Risk Management Plan Table (RMPT)

Description

Creates a summary table showing participant counts and person-time exposure across categories of exposure duration. The table displays both:

• Number and percentage of participants in each exposure duration category

• Total person-time (sum of exposure durations) for each category

By default, the table does not stratify by treatment arms. Please refer to the RMP Best Practice documents for guidance.

Total person-time is computed by summing up the exposure duration (e.g., AVAL) across all participants within each category. The unit can be days, months or years depending on the use-case.

Usage

tbl_rmpt(
  data,
  variable,
  aval,
  by = NULL,
  id = "USUBJID",
  denominator,
  label = "Duration of exposure"
)

## S3 method for class 'tbl_rmpt'
add_overall(
  x,
  last = FALSE,
  col_label = "All Participants  \n(N = {style_roche_number(n)})",
  ...
)

Arguments

Value

A gtsummary table.

Examples

# Create example exposure data

df_adsl <- pharmaverseadam::adsl |> dplyr::filter(SAFFL == "Y")
df_adex <- pharmaverseadam::adex |>
  dplyr::filter(PARAMCD == "TDURD", PARCAT1 == "OVERALL", SAFFL == "Y") |>
  dplyr::mutate(
    AVAL_MONTH = AVAL / 30.4375,
    AVAL_CAT = factor(
      dplyr::case_when(
        AVAL_MONTH < 1 ~ "< 1 month",
        AVAL_MONTH >= 1 & AVAL_MONTH < 3 ~ "1 to <3 months",
        AVAL_MONTH >= 3 & AVAL_MONTH < 6 ~ "3 to <6 months",
        TRUE ~ ">=6 months"
      ),
      levels = c("< 1 month", "1 to <3 months", "3 to <6 months", ">=6 months")
    )
  ) |>
  dplyr::select(
    USUBJID,
    SEX,
    ETHNIC,
    RACE,
    AGEGR1,
    AVAL,
    AVAL_MONTH,
    AVAL_CAT,
    TRT01A
  )
# Example 1 --------------------------------
# Create basic RMPT table
tbl_rmpt(
  data = df_adex,
  variable = AVAL_CAT,
  aval = AVAL,
  by = TRT01A,
  denominator = df_adsl
)

# Example 2 --------------------------------
# Add overall column at the end

tbl_rmpt(
  data = df_adex,
  variable = AVAL_CAT,
  aval = AVAL,
  by = TRT01A,
  denominator = df_adsl
) |>
  add_overall(last = TRUE)

# Example 3 --------------------------------
# RMPT table for other variables (age group and sex), add label
tbl_rmpt(
  data = df_adex,
  variable = AGEGR1,
  aval = AVAL,
  by = SEX,
  denominator = df_adsl,
  label = "Treatment Exposure Duration"
)

Subgroup Analyses

Description

Function adapted from gtforester::tbl_subgroups().

Usage

tbl_roche_subgroups(data, rsp, by, subgroups, .tbl_fun, time_to_event = NULL)

Arguments

Value

a 'gtsummary' table

Examples

set.seed(1)

# prepare sample data
df_adtte <- data.frame(
  time = rexp(100, rate = 0.1),
  status = sample(c(0, 1), 100, replace = TRUE),
  arm = sample(c("Arm A", "Arm B"), 100, replace = TRUE),
  grade = sample(c("I", "II"), 100, replace = TRUE),
  strata = sample(c("1", "2"), 100, replace = TRUE)
) |>
  mutate(arm = relevel(factor(arm), ref = "Arm A")) # Set Reference

# logistic regression -------------------------------------------------------
df_adtte |>
  tbl_roche_subgroups(
    rsp = "status",
    by = "arm",
    subgroups = c("grade"),
    .tbl_fun =
      ~ glm(status ~ arm, data = .x) |>
        tbl_regression(
          show_single_row = arm,
          exponentiate = TRUE # , tidy_fun = broom.helpers::tidy_parameters
        )
  ) |>
  modify_header(starts_with("estimate") ~ "**Odds Ratio**")


# coxph regression ----------------------------------------------------------
# please use browser() inside .tbl_fun to check if the coxph model throws an error
# and use tryCatch to modify the input/output accordingly

df_adtte |>
  tbl_roche_subgroups(
    rsp = status,
    by = arm,
    time_to_event = time, # Specify time variable for time-to-event analyses (different mid table)
    subgroups = c(grade, strata),
    ~ survival::coxph( # Please use coxph for time-to-event analyses
      survival::Surv(time, status) ~ arm,
      data = .x,
      ties = "exact"
    ) |> # Exact Ties
      tbl_regression(
        show_single_row = arm,
        exponentiate = TRUE # Get Hazard Ratios
      )
  ) |>
  modify_header(starts_with("estimate") ~ "**Hazard Ratio**")

Roche Summary Table

Description

This is a thin wrapper of gtsummary::tbl_summary() with the following differences:

• Default summary type for continuous variables is 'continuous2'.

• Number of non-missing observations, when requested, is added for each variable and placed on the row under the variable label/header.

• The ⁠tbl_summary(missing*)⁠ arguments have been renamed to ⁠tbl_roche_summary(nonmissing*)⁠ with updated default values.

• The default footnotes from tbl_summary() are removed.

• Cells with "0 (0.0%)" are converted to "0" with gtsummary::modify_post_fmt_fun().

Usage

tbl_roche_summary(
  data,
  by = NULL,
  label = NULL,
  statistic = list(gtsummary::all_continuous() ~ c("{mean} ({sd})", "{median}",
    "{min} - {max}"), gtsummary::all_categorical() ~ "{n} ({p}%)"),
  digits = NULL,
  type = NULL,
  value = NULL,
  nonmissing = c("no", "always", "ifany"),
  nonmissing_text = "n",
  nonmissing_stat = "{N_nonmiss}",
  sort = gtsummary::all_categorical(FALSE) ~ "alphanumeric",
  percent = c("column", "row", "cell"),
  include = everything()
)

Arguments

Value

a 'gtsummary' table

Examples

# Example 1 ----------------------------------
trial |>
  tbl_roche_summary(
    by = trt,
    include = c(age, grade),
    nonmissing = "always"
  ) |>
  add_overall()

Shift Table

Description

Typical use is tabulating post-baseline measurement stratified by the baseline measurement.

Usage

tbl_shift(
  data,
  variable,
  strata = NULL,
  by = NULL,
  data_header = NULL,
  strata_location = c("new_column", "header"),
  strata_label = "{strata}",
  header = "{level}  \nN = {n}",
  label = NULL,
  nonmissing = "always",
  nonmissing_text = "Total",
  ...
)

## S3 method for class 'tbl_shift'
add_overall(
  x,
  col_label = "All Participants  \n(N = {style_roche_number(n)})",
  last = FALSE,
  ...
)

Arguments

Details

Broadly, this function is a wrapper for chunk below with some additional calls to ⁠gtsummary::modify_*()⁠ function to update the table's headers, indentation, column alignment, etc.

gtsummary::tbl_strata2(
  data = data,
  strata = strata,
   ~ tbl_roche_summary(.x, include = variable, by = by)
)

Value

a 'gtsummary' table

Examples

library(dplyr, warn.conflicts = FALSE)

# subsetting ADLB on one PARAM, and the highest grade
adlb <- pharmaverseadam::adlb |>
  dplyr::select("USUBJID", "TRT01A", "PARAM", "PARAMCD", "ATOXGRH", "BTOXGRH", "VISITNUM") |>
  mutate(TRT01A = factor(TRT01A)) |>
  dplyr::filter(PARAMCD %in% c("CHOLES", "GLUC")) |>
  slice_max(by = c(USUBJID, PARAMCD), order_by = ATOXGRH, n = 1L, with_ties = FALSE) |>
  labelled::set_variable_labels(
    BTOXGRH = "Baseline  \nNCI-CTCAE Grade",
    ATOXGRH = "Post-baseline  \nNCI-CTCAE Grade"
  )
adsl <- pharmaverseadam::adsl[c("USUBJID", "TRT01A")] |>
  dplyr::filter(TRT01A != "Screen Failure")

# Example 1 ----------------------------------
# tabulate baseline grade by worst grade
tbl_shift(
  data = dplyr::filter(adlb, PARAMCD %in% "CHOLES"),
  strata = BTOXGRH,
  variable = ATOXGRH,
  by = TRT01A,
  data_header = adsl
)

# Example 2 ----------------------------------
# same as Ex1, but with the stratifying variable levels in header rows
adlb |>
  dplyr::filter(PARAMCD %in% "CHOLES") |>
  labelled::set_variable_labels(
    BTOXGRH = "Baseline NCI-CTCAE Grade",
    ATOXGRH = "Post-baseline NCI-CTCAE Grade"
  ) |>
  tbl_shift(
    data = ,
    strata = BTOXGRH,
    variable = ATOXGRH,
    strata_location = "header",
    by = TRT01A,
    data_header = adsl
  )

# Example 3 ----------------------------------
# same as Ex2, but with two labs
adlb |>
  labelled::set_variable_labels(
    BTOXGRH = "Baseline NCI-CTCAE Grade",
    ATOXGRH = "Post-baseline NCI-CTCAE Grade"
  ) |>
  tbl_strata_nested_stack(
    strata = PARAM,
    ~ .x |>
      tbl_shift(
        strata = BTOXGRH,
        variable = ATOXGRH,
        strata_location = "header",
        by = TRT01A,
        data_header = adsl
      )
  ) |>
  # Update header with Lab header and indentation (the '\U00A0' character adds whitespace)
  modify_header(
    label = "Lab  \n\U00A0\U00A0\U00A0\U00A0
             Baseline NCI-CTCAE Grade  \n\U00A0\U00A0\U00A0\U00A0\U00A0\U00A0\U00A0\U00A0
             Post-baseline NCI-CTCAE Grade"
  )

# Example 4 ----------------------------------
# Include the treatment variable in a new column
filter(adlb, PARAMCD %in% "CHOLES") |>
  right_join(
    pharmaverseadam::adsl[c("USUBJID", "TRT01A")] |>
      dplyr::filter(TRT01A != "Screen Failure"),
    by = c("USUBJID", "TRT01A")
  ) |>
  tbl_shift(
    strata = TRT01A,
    variable = BTOXGRH,
    by = ATOXGRH,
    header = "{level}",
    strata_label = "{strata}, N={n}",
    label = list(TRT01A = "Actual Treatment"),
    percent = "cell",
    nonmissing = "no"
  ) |>
  modify_spanning_header(all_stat_cols() ~ "Worst Post-baseline NCI-CTCAE Grade")

Survival Quantiles

Description

Create a gtsummary table with Kaplan-Meier estimated survival quantiles. If you must further customize the way these results are presented, see the Details section below for the full details.

Usage

tbl_survfit_quantiles(
  data,
  y = "survival::Surv(time = AVAL, event = 1 - CNSR, type = 'right', origin = 0)",
  by = NULL,
  header = "Time to event",
  estimate_fun = label_roche_number(digits = 1, na = "NE"),
  method.args = list(conf.int = 0.95, conf.type = "plain")
)

## S3 method for class 'tbl_survfit_quantiles'
add_overall(
  x,
  last = FALSE,
  col_label = "All Participants  \nN = {style_roche_number(N)}",
  ...
)

Arguments

Value

a gtsummary table

ARD-first

This function is a helper for creating a common summary. But if you need to modify the appearance of this table, you may need to build it from ARDs.

Here's the general outline for creating this table directly from ARDs.

1. Create an ARD of survival quantiles using cardx::ard_survival_survfit().

2. Construct an ARD of the minimum and maximum survival times using cards::ard_summary().

3. Combine the ARDs and build summary table with gtsummary::tbl_ard_summary().

# get the survival quantiles with 95% CI
ard_surv_quantiles <-
  cardx::ard_survival_survfit(
    x = cards::ADTTE,
    y = survival::Surv(time = AVAL, event = 1 - CNSR, type = 'right', origin = 0),
    variables = "TRTA",
    probs = c(0.25, 0.50, 0.75)
  ) |>
  # modify the shape of the ARD to look like a
  # 'continuous' result to feed into `tbl_ard_summary()`
  dplyr::mutate(
    stat_name = paste0(.data$stat_name, 100 * unlist(.data$variable_level)),
    variable_level = list(NULL)
  )

# get the min/max followup time
ard_surv_min_max <-
  cards::ard_summary(
    data = cards::ADTTE,
    variables = AVAL,
    by = "TRTA",
    statistic = everything() ~ cards::continuous_summary_fns(c("min", "max"))
  )

# stack the ARDs and pass them to `tbl_ard_summary()`
cards::bind_ard(
  ard_surv_quantiles,
  ard_surv_min_max
) |>
  tbl_ard_summary(
    by = "TRTA",
    type = list(prob = "continuous2", AVAL = "continuous"),
    statistic = list(
      prob = c("{estimate50}", "({conf.low50}, {conf.high50})", "{estimate25}, {estimate75}"),
      AVAL = "{min} to {max}"
    ),
    label = list(
      prob = "Time to event",
      AVAL = "Range"
    )
  ) |>
  # directly modify the labels in the table to match spec
  modify_table_body(
    ~ .x |>
      dplyr::mutate(
        label = dplyr::case_when(
          .data$label == "Survival Probability" ~ "Median",
          .data$label == "(CI Lower Bound, CI Upper Bound)" ~ "95% CI",
          .data$label == "Survival Probability, Survival Probability" ~ "25% and 75%-ile",
          .default = .data$label
        )
      )
  ) |>
  # update indentation to match spec
  modify_indent(columns = "label", rows = label == "95% CI", indent = 8L) |>
  modify_indent(columns = "label", rows = .data$label == "Range", indent = 4L) |>
  # remove default footnotes
  remove_footnote_header(columns = all_stat_cols())

Examples

# Example 1 ----------------------------------
tbl_survfit_quantiles(
  data = cards::ADTTE,
  by = "TRTA",
  estimate_fun = label_roche_number(digits = 1, na = "NE")
) |>
  add_overall(last = TRUE, col_label = "**All Participants**  \nN = {n}")

# Example 2: unstratified analysis -----------
tbl_survfit_quantiles(data = cards::ADTTE)

Survival Times

Description

Create a gtsummary table with Kaplan-Meier estimated survival estimates and specified times.

Usage

tbl_survfit_times(
  data,
  times,
  y = "survival::Surv(time = AVAL, event = 1 - CNSR, type = 'right', origin = 0)",
  by = NULL,
  label = "Time {time}",
  statistic = c("{n.risk}", "{estimate}", "({conf.low}, {conf.high})"),
  estimate_fun = label_roche_number(digits = 1, scale = 100),
  method.args = list(conf.int = 0.95, conf.type = "plain")
)

## S3 method for class 'tbl_survfit_times'
add_difference_row(
  x,
  reference,
  statistic = c("{estimate}", "({conf.low}, {conf.high})", "{p.value}"),
  conf.level = 0.95,
  pvalue_fun = label_roche_pvalue(),
  estimate_fun = label_roche_number(digits = 2, scale = 100),
  ...
)

## S3 method for class 'tbl_survfit_times'
add_overall(
  x,
  last = FALSE,
  col_label = "All Participants  \nN = {style_roche_number(N)}",
  ...
)

Arguments

Details

When the statistic argument is modified, the statistic labels will likely also need to be updated. To change the label, call the modify_table_body() function to directly update the underlying x$table_body data frame.

Value

a gtsummary table

Methods (by generic)

• add_difference_row(tbl_survfit_times): Adds survival differences between groups as additional rows to tables created by tbl_survfit_times().

  Difference statistics are calculated using cardx::ard_survival_survfit_diff() for all tbl_survfit_times(times) variable values, using survfit formula:

  survival::survfit(y ~ by, data = data)
  

  where y, by and data are the inputs of the same names to the tbl_survfit_times() object x.

  Pairwise differences are calculated relative to the specified by variable's specified reference level.

Examples

# Example 1 ----------------------------------
tbl_survfit_times(
  data = cards::ADTTE,
  by = "TRTA",
  times = c(30, 60),
  label = "Day {time}"
) |>
  add_overall()
# Example 2 - Survival Differences -----------
tbl_survfit_times(
  data = cards::ADTTE,
  by = "TRTA",
  times = c(30, 60),
  label = "Day {time}"
) |>
  add_difference_row(reference = "Placebo")

Create a gtsummary table with overlapping pooled columns

Description

Generates a gtsummary table that includes both the original treatment arms and user-defined pooled treatment arms. It does this by creating individual tables for the original data and each pool, then merging them together seamlessly using gtsummary::tbl_merge(). This approach keeps the underlying dataset rows completely unique, preserving standard ADaM integrity while bypassing the need for complex pre-processing.

Usage

tbl_with_pools(
  data,
  pools,
  by = "TRT01A",
  denominator = NULL,
  keep_original = TRUE,
  .tbl_fun,
  ...
)

Arguments

Value

A merged gtsummary object of class tbl_merge and tbl_with_pools.

See Also

df_add_poolings() for a more dangerous pre-processing approach that modifies the underlying datasets to create pooled rows (not recommended).

Examples

# Create minimal dummy ADaM data
adsl <- data.frame(
  USUBJID = c("001", "002", "003", "004", "005"),
  TRT01A = c("Drug A", "Drug A", "Drug B", "Drug C", "Drug C"),
  AGE = c(45, 50, 60, 65, 55),
  FLAG = c("Y", "N", "Y", "N", "Y"),
  stringsAsFactors = FALSE
)

adae <- data.frame(
  USUBJID = c("001", "001", "002", "004", "005"),
  TRT01A = c("Drug A", "Drug A", "Drug A", "Drug C", "Drug C"),
  AEBODSYS = c("SOC1", "SOC1", "SOC2", "SOC1", "SOC2"),
  AEDECOD = c("PT1", "PT2", "PT3", "PT1", "PT4"),
  FLAG = c("Y", "Y", "N", "N", "Y"),
  stringsAsFactors = FALSE
)

# Define the requested pools
my_pools <- list(
  "Drugs A and B" = c("Drug A", "Drug B"),
  "All Patients"  = "all"
)

# Example A: Safe pooling with standard gtsummary (no denominator) ---------------
safe_pools <- list("Drugs A and B" = c("Drug A", "Drug B"))

tbl_safe <- tbl_with_pools(
  data = adsl,
  pools = safe_pools,
  by = "TRT01A",
  denominator = NULL,
  keep_original = FALSE,
  .tbl_fun = tbl_summary,
  include = AGE
)
tbl_safe

# Example B: Triggering the skipped pool warning ---------------------------------
# This throws a warning because 'Drug Z' has zero patients in the denominator
warning_pools <- list("Drug Z Pool" = c("Drug Z"))

tbl_warning <- tbl_with_pools(
  data = adae,
  pools = warning_pools,
  by = "TRT01A",
  keep_original = TRUE,
  .tbl_fun = tbl_summary,
  include = AEBODSYS
)
tbl_warning

# Example C: Complex pooling using logical expressions ---------------------------
complex_pools <- list(
  "Flagged Patients" = rlang::expr(FLAG == "Y"),
  "Drug A Flagged"   = rlang::expr(TRT01A == "Drug A" & FLAG == "Y")
)

tbl_complex <- tbl_with_pools(
  data = adsl,
  pools = complex_pools,
  by = "TRT01A",
  denominator = NULL,
  keep_original = FALSE,
  .tbl_fun = tbl_summary,
  include = AGE
)
tbl_complex


# Example D: Use yaml to define the pools config and run the function ------------

# Define the config as a standard R list
config_to_write <- list(
  tbl_with_pools_config = list(
    keep_original = FALSE,
    arm_var = "TRT01A",
    pools = list(
      "Drug A + B"   = c("Drug A", "Drug B"),
      "Drug C + B"   = c("Drug C", "Drug B"),
      "All Patients" = "all"
    )
  )
)

# Write it to a file (using a temp file for this example)
yaml_path <- tempfile(fileext = ".yaml")
yaml::write_yaml(config_to_write, yaml_path)

# Print out what the physical YAML file looks like
cat("--- Contents of the generated YAML file ---\n")
cat(readLines(yaml_path), sep = "\n")
cat("-------------------------------------------\n\n")

# Read the YAML file back into R
arg_specs <- yaml::read_yaml(yaml_path)

# Extract just the poolings config block
pool_args <- arg_specs$tbl_with_pools_config

# Run the function using tbl_hierarchical_rate_and_count
if (!is.null(pool_args)) {
  tbl_pooled_yaml <- tbl_with_pools(
    data = adae,
    pools = pool_args$pools,
    by = pool_args$arm_var,
    denominator = adsl,
    keep_original = pool_args$keep_original,
    .tbl_fun = tbl_hierarchical_rate_and_count,
    variables = c(AEBODSYS, AEDECOD)
  )
  tbl_pooled_yaml
}

Roche Theme

Description

A gtsummary theme for Roche tables

• flextable- and gt-printed tables are styled with reduced padding and font size.

• Uses label_roche_pvalue() as the default formatting function for all p-values.

• Uses label_roche_percent() as the default formatting function for all percent values.

• Font size defaults are 8 points for all the table by the footers that are 7 points.

• Border defaults to flextable::fp_border_default(width = 0.5).

• The add_overall(col_label) default value has been updated.

• The results from gtsummary::tbl_hierarchical() and gtsummary::tbl_hierarchical_count() are now post-processed with gtsummary::remove_footnote_header(), crane::modify_zero_recode(), and crane::modify_header_rm_md().

Usage

theme_gtsummary_roche(
  font_size = NULL,
  print_engine = c("flextable", "gt", "kable", "kable_extra", "huxtable", "tibble"),
  set_theme = TRUE
)

Arguments

Value

theme list

Examples

theme_gtsummary_roche()

tbl_roche_summary(
  trial,
  by = trt,
  include = c(age, grade),
  nonmissing = "always"
)

reset_gtsummary_theme()