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SECURITY.md
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+vignettes/missing_values.Rmd
+ missing_values.Rmd
The packages used in this vignette are:
+ +rtables
requires that split variables to be factors.
+When you try and split a variable that isn’t, a warning message will
+appear. Here we purposefully convert the SEX variable to character to
+demonstrate what happens when we try splitting the rows by this
+variable. To fix this, df_explict_na
will convert this to a
+factor resulting in the table being generated.
+adsl <- tern_ex_adsl
+adsl$SEX <- as.character(adsl$SEX)
+
+vars <- c("AGE", "SEX", "RACE", "BMRKR1")
+var_labels <- c(
+ "Age (yr)",
+ "Sex",
+ "Race",
+ "Continous Level Biomarker 1"
+)
+
+result <- basic_table(show_colcounts = TRUE) %>%
+ split_cols_by(var = "ARM") %>%
+ add_overall_col("All Patients") %>%
+ analyze_vars(
+ vars = vars,
+ var_labels = var_labels
+ ) %>%
+ build_table(adsl)
+#> Warning in as_factor_keep_attributes(x, verbose = verbose): automatically
+#> converting character variable x to factor, better manually convert to factor to
+#> avoid failures
+
+#> Warning in as_factor_keep_attributes(x, verbose = verbose): automatically
+#> converting character variable x to factor, better manually convert to factor to
+#> avoid failures
+
+#> Warning in as_factor_keep_attributes(x, verbose = verbose): automatically
+#> converting character variable x to factor, better manually convert to factor to
+#> avoid failures
+
+#> Warning in as_factor_keep_attributes(x, verbose = verbose): automatically
+#> converting character variable x to factor, better manually convert to factor to
+#> avoid failures
+result
+#> A: Drug X B: Placebo C: Combination All Patients
+#> (N=69) (N=73) (N=58) (N=200)
+#> ———————————————————————————————————————————————————————————————————————————————————————————————————————
+#> Age (yr)
+#> n 69 73 58 200
+#> Mean (SD) 34.1 (6.8) 35.8 (7.1) 36.1 (7.4) 35.3 (7.1)
+#> Median 32.8 35.4 36.2 34.8
+#> Min - Max 22.4 - 48.0 23.3 - 57.5 23.0 - 58.3 22.4 - 58.3
+#> Sex
+#> n 69 73 58 200
+#> F 38 (55.1%) 40 (54.8%) 32 (55.2%) 110 (55%)
+#> M 31 (44.9%) 33 (45.2%) 26 (44.8%) 90 (45%)
+#> Race
+#> n 69 73 58 200
+#> ASIAN 38 (55.1%) 43 (58.9%) 29 (50%) 110 (55%)
+#> BLACK OR AFRICAN AMERICAN 15 (21.7%) 13 (17.8%) 12 (20.7%) 40 (20%)
+#> WHITE 11 (15.9%) 12 (16.4%) 11 (19%) 34 (17%)
+#> AMERICAN INDIAN OR ALASKA NATIVE 4 (5.8%) 3 (4.1%) 6 (10.3%) 13 (6.5%)
+#> MULTIPLE 1 (1.4%) 1 (1.4%) 0 2 (1%)
+#> NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER 0 1 (1.4%) 0 1 (0.5%)
+#> OTHER 0 0 0 0
+#> UNKNOWN 0 0 0 0
+#> Continous Level Biomarker 1
+#> n 69 73 58 200
+#> Mean (SD) 6.3 (3.6) 6.7 (3.5) 6.2 (3.3) 6.4 (3.5)
+#> Median 5.4 6.3 5.4 5.6
+#> Min - Max 0.4 - 17.8 1.0 - 18.5 2.4 - 19.1 0.4 - 19.1
rtables
+Here we purposefully convert all M
values to
+NA
in the SEX
variable. After running
+df_explicit_na
the NA
values are encoded as
+<Missing>
but they are not included in the table. As
+well, the missing values are not included in the n
count
+and they are not included in the denominator value for calculating the
+percent values.
+adsl <- tern_ex_adsl
+adsl$SEX[adsl$SEX == "M"] <- NA
+adsl <- df_explicit_na(adsl)
+
+vars <- c("AGE", "SEX")
+var_labels <- c(
+ "Age (yr)",
+ "Sex"
+)
+
+result <- basic_table(show_colcounts = TRUE) %>%
+ split_cols_by(var = "ARM") %>%
+ add_overall_col("All Patients") %>%
+ analyze_vars(
+ vars = vars,
+ var_labels = var_labels
+ ) %>%
+ build_table(adsl)
+result
+#> A: Drug X B: Placebo C: Combination All Patients
+#> (N=69) (N=73) (N=58) (N=200)
+#> ———————————————————————————————————————————————————————————————————————
+#> Age (yr)
+#> n 69 73 58 200
+#> Mean (SD) 34.1 (6.8) 35.8 (7.1) 36.1 (7.4) 35.3 (7.1)
+#> Median 32.8 35.4 36.2 34.8
+#> Min - Max 22.4 - 48.0 23.3 - 57.5 23.0 - 58.3 22.4 - 58.3
+#> Sex
+#> n 38 40 32 110
+#> F 38 (100%) 40 (100%) 32 (100%) 110 (100%)
+#> M 0 0 0 0
If you want the Na
values to be displayed in the table
+and included in the n
count and as the denominator for
+calculating percent values, use the na_level
argument.
+adsl <- tern_ex_adsl
+adsl$SEX[adsl$SEX == "M"] <- NA
+adsl <- df_explicit_na(adsl, na_level = "Missing Values")
+
+result <- basic_table(show_colcounts = TRUE) %>%
+ split_cols_by(var = "ARM") %>%
+ add_overall_col("All Patients") %>%
+ analyze_vars(
+ vars = vars,
+ var_labels = var_labels
+ ) %>%
+ build_table(adsl)
+result
+#> A: Drug X B: Placebo C: Combination All Patients
+#> (N=69) (N=73) (N=58) (N=200)
+#> ————————————————————————————————————————————————————————————————————————————
+#> Age (yr)
+#> n 69 73 58 200
+#> Mean (SD) 34.1 (6.8) 35.8 (7.1) 36.1 (7.4) 35.3 (7.1)
+#> Median 32.8 35.4 36.2 34.8
+#> Min - Max 22.4 - 48.0 23.3 - 57.5 23.0 - 58.3 22.4 - 58.3
+#> Sex
+#> n 69 73 58 200
+#> F 38 (55.1%) 40 (54.8%) 32 (55.2%) 110 (55%)
+#> M 0 0 0 0
+#> Missing Values 31 (44.9%) 33 (45.2%) 26 (44.8%) 90 (45%)
Numeric variables that have missing values are not altered. This
+means that any NA
value in a numeric variable will not be
+included in the summary statistics, nor will they be included in the
+denominator value for calculating the percent values. Here we make any
+value less than 30 missing in the AGE
variable and only the
+valued greater than 30 are included in the table below.
+adsl <- tern_ex_adsl
+adsl$AGE[adsl$AGE < 30] <- NA
+adsl <- df_explicit_na(adsl)
+
+vars <- c("AGE", "SEX")
+var_labels <- c(
+ "Age (yr)",
+ "Sex"
+)
+
+result <- basic_table(show_colcounts = TRUE) %>%
+ split_cols_by(var = "ARM") %>%
+ add_overall_col("All Patients") %>%
+ analyze_vars(
+ vars = vars,
+ var_labels = var_labels
+ ) %>%
+ build_table(adsl)
+result
+#> A: Drug X B: Placebo C: Combination All Patients
+#> (N=69) (N=73) (N=58) (N=200)
+#> ———————————————————————————————————————————————————————————————————————
+#> Age (yr)
+#> n 46 56 44 146
+#> Mean (SD) 37.8 (5.2) 38.3 (6.3) 39.1 (5.9) 38.3 (5.8)
+#> Median 37.2 37.3 37.5 37.5
+#> Min - Max 30.3 - 48.0 30.0 - 57.5 30.5 - 58.3 30.0 - 58.3
+#> Sex
+#> n 69 73 58 200
+#> F 38 (55.1%) 40 (54.8%) 32 (55.2%) 110 (55%)
+#> M 31 (44.9%) 33 (45.2%) 26 (44.8%) 90 (45%)
tern
Tabulation
+The tern
R package provides functions to create common
+analyses from clinical trials in R
. The core functionality
+for tabulation is built on the more general purpose rtables
+package. New users should first begin by reading the “Introduction
+to tern” and “Introduction
+to rtables
” vignettes.
The packages used in this vignette are:
+ +The datasets used in this vignette are:
+
+adsl <- ex_adsl
+adae <- ex_adae
+adrs <- ex_adrs
tern
Analyze Functions
+Analyze functions are used in combination with the
+rtables
layout functions, in the pipeline which creates the
+rtables
table. They apply some statistical logic to the
+layout of the rtables
table. The table layout is
+materialized with the rtables::build_table
function and the
+data.
The tern
analyze functions are wrappers around
+rtables::analyze
function, they offer various methods
+useful from the perspective of clinical trials and other statistical
+projects.
Examples of the tern
analyze functions are
+tern::count_occurrences
,
+tern::summarize_ancova
or tern::analyze_vars
.
+As there is no one prefix to identify all tern
analyze
+functions it is recommended to use the the
+tern website functions reference.
tern
Analyze Functions
+Please skip this subsection if you are not interested in the
+internals of tern
analyze functions.
Internally tern
analyze functions like
+tern::summarize_ancova
are mainly built in the 4 elements
+chain:
h_ancova() -> tern:::s_ancova() -> tern:::a_ancova() -> summarize_ancova()
+The descriptions for each function type:
+h_*
. These functions are
+useful to help define the analysis.s_*
. Statistics functions should do
+the computation of the numbers that are tabulated later. In order to
+separate computation from formatting, they should not take care of
+rcell
type formatting themselves.a_*
. These have the same
+arguments as the corresponding statistics functions, and can be further
+customized by calling rtables::make_afun()
on them. They
+are used as afun
in rtables::analyze()
.rtables::analyze(..., afun = make_afun(tern::a_*))
. Analyze
+functions are used in combination with the rtables
layout
+functions, in the pipeline which creates the table. They are the last
+element of the chain.We will use the native rtables::analyze
function with
+the tern
formatted analysis functions as a
+afun
parameter.
l <- basic_table() %>%
+ split_cols_by(var = "ARM") %>%
+ split_rows_by(var = "AVISIT") %>%
+ analyze(vars = "AVAL", afun = a_summary)
+
+build_table(l, df = adrs)
+The rtables::make_afun
function is helpful when somebody
+wants to attach some format to the formatted analysis function.
afun <- make_afun(
+ a_summary,
+ .stats = NULL,
+ .formats = c(median = "xx."),
+ .labels = c(median = "My median"),
+ .indent_mods = c(median = 1L)
+)
+
+l2 <- basic_table() %>%
+ split_cols_by(var = "ARM") %>%
+ split_rows_by(var = "AVISIT") %>%
+ analyze(vars = "AVAL", afun = afun)
+
+build_table(l2, df = adrs)
+We are going to create 3 different tables using tern
+analyze functions and the rtables
interface.
Table | +
+tern analyze functions |
+
---|---|
Demographic Table | +
+analyze_vars() and
+summarize_num_patients()
+ |
+
Adverse event Table | +count_occurrences() |
+
Response Table | +
+estimate_proportion() ,
+estimate_proportion_diff() and
+test_proportion_diff()
+ |
+
Demographic tables provide a summary of the characteristics of +patients enrolled in a clinical trial. Typically the table columns +represent treatment arms and variables summarized in the table are +demographic properties such as age, sex, race, etc.
+In the example below the only function from tern
is
+analyze_vars()
and the remaining layout functions are from
+rtables
.
+# Select variables to include in table.
+vars <- c("AGE", "SEX")
+var_labels <- c("Age (yr)", "Sex")
+
+basic_table() %>%
+ split_cols_by(var = "ARM") %>%
+ add_overall_col("All Patients") %>%
+ add_colcounts() %>%
+ analyze_vars(
+ vars = vars,
+ var_labels = var_labels
+ ) %>%
+ build_table(adsl)
+#> A: Drug X B: Placebo C: Combination All Patients
+#> (N=134) (N=134) (N=132) (N=400)
+#> ——————————————————————————————————————————————————————————————————————————————
+#> Age (yr)
+#> n 134 134 132 400
+#> Mean (SD) 33.8 (6.6) 35.4 (7.9) 35.4 (7.7) 34.9 (7.4)
+#> Median 33.0 35.0 35.0 34.0
+#> Min - Max 21.0 - 50.0 21.0 - 62.0 20.0 - 69.0 20.0 - 69.0
+#> Sex
+#> n 134 134 132 400
+#> F 79 (59%) 77 (57.5%) 66 (50%) 222 (55.5%)
+#> M 51 (38.1%) 55 (41%) 60 (45.5%) 166 (41.5%)
+#> U 3 (2.2%) 2 (1.5%) 4 (3%) 9 (2.2%)
+#> UNDIFFERENTIATED 1 (0.7%) 0 2 (1.5%) 3 (0.8%)
To change the display order of categorical variables in a table use
+factor variables and explicitly set the order of the levels. This is the
+case for the display order in columns and rows. Note that the
+forcats
package has many useful functions to help with
+these types of data processing steps (not used below).
+# Reorder the levels in the ARM variable.
+adsl$ARM <- factor(adsl$ARM, levels = c("B: Placebo", "A: Drug X", "C: Combination")) # nolint
+
+# Reorder the levels in the SEX variable.
+adsl$SEX <- factor(adsl$SEX, levels = c("M", "F", "U", "UNDIFFERENTIATED")) # nolint
+
+basic_table() %>%
+ split_cols_by(var = "ARM") %>%
+ add_overall_col("All Patients") %>%
+ add_colcounts() %>%
+ analyze_vars(
+ vars = vars,
+ var_labels = var_labels
+ ) %>%
+ build_table(adsl)
+#> B: Placebo A: Drug X C: Combination All Patients
+#> (N=134) (N=134) (N=132) (N=400)
+#> ——————————————————————————————————————————————————————————————————————————————
+#> Age (yr)
+#> n 134 134 132 400
+#> Mean (SD) 35.4 (7.9) 33.8 (6.6) 35.4 (7.7) 34.9 (7.4)
+#> Median 35.0 33.0 35.0 34.0
+#> Min - Max 21.0 - 62.0 21.0 - 50.0 20.0 - 69.0 20.0 - 69.0
+#> Sex
+#> n 134 134 132 400
+#> M 55 (41%) 51 (38.1%) 60 (45.5%) 166 (41.5%)
+#> F 77 (57.5%) 79 (59%) 66 (50%) 222 (55.5%)
+#> U 2 (1.5%) 3 (2.2%) 4 (3%) 9 (2.2%)
+#> UNDIFFERENTIATED 0 1 (0.7%) 2 (1.5%) 3 (0.8%)
The tern
package includes many functions similar to
+analyze_vars()
. These functions are called layout creating
+functions and are used in combination with other rtables
+layout functions just like in the examples above. Layout creating
+functions are wrapping calls to rtables
+analyze()
, analyze_colvars()
and
+summarize_row_groups()
and provide options for easy
+formatting and analysis modifications.
To customize the display for the demographics table, we can do so via
+the arguments in analyze_vars()
. Most layout creating
+functions in tern
include the standard arguments
+.stats
, .formats
, .labels
and
+.indent_mods
which control which statistics are displayed
+and how the numbers are formatted. Refer to the package help with
+help("analyze_vars")
or ?analyze_vars
to see
+the full set of options.
For this example we will change the default summary for numeric +variables to include the number of records, and the mean and standard +deviation (in a single statistic, i.e. within a single cell). For +categorical variables we modify the summary to include the number of +records and the counts of categories. We also modify the display format +for the mean and standard deviation to print two decimal places instead +of just one.
+
+# Select statistics and modify default formats.
+basic_table() %>%
+ split_cols_by(var = "ARM") %>%
+ add_overall_col("All Patients") %>%
+ add_colcounts() %>%
+ analyze_vars(
+ vars = vars,
+ var_labels = var_labels,
+ .stats = c("n", "mean_sd", "count"),
+ .formats = c(mean_sd = "xx.xx (xx.xx)")
+ ) %>%
+ build_table(adsl)
+#> B: Placebo A: Drug X C: Combination All Patients
+#> (N=134) (N=134) (N=132) (N=400)
+#> ————————————————————————————————————————————————————————————————————————————————
+#> Age (yr)
+#> n 134 134 132 400
+#> Mean (SD) 35.43 (7.90) 33.77 (6.55) 35.43 (7.72) 34.88 (7.44)
+#> Sex
+#> n 134 134 132 400
+#> M 55 51 60 166
+#> F 77 79 66 222
+#> U 2 3 4 9
+#> UNDIFFERENTIATED 0 1 2 3
One feature of a layout
is that it can be used with
+different datasets to create different summaries. For example, here we
+can easily create the same summary of demographics for the Brazil and
+China subgroups, respectively:
+lyt <- basic_table() %>%
+ split_cols_by(var = "ARM") %>%
+ add_overall_col("All Patients") %>%
+ add_colcounts() %>%
+ analyze_vars(
+ vars = vars,
+ var_labels = var_labels
+ )
+
+build_table(lyt, df = adsl %>% dplyr::filter(COUNTRY == "BRA"))
+#> B: Placebo A: Drug X C: Combination All Patients
+#> (N=7) (N=13) (N=10) (N=30)
+#> ——————————————————————————————————————————————————————————————————————————————
+#> Age (yr)
+#> n 7 13 10 30
+#> Mean (SD) 32.0 (6.1) 36.7 (6.4) 38.3 (10.6) 36.1 (8.1)
+#> Median 32.0 37.0 35.0 35.5
+#> Min - Max 25.0 - 42.0 24.0 - 47.0 25.0 - 64.0 24.0 - 64.0
+#> Sex
+#> n 7 13 10 30
+#> M 4 (57.1%) 8 (61.5%) 5 (50%) 17 (56.7%)
+#> F 3 (42.9%) 5 (38.5%) 5 (50%) 13 (43.3%)
+#> U 0 0 0 0
+#> UNDIFFERENTIATED 0 0 0 0
+
+build_table(lyt, df = adsl %>% dplyr::filter(COUNTRY == "CHN"))
+#> B: Placebo A: Drug X C: Combination All Patients
+#> (N=81) (N=74) (N=64) (N=219)
+#> ——————————————————————————————————————————————————————————————————————————————
+#> Age (yr)
+#> n 81 74 64 219
+#> Mean (SD) 35.7 (7.3) 33.0 (6.4) 35.2 (6.4) 34.6 (6.8)
+#> Median 36.0 32.0 35.0 34.0
+#> Min - Max 21.0 - 58.0 23.0 - 48.0 21.0 - 49.0 21.0 - 58.0
+#> Sex
+#> n 81 74 64 219
+#> M 35 (43.2%) 27 (36.5%) 30 (46.9%) 92 (42%)
+#> F 45 (55.6%) 44 (59.5%) 29 (45.3%) 118 (53.9%)
+#> U 1 (1.2%) 2 (2.7%) 3 (4.7%) 6 (2.7%)
+#> UNDIFFERENTIATED 0 1 (1.4%) 2 (3.1%) 3 (1.4%)
The standard table of adverse events is a summary by system organ
+class and preferred term. For frequency counts by preferred term, if
+there are multiple occurrences of the same AE
in an
+individual we count them only once.
To create this table we will need to use a combination of several +layout creating functions in a tabulation pipeline.
+We start by creating the high-level summary. The layout creating
+function in tern
that can do this is
+summarize_num_patients()
:
+basic_table() %>%
+ split_cols_by(var = "ACTARM") %>%
+ add_colcounts() %>%
+ add_overall_col(label = "All Patients") %>%
+ summarize_num_patients(
+ var = "USUBJID",
+ .stats = c("unique", "nonunique"),
+ .labels = c(
+ unique = "Total number of patients with at least one AE",
+ nonunique = "Overall total number of events"
+ )
+ ) %>%
+ build_table(
+ df = adae,
+ alt_counts_df = adsl
+ )
+#> A: Drug X B: Placebo C: Combination All Patients
+#> (N=134) (N=134) (N=132) (N=400)
+#> —————————————————————————————————————————————————————————————————————————————————————————————————————————
+#> Total number of patients with at least one AE 122 (91.0%) 123 (91.8%) 120 (90.9%) 365 (91.2%)
+#> Overall total number of events 609 622 703 1934
Note that for this table, the denominator used for percentages and
+shown in the header of the table (N = xx)
is defined based
+on the subject-level dataset adsl
. This is done by using
+the alt_df_counts
argument in build_table()
,
+which provides an alternative data set for deriving the counts in the
+header. This is often required when we work with data sets that include
+multiple records per patient as df
, such as
+adae
here.
Before building out the rest of the AE
table it is
+helpful to introduce some more tern
package design
+conventions. Each layout creating function in tern
is a
+wrapper for a Statistics function. Statistics functions are the ones
+that do the actual computation of numbers in a table. These functions
+always return named lists whose elements are the statistics available to
+include in a layout via the .stats
argument at the layout
+creating function level.
Statistics functions follow a naming convention to always begin with
+s_*
and for ease of use are documented on the same page as
+their layout creating function counterpart. It is helpful to review a
+Statistic function to understand the logic used to calculate the numbers
+in a table and see what options may be available to modify the
+analysis.
For example, the Statistics function calculating the numbers in
+summarize_num_patients()
is s_num_patients()
.
+The results of this Statistics function is a list with the elements
+unique
, nonunique
and
+unique_count
:
+s_num_patients(x = adae$USUBJID, labelstr = "", .N_col = nrow(adae))
+#> $unique
+#> [1] 365.000000 0.188728
+#> attr(,"label")
+#> [1] ""
+#>
+#> $nonunique
+#> [1] 1934
+#> attr(,"label")
+#> [1] ""
+#>
+#> $unique_count
+#> [1] 365
+#> attr(,"label")
+#> [1] "(n)"
From these results you can see that the unique
and
+nonunique
statistics are those displayed in the “All
+Patients” column in the initial AE
table output above. Also
+you can see that these are raw numbers and are not formatted in any way.
+All formatting functionality is handled at the layout creating function
+level with the .formats
argument.
Now that we know what types of statistics can be derived by
+s_num_patients()
, we can try modifying the default layout
+returned by summarize_num_patients()
. Instead of reporting
+the unique
and nonqunie
statistics, we specify
+that the analysis should include only the unique_count
+statistic. The result will show only the counts of unique patients. Note
+we make this update in both the .stats
and
+.labels
argument of
+summarize_num_patients()
.
+basic_table() %>%
+ split_cols_by(var = "ACTARM") %>%
+ add_colcounts() %>%
+ add_overall_col(label = "All Patients") %>%
+ summarize_num_patients(
+ var = "USUBJID",
+ .stats = "unique_count",
+ .labels = c(unique_count = "Total number of patients with at least one AE")
+ ) %>%
+ build_table(
+ df = adae,
+ alt_counts_df = adsl
+ )
+#> A: Drug X B: Placebo C: Combination All Patients
+#> (N=134) (N=134) (N=132) (N=400)
+#> ——————————————————————————————————————————————————————————————————————————————————————————————————————
+#> Total number of patients with at least one AE 122 123 120 365
Let’s now continue building on the layout for the adverse event +table.
+After we have the top-level summary, we can repeat the same summary
+at each system organ class level. To do this we split the analysis data
+with split_rows_by()
before calling again
+summarize_num_patients()
.
+basic_table() %>%
+ split_cols_by(var = "ACTARM") %>%
+ add_colcounts() %>%
+ add_overall_col(label = "All Patients") %>%
+ summarize_num_patients(
+ var = "USUBJID",
+ .stats = c("unique", "nonunique"),
+ .labels = c(
+ unique = "Total number of patients with at least one AE",
+ nonunique = "Overall total number of events"
+ )
+ ) %>%
+ split_rows_by(
+ "AEBODSYS",
+ child_labels = "visible",
+ nested = FALSE,
+ indent_mod = -1L,
+ split_fun = drop_split_levels
+ ) %>%
+ summarize_num_patients(
+ var = "USUBJID",
+ .stats = c("unique", "nonunique"),
+ .labels = c(
+ unique = "Total number of patients with at least one AE",
+ nonunique = "Overall total number of events"
+ )
+ ) %>%
+ build_table(
+ df = adae,
+ alt_counts_df = adsl
+ )
+#> A: Drug X B: Placebo C: Combination All Patients
+#> (N=134) (N=134) (N=132) (N=400)
+#> ———————————————————————————————————————————————————————————————————————————————————————————————————————————
+#> Total number of patients with at least one AE 122 (91.0%) 123 (91.8%) 120 (90.9%) 365 (91.2%)
+#> Overall total number of events 609 622 703 1934
+#> cl A.1
+#> Total number of patients with at least one AE 78 (58.2%) 75 (56.0%) 89 (67.4%) 242 (60.5%)
+#> Overall total number of events 132 130 160 422
+#> cl B.1
+#> Total number of patients with at least one AE 47 (35.1%) 49 (36.6%) 43 (32.6%) 139 (34.8%)
+#> Overall total number of events 56 60 62 178
+#> cl B.2
+#> Total number of patients with at least one AE 79 (59.0%) 74 (55.2%) 85 (64.4%) 238 (59.5%)
+#> Overall total number of events 129 138 143 410
+#> cl C.1
+#> Total number of patients with at least one AE 43 (32.1%) 46 (34.3%) 43 (32.6%) 132 (33.0%)
+#> Overall total number of events 55 63 64 182
+#> cl C.2
+#> Total number of patients with at least one AE 35 (26.1%) 48 (35.8%) 55 (41.7%) 138 (34.5%)
+#> Overall total number of events 48 53 65 166
+#> cl D.1
+#> Total number of patients with at least one AE 79 (59.0%) 67 (50.0%) 80 (60.6%) 226 (56.5%)
+#> Overall total number of events 127 106 135 368
+#> cl D.2
+#> Total number of patients with at least one AE 47 (35.1%) 58 (43.3%) 57 (43.2%) 162 (40.5%)
+#> Overall total number of events 62 72 74 208
The table looks almost ready. For the final step, we need a layout
+creating function that can produce a count table of event frequencies.
+The layout creating function for this is
+count_occurrences()
. Let’s first try using this function in
+a simpler layout without row splits:
+basic_table() %>%
+ split_cols_by(var = "ACTARM") %>%
+ add_colcounts() %>%
+ add_overall_col(label = "All Patients") %>%
+ count_occurrences(vars = "AEDECOD") %>%
+ build_table(
+ df = adae,
+ alt_counts_df = adsl
+ )
+#> A: Drug X B: Placebo C: Combination All Patients
+#> (N=134) (N=134) (N=132) (N=400)
+#> ———————————————————————————————————————————————————————————————————————
+#> dcd A.1.1.1.1 50 (37.3%) 45 (33.6%) 63 (47.7%) 158 (39.5%)
+#> dcd A.1.1.1.2 48 (35.8%) 48 (35.8%) 50 (37.9%) 146 (36.5%)
+#> dcd B.1.1.1.1 47 (35.1%) 49 (36.6%) 43 (32.6%) 139 (34.8%)
+#> dcd B.2.1.2.1 49 (36.6%) 44 (32.8%) 52 (39.4%) 145 (36.2%)
+#> dcd B.2.2.3.1 48 (35.8%) 54 (40.3%) 51 (38.6%) 153 (38.2%)
+#> dcd C.1.1.1.3 43 (32.1%) 46 (34.3%) 43 (32.6%) 132 (33.0%)
+#> dcd C.2.1.2.1 35 (26.1%) 48 (35.8%) 55 (41.7%) 138 (34.5%)
+#> dcd D.1.1.1.1 50 (37.3%) 42 (31.3%) 51 (38.6%) 143 (35.8%)
+#> dcd D.1.1.4.2 48 (35.8%) 42 (31.3%) 50 (37.9%) 140 (35.0%)
+#> dcd D.2.1.5.3 47 (35.1%) 58 (43.3%) 57 (43.2%) 162 (40.5%)
Putting everything together, the final AE
table looks
+like this:
+basic_table() %>%
+ split_cols_by(var = "ACTARM") %>%
+ add_colcounts() %>%
+ add_overall_col(label = "All Patients") %>%
+ summarize_num_patients(
+ var = "USUBJID",
+ .stats = c("unique", "nonunique"),
+ .labels = c(
+ unique = "Total number of patients with at least one AE",
+ nonunique = "Overall total number of events"
+ )
+ ) %>%
+ split_rows_by(
+ "AEBODSYS",
+ child_labels = "visible",
+ nested = FALSE,
+ indent_mod = -1L,
+ split_fun = drop_split_levels
+ ) %>%
+ summarize_num_patients(
+ var = "USUBJID",
+ .stats = c("unique", "nonunique"),
+ .labels = c(
+ unique = "Total number of patients with at least one AE",
+ nonunique = "Overall total number of events"
+ )
+ ) %>%
+ count_occurrences(vars = "AEDECOD") %>%
+ build_table(
+ df = adae,
+ alt_counts_df = adsl
+ )
+#> A: Drug X B: Placebo C: Combination All Patients
+#> (N=134) (N=134) (N=132) (N=400)
+#> ———————————————————————————————————————————————————————————————————————————————————————————————————————————
+#> Total number of patients with at least one AE 122 (91.0%) 123 (91.8%) 120 (90.9%) 365 (91.2%)
+#> Overall total number of events 609 622 703 1934
+#> cl A.1
+#> Total number of patients with at least one AE 78 (58.2%) 75 (56.0%) 89 (67.4%) 242 (60.5%)
+#> Overall total number of events 132 130 160 422
+#> dcd A.1.1.1.1 50 (37.3%) 45 (33.6%) 63 (47.7%) 158 (39.5%)
+#> dcd A.1.1.1.2 48 (35.8%) 48 (35.8%) 50 (37.9%) 146 (36.5%)
+#> cl B.1
+#> Total number of patients with at least one AE 47 (35.1%) 49 (36.6%) 43 (32.6%) 139 (34.8%)
+#> Overall total number of events 56 60 62 178
+#> dcd B.1.1.1.1 47 (35.1%) 49 (36.6%) 43 (32.6%) 139 (34.8%)
+#> cl B.2
+#> Total number of patients with at least one AE 79 (59.0%) 74 (55.2%) 85 (64.4%) 238 (59.5%)
+#> Overall total number of events 129 138 143 410
+#> dcd B.2.1.2.1 49 (36.6%) 44 (32.8%) 52 (39.4%) 145 (36.2%)
+#> dcd B.2.2.3.1 48 (35.8%) 54 (40.3%) 51 (38.6%) 153 (38.2%)
+#> cl C.1
+#> Total number of patients with at least one AE 43 (32.1%) 46 (34.3%) 43 (32.6%) 132 (33.0%)
+#> Overall total number of events 55 63 64 182
+#> dcd C.1.1.1.3 43 (32.1%) 46 (34.3%) 43 (32.6%) 132 (33.0%)
+#> cl C.2
+#> Total number of patients with at least one AE 35 (26.1%) 48 (35.8%) 55 (41.7%) 138 (34.5%)
+#> Overall total number of events 48 53 65 166
+#> dcd C.2.1.2.1 35 (26.1%) 48 (35.8%) 55 (41.7%) 138 (34.5%)
+#> cl D.1
+#> Total number of patients with at least one AE 79 (59.0%) 67 (50.0%) 80 (60.6%) 226 (56.5%)
+#> Overall total number of events 127 106 135 368
+#> dcd D.1.1.1.1 50 (37.3%) 42 (31.3%) 51 (38.6%) 143 (35.8%)
+#> dcd D.1.1.4.2 48 (35.8%) 42 (31.3%) 50 (37.9%) 140 (35.0%)
+#> cl D.2
+#> Total number of patients with at least one AE 47 (35.1%) 58 (43.3%) 57 (43.2%) 162 (40.5%)
+#> Overall total number of events 62 72 74 208
+#> dcd D.2.1.5.3 47 (35.1%) 58 (43.3%) 57 (43.2%) 162 (40.5%)
A typical response table for a binary clinical trial endpoint may be +composed of several different analyses:
+We can build a table layout like this by following the same approach
+we used for the AE
table: each table section will be
+produced using a different layout creating function from
+tern
.
First we start with some data preparation steps to set up the
+analysis dataset. We select the endpoint to analyze from
+PARAMCD
and define the logical variable is_rsp
+which indicates whether a patient is classified as a responder or
+not.
+# Preprocessing to select an analysis endpoint.
+anl <- adrs %>%
+ dplyr::filter(PARAMCD == "BESRSPI") %>%
+ dplyr::mutate(is_rsp = AVALC %in% c("CR", "PR"))
To create a summary of the proportion of responders in each treatment
+group, use the estimate_proportion()
layout creating
+function:
+basic_table() %>%
+ split_cols_by(var = "ARM") %>%
+ add_colcounts() %>%
+ estimate_proportion(
+ vars = "is_rsp",
+ table_names = "est_prop"
+ ) %>%
+ build_table(anl)
+#> A: Drug X B: Placebo C: Combination
+#> (N=134) (N=134) (N=132)
+#> —————————————————————————————————————————————————————————————————————————————
+#> Responders 114 (85.1%) 90 (67.2%) 120 (90.9%)
+#> 95% CI (Wald, with correction) (78.7, 91.5) (58.8, 75.5) (85.6, 96.2)
To specify which arm in the table should be used as the reference,
+use the argument ref_group
from
+split_cols_by()
. Below we change the reference arm to “B:
+Placebo” and so this arm is displayed as the first column:
+basic_table() %>%
+ split_cols_by(var = "ARM", ref_group = "B: Placebo") %>%
+ add_colcounts() %>%
+ estimate_proportion(
+ vars = "is_rsp"
+ ) %>%
+ build_table(anl)
+#> B: Placebo A: Drug X C: Combination
+#> (N=134) (N=134) (N=132)
+#> —————————————————————————————————————————————————————————————————————————————
+#> Responders 90 (67.2%) 114 (85.1%) 120 (90.9%)
+#> 95% CI (Wald, with correction) (58.8, 75.5) (78.7, 91.5) (85.6, 96.2)
To further customize the analysis, we can use the method
+and conf_level
arguments to modify the type of confidence
+interval that is calculated:
+basic_table() %>%
+ split_cols_by(var = "ARM", ref_group = "B: Placebo") %>%
+ add_colcounts() %>%
+ estimate_proportion(
+ vars = "is_rsp",
+ method = "clopper-pearson",
+ conf_level = 0.9
+ ) %>%
+ build_table(anl)
+#> B: Placebo A: Drug X C: Combination
+#> (N=134) (N=134) (N=132)
+#> ———————————————————————————————————————————————————————————————————————
+#> Responders 90 (67.2%) 114 (85.1%) 120 (90.9%)
+#> 90% CI (Clopper-Pearson) (59.9, 73.9) (79.1, 89.9) (85.7, 94.7)
The next table section needed should summarize the difference in
+response rates between the reference arm each comparison arm. Use
+estimate_proportion_diff()
layout creating function for
+this:
+basic_table() %>%
+ split_cols_by(var = "ARM", ref_group = "B: Placebo") %>%
+ add_colcounts() %>%
+ estimate_proportion_diff(
+ vars = "is_rsp",
+ show_labels = "visible",
+ var_labels = "Unstratified Analysis"
+ ) %>%
+ build_table(anl)
+#> B: Placebo A: Drug X C: Combination
+#> (N=134) (N=134) (N=132)
+#> ——————————————————————————————————————————————————————————————————————————————
+#> Unstratified Analysis
+#> Difference in Response rate (%) 17.9 23.7
+#> 95% CI (Wald, with correction) (7.2, 28.6) (13.7, 33.8)
The final section needed to complete the table includes a statistical
+test for the difference in response rates. Use the
+test_proportion_diff()
layout creating function for
+this:
+basic_table() %>%
+ split_cols_by(var = "ARM", ref_group = "B: Placebo") %>%
+ add_colcounts() %>%
+ test_proportion_diff(vars = "is_rsp") %>%
+ build_table(anl)
+#> B: Placebo A: Drug X C: Combination
+#> (N=134) (N=134) (N=132)
+#> ——————————————————————————————————————————————————————————————————————
+#> p-value (Chi-Squared Test) 0.0006 <0.0001
To customize the output, we use the method
argument to
+select a Chi-Squared test with Schouten correction.
+basic_table() %>%
+ split_cols_by(var = "ARM", ref_group = "B: Placebo") %>%
+ add_colcounts() %>%
+ test_proportion_diff(
+ vars = "is_rsp",
+ method = "schouten"
+ ) %>%
+ build_table(anl)
+#> B: Placebo A: Drug X C: Combination
+#> (N=134) (N=134) (N=132)
+#> ———————————————————————————————————————————————————————————————————————————————————————————————
+#> p-value (Chi-Squared Test with Schouten Correction) 0.0008 <0.0001
Now we can put all the table sections together in one layout
+pipeline. Note there is one more small change needed. Since the primary
+analysis variable in all table sections is the same
+(is_rsp
), we need to give each sub-table a unique name.
+This is done by adding the table_names
argument and
+providing unique names through that:
+basic_table() %>%
+ split_cols_by(var = "ARM", ref_group = "B: Placebo") %>%
+ add_colcounts() %>%
+ estimate_proportion(
+ vars = "is_rsp",
+ method = "clopper-pearson",
+ conf_level = 0.9,
+ table_names = "est_prop"
+ ) %>%
+ estimate_proportion_diff(
+ vars = "is_rsp",
+ show_labels = "visible",
+ var_labels = "Unstratified Analysis",
+ table_names = "est_prop_diff"
+ ) %>%
+ test_proportion_diff(
+ vars = "is_rsp",
+ method = "schouten",
+ table_names = "test_prop_diff"
+ ) %>%
+ build_table(anl)
+#> B: Placebo A: Drug X C: Combination
+#> (N=134) (N=134) (N=132)
+#> ————————————————————————————————————————————————————————————————————————————————————————————————————
+#> Responders 90 (67.2%) 114 (85.1%) 120 (90.9%)
+#> 90% CI (Clopper-Pearson) (59.9, 73.9) (79.1, 89.9) (85.7, 94.7)
+#> Unstratified Analysis
+#> Difference in Response rate (%) 17.9 23.7
+#> 95% CI (Wald, with correction) (7.2, 28.6) (13.7, 33.8)
+#> p-value (Chi-Squared Test with Schouten Correction) 0.0008 <0.0001
Tabulation with tern
builds on top of the the layout
+tabulation framework from rtables
. Complex tables are built
+step by step in a pipeline by combining layout creating functions that
+perform a specific type of analysis.
The tern
analyze functions introduced in this vignette
+are:
analyze_vars()
summarize_num_patients()
count_occurrences()
estimate_proportion()
estimate_proportion_diff()
test_proportion_diff()
Layout creating functions build a formatted layout
by
+controlling features such as labels, numerical display formats and
+indentation. These functions are wrappers for the Statistics functions
+which calculate the raw summaries of each analysis. You can easily spot
+Statistics functions in the documentation because they always begin with
+the prefix s_
. It can be helpful to inspect and run
+Statistics functions to understand ways an analysis can be
+customized.
This vignette shows the general purpose and syntax of the
+tern
R package.
+The tern
R package contains analytical functions for
+creating tables and graphs useful for clinical trials and other
+statistical analysis. The main focus is on the clinical trial reporting
+tables but the graphs related to the clinical trials are also valuable.
+The core functionality for tabulation is built on top of the more
+general purpose rtables
package.
The package provides a large range of functionality to create tables +and graphs used for clinical trial and other statistical analysis.
+rtables
tabulation extended by clinical trials specific
+functions:
MMRM
, logistic regression, Cox
+regression, …rtables
tabulation helper functions:
data visualizations connected with clinical trials:
+data visualizations helper functions:
+The reference of tern
functions is available on the
+tern website functions reference.
rtables
+Analytical functions are used in combination with other
+rtables
layout functions, in the pipeline which creates the
+rtables
table. They apply some statistical logic to the
+layout of the rtables
table. The table layout is
+materialized with the rtables::build_table
function and the
+data.
The tern
analytical functions are wrappers around the
+rtables::analyze
function; they offer various methods
+useful from the perspective of clinical trials and other statistical
+projects.
Examples of the tern
analytical functions are
+tern::count_occurrences
,
+tern::summarize_ancova
and tern::analyze_vars
.
+As there is no one prefix to identify all tern
analytical
+functions it is recommended to use the reference subsection on the
+tern website.
In the rtables
code below we first describe the two
+tables and assign the descriptions to the variables lyt
and
+lyt2
. We then built the tables using the actual data with
+rtables::build_table
. The description of a table is called
+a table layout. The analyze
+instruction adds to the layout that the ARM
+variable should be analyzed with the mean
analysis function
+and the result should be rounded to 1 decimal place. Hence, a
+layout is “pre-data”; that is, it’s a description of
+how to build a table once we get data.
Defining the table layout with a pure rtables
code.
+# Create table layout pure rtables
+lyt <- rtables::basic_table() %>%
+ rtables::split_cols_by(var = "ARM") %>%
+ rtables::split_rows_by(var = "AVISIT") %>%
+ rtables::analyze(vars = "AVAL", mean, format = "xx.x")
Below the only tern
function is
+analyze_vars
which replaces the
+rtables::analyze
function above.
+# Create table layout with tern analyze_vars analyze function
+lyt2 <- rtables::basic_table() %>%
+ rtables::split_cols_by(var = "ARM") %>%
+ rtables::split_rows_by(var = "AVISIT") %>%
+ tern::analyze_vars(vars = "AVAL", .formats = c("mean_sd" = "(xx.xx, xx.xx)"))
+# Apply table layout to data and produce `rtables` object
+
+adrs <- formatters::ex_adrs
+
+rtables::build_table(lyt, df = adrs)
+#> A: Drug X B: Placebo C: Combination
+#> ——————————————————————————————————————————————————————————
+#> SCREENING
+#> mean 3.0 3.0 3.0
+#> BASELINE
+#> mean 2.5 2.8 2.5
+#> END OF INDUCTION
+#> mean 1.7 2.1 1.6
+#> FOLLOW UP
+#> mean 2.2 2.9 2.0
+rtables::build_table(lyt2, df = adrs)
+#> A: Drug X B: Placebo C: Combination
+#> ———————————————————————————————————————————————————————————————
+#> SCREENING
+#> n 154 178 144
+#> Mean (SD) (3.00, 0.00) (3.00, 0.00) (3.00, 0.00)
+#> Median 3.0 3.0 3.0
+#> Min - Max 3.0 - 3.0 3.0 - 3.0 3.0 - 3.0
+#> BASELINE
+#> n 136 146 124
+#> Mean (SD) (2.46, 0.88) (2.77, 1.00) (2.46, 1.08)
+#> Median 3.0 3.0 3.0
+#> Min - Max 1.0 - 4.0 1.0 - 5.0 1.0 - 5.0
+#> END OF INDUCTION
+#> n 218 205 217
+#> Mean (SD) (1.75, 0.90) (2.14, 1.28) (1.65, 1.06)
+#> Median 2.0 2.0 1.0
+#> Min - Max 1.0 - 4.0 1.0 - 5.0 1.0 - 5.0
+#> FOLLOW UP
+#> n 164 153 167
+#> Mean (SD) (2.23, 1.26) (2.89, 1.29) (1.97, 1.01)
+#> Median 2.0 4.0 2.0
+#> Min - Max 1.0 - 4.0 1.0 - 4.0 1.0 - 4.0
We see that tern
offers advanced analysis by extending
+rtables
function calls with only one additional function
+call.
More examples with tabulation analyze functions are presented
+in the Tabulation
vignette.
Clinical trial related plots complement the rich palette of
+tern
tabulation analysis functions. Thus the
+tern
package delivers a full-featured tool for clinical
+trial reporting. The tern
plot functions return
+ggplot2
or gTree
objects, the latter is
+returned when a table is attached to the plot.
+adsl <- formatters::ex_adsl
+adlb <- formatters::ex_adlb
+adlb <- dplyr::filter(adlb, PARAMCD == "ALT", AVISIT != "SCREENING")
The optional nestcolor
package can be loaded in to apply
+the standardized NEST color palette to all tern
plots.
Line plot without a table generated by the
+tern::g_lineplot
function.
+# Mean with CI
+tern::g_lineplot(adlb, adsl, subtitle = "Laboratory Test:")
Line plot with a table generated by the tern::g_lineplot
+function.
+# Mean with CI, table and customized confidence level
+tern::g_lineplot(
+ adlb,
+ adsl,
+ table = c("n", "mean", "mean_ci"),
+ title = "Plot of Mean and 80% Confidence Limits by Visit"
+)
The first plot is a ggplot2
object and the second plot
+is a gTree
object, as the latter contains the table. The
+second plot has to be properly resized to get a clear and readable table
+content.
The tern
functions used for plot generation are mostly
+g_
prefixed. All tern
plot functions are
+listed on the
+tern website functions reference.
Most of tern
outputs could be easily accommodated into
+shiny
apps. We recommend applying tern
outputs
+into teal
apps. The teal
+package is a shiny-based interactive exploration framework for
+analyzing data. teal
shiny apps with tern
+outputs are available in the teal.modules.clinical
+package.
In summary, tern
contains many additional functions for
+creating tables, listing and graphs used in clinical trials and other
+statistical analyses. The design of the package gives users a lot of
+flexibility to meet the analysis needs in a regulatory or exploratory
+reporting context.
For more information please explore the tern +website.
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