TLG Catalog - Stable
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  3. LBT12
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  • Appendix
    • Reproducibility

  • Index

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  • Reproducibility
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  1. Tables
  2. Lab Results
  3. LBT12

LBT12

Liver Laboratory Tests by Time on Treatment – Patients with Elevated Post-Baseline AST or ALT Levels (with Respect to ULN)


Output

  • Standard Table
  • Data Setup
  • Preview
  • Try this using WebR
Code
result <- basic_table() %>%
  split_cols_by("TITLE") %>%
  split_cols_by("APERIODC") %>%
  split_rows_by("PARAM") %>%
  split_rows_by("ACTARM", split_fun = drop_split_levels, child_labels = "hidden") %>%
  count_occurrences("ARM_AVALC", .stats = "fraction", denom = "n", drop = TRUE) %>%
  build_table(anl)

criteria_fun <- function(tr) {
  row_label <- obj_label(tr)
  dplyr::if_else(row_label == "Criteria not met", TRUE, FALSE)
}

result <- result %>% trim_rows(criteria = criteria_fun)
result
                              First Elevated Result Occurring During  
                                  PERIOD 1              PERIOD 2      
——————————————————————————————————————————————————————————————————————
AST >3x ULN                                                           
  A: Drug X                     11/134 (8.2%)        21/134 (15.7%)   
  B: Placebo                   17/134 (12.7%)        16/134 (11.9%)   
  C: Combination                10/132 (7.6%)         8/132 (6.1%)    
ALT >3x ULN                                                           
  A: Drug X                    14/134 (10.4%)         8/134 (6.0%)    
  B: Placebo                   24/134 (17.9%)        18/134 (13.4%)   
  C: Combination               16/132 (12.1%)         10/132 (7.6%)   
AST >3x ULN or ALT >x3 ULN                                            
  A: Drug X                    14/134 (10.4%)        15/134 (11.2%)   
  B: Placebo                    8/134 (6.0%)          13/134 (9.7%)   
  C: Combination                11/132 (8.3%)         12/132 (9.1%)   
Experimental use!

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Code
library(dplyr)
library(tern)

adhy <- random.cdisc.data::cadhy

anl <- adhy
anl$APERIODC <- as.factor(anl$APERIODC) # to ensure the table is built even if there is no patients after filtering
anl$ACTARM <- as.factor(anl$ACTARM) # to ensure the table is built even if there is no patients after filtering

anl <- anl %>%
  filter(
    SAFFL == "Y",
    PARAMCD %in% c("ASTPULN", "ALTPULN", "ALTASTPU") & AVISIT == "POST-BASELINE"
  ) %>%
  mutate(
    ARM_AVALC = factor(
      case_when(
        AVALC == "Y" ~ as.character(ACTARM),
        TRUE ~ "Criteria not met"
      ),
      levels = c(levels(anl$ACTARM), "Criteria not met")
    ),
    PARAM = factor(
      case_when(
        PARAMCD == "ASTPULN" ~ "AST >3x ULN",
        PARAMCD == "ALTPULN" ~ "ALT >3x ULN",
        PARAMCD == "ALTASTPU" ~ "AST >3x ULN or ALT >x3 ULN"
      ),
      levels = c("AST >3x ULN", "ALT >3x ULN", "AST >3x ULN or ALT >x3 ULN")
    ),
    TITLE = factor("First Elevated Result Occurring During")
  )

anl <- df_explicit_na(anl)

Reproducibility

Timestamp

[1] "2025-04-26 17:48:10 UTC"

Session Info

─ Session info ───────────────────────────────────────────────────────────────
 setting  value
 version  R version 4.4.2 (2024-10-31)
 os       Ubuntu 24.04.1 LTS
 system   x86_64, linux-gnu
 ui       X11
 language (EN)
 collate  en_US.UTF-8
 ctype    en_US.UTF-8
 tz       Etc/UTC
 date     2025-04-26
 pandoc   3.6.3 @ /usr/bin/ (via rmarkdown)
 quarto   1.6.43 @ /usr/local/bin/quarto

─ Packages ───────────────────────────────────────────────────────────────────
 package           * version   date (UTC) lib source
 backports           1.5.0     2024-05-23 [1] RSPM
 brio                1.1.5     2024-04-24 [1] RSPM
 broom               1.0.8     2025-03-28 [1] RSPM
 checkmate           2.3.2     2024-07-29 [1] RSPM
 cli                 3.6.5     2025-04-23 [1] RSPM
 codetools           0.2-20    2024-03-31 [2] CRAN (R 4.4.2)
 curl                6.2.2     2025-03-24 [1] RSPM
 dichromat           2.0-0.1   2022-05-02 [1] CRAN (R 4.4.2)
 digest              0.6.37    2024-08-19 [1] RSPM
 dplyr             * 1.1.4     2023-11-17 [1] RSPM
 evaluate            1.0.3     2025-01-10 [1] RSPM
 farver              2.1.2     2024-05-13 [1] RSPM
 fastmap             1.2.0     2024-05-15 [1] RSPM
 forcats             1.0.0     2023-01-29 [1] RSPM
 formatters        * 0.5.11    2025-04-09 [1] RSPM
 generics            0.1.3     2022-07-05 [1] RSPM
 ggplot2             3.5.2     2025-04-09 [1] RSPM
 glue                1.8.0     2024-09-30 [1] RSPM
 gtable              0.3.6     2024-10-25 [1] RSPM
 htmltools           0.5.8.1   2024-04-04 [1] RSPM
 htmlwidgets         1.6.4     2023-12-06 [1] RSPM
 jsonlite            2.0.0     2025-03-27 [1] RSPM
 knitr               1.50      2025-03-16 [1] RSPM
 lattice             0.22-7    2025-04-02 [2] CRAN (R 4.4.2)
 lifecycle           1.0.4     2023-11-07 [1] RSPM
 magrittr          * 2.0.3     2022-03-30 [1] RSPM
 Matrix              1.7-3     2025-03-11 [1] CRAN (R 4.4.2)
 nestcolor           0.1.3     2025-01-21 [1] RSPM
 pillar              1.10.2    2025-04-05 [1] RSPM
 pkgcache            2.2.3     2024-09-12 [1] RSPM
 pkgconfig           2.0.3     2019-09-22 [1] RSPM
 processx            3.8.6     2025-02-21 [1] RSPM
 ps                  1.9.1     2025-04-12 [1] RSPM
 purrr               1.0.4     2025-02-05 [1] RSPM
 R6                  2.6.1     2025-02-15 [1] RSPM
 random.cdisc.data   0.3.16    2024-10-10 [1] RSPM
 rbibutils           2.3       2024-10-04 [1] RSPM
 RColorBrewer        1.1-3     2022-04-03 [1] RSPM
 Rdpack              2.6.4     2025-04-09 [1] RSPM
 rlang               1.1.6     2025-04-11 [1] RSPM
 rmarkdown           2.29      2024-11-04 [1] RSPM
 rtables           * 0.6.12    2025-04-11 [1] RSPM
 scales              1.4.0     2025-04-24 [1] RSPM
 sessioninfo         1.2.3     2025-02-05 [1] any (@1.2.3)
 stringi             1.8.7     2025-03-27 [1] RSPM
 stringr             1.5.1     2023-11-14 [1] RSPM
 survival            3.8-3     2024-12-17 [1] CRAN (R 4.4.2)
 tern              * 0.9.8.433 2025-04-26 [1] https://i~
 testthat            3.2.3     2025-01-13 [1] RSPM
 tibble              3.2.1     2023-03-20 [1] RSPM
 tidyr               1.3.1     2024-01-24 [1] RSPM
 tidyselect          1.2.1     2024-03-11 [1] RSPM
 vctrs               0.6.5     2023-12-01 [1] RSPM
 xfun                0.52      2025-04-02 [1] RSPM
 yaml                2.3.10    2024-07-26 [1] RSPM

 [1] /usr/local/lib/R/site-library
 [2] /usr/local/lib/R/library
 [3] /github/home/R/x86_64-pc-linux-gnu-library/4.4
 * ── Packages attached to the search path.

──────────────────────────────────────────────────────────────────────────────

.lock file

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LBT11_BL
LBT12_BL
Source Code
---
title: LBT12
subtitle: Liver Laboratory Tests by Time on Treatment -- Patients with Elevated Post-Baseline AST or ALT Levels (with Respect to ULN)
---

------------------------------------------------------------------------

{{< include ../../_utils/envir_hook.qmd >}}

```{r setup, echo = FALSE, warning = FALSE, message = FALSE}
library(dplyr)
library(tern)

adhy <- random.cdisc.data::cadhy

anl <- adhy
anl$APERIODC <- as.factor(anl$APERIODC) # to ensure the table is built even if there is no patients after filtering
anl$ACTARM <- as.factor(anl$ACTARM) # to ensure the table is built even if there is no patients after filtering

anl <- anl %>%
  filter(
    SAFFL == "Y",
    PARAMCD %in% c("ASTPULN", "ALTPULN", "ALTASTPU") & AVISIT == "POST-BASELINE"
  ) %>%
  mutate(
    ARM_AVALC = factor(
      case_when(
        AVALC == "Y" ~ as.character(ACTARM),
        TRUE ~ "Criteria not met"
      ),
      levels = c(levels(anl$ACTARM), "Criteria not met")
    ),
    PARAM = factor(
      case_when(
        PARAMCD == "ASTPULN" ~ "AST >3x ULN",
        PARAMCD == "ALTPULN" ~ "ALT >3x ULN",
        PARAMCD == "ALTASTPU" ~ "AST >3x ULN or ALT >x3 ULN"
      ),
      levels = c("AST >3x ULN", "ALT >3x ULN", "AST >3x ULN or ALT >x3 ULN")
    ),
    TITLE = factor("First Elevated Result Occurring During")
  )

anl <- df_explicit_na(anl)
```

```{r include = FALSE}
webr_code_labels <- c("setup")
```

{{< include ../../_utils/webr_no_include.qmd >}}

## Output

:::: panel-tabset
## Standard Table

::: {.panel-tabset .nav-justified group="webr"}
## {{< fa regular file-lines sm fw >}} Preview

```{r variant1, test = list(result_v1 = "result")}
result <- basic_table() %>%
  split_cols_by("TITLE") %>%
  split_cols_by("APERIODC") %>%
  split_rows_by("PARAM") %>%
  split_rows_by("ACTARM", split_fun = drop_split_levels, child_labels = "hidden") %>%
  count_occurrences("ARM_AVALC", .stats = "fraction", denom = "n", drop = TRUE) %>%
  build_table(anl)

criteria_fun <- function(tr) {
  row_label <- obj_label(tr)
  dplyr::if_else(row_label == "Criteria not met", TRUE, FALSE)
}

result <- result %>% trim_rows(criteria = criteria_fun)
result
```

```{r include = FALSE}
webr_code_labels <- c("variant1")
```

{{< include ../../_utils/webr.qmd >}}
:::

## Data Setup

```{r setup}
#| code-fold: show
```
::::

{{< include ../../_utils/save_results.qmd >}}

{{< include ../../repro.qmd >}}

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