TL Catalog
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  2. Exposure
  3. TSIEX07
  • Introduction

  • Index

  • Tables
    • Adverse Events
      • TSFAE01A
      • TSFAE01B
      • TSFAE02
      • TSFAE02A
      • TSFAE03
      • TSFAE03A
      • TSFAE04
      • TSFAE04A
      • TSFAE05
      • TSFAE05A
      • TSFAE06A
      • TSFAE06B
      • TSFAE07A
      • TSFAE07B
      • TSFAE08
      • TSFAE09
      • TSFAE10
      • TSFAE11
      • TSFAE12
      • TSFAE13
      • TSFAE14
      • TSFAE15
      • TSFAE16
      • TSFAE17A
      • TSFAE17B
      • TSFAE17C
      • TSFAE17D
      • TSFAE19A
      • TSFAE19B
      • TSFAE19C
      • TSFAE19D
      • TSFAE20A
      • TSFAE20B
      • TSFAE20C
      • TSFAE21A
      • TSFAE21B
      • TSFAE21C
      • TSFAE21D
      • TSFAE22A
      • TSFAE22B
      • TSFAE22C
      • TSFAE23A
      • TSFAE23B
      • TSFAE23C
      • TSFAE23D
      • TSFAE24A
      • TSFAE24B
      • TSFAE24C
      • TSFAE24D
      • TSFAE24F
      • TSFDTH01
    • Clinical Laboratory Evaluation
      • TSFLAB01
      • TSFLAB01A
      • TSFLAB02
      • TSFLAB02A
      • TSFLAB02B
      • TSFLAB03
      • TSFLAB03A
      • TSFLAB04A
      • TSFLAB04B
      • TSFLAB05
      • TSFLAB06
      • TSFLAB07
    • Demographic
      • TSIDEM01
      • TSIDEM02
      • TSIMH01
    • Disposition of Subjects
      • TSIDS01
      • TSIDS02
      • TSIDS02A
    • Electrocardiograms
      • TSFECG01
      • TSFECG01A
      • TSFECG02
      • TSFECG03
      • TSFECG04
      • TSFECG05
    • Exposure
      • TSIEX01
      • TSIEX02
      • TSIEX03
      • TSIEX04
      • TSIEX06
      • TSIEX07
      • TSIEX08
      • TSIEX09
      • TSIEX10
      • TSIEX11
    • Pharmacokinetics
      • TPK01A
      • TPK01B
      • TPK02
      • TPK03
    • Prior and Concomitant Therapies
      • TSICM01
      • TSICM02
      • TSICM03
      • TSICM04
      • TSICM05
      • TSICM06
      • TSICM07
      • TSICM08
    • Vital Signs and Physical Findings
      • TSFVIT01
      • TSFVIT01A
      • TSFVIT02
      • TSFVIT03
      • TSFVIT04
      • TSFVIT05
      • TSFVIT06
  • Listings
    • Adverse Events
      • LSFAE01
      • LSFAE02
      • LSFAE03
      • LSFAE04
      • LSFAE05
      • LSFAE06A
      • LSFAE06B
      • LSFDTH01
    • Clinical Laboratory Evaluation
      • LSFLAB01
    • Demographic
      • LSIDEM01
      • LSIDEM02
      • LSIMH01
    • Disposition of Subjects
      • LSIDS01
      • LSIDS02
      • LSIDS03
      • LSIDS04
      • LSIDS05
    • Electrocardiograms
      • LSFECG01
      • LSFECG02
    • Exposure
      • LSIEX01
      • LSIEX02
      • LSIEX03
    • Prior and Concomitant Therapies
      • LSICM01
    • Vital Signs and Physical Findings
      • LSFVIT01
      • LSFVIT02

  • Reproducibility

  • Changelog

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  1. Tables
  2. Exposure
  3. TSIEX07

TSIEX07

Dose Levels Over Time


Output

  • Preview
Code
# Program Name:              tsiex07.R

# Prep Environment

library(envsetup)
library(tern)
library(dplyr)
library(rtables)
library(junco)

# Define script level parameters:

# - Define output ID and file location

tblid <- "TSIEX07"
fileid <- tblid
tab_titles <- get_titles_from_file(input_path = '../../_data/', tblid)
string_map <- default_str_map


trtvar <- "TRT01A"
popfl <- "SAFFL"

dose_order <- c("60", "120", "180", "240", "300", "480", "720", "960", "Total")

# Process Data:

# Read in required data
adsl <- pharmaverseadamjnj::adsl %>%
  filter(!!rlang::sym(popfl) == "Y" & !!rlang::sym(trtvar) != "Placebo") %>%
  select(USUBJID, all_of(trtvar), all_of(popfl))

adex <- pharmaverseadamjnj::adex %>%
  filter(!grepl("UNSCHEDULED", AVISIT, ignore.case = TRUE)) %>%
  filter(!is.na(ADOSE)) %>%
  mutate(ADOSEC = as.factor(ADOSE)) %>%
  select(USUBJID, ADOSEC, AVISIT, AVISITN)

# Convert AVISIT to sentence case and apply levels to maintain ordering
avisit_levs <- stringr::str_to_sentence(levels(adex$AVISIT))
adex$AVISIT <- stringr::str_to_sentence(adex$AVISIT)
adex$AVISIT <- factor(adex$AVISIT, levels = avisit_levs)

# Create Total column manually as we cannot use the table layout option since patients can
# appear in multiple dose level columns

extot_ <- adex %>%
  group_by(USUBJID, AVISIT) %>%
  slice(1) %>%
  mutate(ADOSEC = "Total") %>%
  ungroup()

extot <- bind_rows(adex, extot_)

# join data together
ex <- extot %>% inner_join(., adsl, by = c("USUBJID"))

ex$colspan_trt <- factor(
  ifelse(ex$ADOSEC == "Total", " ", "Active Study Agent"),
  levels = c("Active Study Agent", " ")
)

ex$ADOSEC <- factor(ex$ADOSEC, levels = dose_order)

# Create dataset to be used for column counts
adex_unique <- ex %>%
  group_by(USUBJID, ADOSEC) %>%
  slice(1) %>%
  ungroup()

# Define layout and build table:

lyt <- rtables::basic_table(
  top_level_section_div = " ",
  show_colcounts = TRUE,
  colcount_format = "N=xx"
) %>%
  split_cols_by("colspan_trt", split_fun = trim_levels_in_group("ADOSEC")) %>%
  split_cols_by("ADOSEC") %>%
  tern::count_occurrences(
    "AVISIT",
    .stats = "count_fraction_fixed_dp",
    .formats = c("count_fraction_fixed_dp" = jjcsformat_count_fraction),
    var_labels = " ",
    show_labels = "hidden"
  ) %>%
  append_topleft("Time Point, n (%)")

result <- build_table(lyt, ex, alt_counts_df = adex_unique)

# Add titles and footnotes:

result <- set_titles(result, tab_titles)

# Convert to tbl file and output table

tt_to_tlgrtf(string_map = string_map, tt = result, file = fileid, orientation = "landscape")

TSIEX07: Dose Levels Over Time; Safety Analysis Set (Study jjcs - core)

Active Study Agent

60

120

240

300

480

720

960

Total

Time Point, n (%)

N=3

N=3

N=3

N=8

N=26

N=98

N=51

N=125

Baseline

1 (33.3%)

2 (66.7%)

3 (100.0%)

3 (37.5%)

13 (50.0%)

94 (95.9%)

9 (17.6%)

125 (100.0%)

Week 2

1 (33.3%)

1 (33.3%)

0

3 (37.5%)

3 (11.5%)

2 (2.0%)

41 (80.4%)

104 (83.2%)

Week 24

2 (66.7%)

0

0

2 (25.0%)

12 (46.2%)

17 (17.3%)

2 (3.9%)

35 (28.0%)

Download RTF file

TSIEX06
TSIEX08
Source Code
---
title: TSIEX07
subtitle: Dose Levels Over Time
---

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

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

```{r setup, echo = FALSE, warning = FALSE, message = FALSE}
options(docx.add_datetime = FALSE, tidytlg.add_datetime = FALSE)
envsetup_config_name <- "default"

# Path to the combined config file
envsetup_file_path <- file.path("../..", "envsetup.yml")

Sys.setenv(ENVSETUP_ENVIRON = '')
library(envsetup)
loaded_config <- config::get(config = envsetup_config_name, file = envsetup_file_path)
envsetup::rprofile(loaded_config)


dpscomp <- compound
dpspdr <- paste(protocol,dbrelease,rpteff,sep="__")

aptcomp <- compound
aptpdr <- paste(protocol,dbrelease,rpteff,sep="__")

###### Study specific updates (formerly in envre)

dpscomp <- "standards"
dpspdr <- "jjcs__NULL__jjcs - core"

apt <- FALSE
library(junco)
default_str_map <- rbind(default_str_map, c("&ctcae", "5.0"))

```

## Output

:::: panel-tabset
## {{< fa regular file-lines sm fw >}} Preview

```{r variant1, results='hide', warning = FALSE, message = FALSE}

# Program Name:              tsiex07.R

# Prep Environment

library(envsetup)
library(tern)
library(dplyr)
library(rtables)
library(junco)

# Define script level parameters:

# - Define output ID and file location

tblid <- "TSIEX07"
fileid <- tblid
tab_titles <- get_titles_from_file(input_path = '../../_data/', tblid)
string_map <- default_str_map


trtvar <- "TRT01A"
popfl <- "SAFFL"

dose_order <- c("60", "120", "180", "240", "300", "480", "720", "960", "Total")

# Process Data:

# Read in required data
adsl <- pharmaverseadamjnj::adsl %>%
  filter(!!rlang::sym(popfl) == "Y" & !!rlang::sym(trtvar) != "Placebo") %>%
  select(USUBJID, all_of(trtvar), all_of(popfl))

adex <- pharmaverseadamjnj::adex %>%
  filter(!grepl("UNSCHEDULED", AVISIT, ignore.case = TRUE)) %>%
  filter(!is.na(ADOSE)) %>%
  mutate(ADOSEC = as.factor(ADOSE)) %>%
  select(USUBJID, ADOSEC, AVISIT, AVISITN)

# Convert AVISIT to sentence case and apply levels to maintain ordering
avisit_levs <- stringr::str_to_sentence(levels(adex$AVISIT))
adex$AVISIT <- stringr::str_to_sentence(adex$AVISIT)
adex$AVISIT <- factor(adex$AVISIT, levels = avisit_levs)

# Create Total column manually as we cannot use the table layout option since patients can
# appear in multiple dose level columns

extot_ <- adex %>%
  group_by(USUBJID, AVISIT) %>%
  slice(1) %>%
  mutate(ADOSEC = "Total") %>%
  ungroup()

extot <- bind_rows(adex, extot_)

# join data together
ex <- extot %>% inner_join(., adsl, by = c("USUBJID"))

ex$colspan_trt <- factor(
  ifelse(ex$ADOSEC == "Total", " ", "Active Study Agent"),
  levels = c("Active Study Agent", " ")
)

ex$ADOSEC <- factor(ex$ADOSEC, levels = dose_order)

# Create dataset to be used for column counts
adex_unique <- ex %>%
  group_by(USUBJID, ADOSEC) %>%
  slice(1) %>%
  ungroup()

# Define layout and build table:

lyt <- rtables::basic_table(
  top_level_section_div = " ",
  show_colcounts = TRUE,
  colcount_format = "N=xx"
) %>%
  split_cols_by("colspan_trt", split_fun = trim_levels_in_group("ADOSEC")) %>%
  split_cols_by("ADOSEC") %>%
  tern::count_occurrences(
    "AVISIT",
    .stats = "count_fraction_fixed_dp",
    .formats = c("count_fraction_fixed_dp" = jjcsformat_count_fraction),
    var_labels = " ",
    show_labels = "hidden"
  ) %>%
  append_topleft("Time Point, n (%)")

result <- build_table(lyt, ex, alt_counts_df = adex_unique)

# Add titles and footnotes:

result <- set_titles(result, tab_titles)

# Convert to tbl file and output table

tt_to_tlgrtf(string_map = string_map, tt = result, file = fileid, orientation = "landscape")
```
```{r result1, echo=FALSE, message=FALSE, warning=FALSE, test = list(result_v1 = "result")}
tt_to_flextable_j(result, tblid, string_map = string_map) 
```

[Download RTF file](`r paste0(tolower(tblid), '.rtf')`)
::::

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