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Add ADAL01 #116

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Add ADAL01 - missing 4 columns
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152 changes: 152 additions & 0 deletions book/listings/pharmacokinetic/adal01.qmd
Original file line number Diff line number Diff line change
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---
title: ADAL01
subtitle: Listing of Anti-Drug Antibody Data for Patients with At Least One ADA Sample Datum by Treatment
---

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

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

:::: panel-tabset
```{r setup, message=FALSE, echo=FALSE}
#| code-fold: show

library(dplyr)
library(rlistings)
library(random.cdisc.data)

adpc <- cadpc
adab <- cadab

trt <- "A: Drug X"
min_titer_ada <- 1.10
min_titer_nab <- 1.10
min_conc <- 3.0

if (unique(adpc$RELTMU) == "hr") adpc$NFRLT <- adpc$NFRLT / 24
adpc_f <- adpc %>% filter(PARAM == "Plasma Drug X")


drug_a <- unique(adab$PARCAT1)[1]
drugcd <- unique(adab$PARAMCD[adab$PARAM == "Antibody titer units"])[1]
conc_u <- unique(adpc_f$AVALU)

adpc_f <- adpc_f %>% select(USUBJID, NFRLT, AVAL)
adab1 <- adab %>%
filter(ARM == trt) %>%
select(-PARAM, -PARCAT1, -AVALC, -AVALU) %>%
left_join(
adpc_f,
by = c("USUBJID", "NFRLT"),
suffix = c("_ab", "_pk")
) %>%
filter(!is.na(AVAL_ab))

adab_f <- adab1 %>%
tidyr::pivot_wider(
id_cols = c(USUBJID, VISIT, NFRLT, ISTPT, AVAL_pk),
names_from = PARAMCD,
values_from = AVAL_ab
)
# Select the necessary ADA parameters
adab_f1 <- adab_f %>%
select(USUBJID, VISIT, NFRLT, ISTPT, AVAL_pk, R1800000, R1800001, RESULT1, RESULT2, ADASTAT1, ADASTAT2) %>%
mutate(ADA = R1800000, NAB = R1800001) %>%
select(-R1800000, -R1800001)


# Find subject level ADA status
adab_s <- adab_f1 %>%
select(USUBJID, ADASTAT1, ADASTAT2) %>%
filter(!is.na(ADASTAT1), !is.na(ADASTAT2))
# Find time-vary ADA records
adab_r <- adab_f1 %>%
select(-ADASTAT1, -ADASTAT2) %>%
filter(!is.na(VISIT))

adab_o <- adab_r %>% left_join(adab_s, by = "USUBJID")

out <- adab_o %>%
mutate(AVAL_pk = ifelse(AVAL_pk == 0, NA, AVAL_pk)) %>%
mutate(NFRLT = as.numeric(NFRLT)) %>%
mutate(
RESULT1 = ifelse(RESULT1 == 1, "Positive", "Negative"),
RESULT2 = ifelse(RESULT2 == 1, "Positive", "Negative"),
ADASTAT1 = ifelse(ADASTAT1 == 1, "Positive", "Negative"),
ADASTAT2 = ifelse(ADASTAT2 == 1, "Positive", "Negative"),
# ADA = ifelse(ADA < min_titer_ada, NA, ADA),
# NAB = ifelse(NAB < min_titer_nab, NA, NAB),
AVAL_pk = ifelse(AVAL_pk < min_conc, "BLQ", AVAL_pk)
) %>%
select(
USUBJID, VISIT, ISTPT, NFRLT, ADA, NAB, RESULT1, RESULT2, ADASTAT1, ADASTAT2,
AVAL_pk
) %>%
mutate_at(
c("NFRLT", "ADA", "NAB", "AVAL_pk"),
~ ifelse(is.na(.), replace(., is.na(.), "N/A"), format(round(., 2), nsmall = 2))
)

var_labels(out) <- names(out)

out <- out %>%
arrange(USUBJID, VISIT, desc(ISTPT), NFRLT) %>%
group_by(USUBJID) %>%
mutate(
ADASTAT1 = ifelse(row_number() == 1, ADASTAT1, ""),
ADASTAT2 = ifelse(row_number() == 1, ADASTAT2, "")
) %>% # Keep only the first value in ADA status, set others to ""
var_relabel(
USUBJID = "Subject ID",
VISIT = "Visit",
ISTPT = "Timepoint",
NFRLT = "Nominal\nTime\n(hr)",
RESULT1 = "Sample\nADA\nResult",
ADA = "ADA\nTiter\nUnits\n(1)",
ADASTAT1 = "Patient\nTreatment\nEmergent ADA\nStatus",
RESULT2 = "Sample\nNeutralizing\nAntibody\n(NAb) Result",
NAB = "NAb\nTiter\nUnits\n(2)",
ADASTAT2 = "Patient\nTreatment\nEmergent NAb\nStatus",
AVAL_pk = paste0("Drug\nConcentration\n(", conc_u, ") (3)")
)
```

## Standard Listing

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

```{r lsting, test = list(lsting = "lsting")}
lsting <- as_listing(
out,
key_cols = c("USUBJID", "VISIT"),
disp_cols = names(out),
main_title = paste0(
"Listing of Anti-", drugcd, " Antibody Data for Patients with At Least One ADA Sample Datum by Treatment, ",
"PK Population\nProtocol: ", drug_a
),
subtitles = paste("\nTreatment Group:", trt),
main_footer = "(1) Minimum reportable titer = 1.10 (example only)
(2) Minimum reportable titer = 1.10 (example only)
(3) Minimum reportable concentration = 3.0 (example only)
BLQ = Below Limit of Quantitation, LTR = Lower than Reportable, N/A = Not Applicable, N.C. = Not Calculable,
ADA = Anti-Drug Antibodies (is also referred to as ATA, or Anti-Therapeutic Antibodies)
ROXXXXXXX is also known as [drug]"
)

tail(lsting, 50)[1:24, ]
```

`r webr_code_labels <- c("setup", "lsting")` {{< include ../../_utils/webr.qmd >}}
:::

## Data Setup

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

{{< include ../../test-utils/save_results.qmd >}}
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{{< include ../../repro.qmd >}}
20 changes: 20 additions & 0 deletions package/tests/testthat/_snaps/development/listings-ADA-adal01.md
Original file line number Diff line number Diff line change
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# listings/ADA/adal01.qmd lsting development

Code
print(data_snap[[i]])
Output
# A tibble: 268 × 11
USUBJID VISIT ISTPT NFRLT ADA NAB RESULT1 RESULT2 ADASTAT1 ADASTAT2 AVAL_pk
<lstng_ky> <lstng_ky> <fct> <chr> <chr> <chr> <chr> <chr> <chr> <chr> <chr>
1 AB12345-BRA-1-id-105 Day 1 Predose 0.00 N/A N/A Negative Negative "Negative" "Negative" N/A
2 AB12345-BRA-1-id-105 Day 2 24H 1.00 N/A N/A Negative Negative "" "" N/A
3 AB12345-BRA-1-id-134 Day 1 Predose 0.00 N/A N/A Negative Negative "Negative" "Negative" N/A
4 AB12345-BRA-1-id-134 Day 2 24H 1.00 N/A N/A Negative Negative "" "" N/A
5 AB12345-BRA-1-id-42 Day 1 Predose 0.00 N/A N/A Negative Negative "Negative" "Negative" N/A
6 AB12345-BRA-1-id-42 Day 2 24H 1.00 N/A N/A Negative Negative "" "" N/A
7 AB12345-BRA-1-id-93 Day 1 Predose 0.00 N/A N/A Negative Negative "Positive" "Negative" N/A
8 AB12345-BRA-1-id-93 Day 2 24H 1.00 1.01 1.01 Positive Positive "" "" N/A
9 AB12345-BRA-11-id-217 Day 1 Predose 0.00 1.08 1.08 Positive Positive "Positive" "Negative" N/A
10 AB12345-BRA-11-id-217 Day 2 24H 1.00 1.23 1.23 Positive Positive "" "" N/A
# i 258 more rows

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