# Layout for Baseline Prevalence of NAbslyt_bl <-basic_table(show_colcounts =TRUE) %>%split_cols_by("ACTARM",split_fun = custom_column_split_fun ) %>%count_patients_with_flags("USUBJID",flag_variables =c("ADABLPFL", "PADABLPFL"),table_names ="t1",.stats ="count",var_labels ="Baseline Prevalence of NAbs",show_labels ="visible" ) %>%count_patients_with_flags("USUBJID",flag_variables ="PNABBLFL",table_names ="t2",.indent_mods =1L ) %>%count_patients_with_flags("USUBJID",flag_variables ="NNABBLFL",.stats ="count",table_names ="t3",.indent_mods =1L,show_labels ="hidden" )# Layout for incidence of NAbslyt_pb <-basic_table(show_colcounts =TRUE) %>%split_cols_by("ACTARM",split_fun = custom_column_split_fun ) %>%count_patients_with_flags("USUBJID",flag_variables =c("ADPBLPFL", "ADAPFL"),.stats ="count",var_labels ="Incidence of Treatment Emergent NAbs",show_labels ="visible",table_names ="tb1" ) %>%count_patients_with_flags("USUBJID",flag_variables ="TENABPFL",table_names ="tb2",.indent_mods =1L,show_labels ="hidden" ) %>%count_patients_with_flags("USUBJID",flag_variables =c("TINPBFL", "TENPBFL"),.stats ="count",table_names ="tb3",.indent_mods =1L,show_labels ="hidden" ) %>%count_patients_with_flags("USUBJID",flag_variables ="NABNFL",table_names ="tb4",.indent_mods =1L,show_labels ="hidden" ) %>%count_patients_with_flags("USUBJID",flag_variables ="TUNPBFL",.stats ="count",table_names ="tb5",.indent_mods =1L,show_labels ="hidden" )result_1 <-build_table(lyt_bl, df = adab_b, alt_counts_df = adsl)result_2 <-build_table(lyt_pb, df = adab_pb, alt_counts_df = adsl)# Combine tablesresult <-rbind(result_1, result_2)main_title(result) <-paste("Baseline Prevalence and Incidence of Treatment Emergent NAbs")subtitles(result) <-paste("Protocol:", unique(adab$PARCAT1)[1])main_footer(result) <-"NAb = Neutralizing Antibodies ADA = Anti-Drug Antibodies (is also referred to as ATA, or Anti-Therapeutic Antibodies) Baseline evaluable patient for ADA = a patient with an ADA assay result from a baseline sample(s) Baseline evaluable patient for NAb = a patient with a NAb assay result from a baseline sample(s) Post-baseline evaluable patient for ADA = a patient with an ADA assay result from at least one post-baseline sample Post-baseline evaluable patient for NAb = a patient with a NAb assay result from at least one post-baseline sample Number of patients positive for ADA = the number of post-baseline evaluable patients for ADA determined to have Treatment Emergent ADA during the study period.Number of patients positive for Treatment Emergent NAb = the number (and percentage) of post-baseline evaluable patients for ADA determined to have treatment-induced NAb or treatment-enhanced NAb during the study period.Treatment-induced = a patient with negative or missing baseline result(s) and at least one positive post-baseline result. Treatment-enhanced = a patient with positive result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result.Number of patients negative for Treatment Emergent NAb = number of post-baseline evaluable patients with negative or missing baseline NAb result(s) and all negative post-baseline NAb results, or a patient who is NAb treatment unaffected.Treatment unaffected = A post-baseline evaluable patient with a positive result at baseline and (a) where all post-baseline titer results are less than 0.60 t.u. greater than the baseline titer result, OR (b) where all post-baseline results are negative or missing. For any positive sample with titer result less than the minimum reportable titer or any positive sample where a titer cannot be obtained, titer value is imputed as equal to the minimum reportable titer."result
Baseline Prevalence and Incidence of Treatment Emergent NAbs
Protocol: A: Drug X Antibody
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A: Drug X C: Combination All Drug X B: Placebo All Patients
(N=134) (N=132) (N=266) (N=134) (N=400)
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Baseline Prevalence of NAbs
Baseline evaluable patients for ADA 134 132 266 0 266
Patients with a positive ADA sample at baseline 63 64 127 0 127
Patients with a positive NAb sample at baseline 0 0 0 0 0
Patient with no positive NAb samples at baseline 0 0 0 0 0
Incidence of Treatment Emergent NAbs
Post-baseline evaluable patients for ADA 134 132 266 0 266
Patients positive for ADA 66 59 125 0 125
Patients positive for Treatment Emergent NAb 0 0 0 0 0
Treatment-induced NAb 0 0 0 0 0
Treatment-enhanced NAb 0 0 0 0 0
Patients negative for NAb 0 0 0 0 0
Treatment unaffected 0 0 0 0 0
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NAb = Neutralizing Antibodies ADA = Anti-Drug Antibodies (is also referred to as ATA, or Anti-Therapeutic Antibodies) Baseline evaluable patient for ADA = a patient with an ADA assay result from a baseline sample(s)
Baseline evaluable patient for NAb = a patient with a NAb assay result from a baseline sample(s)
Post-baseline evaluable patient for ADA = a patient with an ADA assay result from at least one post-baseline sample
Post-baseline evaluable patient for NAb = a patient with a NAb assay result from at least one post-baseline sample
Number of patients positive for ADA = the number of post-baseline evaluable patients for ADA determined to have Treatment Emergent ADA during the study period.
Number of patients positive for Treatment Emergent NAb = the number (and percentage) of post-baseline evaluable patients for ADA determined to have treatment-induced NAb or treatment-enhanced NAb during the study period.
Treatment-induced = a patient with negative or missing baseline result(s) and at least one positive post-baseline result. Treatment-enhanced = a patient with positive result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result.
Number of patients negative for Treatment Emergent NAb = number of post-baseline evaluable patients with negative or missing baseline NAb result(s) and all negative post-baseline NAb results, or a patient who is NAb treatment unaffected.
Treatment unaffected = A post-baseline evaluable patient with a positive result at baseline and (a) where all post-baseline titer results are less than 0.60 t.u. greater than the baseline titer result, OR (b) where all post-baseline results are negative or missing. For any positive sample with titer result less than the minimum reportable titer or any positive sample where a titer cannot be obtained, titer value is imputed as equal to the minimum reportable titer.
Experimental use!
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Code
library(tern)library(dplyr)library(tibble)adsl <- random.cdisc.data::cadsladab <- random.cdisc.data::cadab# Order needed for the columns is c(1, 3, 4, 2, 5)reorder_facets <-function(splret, spl, fulldf, ...) { ord <-c(1, 3, 4, 2, 5)make_split_result( splret$values[ord], splret$datasplit[ord], splret$labels[ord] )}# Create a custom split function for adding the new columns (facets) and sorting themcustom_column_split_fun <-make_split_fun(post =list(add_combo_facet("all_X",label ="All Drug X",levels =c("A: Drug X", "C: Combination") ),add_combo_facet("all_pt",label ="All Patients",levels =c("A: Drug X", "B: Placebo", "C: Combination") ), reorder_facets ))# Ensure character variables are converted to factors and empty strings and NAs are explicit missing levels.adsl <-df_explicit_na(adsl)# Baseline Ptsadab_b <-df_explicit_na(adab) %>%filter( ABLFL =="Y", ADABLPFL =="Y", PARAM %in%c("ADA interpreted per sample result","NAB interpreted per sample result" ) ) %>%select(-PARAMCD, -AVALC, -AVALU) %>% tidyr::pivot_wider(names_from = PARAM,values_from = AVAL ) %>%mutate(across(any_of(c("ADA interpreted per sample result","NAB interpreted per sample result" )), as.logical ) ) %>%mutate(ADABLPFL = ADABLPFL =="Y",PADABLPFL =if (exists("ADA interpreted per sample result", where = .)) {`ADA interpreted per sample result`=="TRUE" } else {FALSE },PNABBLFL =if (exists("NAB interpreted per sample result", where = .)) {`NAB interpreted per sample result`=="TRUE" } else {FALSE },NNABBLFL =if (exists("NAB interpreted per sample result", where = .)) {`NAB interpreted per sample result`=="FALSE" } else {FALSE } ) %>%var_relabel(ADABLPFL ="Baseline evaluable patients for ADA",PADABLPFL ="Patients with a positive ADA sample at baseline",PNABBLFL ="Patients with a positive NAb sample at baseline",NNABBLFL ="Patient with no positive NAb samples at baseline" )# Post Baseline Treatment Enhanced NAb positive Ptsadab_pb <-df_explicit_na(adab) %>%filter( ABLFL !="Y", ADPBLPFL =="Y", PARAM %in%c("ADA interpreted per sample result","Treatment Emergent - Positive, Neutralizing Antibody","Treatment induced ADA, Neutralizing Antibody","Treatment enhanced ADA, Neutralizing Antibody","NAB interpreted per sample result","Treatment unaffected, Neutralizing Antibody" ) ) %>%select(-PARAMCD, -AVALC, -AVALU, -ARRLT, -NRRLT) %>%unique() %>% tidyr::pivot_wider(names_from = PARAM,values_from = AVAL ) %>%mutate(across(any_of(c("ADA interpreted per sample result", "NAB interpreted per sample result","Treatment Emergent - Positive, Neutralizing Antibody","Treatment induced ADA, Neutralizing Antibody","Treatment enhanced ADA, Neutralizing Antibody","Treatment unaffected, Neutralizing Antibody" )), as.logical ) ) %>%mutate(ADPBLPFL = ADPBLPFL =="Y",ADAPFL =if (exists("ADA interpreted per sample result", where = .)) {`ADA interpreted per sample result`=="TRUE" } else {FALSE },TENABPFL =if (exists("Treatment Emergent - Positive, Neutralizing Antibody", where = .)) {`Treatment Emergent - Positive, Neutralizing Antibody`=="TRUE" } else {FALSE },TINPBFL =if (exists("Treatment induced ADA, Neutralizing Antibody", where = .)) {`Treatment induced ADA, Neutralizing Antibody`=="TRUE" } else {FALSE },TENPBFL =if (exists("Treatment enhanced ADA, Neutralizing Antibody", where = .)) {`Treatment enhanced ADA, Neutralizing Antibody`=="TRUE" } else {FALSE },NABNFL =if (exists("NAB interpreted per sample result", where = .)) {`NAB interpreted per sample result`=="FALSE" } else {FALSE },TUNPBFL =if (exists("Treatment unaffected, Neutralizing Antibody", where = .)) {`Treatment unaffected, Neutralizing Antibody`=="TRUE" } else {FALSE } ) %>%var_relabel(ADPBLPFL ="Post-baseline evaluable patients for ADA",ADAPFL ="Patients positive for ADA",TENABPFL ="Patients positive for Treatment Emergent NAb",TINPBFL ="Treatment-induced NAb",TENPBFL ="Treatment-enhanced NAb",NABNFL ="Patients negative for NAb",TUNPBFL ="Treatment unaffected" )
---title: ADAT04Asubtitle: Baseline Prevalence and Incidence of Treatment Emergent NAbs---------------------------------------------------------------------------{{< include ../../_utils/envir_hook.qmd >}}```{r setup, echo = FALSE, warning = FALSE, message = FALSE}library(tern)library(dplyr)library(tibble)adsl <- random.cdisc.data::cadsladab <- random.cdisc.data::cadab# Order needed for the columns is c(1, 3, 4, 2, 5)reorder_facets <- function(splret, spl, fulldf, ...) { ord <- c(1, 3, 4, 2, 5) make_split_result( splret$values[ord], splret$datasplit[ord], splret$labels[ord] )}# Create a custom split function for adding the new columns (facets) and sorting themcustom_column_split_fun <- make_split_fun( post = list( add_combo_facet("all_X", label = "All Drug X", levels = c("A: Drug X", "C: Combination") ), add_combo_facet("all_pt", label = "All Patients", levels = c("A: Drug X", "B: Placebo", "C: Combination") ), reorder_facets ))# Ensure character variables are converted to factors and empty strings and NAs are explicit missing levels.adsl <- df_explicit_na(adsl)# Baseline Ptsadab_b <- df_explicit_na(adab) %>% filter( ABLFL == "Y", ADABLPFL == "Y", PARAM %in% c( "ADA interpreted per sample result", "NAB interpreted per sample result" ) ) %>% select(-PARAMCD, -AVALC, -AVALU) %>% tidyr::pivot_wider( names_from = PARAM, values_from = AVAL ) %>% mutate( across( any_of(c( "ADA interpreted per sample result", "NAB interpreted per sample result" )), as.logical ) ) %>% mutate( ADABLPFL = ADABLPFL == "Y", PADABLPFL = if (exists("ADA interpreted per sample result", where = .)) { `ADA interpreted per sample result` == "TRUE" } else { FALSE }, PNABBLFL = if (exists("NAB interpreted per sample result", where = .)) { `NAB interpreted per sample result` == "TRUE" } else { FALSE }, NNABBLFL = if (exists("NAB interpreted per sample result", where = .)) { `NAB interpreted per sample result` == "FALSE" } else { FALSE } ) %>% var_relabel( ADABLPFL = "Baseline evaluable patients for ADA", PADABLPFL = "Patients with a positive ADA sample at baseline", PNABBLFL = "Patients with a positive NAb sample at baseline", NNABBLFL = "Patient with no positive NAb samples at baseline" )# Post Baseline Treatment Enhanced NAb positive Ptsadab_pb <- df_explicit_na(adab) %>% filter( ABLFL != "Y", ADPBLPFL == "Y", PARAM %in% c( "ADA interpreted per sample result", "Treatment Emergent - Positive, Neutralizing Antibody", "Treatment induced ADA, Neutralizing Antibody", "Treatment enhanced ADA, Neutralizing Antibody", "NAB interpreted per sample result", "Treatment unaffected, Neutralizing Antibody" ) ) %>% select(-PARAMCD, -AVALC, -AVALU, -ARRLT, -NRRLT) %>% unique() %>% tidyr::pivot_wider( names_from = PARAM, values_from = AVAL ) %>% mutate( across( any_of(c( "ADA interpreted per sample result", "NAB interpreted per sample result", "Treatment Emergent - Positive, Neutralizing Antibody", "Treatment induced ADA, Neutralizing Antibody", "Treatment enhanced ADA, Neutralizing Antibody", "Treatment unaffected, Neutralizing Antibody" )), as.logical ) ) %>% mutate( ADPBLPFL = ADPBLPFL == "Y", ADAPFL = if (exists("ADA interpreted per sample result", where = .)) { `ADA interpreted per sample result` == "TRUE" } else { FALSE }, TENABPFL = if (exists("Treatment Emergent - Positive, Neutralizing Antibody", where = .)) { `Treatment Emergent - Positive, Neutralizing Antibody` == "TRUE" } else { FALSE }, TINPBFL = if (exists("Treatment induced ADA, Neutralizing Antibody", where = .)) { `Treatment induced ADA, Neutralizing Antibody` == "TRUE" } else { FALSE }, TENPBFL = if (exists("Treatment enhanced ADA, Neutralizing Antibody", where = .)) { `Treatment enhanced ADA, Neutralizing Antibody` == "TRUE" } else { FALSE }, NABNFL = if (exists("NAB interpreted per sample result", where = .)) { `NAB interpreted per sample result` == "FALSE" } else { FALSE }, TUNPBFL = if (exists("Treatment unaffected, Neutralizing Antibody", where = .)) { `Treatment unaffected, Neutralizing Antibody` == "TRUE" } else { FALSE } ) %>% var_relabel( ADPBLPFL = "Post-baseline evaluable patients for ADA", ADAPFL = "Patients positive for ADA", TENABPFL = "Patients positive for Treatment Emergent NAb", TINPBFL = "Treatment-induced NAb", TENPBFL = "Treatment-enhanced NAb", NABNFL = "Patients negative for NAb", TUNPBFL = "Treatment unaffected" )``````{r include = FALSE}webr_code_labels <- c("setup")```{{< include ../../_utils/webr_no_include.qmd >}}## Output:::: panel-tabset## Summary of Treatment Emergent NAbs::: {.panel-tabset .nav-justified group="webr"}## {{< fa regular file-lines sm fw >}} Preview```{r variant1, test = list(result_v1 = "result")}# Layout for Baseline Prevalence of NAbslyt_bl <- basic_table(show_colcounts = TRUE) %>% split_cols_by( "ACTARM", split_fun = custom_column_split_fun ) %>% count_patients_with_flags( "USUBJID", flag_variables = c("ADABLPFL", "PADABLPFL"), table_names = "t1", .stats = "count", var_labels = "Baseline Prevalence of NAbs", show_labels = "visible" ) %>% count_patients_with_flags( "USUBJID", flag_variables = "PNABBLFL", table_names = "t2", .indent_mods = 1L ) %>% count_patients_with_flags( "USUBJID", flag_variables = "NNABBLFL", .stats = "count", table_names = "t3", .indent_mods = 1L, show_labels = "hidden" )# Layout for incidence of NAbslyt_pb <- basic_table(show_colcounts = TRUE) %>% split_cols_by( "ACTARM", split_fun = custom_column_split_fun ) %>% count_patients_with_flags( "USUBJID", flag_variables = c("ADPBLPFL", "ADAPFL"), .stats = "count", var_labels = "Incidence of Treatment Emergent NAbs", show_labels = "visible", table_names = "tb1" ) %>% count_patients_with_flags( "USUBJID", flag_variables = "TENABPFL", table_names = "tb2", .indent_mods = 1L, show_labels = "hidden" ) %>% count_patients_with_flags( "USUBJID", flag_variables = c("TINPBFL", "TENPBFL"), .stats = "count", table_names = "tb3", .indent_mods = 1L, show_labels = "hidden" ) %>% count_patients_with_flags( "USUBJID", flag_variables = "NABNFL", table_names = "tb4", .indent_mods = 1L, show_labels = "hidden" ) %>% count_patients_with_flags( "USUBJID", flag_variables = "TUNPBFL", .stats = "count", table_names = "tb5", .indent_mods = 1L, show_labels = "hidden" )result_1 <- build_table(lyt_bl, df = adab_b, alt_counts_df = adsl)result_2 <- build_table(lyt_pb, df = adab_pb, alt_counts_df = adsl)# Combine tablesresult <- rbind(result_1, result_2)main_title(result) <- paste( "Baseline Prevalence and Incidence of Treatment Emergent NAbs")subtitles(result) <- paste("Protocol:", unique(adab$PARCAT1)[1])# nolint start: line_length.main_footer(result) <- "NAb = Neutralizing Antibodies ADA = Anti-Drug Antibodies (is also referred to as ATA, or Anti-Therapeutic Antibodies) Baseline evaluable patient for ADA = a patient with an ADA assay result from a baseline sample(s) Baseline evaluable patient for NAb = a patient with a NAb assay result from a baseline sample(s) Post-baseline evaluable patient for ADA = a patient with an ADA assay result from at least one post-baseline sample Post-baseline evaluable patient for NAb = a patient with a NAb assay result from at least one post-baseline sample Number of patients positive for ADA = the number of post-baseline evaluable patients for ADA determined to have Treatment Emergent ADA during the study period.Number of patients positive for Treatment Emergent NAb = the number (and percentage) of post-baseline evaluable patients for ADA determined to have treatment-induced NAb or treatment-enhanced NAb during the study period.Treatment-induced = a patient with negative or missing baseline result(s) and at least one positive post-baseline result. Treatment-enhanced = a patient with positive result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result.Number of patients negative for Treatment Emergent NAb = number of post-baseline evaluable patients with negative or missing baseline NAb result(s) and all negative post-baseline NAb results, or a patient who is NAb treatment unaffected.Treatment unaffected = A post-baseline evaluable patient with a positive result at baseline and (a) where all post-baseline titer results are less than 0.60 t.u. greater than the baseline titer result, OR (b) where all post-baseline results are negative or missing. For any positive sample with titer result less than the minimum reportable titer or any positive sample where a titer cannot be obtained, titer value is imputed as equal to the minimum reportable titer."# nolint end: line_length.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 >}}