# 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"),.stats ="count",var_labels ="Baseline Prevalence of NAbs",show_labels ="visible",table_names ="t1" ) %>%count_patients_with_flags("USUBJID",flag_variables ="PNABBLFL",table_names ="t2",.indent_mods =1L,show_labels ="hidden" ) %>%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 NAbs",show_labels ="visible",table_names ="tb1" ) %>%count_patients_with_flags("USUBJID",flag_variables ="NABPFL",table_names ="tb2",.indent_mods =1L,show_labels ="hidden" ) %>%count_patients_with_flags("USUBJID",flag_variables ="NABNFL",.stats ="count",table_names ="tb3",.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 tables.result <-rbind(result_1, result_2)main_title(result) <-paste("Baseline Prevalence and Incidence of Neutralizing Antibodies (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 NAb = the number (and percentage) of post-baseline evaluable patients for ADA determined to have at least one positive post-baseline NAb result during the study period. Number of patients negative for NAb = number of post-baseline evaluable patients with all negative post-baseline NAb results."result
Baseline Prevalence and Incidence of Neutralizing Antibodies (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
Patients with no positive NAb sample at baseline 0 0 0 0 0
Incidence of NAbs
Post-baseline evaluable patients for ADA 134 132 266 0 266
Patients positive for ADA 66 59 125 0 125
Patients positive for NAb 0 0 0 0 0
Patients negative for NAb 134 132 266 0 266
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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 NAb = the number (and percentage) of post-baseline evaluable patients for ADA determined to have at least one positive post-baseline NAb result during the study period. Number of patients negative for NAb = number of post-baseline evaluable patients with all negative post-baseline NAb results.
Experimental use!
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