# 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 ="ADABLPFL",.stats ="count",var_labels ="Baseline Prevalence of ADAs",show_labels ="visible",table_names ="t1" ) %>%count_patients_with_flags("USUBJID",flag_variables ="PADABLPFL",table_names ="t2",.indent_mods =1L,var_labels ="a",show_labels ="hidden" ) %>%count_patients_with_flags("USUBJID",flag_variables ="NADABLPFL",.stats ="count",show_labels ="hidden",.indent_mods =1L,table_names ="t3" )# 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 ="ADPBLPFL",.stats ="count",var_labels ="Incidence of Treatment Emergent ADAs",show_labels ="visible",table_names ="tb1" ) %>%count_patients_with_flags("USUBJID",flag_variables ="PTEFL",table_names ="tb2",.indent_mods =1L,show_labels ="hidden" ) %>%count_patients_with_flags("USUBJID",flag_variables =c("TIFL", "TEFL"),.stats ="count",table_names ="tb3",.indent_mods =2L,show_labels ="hidden" ) %>%count_patients_with_flags("USUBJID",flag_variables ="NTEFL",table_names ="tb4",.indent_mods =1L,show_labels ="hidden" ) %>%count_patients_with_flags("USUBJID",flag_variables ="TUFL",.stats ="count",table_names ="tb5",.indent_mods =2L,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_1@col_info <- result_2@col_inforesult <-rbind(result_1, result_2)main_title(result) <-paste("Baseline Prevalence and Incidence of Treatment Emergent ADA")main_footer(result) <-"ADA = Anti-Drug Antibodies (is also referred to as ATA, or Anti-Therapeutic Antibodies) Baseline evaluable patient = a patient with an ADA assay result from a baseline sample(s) Post-baseline evaluable patient = a patient with an ADA assay result from at least one post-baseline sample Number of patients positive for Treatment Emergent ADA = the number (and percentage) of post-baseline evaluable patients determined to have treatment-induced ADA or treatment-enhanced ADA during the study period. Treatment-induced ADA = a patient with negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a patient with positive ADA 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 ADA = number of post-baseline evaluable patients with negative or missing baseline ADA result(s) and all negative post-baseline results, or a patient who is treatment unaffected. Treatment unaffected = A post-baseline evaluable patient with a positive ADA 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 ADA
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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 ADAs
Baseline evaluable patients 134 132 266 0 266
Patient with a positive sample at baseline 63 (47.0%) 64 (48.5%) 127 (47.7%) 0 127 (47.7%)
Patient with no positive samples at baseline 71 68 139 0 139
Incidence of Treatment Emergent ADAs
Post-baseline evaluable patients 134 132 266 0 266
Patient positive for Treatment Emergent ADA 0 0 0 0 0
Treatment-induced ADA 0 0 0 0 0
Treatment-enhanced ADA 0 0 0 0 0
Patient negative for Treatment Emergent ADA 0 0 0 0 0
Treatment unaffected 0 0 0 0 0
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ADA = Anti-Drug Antibodies (is also referred to as ATA, or Anti-Therapeutic Antibodies) Baseline evaluable patient = a patient with an ADA assay result from a baseline sample(s)
Post-baseline evaluable patient = a patient with an ADA assay result from at least one post-baseline sample Number of patients positive for Treatment Emergent
ADA = the number (and percentage) of post-baseline evaluable patients determined to have treatment-induced ADA or treatment-enhanced ADA during the study period.
Treatment-induced ADA = a patient with negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result.
Treatment-enhanced ADA = a patient with positive ADA 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 ADA = number of post-baseline evaluable patients with negative or missing baseline ADA result(s) and all negative post-baseline results, or a patient who is treatment unaffected.
Treatment unaffected = A post-baseline evaluable patient with a positive ADA 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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