Code
# Layout for post-baseline evaluable patient variables from adab dataset.
lyt_adab <- basic_table(show_colcounts = TRUE) %>%
split_cols_by(
"ACTARM",
split_fun = drop_split_levels
) %>%
count_patients_with_flags(
"USUBJID",
flag_variables = "ADPBLPFL",
.stats = "count",
table_names = "post_baseline"
) %>%
count_patients_with_flags(
"USUBJID",
flag_variables = "TI_ADA"
)
# Layout for treatment-induced patient variables from adab dataset.
lyt_adab_ti <- basic_table(show_colcounts = TRUE) %>%
split_cols_by(
"ACTARM",
split_fun = keep_split_levels(levels(adab_ti$ACTARM)[-2]) # temp fix
) %>%
count_patients_with_flags(
"USUBJID",
flag_variables = c("Transient ADA", "Persistent ADA"),
var_labels = "Treatment-induced ADA patients with",
show_labels = "visible"
) %>%
analyze_vars(
"Time to onset of ADA",
.stats = "median",
nested = FALSE,
.labels = c(median = "Median time to onset of ADA (weeks)")
) %>%
analyze_vars(
"Antibody titer units",
.stats = "range",
nested = FALSE,
.labels = c(range = "ADA titer range (min - max)")
)
result_adab <- build_table(lyt_adab, df = adab, alt_counts_df = adsl)
result_adab_ti <- build_table(lyt_adab_ti, df = adab_ti, alt_counts_df = adsl)
# Combine tables.
col_info(result_adab) <- col_info(result_adab_ti)
result <- rbind(
result_adab,
result_adab_ti
)
main_title(result) <- paste(
"Summary of Patients with Treatment-Induced ADA, PK Population"
)
subtitles(result) <- paste("Protocol:", unique(adab$PARCAT1)[1])
main_footer(result) <- paste(
"ADA = Anti-Drug Antibodies (is also referred to as ATA, or Anti-Therapeutic
Antibodies)
Treatment-induced ADA = negative or missing baseline.
ADA result(s) and at least one positive post-baseline ADA result.
Transient ADA = ADA positive result detected (a) at only one post-baseline
sampling timepoint (excluding last timepoint) OR (b) at 2 or more timepoints
during treatment where the first and last ADA positive samples are separated
by a period of < 16 weeks, irrespective of any negative samples in between.
Persistent ADA = ADA positive result detected (a) at the last post-baseline
sampling timepoint, OR (b) at 2 or more time points during treatment where
the first and last ADA positive samples are separated by a period ≥ 16
weeks, irrespective of any negative samples in between."
)
resultSummary of Patients with Treatment-Induced ADA, PK Population
Protocol: A: Drug X Antibody
—————————————————————————————————————————————————————————————————
A: Drug X C: Combination
(N=134) (N=132)
—————————————————————————————————————————————————————————————————
Post-baseline evaluable patients 134 132
Treatment-induced ADA patients 38 (28.4%) 26 (19.7%)
Treatment-induced ADA patients with
Transient ADA 0 0
Persistent ADA 0 0
Median time to onset of ADA (weeks) 0.1 0.1
ADA titer range (min - max) NA NA
—————————————————————————————————————————————————————————————————
ADA = Anti-Drug Antibodies (is also referred to as ATA, or Anti-Therapeutic
Antibodies)
Treatment-induced ADA = negative or missing baseline.
ADA result(s) and at least one positive post-baseline ADA result.
Transient ADA = ADA positive result detected (a) at only one post-baseline
sampling timepoint (excluding last timepoint) OR (b) at 2 or more timepoints
during treatment where the first and last ADA positive samples are separated
by a period of < 16 weeks, irrespective of any negative samples in between.
Persistent ADA = ADA positive result detected (a) at the last post-baseline
sampling timepoint, OR (b) at 2 or more time points during treatment where
the first and last ADA positive samples are separated by a period ≥ 16
weeks, irrespective of any negative samples in between.