# Count deaths by treatment arm
death_table <- event_count(
adsl,
patient = "USUBJID",
treat = "ARM",
label = "Total number of deaths",
.filters = "DTHFL == 'Y'"
)
# Count study withdrawals due to adverse events
withdrawal_table <- event_count(
adsl,
patient = "USUBJID",
treat = "ARM",
label = "Total number of patients withdrawn from study due to an AE",
.filters = "DCSREAS == 'ADVERSE EVENT'"
)
# Count patients with at least one adverse event
patients_with_ae_table <- event_count(
adae,
patient = "USUBJID",
treat = "ARM",
label = "Total number of patients with at least one AE"
)
# Count total number of adverse events (not patients)
total_ae_events_table <- total_events(
dt = adae,
treat = "ARM",
label = "Total number of AEs"
)
# Summarise AESIs (e.g., serious, related, severe, etc.)
aesi_vars <- c("FATAL", "SER", "SERWD", "SERDSM", "RELSER",
"WD", "DSM", "REL", "RELWD", "RELDSM", "SEV")
aesi_table <- multi_event_true(
dt = aesi,
event_vars = aesi_vars,
patient = "USUBJID",
treat = "ARM",
heading = "Total number of patients with at least one",
.total_dt = adsl,
indent = " "
)
# Combine all safety tables into a single summary table
safety_summary <- merge_table_lists(list(
patients_with_ae_table,
total_ae_events_table,
death_table,
withdrawal_table,
aesi_table
))
safety_summary
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