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# Name: ADVS
#
# Label: Vital Signs Analysis Dataset
#
# Input: adsl, vs
library(admiral)
library(pharmaversesdtm) # Contains example datasets from the CDISC pilot project
library(dplyr)
library(lubridate)
library(stringr)
# Load source datasets ----
# Use e.g. `haven::read_sas()` to read in .sas7bdat, or other suitable functions
# as needed and assign to the variables below.
# For illustration purposes read in admiral test data
data("vs")
data("admiral_adsl")
adsl <- admiral_adsl
# When SAS datasets are imported into R using haven::read_sas(), missing
# character values from SAS appear as "" characters in R, instead of appearing
# as NA values. Further details can be obtained via the following link:
# https://pharmaverse.github.io/admiral/cran-release/articles/admiral.html#handling-of-missing-values # nolint
vs <- convert_blanks_to_na(vs)
# Lookup tables ----
# Assign PARAMCD, PARAM, and PARAMN
param_lookup <- tibble::tribble(
~VSTESTCD, ~PARAMCD, ~PARAM, ~PARAMN,
"SYSBP", "SYSBP", "Systolic Blood Pressure (mmHg)", 1,
"DIABP", "DIABP", "Diastolic Blood Pressure (mmHg)", 2,
"PULSE", "PULSE", "Pulse Rate (beats/min)", 3,
"WEIGHT", "WEIGHT", "Weight (kg)", 4,
"HEIGHT", "HEIGHT", "Height (cm)", 5,
"TEMP", "TEMP", "Temperature (C)", 6,
"MAP", "MAP", "Mean Arterial Pressure (mmHg)", 7,
"BMI", "BMI", "Body Mass Index(kg/m^2)", 8,
"BSA", "BSA", "Body Surface Area(m^2)", 9
)
attr(param_lookup$VSTESTCD, "label") <- "Vital Signs Test Short Name"
# Assign ANRLO/HI, A1LO/HI
range_lookup <- tibble::tribble(
~PARAMCD, ~ANRLO, ~ANRHI, ~A1LO, ~A1HI,
"SYSBP", 90, 130, 70, 140,
"DIABP", 60, 80, 40, 90,
"PULSE", 60, 100, 40, 110,
"TEMP", 36.5, 37.5, 35, 38
)
# ASSIGN AVALCAT1
avalcat_lookup <- tibble::tribble(
~PARAMCD, ~AVALCA1N, ~AVALCAT1,
"HEIGHT", 1, ">100 cm",
"HEIGHT", 2, "<= 100 cm"
)
# User defined functions ----
# Here are some examples of how you can create your own functions that
# operates on vectors, which can be used in `mutate()`.
format_avalcat1n <- function(param, aval) {
case_when(
param == "HEIGHT" & aval > 140 ~ 1,
param == "HEIGHT" & aval <= 140 ~ 2
)
}
# Derivations ----
# Get list of ADSL vars required for derivations
adsl_vars <- exprs(TRTSDT, TRTEDT, TRT01A, TRT01P)
advs <- vs %>%
# Join ADSL with VS (need TRTSDT for ADY derivation)
derive_vars_merged(
dataset_add = adsl,
new_vars = adsl_vars,
by_vars = exprs(STUDYID, USUBJID)
) %>%
## Calculate ADT, ADY ----
derive_vars_dt(
new_vars_prefix = "A",
dtc = VSDTC
) %>%
derive_vars_dy(reference_date = TRTSDT, source_vars = exprs(ADT))
advs <- advs %>%
## Add PARAMCD only - add PARAM etc later ----
derive_vars_merged_lookup(
dataset_add = param_lookup,
new_vars = exprs(PARAMCD),
by_vars = exprs(VSTESTCD)
) %>%
## Calculate AVAL and AVALC ----
mutate(
AVAL = VSSTRESN,
AVALC = VSSTRESC
) %>%
## Derive new parameters based on existing records ----
# Note that, for the following three `derive_param_*()` functions, only the
# variables specified in `by_vars` will be populated in the newly created
# records.
# Derive Mean Arterial Pressure
derive_param_map(
by_vars = exprs(STUDYID, USUBJID, !!!adsl_vars, VISIT, VISITNUM, ADT, ADY, VSTPT, VSTPTNUM),
set_values_to = exprs(PARAMCD = "MAP"),
get_unit_expr = VSSTRESU,
filter = VSSTAT != "NOT DONE" | is.na(VSSTAT)
) %>%
# Derive Body Surface Area
derive_param_bsa(
by_vars = exprs(STUDYID, USUBJID, !!!adsl_vars, VISIT, VISITNUM, ADT, ADY, VSTPT, VSTPTNUM),
method = "Mosteller",
set_values_to = exprs(PARAMCD = "BSA"),
get_unit_expr = VSSTRESU,
filter = VSSTAT != "NOT DONE" | is.na(VSSTAT),
constant_by_vars = exprs(USUBJID)
) %>%
# Derive Body Mass Index
derive_param_bmi(
by_vars = exprs(STUDYID, USUBJID, !!!adsl_vars, VISIT, VISITNUM, ADT, ADY, VSTPT, VSTPTNUM),
set_values_to = exprs(PARAMCD = "BMI"),
get_unit_expr = VSSTRESU,
filter = VSSTAT != "NOT DONE" | is.na(VSSTAT),
constant_by_vars = exprs(USUBJID)
)
## Get visit info ----
# See also the "Visit and Period Variables" vignette
# (https://pharmaverse.github.io/admiral/cran-release/articles/visits_periods.html#visits)
advs <- advs %>%
# Derive Timing
mutate(
ATPTN = VSTPTNUM,
ATPT = VSTPT,
AVISIT = case_when(
str_detect(VISIT, "SCREEN|UNSCHED|RETRIEVAL|AMBUL") ~ NA_character_,
!is.na(VISIT) ~ str_to_title(VISIT),
TRUE ~ NA_character_
),
AVISITN = as.numeric(case_when(
VISIT == "BASELINE" ~ "0",
str_detect(VISIT, "WEEK") ~ str_trim(str_replace(VISIT, "WEEK", "")),
TRUE ~ NA_character_
))
)
## Derive a new record as a summary record (e.g. mean of the triplicates at each time point) ----
advs <- advs %>%
derive_summary_records(
by_vars = exprs(STUDYID, USUBJID, !!!adsl_vars, PARAMCD, AVISITN, AVISIT, ADT, ADY),
filter = !is.na(AVAL),
analysis_var = AVAL,
summary_fun = mean,
set_values_to = exprs(DTYPE = "AVERAGE")
)
advs <- advs %>%
## Calculate ONTRTFL ----
derive_var_ontrtfl(
start_date = ADT,
ref_start_date = TRTSDT,
ref_end_date = TRTEDT,
filter_pre_timepoint = AVISIT == "Baseline"
)
## Calculate ANRIND : requires the reference ranges ANRLO, ANRHI ----
# Also accommodates the ranges A1LO, A1HI
advs <- advs %>%
derive_vars_merged(dataset_add = range_lookup, by_vars = exprs(PARAMCD)) %>%
# Calculate ANRIND
derive_var_anrind()
## Derive baseline flags ----
advs <- advs %>%
# Calculate BASETYPE
derive_basetype_records(
basetypes = exprs(
"LAST: AFTER LYING DOWN FOR 5 MINUTES" = ATPTN == 815,
"LAST: AFTER STANDING FOR 1 MINUTE" = ATPTN == 816,
"LAST: AFTER STANDING FOR 3 MINUTES" = ATPTN == 817,
"LAST" = is.na(ATPTN)
)
) %>%
# Calculate ABLFL
restrict_derivation(
derivation = derive_var_extreme_flag,
args = params(
by_vars = exprs(STUDYID, USUBJID, BASETYPE, PARAMCD),
order = exprs(ADT, VISITNUM, VSSEQ),
new_var = ABLFL,
mode = "last"
),
filter = (!is.na(AVAL) &
ADT <= TRTSDT & !is.na(BASETYPE) & is.na(DTYPE))
)
## Derive baseline information ----
advs <- advs %>%
# Calculate BASE
derive_var_base(
by_vars = exprs(STUDYID, USUBJID, PARAMCD, BASETYPE),
source_var = AVAL,
new_var = BASE
) %>%
# Calculate BASEC
derive_var_base(
by_vars = exprs(STUDYID, USUBJID, PARAMCD, BASETYPE),
source_var = AVALC,
new_var = BASEC
) %>%
# Calculate BNRIND
derive_var_base(
by_vars = exprs(STUDYID, USUBJID, PARAMCD, BASETYPE),
source_var = ANRIND,
new_var = BNRIND
) %>%
# Calculate CHG
derive_var_chg() %>%
# Calculate PCHG
derive_var_pchg()
## ANL01FL: Flag last result within an AVISIT and ATPT for post-baseline records ----
advs <- advs %>%
restrict_derivation(
derivation = derive_var_extreme_flag,
args = params(
new_var = ANL01FL,
by_vars = exprs(USUBJID, PARAMCD, AVISIT, ATPT, DTYPE),
order = exprs(ADT, AVAL),
mode = "last"
),
filter = !is.na(AVISITN) & ONTRTFL == "Y"
)
## Get treatment information ----
# See also the "Visit and Period Variables" vignette
# (https://pharmaverse.github.io/admiral/cran-release/articles/visits_periods.html#treatment_bds)
advs <- advs %>%
# Assign TRTA, TRTP
# Create End of Treatment Record
derive_extreme_records(
by_vars = exprs(STUDYID, USUBJID, PARAMCD, ATPTN),
order = exprs(ADT, AVISITN, AVAL),
mode = "last",
filter_add = (4 < AVISITN & AVISITN <= 13 & ANL01FL == "Y" & is.na(DTYPE)),
set_values_to = exprs(
AVISIT = "End of Treatment",
AVISITN = 99,
DTYPE = "LOV"
)
) %>%
mutate(
TRTP = TRT01P,
TRTA = TRT01A
)
## Get ASEQ and AVALCATx and add PARAM/PARAMN ----
advs <- advs %>%
# Calculate ASEQ
derive_var_obs_number(
new_var = ASEQ,
by_vars = exprs(STUDYID, USUBJID),
order = exprs(PARAMCD, ADT, AVISITN, VISITNUM, ATPTN, DTYPE),
check_type = "error"
) %>%
# Derive AVALCA1N and AVALCAT1
mutate(AVALCA1N = format_avalcat1n(param = PARAMCD, aval = AVAL)) %>%
derive_vars_merged(dataset_add = avalcat_lookup, by_vars = exprs(PARAMCD, AVALCA1N)) %>%
# Derive PARAM and PARAMN
derive_vars_merged(dataset_add = select(param_lookup, -VSTESTCD), by_vars = exprs(PARAMCD))
# Add all ADSL variables
advs <- advs %>%
derive_vars_merged(
dataset_add = select(adsl, !!!negate_vars(adsl_vars)),
by_vars = exprs(STUDYID, USUBJID)
)
# Final Steps, Select final variables and Add labels
# This process will be based on your metadata, no example given for this reason
# ...
# Save output ----
dir <- tempdir() # Change to whichever directory you want to save the dataset in
saveRDS(advs, file = file.path(dir, "advs.rds"), compress = "bzip2")
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