Nothing
## ----setup, include = FALSE---------------------------------------------------
knitr::opts_chunk$set(
collapse = TRUE,
comment = "#>"
)
library(admiraldev)
## ----message=FALSE------------------------------------------------------------
library(admiral)
library(admiralonco)
library(dplyr)
library(pharmaversesdtm)
library(pharmaverseadam)
library(lubridate)
library(stringr)
data("adsl")
data("rs_onco_recist")
data("tu_onco_recist")
rs <- rs_onco_recist
tu <- tu_onco_recist
rs <- convert_blanks_to_na(rs)
tu <- convert_blanks_to_na(tu)
## ----echo=FALSE---------------------------------------------------------------
# select subjects from adsl such that there is one subject without RS data
rs_subjects <- unique(rs$USUBJID)
adsl_subjects <- unique(adsl$USUBJID)
adsl <- filter(
adsl,
USUBJID %in% union(rs_subjects, setdiff(adsl_subjects, rs_subjects)[1])
)
## ----eval=TRUE----------------------------------------------------------------
adsl_vars <- exprs(RANDDT)
adrs <- derive_vars_merged(
rs,
dataset_add = adsl,
new_vars = adsl_vars,
by_vars = get_admiral_option("subject_keys")
)
## ----eval=TRUE, echo=FALSE----------------------------------------------------
dataset_vignette(
adrs,
display_vars = exprs(USUBJID, RSTESTCD, RSDTC, VISIT, RANDDT),
filter = RSTESTCD == "OVRLRESP"
)
## -----------------------------------------------------------------------------
adrs <- adrs %>%
filter(RSEVAL == "INVESTIGATOR" & RSTESTCD == "OVRLRESP") %>%
mutate(
PARAMCD = "OVR",
PARAM = "Overall Response by Investigator",
PARCAT1 = "Tumor Response",
PARCAT2 = "Investigator",
PARCAT3 = "RECIST 1.1"
)
## ----echo=FALSE---------------------------------------------------------------
dataset_vignette(
adrs,
display_vars = exprs(USUBJID, VISIT, RSTESTCD, RSEVAL, PARAMCD, PARAM, PARCAT1, PARCAT2, PARCAT3)
)
## -----------------------------------------------------------------------------
adrs <- adrs %>%
derive_vars_dt(
dtc = RSDTC,
new_vars_prefix = "A",
highest_imputation = "D",
date_imputation = "last"
) %>%
mutate(AVISIT = VISIT)
## ----echo=FALSE---------------------------------------------------------------
dataset_vignette(
adrs,
display_vars = exprs(USUBJID, AVISIT, PARAMCD, PARAM, RSSTRESC, RSDTC, ADT, ADTF)
)
## -----------------------------------------------------------------------------
adrs <- adrs %>%
mutate(
AVALC = RSSTRESC,
AVAL = aval_resp(AVALC)
)
## ----echo=FALSE---------------------------------------------------------------
dataset_vignette(
adrs,
display_vars = exprs(USUBJID, AVISIT, PARAMCD, PARAM, RSSTRESC, AVALC, AVAL)
)
## -----------------------------------------------------------------------------
worst_resp <- function(arg) {
case_when(
arg == "NE" ~ 1,
arg == "CR" ~ 2,
arg == "PR" ~ 3,
arg == "SD" ~ 4,
arg == "NON-CR/NON-PD" ~ 5,
arg == "PD" ~ 6,
TRUE ~ 0
)
}
adrs <- adrs %>%
restrict_derivation(
derivation = derive_var_extreme_flag,
args = params(
by_vars = c(get_admiral_option("subject_keys"), exprs(ADT)),
order = exprs(worst_resp(AVALC), RSSEQ),
new_var = ANL01FL,
mode = "last"
),
filter = !is.na(AVAL) & ADT >= RANDDT
)
## ----echo=FALSE---------------------------------------------------------------
dataset_vignette(
adrs,
display_vars = exprs(USUBJID, AVISIT, PARAMCD, PARAM, AVALC, ADT, RANDDT, ANL01FL)
)
## ----eval=FALSE---------------------------------------------------------------
# adrs <- adrs %>%
# mutate(
# ANL01FL = case_when(
# !is.na(AVAL) & ADT >= RANDDT & ADT < NACTDT ~ "Y",
# TRUE ~ NA_character_
# )
# )
## -----------------------------------------------------------------------------
adrs <- adrs %>%
derive_var_relative_flag(
by_vars = get_admiral_option("subject_keys"),
order = exprs(ADT, RSSEQ),
new_var = ANL02FL,
condition = AVALC == "PD",
mode = "first",
selection = "before",
inclusive = TRUE
)
## ----echo=FALSE---------------------------------------------------------------
dataset_vignette(
adrs,
display_vars = exprs(USUBJID, AVISIT, PARAMCD, AVALC, ADT, ANL01FL, ANL02FL)
)
## -----------------------------------------------------------------------------
ovr <- filter(adrs, PARAMCD == "OVR" & ANL01FL == "Y" & ANL02FL == "Y")
## ----echo=FALSE---------------------------------------------------------------
dataset_vignette(
ovr,
display_vars = exprs(USUBJID, AVISIT, AVALC, ADT, RANDDT)
)
## -----------------------------------------------------------------------------
confirmation_period <- 21
crsp_y_cr <- event_joined(
description = paste(
"Define confirmed response as CR followed by CR at least",
confirmation_period,
"days later and at most one NE in between"
),
dataset_name = "ovr",
join_vars = exprs(AVALC, ADT),
join_type = "after",
order = exprs(ADT),
first_cond_upper = AVALC.join == "CR" &
ADT.join >= ADT + days(confirmation_period),
condition = AVALC == "CR" &
all(AVALC.join %in% c("CR", "NE")) &
count_vals(var = AVALC.join, val = "NE") <= 1,
set_values_to = exprs(AVALC = "Y")
)
crsp_y_pr <- event_joined(
description = paste(
"Define confirmed response as PR followed by CR or PR at least",
confirmation_period,
"days later, at most one NE in between, and no PR after CR"
),
dataset_name = "ovr",
join_vars = exprs(AVALC, ADT),
join_type = "after",
order = exprs(ADT),
first_cond_upper = AVALC.join %in% c("CR", "PR") &
ADT.join >= ADT + days(confirmation_period),
condition = AVALC == "PR" &
all(AVALC.join %in% c("CR", "PR", "NE")) &
count_vals(var = AVALC.join, val = "NE") <= 1 &
(
min_cond(
var = ADT.join,
cond = AVALC.join == "CR"
) > max_cond(var = ADT.join, cond = AVALC.join == "PR") |
count_vals(var = AVALC.join, val = "CR") == 0 |
count_vals(var = AVALC.join, val = "PR") == 0
),
set_values_to = exprs(AVALC = "Y")
)
cbor_cr <- event_joined(
description = paste(
"Define complete response (CR) for confirmed best overall response (CBOR) as",
"CR followed by CR at least",
confirmation_period,
"days later and at most one NE in between"
),
dataset_name = "ovr",
join_vars = exprs(AVALC, ADT),
join_type = "after",
first_cond_upper = AVALC.join == "CR" &
ADT.join >= ADT + confirmation_period,
condition = AVALC == "CR" &
all(AVALC.join %in% c("CR", "NE")) &
count_vals(var = AVALC.join, val = "NE") <= 1,
set_values_to = exprs(AVALC = "CR")
)
cbor_pr <- event_joined(
description = paste(
"Define partial response (PR) for confirmed best overall response (CBOR) as",
"PR followed by CR or PR at least",
confirmation_period,
"28 days later, at most one NE in between, and no PR after CR"
),
dataset_name = "ovr",
join_vars = exprs(AVALC, ADT),
join_type = "after",
first_cond_upper = AVALC.join %in% c("CR", "PR") &
ADT.join >= ADT + confirmation_period,
condition = AVALC == "PR" &
all(AVALC.join %in% c("CR", "PR", "NE")) &
count_vals(var = AVALC.join, val = "NE") <= 1 &
(
min_cond(
var = ADT.join,
cond = AVALC.join == "CR"
) > max_cond(var = ADT.join, cond = AVALC.join == "PR") |
count_vals(var = AVALC.join, val = "CR") == 0 |
count_vals(var = AVALC.join, val = "PR") == 0
),
set_values_to = exprs(AVALC = "PR")
)
no_data_n <- event(
description = "Define no response for all patients in adsl (should be used as last event)",
dataset_name = "adsl",
condition = TRUE,
set_values_to = exprs(AVALC = "N"),
keep_source_vars = adsl_vars
)
no_data_missing <- event(
description = paste(
"Define missing response (MISSING) for all patients in adsl (should be used",
"as last event)"
),
dataset_name = "adsl",
condition = TRUE,
set_values_to = exprs(AVALC = "MISSING"),
keep_source_vars = adsl_vars
)
## -----------------------------------------------------------------------------
adrs <- adrs %>%
derive_extreme_records(
dataset_ref = adsl,
dataset_add = adrs,
by_vars = get_admiral_option("subject_keys"),
filter_add = PARAMCD == "OVR" & AVALC == "PD" & ANL01FL == "Y",
order = exprs(ADT, RSSEQ),
mode = "first",
exist_flag = AVALC,
false_value = "N",
set_values_to = exprs(
PARAMCD = "PD",
PARAM = "Disease Progression by Investigator",
PARCAT1 = "Tumor Response",
PARCAT2 = "Investigator",
PARCAT3 = "RECIST 1.1",
AVAL = yn_to_numeric(AVALC),
ANL01FL = "Y"
)
)
## ----echo=FALSE---------------------------------------------------------------
dataset_vignette(
adrs,
display_vars = exprs(USUBJID, AVISIT, PARAMCD, PARAM, AVALC, ADT, ANL01FL),
filter = PARAMCD == "PD"
)
## -----------------------------------------------------------------------------
rsp_y
## -----------------------------------------------------------------------------
adrs <- adrs %>%
derive_extreme_event(
by_vars = get_admiral_option("subject_keys"),
order = exprs(event_nr, ADT),
tmp_event_nr_var = event_nr,
mode = "first",
events = list(rsp_y, no_data_n),
source_datasets = list(
ovr = ovr,
adsl = adsl
),
set_values_to = exprs(
PARAMCD = "RSP",
PARAM = "Response by Investigator (confirmation not required)",
PARCAT1 = "Tumor Response",
PARCAT2 = "Investigator",
PARCAT3 = "RECIST 1.1",
AVAL = yn_to_numeric(AVALC),
ANL01FL = "Y"
)
)
## ----echo=FALSE---------------------------------------------------------------
dataset_vignette(
adrs,
display_vars = exprs(USUBJID, AVISIT, PARAMCD, PARAM, AVALC, ADT, ANL01FL),
filter = PARAMCD == "RSP"
)
## -----------------------------------------------------------------------------
cb_y
## -----------------------------------------------------------------------------
adrs <- adrs %>%
derive_extreme_event(
by_vars = get_admiral_option("subject_keys"),
order = exprs(desc(AVALC), ADT, event_nr),
tmp_event_nr_var = event_nr,
mode = "first",
events = list(rsp_y, cb_y, no_data_n),
source_datasets = list(
ovr = ovr,
adsl = adsl
),
set_values_to = exprs(
PARAMCD = "CB",
PARAM = "Clinical Benefit by Investigator (confirmation for response not required)",
PARCAT1 = "Tumor Response",
PARCAT2 = "Investigator",
PARCAT3 = "RECIST 1.1",
AVAL = yn_to_numeric(AVALC),
ANL01FL = "Y"
)
)
## ----echo=FALSE---------------------------------------------------------------
dataset_vignette(
adrs,
display_vars = exprs(USUBJID, AVISIT, PARAMCD, PARAM, AVALC, ADT, RANDDT, ANL01FL),
filter = PARAMCD == "CB"
)
## -----------------------------------------------------------------------------
adrs <- adrs %>%
derive_extreme_event(
by_vars = get_admiral_option("subject_keys"),
order = exprs(event_nr, ADT),
tmp_event_nr_var = event_nr,
mode = "first",
source_datasets = list(
ovr = ovr,
adsl = adsl
),
events = list(bor_cr, bor_pr, bor_sd, bor_non_crpd, bor_pd, bor_ne, no_data_missing),
set_values_to = exprs(
PARAMCD = "BOR",
PARAM = "Best Overall Response by Investigator (confirmation not required)",
PARCAT1 = "Tumor Response",
PARCAT2 = "Investigator",
PARCAT3 = "RECIST 1.1",
AVAL = aval_resp(AVALC),
ANL01FL = "Y"
)
)
## ----echo=FALSE---------------------------------------------------------------
dataset_vignette(
adrs,
display_vars = exprs(USUBJID, AVISIT, PARAMCD, PARAM, AVALC, ADT, RANDDT, ANL01FL),
filter = PARAMCD == "BOR"
)
## ----eval=FALSE---------------------------------------------------------------
# aval_resp_new <- function(arg) {
# case_when(
# arg == "CR" ~ 7,
# arg == "PR" ~ 6,
# arg == "SD" ~ 5,
# arg == "NON-CR/NON-PD" ~ 4,
# arg == "PD" ~ 3,
# arg == "NE" ~ 2,
# arg == "MISSING" ~ 1,
# TRUE ~ NA_real_
# )
# }
## -----------------------------------------------------------------------------
adrs <- adrs %>%
derive_extreme_records(
dataset_ref = adsl,
dataset_add = adrs,
by_vars = get_admiral_option("subject_keys"),
filter_add = PARAMCD == "BOR" & AVALC %in% c("CR", "PR"),
exist_flag = AVALC,
false_value = "N",
set_values_to = exprs(
PARAMCD = "BCP",
PARAM = "Best Overall Response of CR/PR by Investigator (confirmation not required)",
PARCAT1 = "Tumor Response",
PARCAT2 = "Investigator",
PARCAT3 = "RECIST 1.1",
AVAL = yn_to_numeric(AVALC),
ANL01FL = "Y"
)
)
## ----echo=FALSE---------------------------------------------------------------
dataset_vignette(
adrs,
display_vars = exprs(USUBJID, AVISIT, PARAMCD, PARAM, AVALC, ADT, ANL01FL),
filter = PARAMCD == "BCP"
)
## -----------------------------------------------------------------------------
crsp_y_cr
## -----------------------------------------------------------------------------
crsp_y_pr
## -----------------------------------------------------------------------------
cbor_cr
## -----------------------------------------------------------------------------
cbor_pr
## -----------------------------------------------------------------------------
adrs <- adrs %>%
derive_extreme_event(
by_vars = get_admiral_option("subject_keys"),
order = exprs(desc(AVALC), ADT, event_nr),
tmp_event_nr_var = event_nr,
mode = "first",
source_datasets = list(
ovr = ovr,
adsl = adsl
),
events = list(crsp_y_cr, crsp_y_pr, no_data_n),
set_values_to = exprs(
PARAMCD = "CRSP",
PARAM = "Confirmed Response by Investigator",
PARCAT1 = "Tumor Response",
PARCAT2 = "Investigator",
PARCAT3 = "RECIST 1.1",
AVAL = yn_to_numeric(AVALC),
ANL01FL = "Y"
)
)
adrs <- adrs %>%
derive_extreme_event(
by_vars = get_admiral_option("subject_keys"),
order = exprs(desc(AVALC), ADT, event_nr),
tmp_event_nr_var = event_nr,
mode = "first",
events = list(crsp_y_cr, crsp_y_pr, cb_y, no_data_n),
source_datasets = list(
ovr = ovr,
adsl = adsl
),
set_values_to = exprs(
PARAMCD = "CCB",
PARAM = "Confirmed Clinical Benefit by Investigator",
PARCAT1 = "Tumor Response",
PARCAT2 = "Investigator",
PARCAT3 = "RECIST 1.1",
AVAL = yn_to_numeric(AVALC),
ANL01FL = "Y"
)
)
adrs <- adrs %>%
derive_extreme_event(
by_vars = get_admiral_option("subject_keys"),
order = exprs(event_nr, ADT),
tmp_event_nr_var = event_nr,
mode = "first",
events = list(cbor_cr, cbor_pr, bor_sd, bor_non_crpd, bor_pd, bor_ne, no_data_missing),
source_datasets = list(
ovr = ovr,
adsl = adsl
),
set_values_to = exprs(
PARAMCD = "CBOR",
PARAM = "Best Confirmed Overall Response by Investigator",
PARCAT1 = "Tumor Response",
PARCAT2 = "Investigator",
PARCAT3 = "RECIST 1.1",
AVAL = aval_resp(AVALC),
ANL01FL = "Y"
)
) %>%
derive_extreme_records(
dataset_ref = adsl,
dataset_add = adrs,
by_vars = get_admiral_option("subject_keys"),
filter_add = PARAMCD == "CBOR" & AVALC %in% c("CR", "PR"),
exist_flag = AVALC,
false_value = "N",
set_values_to = exprs(
PARAMCD = "CBCP",
PARAM = "Best Confirmed Overall Response of CR/PR by Investigator",
PARCAT1 = "Tumor Response",
PARCAT2 = "Investigator",
PARCAT3 = "RECIST 1.1",
AVAL = yn_to_numeric(AVALC),
ANL01FL = "Y"
)
)
## ----echo=FALSE---------------------------------------------------------------
dataset_vignette(
adrs,
display_vars = exprs(USUBJID, AVISIT, PARAMCD, PARAM, AVALC, ADT, RANDDT, ANL01FL),
filter = PARAMCD %in% c("CRSP", "CCB", "CBOR", "CBCP")
)
## -----------------------------------------------------------------------------
cb_y_pd <- event(
description = paste(
"Define PD occuring more than 42 days after",
"randomization as clinical benefit"
),
dataset_name = "ovr",
condition = AVALC == "PD" & ADT > RANDDT + 42,
set_values_to = exprs(AVALC = "Y")
)
adrs <- adrs %>%
derive_extreme_event(
by_vars = get_admiral_option("subject_keys"),
order = exprs(desc(AVALC), ADT, event_nr),
tmp_event_nr_var = event_nr,
mode = "first",
events = list(crsp_y_cr, crsp_y_pr, cb_y, cb_y_pd, no_data_n),
source_datasets = list(
ovr = ovr,
adsl = adsl
),
set_values_to = exprs(
PARAMCD = "ACCB",
PARAM = "Alternative Confirmed Clinical Benefit by Investigator",
PARCAT1 = "Tumor Response",
PARCAT2 = "Investigator",
PARCAT3 = "RECIST 1.1",
AVAL = yn_to_numeric(AVALC),
ANL01FL = "Y"
)
)
## -----------------------------------------------------------------------------
bor_ned <- event(
description = paste(
"Define no evidence of disease (NED) for best overall response (BOR) as NED",
"occuring at least 42 days after randomization"
),
dataset_name = "ovr",
condition = AVALC == "NED" & ADT >= RANDDT + 42,
set_values_to = exprs(AVALC = "NED")
)
adrs <- adrs %>%
derive_extreme_event(
by_vars = get_admiral_option("subject_keys"),
order = exprs(event_nr, ADT),
tmp_event_nr_var = event_nr,
mode = "first",
source_datasets = list(
ovr = ovr,
adsl = adsl
),
events = list(bor_cr, bor_pr, bor_sd, bor_non_crpd, bor_ned, bor_pd, bor_ne, no_data_missing),
set_values_to = exprs(
PARAMCD = "A1BOR",
PARAM = paste(
"Best Overall Response by Investigator (confirmation not required)",
"- RECIST 1.1 adjusted for NED at Baseline"
),
PARCAT1 = "Tumor Response",
PARCAT2 = "Investigator",
PARCAT3 = "RECIST 1.1 adjusted for NED at Baseline",
AVAL = aval_resp(AVALC),
ANL01FL = "Y"
)
)
## -----------------------------------------------------------------------------
adrs_bicr <- rs %>%
filter(
RSEVAL == "INDEPENDENT ASSESSOR" & RSACPTFL == "Y" & RSTESTCD == "OVRLRESP"
) %>%
mutate(
PARAMCD = "OVRB",
PARAM = "Overall Response by BICR",
PARCAT1 = "Tumor Response",
PARCAT2 = "Blinded Independent Central Review",
PARCAT3 = "RECIST 1.1"
)
## ----echo=FALSE---------------------------------------------------------------
dataset_vignette(
adrs_bicr,
display_vars = exprs(USUBJID, VISIT, RSTESTCD, RSEVAL, PARAMCD, PARAM, PARCAT1, PARCAT2, PARCAT3),
filter = PARAMCD == "OVRB"
)
## -----------------------------------------------------------------------------
adsldth <- adsl %>%
select(!!!get_admiral_option("subject_keys"), DTHDT, !!!adsl_vars)
adrs <- adrs %>%
derive_extreme_records(
dataset_ref = adsldth,
dataset_add = adsldth,
by_vars = get_admiral_option("subject_keys"),
filter_add = !is.na(DTHDT),
exist_flag = AVALC,
false_value = "N",
set_values_to = exprs(
PARAMCD = "DEATH",
PARAM = "Death",
PARCAT1 = "Reference Event",
AVAL = yn_to_numeric(AVALC),
ANL01FL = "Y",
ADT = DTHDT
)
) %>%
select(-DTHDT)
## ----echo=FALSE---------------------------------------------------------------
dataset_vignette(
adrs,
display_vars = exprs(USUBJID, AVISIT, PARAMCD, PARAM, AVALC, ADT, ANL01FL),
filter = PARAMCD == "DEATH"
)
## -----------------------------------------------------------------------------
adrs <- adrs %>%
derive_extreme_records(
dataset_ref = adsl,
dataset_add = adrs,
by_vars = get_admiral_option("subject_keys"),
filter_add = PARAMCD == "OVR" & ANL01FL == "Y",
order = exprs(ADT, RSSEQ),
mode = "last",
set_values_to = exprs(
PARAMCD = "LSTA",
PARAM = "Last Disease Assessment by Investigator",
PARCAT1 = "Tumor Response",
PARCAT2 = "Investigator",
PARCAT3 = "RECIST 1.1",
ANL01FL = "Y"
)
)
## ----echo=FALSE---------------------------------------------------------------
dataset_vignette(
adrs,
display_vars = exprs(USUBJID, AVISIT, PARAMCD, PARAM, AVALC, ADT, ANL01FL),
filter = PARAMCD == "LSTA"
)
## -----------------------------------------------------------------------------
adslmdis <- adsl %>%
select(!!!get_admiral_option("subject_keys"), !!!adsl_vars)
adrs <- adrs %>%
derive_param_exist_flag(
dataset_ref = adslmdis,
dataset_add = tu,
condition = TUEVAL == "INVESTIGATOR" & TUSTRESC == "TARGET" & VISIT == "SCREENING",
false_value = "N",
missing_value = "N",
set_values_to = exprs(
PARAMCD = "MDIS",
PARAM = "Measurable Disease at Baseline by Investigator",
PARCAT2 = "Investigator",
PARCAT3 = "RECIST 1.1",
AVAL = yn_to_numeric(AVALC),
ANL01FL = "Y"
)
)
## ----echo=FALSE---------------------------------------------------------------
dataset_vignette(
adrs,
display_vars = exprs(USUBJID, AVISIT, PARAMCD, PARAM, AVALC, ADT, ANL01FL),
filter = PARAMCD == "MDIS"
)
## ----eval=TRUE----------------------------------------------------------------
adrs <- adrs %>%
derive_var_obs_number(
by_vars = get_admiral_option("subject_keys"),
order = exprs(PARAMCD, ADT, VISITNUM, RSSEQ),
check_type = "error"
)
## ----eval=TRUE, echo=FALSE----------------------------------------------------
dataset_vignette(
adrs,
display_vars = exprs(USUBJID, PARAMCD, ADT, VISITNUM, AVISIT, ASEQ),
filter = USUBJID == "01-701-1015"
)
## ----eval=TRUE----------------------------------------------------------------
adrs <- adrs %>%
derive_vars_merged(
dataset_add = select(adsl, !!!negate_vars(adsl_vars)),
by_vars = get_admiral_option("subject_keys")
)
## ----eval=TRUE, echo=FALSE----------------------------------------------------
dataset_vignette(
adrs,
display_vars = exprs(USUBJID, RFSTDTC, RFENDTC, DTHDTC, DTHFL, AGE, AGEU),
filter = USUBJID == "01-701-1015"
)
Any scripts or data that you put into this service are public.
Add the following code to your website.
For more information on customizing the embed code, read Embedding Snippets.