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This article describes creating an OCCDS ADaM. Examples are currently
presented and tested in the context of ADAE
. However, the
examples could be applied to other OCCDS ADaMs such as
ADCM
, ADMH
, ADDV
, etc.
Note: All examples assume CDISC SDTM and/or ADaM format as input unless otherwise specified.
To start, all data frames needed for the creation of
ADAE
should be read into the environment. This will be a
company specific process. Some of the data frames needed may be
AE
and ADSL
For example purpose, the CDISC Pilot SDTM and ADaM datasets —which
are included in {pharmaversesdtm}
— are used.
library(admiral)
library(dplyr, warn.conflicts = FALSE)
library(pharmaversesdtm)
library(lubridate)
data("ae")
data("admiral_adsl")
ae <- convert_blanks_to_na(ae)
adsl <- admiral_adsl
At this step, it may be useful to join ADSL
to your
AE
domain as well. Only the ADSL
variables
used for derivations are selected at this step. The rest of the relevant
ADSL
variables would be added later.
adsl_vars <- exprs(TRTSDT, TRTEDT, TRT01A, TRT01P, DTHDT, EOSDT)
adae <- derive_vars_merged(
ae,
dataset_add = adsl,
new_vars = adsl_vars,
by = exprs(STUDYID, USUBJID)
)
USUBJID | AESEQ | AETERM | AESTDTC | TRTSDT | TRTEDT | TRT01A | TRT01P | DTHDT | EOSDT |
---|---|---|---|---|---|---|---|---|---|
01-701-1015 | 1 | APPLICATION SITE ERYTHEMA | 2014-01-03 | 2014-01-02 | 2014-07-02 | Placebo | Placebo | NA | 2014-07-02 |
01-701-1015 | 2 | APPLICATION SITE PRURITUS | 2014-01-03 | 2014-01-02 | 2014-07-02 | Placebo | Placebo | NA | 2014-07-02 |
01-701-1015 | 3 | DIARRHOEA | 2014-01-09 | 2014-01-02 | 2014-07-02 | Placebo | Placebo | NA | 2014-07-02 |
01-701-1023 | 3 | ATRIOVENTRICULAR BLOCK SECOND DEGREE | 2012-08-26 | 2012-08-05 | 2012-09-01 | Placebo | Placebo | NA | 2012-09-02 |
01-701-1023 | 1 | ERYTHEMA | 2012-08-07 | 2012-08-05 | 2012-09-01 | Placebo | Placebo | NA | 2012-09-02 |
01-701-1023 | 2 | ERYTHEMA | 2012-08-07 | 2012-08-05 | 2012-09-01 | Placebo | Placebo | NA | 2012-09-02 |
01-701-1023 | 4 | ERYTHEMA | 2012-08-07 | 2012-08-05 | 2012-09-01 | Placebo | Placebo | NA | 2012-09-02 |
01-703-1086 | 1 | APPLICATION SITE IRRITATION | 2012-09-13 | 2012-09-02 | 2012-12-04 | Xanomeline Low Dose | Xanomeline Low Dose | NA | 2012-12-24 |
01-703-1086 | 2 | APPLICATION SITE IRRITATION | 2012-09-13 | 2012-09-02 | 2012-12-04 | Xanomeline Low Dose | Xanomeline Low Dose | NA | 2012-12-24 |
01-703-1086 | 3 | APPLICATION SITE IRRITATION | 2012-09-13 | 2012-09-02 | 2012-12-04 | Xanomeline Low Dose | Xanomeline Low Dose | NA | 2012-12-24 |
This part derives ASTDTM
, ASTDT
,
ASTDY
, AENDTM
, AENDT
, and
AENDY
. The function derive_vars_dtm()
can be
used to derive ASTDTM
and AENDTM
where
ASTDTM
could be company-specific. ASTDT
and
AENDT
can be derived from ASTDTM
and
AENDTM
, respectively, using function
derive_vars_dtm_to_dt()
. derive_vars_dy()
can
be used to create ASTDY
and AENDY
.
adae <- adae %>%
derive_vars_dtm(
dtc = AESTDTC,
new_vars_prefix = "AST",
highest_imputation = "M",
min_dates = exprs(TRTSDT)
) %>%
derive_vars_dtm(
dtc = AEENDTC,
new_vars_prefix = "AEN",
highest_imputation = "M",
date_imputation = "last",
time_imputation = "last",
max_dates = exprs(DTHDT, EOSDT)
) %>%
derive_vars_dtm_to_dt(exprs(ASTDTM, AENDTM)) %>%
derive_vars_dy(
reference_date = TRTSDT,
source_vars = exprs(ASTDT, AENDT)
)
USUBJID | AESTDTC | AEENDTC | ASTDTM | ASTDT | ASTDY | AENDTM | AENDT | AENDY |
---|---|---|---|---|---|---|---|---|
01-701-1015 | 2014-01-03 | NA | 2014-01-03 | 2014-01-03 | 2 | NA | NA | NA |
01-701-1015 | 2014-01-03 | NA | 2014-01-03 | 2014-01-03 | 2 | NA | NA | NA |
01-701-1015 | 2014-01-09 | 2014-01-11 | 2014-01-09 | 2014-01-09 | 8 | 2014-01-11 23:59:59 | 2014-01-11 | 10 |
01-701-1023 | 2012-08-26 | NA | 2012-08-26 | 2012-08-26 | 22 | NA | NA | NA |
01-701-1023 | 2012-08-07 | 2012-08-30 | 2012-08-07 | 2012-08-07 | 3 | 2012-08-30 23:59:59 | 2012-08-30 | 26 |
01-701-1023 | 2012-08-07 | NA | 2012-08-07 | 2012-08-07 | 3 | NA | NA | NA |
01-701-1023 | 2012-08-07 | 2012-08-30 | 2012-08-07 | 2012-08-07 | 3 | 2012-08-30 23:59:59 | 2012-08-30 | 26 |
01-703-1086 | 2012-09-13 | 2013-01-02 | 2012-09-13 | 2012-09-13 | 12 | 2013-01-02 23:59:59 | 2013-01-02 | 123 |
01-703-1086 | 2012-09-13 | 2013-01-02 | 2012-09-13 | 2012-09-13 | 12 | 2013-01-02 23:59:59 | 2013-01-02 | 123 |
01-703-1086 | 2012-09-13 | 2013-01-02 | 2012-09-13 | 2012-09-13 | 12 | 2013-01-02 23:59:59 | 2013-01-02 | 123 |
See also Date and Time Imputation.
The function derive_vars_duration()
can be used to
create the variables ADURN
and ADURU
.
adae <- adae %>%
derive_vars_duration(
new_var = ADURN,
new_var_unit = ADURU,
start_date = ASTDT,
end_date = AENDT
)
USUBJID | AESTDTC | AEENDTC | ASTDT | AENDT | ADURN | ADURU |
---|---|---|---|---|---|---|
01-701-1015 | 2014-01-03 | NA | 2014-01-03 | NA | NA | NA |
01-701-1015 | 2014-01-03 | NA | 2014-01-03 | NA | NA | NA |
01-701-1015 | 2014-01-09 | 2014-01-11 | 2014-01-09 | 2014-01-11 | 3 | DAYS |
01-701-1023 | 2012-08-26 | NA | 2012-08-26 | NA | NA | NA |
01-701-1023 | 2012-08-07 | 2012-08-30 | 2012-08-07 | 2012-08-30 | 24 | DAYS |
01-701-1023 | 2012-08-07 | NA | 2012-08-07 | NA | NA | NA |
01-701-1023 | 2012-08-07 | 2012-08-30 | 2012-08-07 | 2012-08-30 | 24 | DAYS |
01-703-1086 | 2012-09-13 | 2013-01-02 | 2012-09-13 | 2013-01-02 | 112 | DAYS |
01-703-1086 | 2012-09-13 | 2013-01-02 | 2012-09-13 | 2013-01-02 | 112 | DAYS |
01-703-1086 | 2012-09-13 | 2013-01-02 | 2012-09-13 | 2013-01-02 | 112 | DAYS |
The function derive_vars_atc()
can be used to derive ATC
Class Variables.
It helps to add Anatomical Therapeutic Chemical class variables from
FACM
to ADCM
.
The expected result is the input dataset with ATC variables added.
cm <- tibble::tribble(
~USUBJID, ~CMGRPID, ~CMREFID, ~CMDECOD,
"BP40257-1001", "14", "1192056", "PARACETAMOL",
"BP40257-1001", "18", "2007001", "SOLUMEDROL",
"BP40257-1002", "19", "2791596", "SPIRONOLACTONE"
)
facm <- tibble::tribble(
~USUBJID, ~FAGRPID, ~FAREFID, ~FATESTCD, ~FASTRESC,
"BP40257-1001", "1", "1192056", "CMATC1CD", "N",
"BP40257-1001", "1", "1192056", "CMATC2CD", "N02",
"BP40257-1001", "1", "1192056", "CMATC3CD", "N02B",
"BP40257-1001", "1", "1192056", "CMATC4CD", "N02BE",
"BP40257-1001", "1", "2007001", "CMATC1CD", "D",
"BP40257-1001", "1", "2007001", "CMATC2CD", "D10",
"BP40257-1001", "1", "2007001", "CMATC3CD", "D10A",
"BP40257-1001", "1", "2007001", "CMATC4CD", "D10AA",
"BP40257-1001", "2", "2007001", "CMATC1CD", "D",
"BP40257-1001", "2", "2007001", "CMATC2CD", "D07",
"BP40257-1001", "2", "2007001", "CMATC3CD", "D07A",
"BP40257-1001", "2", "2007001", "CMATC4CD", "D07AA",
"BP40257-1001", "3", "2007001", "CMATC1CD", "H",
"BP40257-1001", "3", "2007001", "CMATC2CD", "H02",
"BP40257-1001", "3", "2007001", "CMATC3CD", "H02A",
"BP40257-1001", "3", "2007001", "CMATC4CD", "H02AB",
"BP40257-1002", "1", "2791596", "CMATC1CD", "C",
"BP40257-1002", "1", "2791596", "CMATC2CD", "C03",
"BP40257-1002", "1", "2791596", "CMATC3CD", "C03D",
"BP40257-1002", "1", "2791596", "CMATC4CD", "C03DA"
)
derive_vars_atc(cm, facm)
#> Warning: Values from `FASTRESC` are not uniquely identified; output will contain
#> list-cols.
#> • Use `values_fn = list` to suppress this warning.
#> • Use `values_fn = {summary_fun}` to summarise duplicates.
#> • Use the following dplyr code to identify duplicates.
#> {data} |>
#> dplyr::summarise(n = dplyr::n(), .by = c(USUBJID, FAREFID, FATESTCD)) |>
#> dplyr::filter(n > 1L)
#> # A tibble: 3 × 8
#> USUBJID CMGRPID CMREFID CMDECOD ATC1CD ATC2CD ATC3CD ATC4CD
#> <chr> <chr> <chr> <chr> <list> <list> <list> <list>
#> 1 BP40257-1001 14 1192056 PARACETAMOL <chr [1]> <chr [1]> <chr> <chr>
#> 2 BP40257-1001 18 2007001 SOLUMEDROL <chr [3]> <chr [3]> <chr> <chr>
#> 3 BP40257-1002 19 2791596 SPIRONOLACTONE <chr [1]> <chr [1]> <chr> <chr>
TRTA
and TRTP
must match at least one value
of the character treatment variables in ADSL (e.g.,
TRTxxA
/TRTxxP
,
TRTSEQA
/TRTSEQP
,
TRxxAGy
/TRxxPGy
).
An example of a simple implementation for a study without periods could be:
adae <- mutate(adae, TRTP = TRT01P, TRTA = TRT01A)
count(adae, TRTP, TRTA, TRT01P, TRT01A)
#> # A tibble: 2 × 5
#> TRTP TRTA TRT01P TRT01A n
#> <chr> <chr> <chr> <chr> <int>
#> 1 Placebo Placebo Placebo Placebo 10
#> 2 Xanomeline Low Dose Xanomeline Low Dose Xanomeline Low Dose Xanomeline … 6
For studies with periods see the “Visit and Period Variables” vignette.
The function derive_vars_joined()
can be used to derive
the last dose date before the start of the event.
data(ex_single)
ex_single <- derive_vars_dtm(
ex_single,
dtc = EXSTDTC,
new_vars_prefix = "EXST",
flag_imputation = "none"
)
adae <- derive_vars_joined(
adae,
ex_single,
by_vars = exprs(STUDYID, USUBJID),
new_vars = exprs(LDOSEDTM = EXSTDTM),
join_vars = exprs(EXSTDTM),
join_type = "all",
order = exprs(EXSTDTM),
filter_add = (EXDOSE > 0 | (EXDOSE == 0 & grepl("PLACEBO", EXTRT))) & !is.na(EXSTDTM),
filter_join = EXSTDTM <= ASTDTM,
mode = "last"
)
USUBJID | AEDECOD | AESEQ | AESTDTC | AEENDTC | ASTDT | AENDT | LDOSEDTM |
---|---|---|---|---|---|---|---|
01-701-1015 | APPLICATION SITE ERYTHEMA | 1 | 2014-01-03 | NA | 2014-01-03 | NA | 2014-01-03 |
01-701-1015 | APPLICATION SITE PRURITUS | 2 | 2014-01-03 | NA | 2014-01-03 | NA | 2014-01-03 |
01-701-1015 | DIARRHOEA | 3 | 2014-01-09 | 2014-01-11 | 2014-01-09 | 2014-01-11 | 2014-01-09 |
01-701-1023 | ATRIOVENTRICULAR BLOCK SECOND DEGREE | 3 | 2012-08-26 | NA | 2012-08-26 | NA | 2012-08-26 |
01-701-1023 | ERYTHEMA | 1 | 2012-08-07 | 2012-08-30 | 2012-08-07 | 2012-08-30 | 2012-08-07 |
01-701-1023 | ERYTHEMA | 2 | 2012-08-07 | NA | 2012-08-07 | NA | 2012-08-07 |
01-701-1023 | ERYTHEMA | 4 | 2012-08-07 | 2012-08-30 | 2012-08-07 | 2012-08-30 | 2012-08-07 |
01-703-1086 | APPLICATION SITE IRRITATION | 1 | 2012-09-13 | 2013-01-02 | 2012-09-13 | 2013-01-02 | 2012-09-13 |
01-703-1086 | APPLICATION SITE IRRITATION | 2 | 2012-09-13 | 2013-01-02 | 2012-09-13 | 2013-01-02 | 2012-09-13 |
01-703-1086 | APPLICATION SITE IRRITATION | 3 | 2012-09-13 | 2013-01-02 | 2012-09-13 | 2013-01-02 | 2012-09-13 |
The variables ASEV
, AREL
, and
ATOXGR
can be added using simple
dplyr::mutate()
assignments, if no imputation is
required.
To derive the treatment emergent flag TRTEMFL
, one can
call derive_var_trtemfl()
. In the example below, we use 30
days in the flag derivation.
adae <- adae %>%
derive_var_trtemfl(
trt_start_date = TRTSDT,
trt_end_date = TRTEDT,
end_window = 30
)
USUBJID | TRTSDT | TRTEDT | AESTDTC | ASTDT | TRTEMFL |
---|---|---|---|---|---|
01-701-1015 | 2014-01-02 | 2014-07-02 | 2014-01-03 | 2014-01-03 | Y |
01-701-1015 | 2014-01-02 | 2014-07-02 | 2014-01-03 | 2014-01-03 | Y |
01-701-1015 | 2014-01-02 | 2014-07-02 | 2014-01-09 | 2014-01-09 | Y |
01-701-1023 | 2012-08-05 | 2012-09-01 | 2012-08-26 | 2012-08-26 | Y |
01-701-1023 | 2012-08-05 | 2012-09-01 | 2012-08-07 | 2012-08-07 | Y |
01-701-1023 | 2012-08-05 | 2012-09-01 | 2012-08-07 | 2012-08-07 | Y |
01-701-1023 | 2012-08-05 | 2012-09-01 | 2012-08-07 | 2012-08-07 | Y |
01-703-1086 | 2012-09-02 | 2012-12-04 | 2012-09-13 | 2012-09-13 | Y |
01-703-1086 | 2012-09-02 | 2012-12-04 | 2012-09-13 | 2012-09-13 | Y |
01-703-1086 | 2012-09-02 | 2012-12-04 | 2012-09-13 | 2012-09-13 | Y |
To derive on-treatment flag (ONTRTFL
) in an ADaM dataset
with a single occurrence date, we use
derive_var_ontrtfl()
.
The expected result is the input dataset with an additional column
named ONTRTFL
with a value of "Y"
or
NA
.
If you want to also check an end date, you could add the
end_date
argument. Note that in this scenario you could set
span_period = TRUE
if you want occurrences that started
prior to drug intake, and was ongoing or ended after this time to be
considered as on-treatment.
bds1 <- tibble::tribble(
~USUBJID, ~ADT, ~TRTSDT, ~TRTEDT,
"P01", ymd("2020-02-24"), ymd("2020-01-01"), ymd("2020-03-01"),
"P02", ymd("2020-01-01"), ymd("2020-01-01"), ymd("2020-03-01"),
"P03", ymd("2019-12-31"), ymd("2020-01-01"), ymd("2020-03-01")
)
derive_var_ontrtfl(
bds1,
start_date = ADT,
ref_start_date = TRTSDT,
ref_end_date = TRTEDT
)
#> # A tibble: 3 × 5
#> USUBJID ADT TRTSDT TRTEDT ONTRTFL
#> <chr> <date> <date> <date> <chr>
#> 1 P01 2020-02-24 2020-01-01 2020-03-01 Y
#> 2 P02 2020-01-01 2020-01-01 2020-03-01 Y
#> 3 P03 2019-12-31 2020-01-01 2020-03-01 <NA>
bds2 <- tibble::tribble(
~USUBJID, ~ADT, ~TRTSDT, ~TRTEDT,
"P01", ymd("2020-07-01"), ymd("2020-01-01"), ymd("2020-03-01"),
"P02", ymd("2020-04-30"), ymd("2020-01-01"), ymd("2020-03-01"),
"P03", ymd("2020-03-15"), ymd("2020-01-01"), ymd("2020-03-01")
)
derive_var_ontrtfl(
bds2,
start_date = ADT,
ref_start_date = TRTSDT,
ref_end_date = TRTEDT,
ref_end_window = 60
)
#> # A tibble: 3 × 5
#> USUBJID ADT TRTSDT TRTEDT ONTRTFL
#> <chr> <date> <date> <date> <chr>
#> 1 P01 2020-07-01 2020-01-01 2020-03-01 <NA>
#> 2 P02 2020-04-30 2020-01-01 2020-03-01 Y
#> 3 P03 2020-03-15 2020-01-01 2020-03-01 Y
bds3 <- tibble::tribble(
~ADTM, ~TRTSDTM, ~TRTEDTM, ~TPT,
"2020-01-02T12:00", "2020-01-01T12:00", "2020-03-01T12:00", NA,
"2020-01-01T12:00", "2020-01-01T12:00", "2020-03-01T12:00", "PRE",
"2019-12-31T12:00", "2020-01-01T12:00", "2020-03-01T12:00", NA
) %>%
mutate(
ADTM = ymd_hm(ADTM),
TRTSDTM = ymd_hm(TRTSDTM),
TRTEDTM = ymd_hm(TRTEDTM)
)
derive_var_ontrtfl(
bds3,
start_date = ADTM,
ref_start_date = TRTSDTM,
ref_end_date = TRTEDTM,
filter_pre_timepoint = TPT == "PRE"
)
#> # A tibble: 3 × 5
#> ADTM TRTSDTM TRTEDTM TPT ONTRTFL
#> <dttm> <dttm> <dttm> <chr> <chr>
#> 1 2020-01-02 12:00:00 2020-01-01 12:00:00 2020-03-01 12:00:00 <NA> Y
#> 2 2020-01-01 12:00:00 2020-01-01 12:00:00 2020-03-01 12:00:00 PRE <NA>
#> 3 2019-12-31 12:00:00 2020-01-01 12:00:00 2020-03-01 12:00:00 <NA> <NA>
The function derive_var_extreme_flag()
can help derive
variables such as AOCCIFL
, AOCCPIFL
,
AOCCSIFL
, and AOCCzzFL
.
If grades were collected, the following can be used to flag first occurrence of maximum toxicity grade.
adae <- adae %>%
restrict_derivation(
derivation = derive_var_extreme_flag,
args = params(
by_vars = exprs(USUBJID),
order = exprs(desc(ATOXGR), ASTDTM, AESEQ),
new_var = AOCCIFL,
mode = "first"
),
filter = TRTEMFL == "Y"
)
Similarly, ASEV
can also be used to derive the
occurrence flags, if severity is collected. In this case, the variable
will need to be recoded to a numeric variable. Flag first occurrence of
most severe adverse event:
adae <- adae %>%
restrict_derivation(
derivation = derive_var_extreme_flag,
args = params(
by_vars = exprs(USUBJID),
order = exprs(
as.integer(factor(
ASEV,
levels = c("DEATH THREATENING", "SEVERE", "MODERATE", "MILD")
)),
ASTDTM, AESEQ
),
new_var = AOCCIFL,
mode = "first"
),
filter = TRTEMFL == "Y"
)
USUBJID | ASTDTM | ASEV | AESEQ | TRTEMFL | AOCCIFL |
---|---|---|---|---|---|
01-701-1015 | 2014-01-03 | MILD | 1 | Y | Y |
01-701-1015 | 2014-01-03 | MILD | 2 | Y | NA |
01-701-1015 | 2014-01-09 | MILD | 3 | Y | NA |
01-701-1023 | 2012-08-07 | MODERATE | 2 | Y | Y |
01-701-1023 | 2012-08-07 | MILD | 1 | Y | NA |
01-701-1023 | 2012-08-07 | MILD | 4 | Y | NA |
01-701-1023 | 2012-08-26 | MILD | 3 | Y | NA |
01-703-1086 | 2012-09-13 | SEVERE | 3 | Y | Y |
01-703-1086 | 2012-09-13 | MODERATE | 2 | Y | NA |
01-703-1086 | 2012-09-13 | MILD | 1 | Y | NA |
For deriving query variables SMQzzNAM
,
SMQzzCD
, SMQzzSC
, SMQzzSCN
, or
CQzzNAM
the derive_vars_query()
function can
be used. As input it expects a queries dataset, which provides the
definition of the queries. See Queries
dataset documentation for a detailed description of the queries
dataset. The create_query_data()
function can be used to
create queries datasets.
The following example shows how to derive query variables for Standardized MedDRA Queries (SMQs) in ADAE.
PREFIX | GRPNAME | GRPID | SCOPE | SCOPEN | SRCVAR | TERMCHAR | TERMNUM |
---|---|---|---|---|---|---|---|
CQ01 | Dermatologic events | NA | NA | NA | AELLT | APPLICATION SITE ERYTHEMA | NA |
CQ01 | Dermatologic events | NA | NA | NA | AELLT | APPLICATION SITE PRURITUS | NA |
CQ01 | Dermatologic events | NA | NA | NA | AELLT | ERYTHEMA | NA |
CQ01 | Dermatologic events | NA | NA | NA | AELLT | LOCALIZED ERYTHEMA | NA |
CQ01 | Dermatologic events | NA | NA | NA | AELLT | GENERALIZED PRURITUS | NA |
SMQ02 | Immune-Mediated Hypothyroidism | 20000160 | BROAD | 1 | AEDECOD | BIOPSY THYROID GLAND ABNORMAL | NA |
SMQ02 | Immune-Mediated Hypothyroidism | 20000160 | BROAD | 1 | AEDECOD | BLOOD THYROID STIMULATING HORMONE ABNORMAL | NA |
SMQ02 | Immune-Mediated Hypothyroidism | 20000160 | NARROW | 2 | AEDECOD | BIOPSY THYROID GLAND INCREASED | NA |
SMQ03 | Immune-Mediated Guillain-Barre Syndrome | 20000131 | NARROW | 2 | AEDECOD | GUILLAIN-BARRE SYNDROME | NA |
SMQ03 | Immune-Mediated Guillain-Barre Syndrome | 20000131 | NARROW | 2 | AEDECOD | MILLER FISHER SYNDROME | NA |
adae1 <- tibble::tribble(
~USUBJID, ~ASTDTM, ~AETERM, ~AESEQ, ~AEDECOD, ~AELLT, ~AELLTCD,
"01", "2020-06-02 23:59:59", "ALANINE AMINOTRANSFERASE ABNORMAL",
3, "Alanine aminotransferase abnormal", NA_character_, NA_integer_,
"02", "2020-06-05 23:59:59", "BASEDOW'S DISEASE",
5, "Basedow's disease", NA_character_, 1L,
"03", "2020-06-07 23:59:59", "SOME TERM",
2, "Some query", "Some term", NA_integer_,
"05", "2020-06-09 23:59:59", "ALVEOLAR PROTEINOSIS",
7, "Alveolar proteinosis", NA_character_, NA_integer_
)
adae_query <- derive_vars_query(dataset = adae1, dataset_queries = queries)
USUBJID | ASTDTM | AETERM | AESEQ | AEDECOD | AELLT | AELLTCD | SMQ02NAM | SMQ02CD | SMQ02SC | SMQ02SCN | SMQ03NAM | SMQ03CD | SMQ03SC | SMQ03SCN | SMQ05NAM | SMQ05CD | SMQ05SC | SMQ05SCN | CQ01NAM | CQ04NAM | CQ04CD | CQ06NAM | CQ06CD |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
01 | 2020-06-02 23:59:59 | ALANINE AMINOTRANSFERASE ABNORMAL | 3 | Alanine aminotransferase abnormal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
02 | 2020-06-05 23:59:59 | BASEDOW’S DISEASE | 5 | Basedow’s disease | NA | 1 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | Immune-Mediated Colitis | 10009888 |
03 | 2020-06-07 23:59:59 | SOME TERM | 2 | Some query | Some term | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
05 | 2020-06-09 23:59:59 | ALVEOLAR PROTEINOSIS | 7 | Alveolar proteinosis | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | Immune-Mediated Pneumonitis | 20000042 | NARROW | 2 | NA | NA | NA | NA | NA |
Similarly to SMQ, the derive_vars_query()
function can
be used to derive Standardized Drug Groupings (SDG).
sdg <- tibble::tribble(
~PREFIX, ~GRPNAME, ~GRPID, ~SCOPE, ~SCOPEN, ~SRCVAR, ~TERMCHAR, ~TERMNUM,
"SDG01", "Diuretics", 11, "BROAD", 1, "CMDECOD", "Diuretic 1", NA,
"SDG01", "Diuretics", 11, "BROAD", 1, "CMDECOD", "Diuretic 2", NA,
"SDG02", "Costicosteroids", 12, "BROAD", 1, "CMDECOD", "Costicosteroid 1", NA,
"SDG02", "Costicosteroids", 12, "BROAD", 1, "CMDECOD", "Costicosteroid 2", NA,
"SDG02", "Costicosteroids", 12, "BROAD", 1, "CMDECOD", "Costicosteroid 3", NA,
)
adcm <- tibble::tribble(
~USUBJID, ~ASTDTM, ~CMDECOD,
"01", "2020-06-02 23:59:59", "Diuretic 1",
"02", "2020-06-05 23:59:59", "Diuretic 1",
"03", "2020-06-07 23:59:59", "Costicosteroid 2",
"05", "2020-06-09 23:59:59", "Diuretic 2"
)
adcm_query <- derive_vars_query(adcm, sdg)
USUBJID | ASTDTM | CMDECOD | SDG01NAM | SDG01CD | SDG01SC | SDG01SCN | SDG02NAM | SDG02CD | SDG02SC | SDG02SCN |
---|---|---|---|---|---|---|---|---|---|---|
01 | 2020-06-02 23:59:59 | Diuretic 1 | Diuretics | 11 | BROAD | 1 | NA | NA | NA | NA |
02 | 2020-06-05 23:59:59 | Diuretic 1 | Diuretics | 11 | BROAD | 1 | NA | NA | NA | NA |
03 | 2020-06-07 23:59:59 | Costicosteroid 2 | NA | NA | NA | NA | Costicosteroids | 12 | BROAD | 1 |
05 | 2020-06-09 23:59:59 | Diuretic 2 | Diuretics | 11 | BROAD | 1 | NA | NA | NA | NA |
ADSL
variablesIf needed, the other ADSL
variables can now be
added:
adae <- adae %>%
derive_vars_merged(
dataset_add = select(adsl, !!!negate_vars(adsl_vars)),
by_vars = exprs(STUDYID, USUBJID)
)
USUBJID | AEDECOD | ASTDTM | DTHDT | RFSTDTC | RFENDTC | AGE | AGEU | SEX |
---|---|---|---|---|---|---|---|---|
01-701-1015 | APPLICATION SITE ERYTHEMA | 2014-01-03 | NA | 2014-01-02 | 2014-07-02 | 63 | YEARS | F |
01-701-1015 | APPLICATION SITE PRURITUS | 2014-01-03 | NA | 2014-01-02 | 2014-07-02 | 63 | YEARS | F |
01-701-1015 | DIARRHOEA | 2014-01-09 | NA | 2014-01-02 | 2014-07-02 | 63 | YEARS | F |
01-701-1023 | ERYTHEMA | 2012-08-07 | NA | 2012-08-05 | 2012-09-02 | 64 | YEARS | M |
01-701-1023 | ERYTHEMA | 2012-08-07 | NA | 2012-08-05 | 2012-09-02 | 64 | YEARS | M |
01-701-1023 | ERYTHEMA | 2012-08-07 | NA | 2012-08-05 | 2012-09-02 | 64 | YEARS | M |
01-701-1023 | ATRIOVENTRICULAR BLOCK SECOND DEGREE | 2012-08-26 | NA | 2012-08-05 | 2012-09-02 | 64 | YEARS | M |
01-703-1086 | APPLICATION SITE IRRITATION | 2012-09-13 | NA | 2012-09-02 | 2012-12-24 | 71 | YEARS | M |
01-703-1086 | APPLICATION SITE IRRITATION | 2012-09-13 | NA | 2012-09-02 | 2012-12-24 | 71 | YEARS | M |
01-703-1086 | APPLICATION SITE IRRITATION | 2012-09-13 | NA | 2012-09-02 | 2012-12-24 | 71 | YEARS | M |
The function derive_var_obs_number()
can be used for
deriving ASEQ
variable to ensure the uniqueness of subject
records within the dataset.
For example, there can be multiple records present in
ADCM
for a single subject with the same ASTDTM
and CMSEQ
variables. But these records still differ at ATC
level:
adcm <- tibble::tribble(
~USUBJID, ~ASTDTM, ~CMSEQ, ~CMDECOD, ~ATC1CD, ~ATC2CD, ~ATC3CD, ~ATC4CD,
"BP40257-1001", "2013-07-05 UTC", "14", "PARACETAMOL", "N", "N02", "N02B", "N02BE",
"BP40257-1001", "2013-08-15 UTC", "18", "SOLUMEDROL", "D", "D10", "D10A", "D10AA",
"BP40257-1001", "2013-08-15 UTC", "18", "SOLUMEDROL", "D", "D07", "D07A", "D07AA",
"BP40257-1001", "2013-08-15 UTC", "18", "SOLUMEDROL", "H", "H02", "H02A", "H02AB",
"BP40257-1002", "2012-12-15 UTC", "19", "SPIRONOLACTONE", "C", "C03", "C03D", "C03DA"
)
adcm_aseq <- adcm %>%
derive_var_obs_number(
by_vars = exprs(USUBJID),
order = exprs(ASTDTM, CMSEQ, ATC1CD, ATC2CD, ATC3CD, ATC4CD),
new_var = ASEQ,
check_type = "error"
)
USUBJID | ASTDTM | CMSEQ | CMDECOD | ATC1CD | ATC2CD | ATC3CD | ATC4CD | ASEQ |
---|---|---|---|---|---|---|---|---|
BP40257-1001 | 2013-07-05 UTC | 14 | PARACETAMOL | N | N02 | N02B | N02BE | 1 |
BP40257-1001 | 2013-08-15 UTC | 18 | SOLUMEDROL | D | D07 | D07A | D07AA | 2 |
BP40257-1001 | 2013-08-15 UTC | 18 | SOLUMEDROL | D | D10 | D10A | D10AA | 3 |
BP40257-1001 | 2013-08-15 UTC | 18 | SOLUMEDROL | H | H02 | H02A | H02AB | 4 |
BP40257-1002 | 2012-12-15 UTC | 19 | SPIRONOLACTONE | C | C03 | C03D | C03DA | 1 |
Adding labels and attributes for SAS transport files is supported by the following packages:
metacore: establish a common foundation for the use of metadata within an R session.
metatools: enable the use of metacore objects. Metatools can be used to build datasets or enhance columns in existing datasets as well as checking datasets against the metadata.
xportr: functionality to associate all metadata information to a local R data frame, perform data set level validation checks and convert into a transport v5 file(xpt).
NOTE: All these packages are in the experimental phase, but the vision is to have them associated with an End to End pipeline under the umbrella of the pharmaverse. An example of applying metadata and perform associated checks can be found at the pharmaverse E2E example.
ADaM | Sourcing Command |
---|---|
ADAE | use_ad_template("ADAE") |
ADCM | use_ad_template("ADCM") |
These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.
Health stats visible at Monitor.