Adverse Event Analysis Dataset (ADAE)
radae.Rd
Function for generating random Adverse Event Analysis Dataset for a given Subject-Level Analysis Dataset.
Arguments
- adsl
(
data.frame
)
Subject-Level Analysis Dataset (ADSL).- max_n_aes
(
integer
)
Maximum number of AEs per patient. Defaults to 10.- lookup
(
data.frame
)
Additional parameters.- lookup_aag
(
data.frame
)
Additional metadata parameters.- seed
(
numeric
)
Seed to use for reproducible random number generation.- na_percentage
(
proportion
)
Default percentage of values to be replaced byNA
.- na_vars
(
list
)
A named list where the name of each element is a column name ofds
. Each element of this list should be a numeric vector with two elements:seed
(numeric
)
The seed to be used for this element - can beNA
.percentage
(proportion
)
Percentage of elements to be replaced withNA
. IfNA
,na_percentage
is used as a default.
- cached
boolean whether the cached ADAE data
cadae
should be returned or new data should be generated. If set toTRUE
then the other arguments toradae
will be ignored.
Details
One record per each record in the corresponding SDTM domain.
Keys: STUDYID
, USUBJID
, ASTDTM
, AETERM
, AESEQ
Examples
library(random.cdisc.data)
adsl <- radsl(N = 10, study_duration = 2, seed = 1)
adae <- radae(adsl, seed = 2)
adae
#> # A tibble: 51 × 92
#> STUDYID USUBJID SUBJID SITEID AGE AGEU SEX RACE ETHNIC COUNTRY DTHFL
#> <chr> <chr> <chr> <chr> <int> <fct> <fct> <fct> <fct> <fct> <fct>
#> 1 AB12345 AB12345-B… id-9 BRA-1 35 YEARS F BLAC… UNKNO… BRA N
#> 2 AB12345 AB12345-B… id-9 BRA-1 35 YEARS F BLAC… UNKNO… BRA N
#> 3 AB12345 AB12345-B… id-9 BRA-1 35 YEARS F BLAC… UNKNO… BRA N
#> 4 AB12345 AB12345-B… id-9 BRA-1 35 YEARS F BLAC… UNKNO… BRA N
#> 5 AB12345 AB12345-B… id-9 BRA-1 35 YEARS F BLAC… UNKNO… BRA N
#> 6 AB12345 AB12345-B… id-8 BRA-9 31 YEARS F ASIAN NOT H… BRA Y
#> 7 AB12345 AB12345-B… id-8 BRA-9 31 YEARS F ASIAN NOT H… BRA Y
#> 8 AB12345 AB12345-B… id-8 BRA-9 31 YEARS F ASIAN NOT H… BRA Y
#> 9 AB12345 AB12345-B… id-8 BRA-9 31 YEARS F ASIAN NOT H… BRA Y
#> 10 AB12345 AB12345-B… id-8 BRA-9 31 YEARS F ASIAN NOT H… BRA Y
#> # ℹ 41 more rows
#> # ℹ 81 more variables: INVID <chr>, INVNAM <chr>, ARM <fct>, ARMCD <fct>,
#> # ACTARM <fct>, ACTARMCD <fct>, TRT01P <fct>, TRT01A <fct>, TRT02P <fct>,
#> # TRT02A <fct>, REGION1 <fct>, STRATA1 <fct>, STRATA2 <fct>, BMRKR1 <dbl>,
#> # BMRKR2 <fct>, ITTFL <fct>, SAFFL <fct>, BMEASIFL <fct>, BEP01FL <fct>,
#> # AEWITHFL <fct>, RANDDT <date>, TRTSDTM <dttm>, TRTEDTM <dttm>,
#> # TRT01SDTM <dttm>, TRT01EDTM <dttm>, TRT02SDTM <dttm>, TRT02EDTM <dttm>, …
# Add metadata.
aag <- utils::read.table(
sep = ",", header = TRUE,
text = paste(
"NAMVAR,SRCVAR,GRPTYPE,REFNAME,REFTERM,SCOPE",
"CQ01NAM,AEDECOD,CUSTOM,D.2.1.5.3/A.1.1.1.1 AESI,dcd D.2.1.5.3,",
"CQ01NAM,AEDECOD,CUSTOM,D.2.1.5.3/A.1.1.1.1 AESI,dcd A.1.1.1.1,",
"SMQ01NAM,AEDECOD,SMQ,C.1.1.1.3/B.2.2.3.1 AESI,dcd C.1.1.1.3,BROAD",
"SMQ01NAM,AEDECOD,SMQ,C.1.1.1.3/B.2.2.3.1 AESI,dcd B.2.2.3.1,BROAD",
"SMQ02NAM,AEDECOD,SMQ,Y.9.9.9.9/Z.9.9.9.9 AESI,dcd Y.9.9.9.9,NARROW",
"SMQ02NAM,AEDECOD,SMQ,Y.9.9.9.9/Z.9.9.9.9 AESI,dcd Z.9.9.9.9,NARROW",
sep = "\n"
), stringsAsFactors = FALSE
)
adae <- radae(adsl, lookup_aag = aag)
with(
adae,
cbind(
table(AEDECOD, SMQ01NAM),
table(AEDECOD, CQ01NAM)
)
)
#> C.1.1.1.3/B.2.2.3.1 AESI D.2.1.5.3/A.1.1.1.1 AESI
#> dcd A.1.1.1.1 0 9
#> dcd A.1.1.1.2 0 0
#> dcd B.1.1.1.1 0 0
#> dcd B.2.1.2.1 0 0
#> dcd B.2.2.3.1 11 0
#> dcd C.1.1.1.3 10 0
#> dcd C.2.1.2.1 0 0
#> dcd D.1.1.1.1 0 0
#> dcd D.1.1.4.2 0 0
#> dcd D.2.1.5.3 0 6