Protocol Deviations Analysis Dataset (ADDV) — raddv • random.cdisc.data

Function for generating random Protocol Deviations Analysis Dataset for a given Subject-Level Analysis Dataset.

raddv(
  ADSL,
  max_n_dv = 3L,
  p_dv = 0.15,
  lookup = NULL,
  seed = NULL,
  na_percentage = 0,
  na_vars = list(ASTDT = c(seed = 1234, percentage = 0.1), DVCAT = c(seed = 1234,
    percentage = 0.1)),
  cached = FALSE
)

Arguments

ADSL

Subject-Level Analysis Dataset (ADSL).

max_n_dv

Maximum number of deviations per patient.

p_dv

Probability of a patient to have protocol deviations.

lookup

Data.frame containing additional parameters.

seed

Seed for random number generation.

na_percentage

(numeric) Default percentage of values to be replaced by NA

na_vars

(list) A named list where the name of each element is a column name of ds. Each element of this list should be a numeric vector with two elements

seed The seed to be used for this element - can be left NA
percentage How many element should be replaced. 0 is 0 % 1 is 100 %, can be left NA and default percentage is used. This will overwrite default percentage (percentage argument))

cached

boolean whether the cached ADDV data caddv should be returned or new data should be generated. If set to TRUE then the other arguments to raddv will be ignored.

Value

data.frame

Details

One record per each record in the corresponding SDTM domain.

Keys: STUDYID USUBJID ASTDT DVTERM DVSEQ.

Examples

ADSL <- radsl(N = 10, seed = 1, study_duration = 2)
raddv(ADSL, seed = 2)
#> # A tibble: 9 × 55
#>   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-BR… id-9   BRA-1     35 YEARS F     BLAC… NOT H… BRA     N    
#> 2 AB12345 AB12345-BR… id-9   BRA-1     35 YEARS F     BLAC… NOT H… BRA     N    
#> 3 AB12345 AB12345-BR… id-9   BRA-1     35 YEARS F     BLAC… NOT H… BRA     N    
#> 4 AB12345 AB12345-CH… id-5   CHN-3     36 YEARS F     ASIAN NOT H… CHN     N    
#> 5 AB12345 AB12345-CH… id-5   CHN-3     36 YEARS F     ASIAN NOT H… CHN     N    
#> 6 AB12345 AB12345-CH… id-5   CHN-3     36 YEARS F     ASIAN NOT H… CHN     N    
#> 7 AB12345 AB12345-US… id-3   USA-13    35 YEARS F     AMER… NOT H… USA     N    
#> 8 AB12345 AB12345-US… id-3   USA-13    35 YEARS F     AMER… NOT H… USA     N    
#> 9 AB12345 AB12345-US… id-3   USA-13    35 YEARS F     AMER… NOT H… USA     N    
#> # … with 44 more variables: INVID <chr>, INVNAM <chr>, ARM <fct>, ARMCD <fct>,
#> #   ACTARM <fct>, ACTARMCD <fct>, TRT01P <fct>, TRT01A <fct>, REGION1 <fct>,
#> #   STRATA1 <fct>, STRATA2 <fct>, BMRKR1 <dbl>, BMRKR2 <fct>, ITTFL <fct>,
#> #   SAFFL <fct>, BMEASIFL <fct>, BEP01FL <fct>, RANDDT <date>, TRTSDTM <dttm>,
#> #   TRTEDTM <dttm>, EOSSTT <fct>, EOTSTT <fct>, EOSDT <date>, EOSDY <int>,
#> #   DCSREAS <fct>, DTHDT <date>, DTHCAUS <fct>, DTHCAT <fct>, LDDTHELD <int>,
#> #   LDDTHGR1 <fct>, LSTALVDT <date>, DTHADY <int>, study_duration_secs <dbl>, …