VST02 Table 1 (Default) Vital Sign Abnormalities Table 1

Assessments Outside Normal Limits Regardless of Abnormality at Baseline Table.

vst02_1(
  adam_db,
  armvar = .study$actualarm,
  lbl_vs_assessment = "Assessment",
  lbl_vs_abnormality = "Abnormality",
  lbl_overall = .study$lbl_overall,
  prune_0 = FALSE,
  deco = std_deco("VST02"),
  .study = list(actualarm = "ACTARM", lbl_overall = NULL)
)

vst02_1_lyt(
  armvar = .study$actualarm,
  lbl_vs_assessment = "Assessment",
  lbl_vs_abnormality = "Abnormality",
  lbl_overall = .study$lbl_overall,
  deco = std_deco("VST02"),
  .study = list(actualarm = "ACTARM", lbl_overall = NULL)
)

vst02_1_pre(adam_db)

Arguments

adam_db: (dm) object containing the ADaM datasets
armvar: (character) variable used for column splitting
lbl_vs_assessment: (character) the label of the assessment variable.
lbl_vs_abnormality: (character) the label of the abnormality variable.
lbl_overall: (character) label used for overall column, if set to NULL the overall column is omitted
prune_0: (logical) remove 0 count rows
deco: (character) decoration with title, subtitles and main_footer content
.study: (list) with default values for the arguments of the function

Details

Only count LOW or HIGH values.
Results of "LOW LOW" are treated as the same as "LOW", and "HIGH HIGH" the same as "HIGH".
Does not include a total column by default.
Does not remove zero-count rows unless overridden with prune_0 = TRUE.

Functions

vst02_1_lyt: vst02_1 Layout
vst02_1_pre: vst02_1 Preprocessing

Examples

library(dm)

db <- syn_test_data() %>%
  dm_zoom_to("advs") %>%
  filter(PARAM %in% c("Temperature")) %>%
  dm_update_zoomed() %>%
  vst02_1_pre()

vst02_1(adam_db = db)
#> Vital Signs Assessments Outside Normal Limits Regardless of Abnormality at Baseline: {Specify Population}
#> Protocol: {{protocol}}
#> 
#> ———————————————————————————————————————————————————————————————
#> Assessment       A: Drug X        B: Placebo     C: Combination
#>  Abnormality      (N=134)          (N=134)          (N=132)    
#> ———————————————————————————————————————————————————————————————
#> Temperature                                                    
#>   Low          66/134 (49.3%)   68/134 (50.7%)   81/132 (61.4%)
#>   High          67/134 (50%)    66/134 (49.3%)   69/132 (52.3%)
#> ———————————————————————————————————————————————————————————————
#> 
#> Abnormalities are based on the {specify range used} ranges.  Table entries provide the number of patients with a during-treatment assessment abnormality in the direction specified regardless of abnormality at baseline.  Abnormalities reported in patients with missing baseline values are included. Any values collected more than {specify time interval} after the last dose of study drug are not included.
vst02_1_lyt(
  armvar = "ACTARM",
  lbl_overall = NULL
)
#> A Pre-data Table Layout
#> 
#> Column-Split Structure:
#> ACTARM (lvls) 
#> 
#> Row-Split Structure:
#> PARAM (lvls) -> ANRIND (** analysis **) 
#> 
syn_test_data() %>%
  vst02_1_pre()
#> ── Metadata ────────────────────────────────────────────────────────────────────
#> Tables: `adsl`, `adae`, `adaette`, `adcm`, `addv`, … (15 total)
#> Columns: 846
#> Primary keys: 2
#> Foreign keys: 1