AET02 Table 3 (Supplementary) Adverse Events by Dictionary-Derived Term Table 3

The AET02_3 table provides an overview of the number of patients experiencing adverse events and the number of adverse events categorized by Dictionary-Derived Term.

aet02_3(
  adam_db,
  armvar = .study$actualarm,
  lbl_overall = .study$lbl_overall,
  prune_0 = TRUE,
  deco = std_deco("AET02"),
  .study = list(actualarm = "ACTARM", lbl_overall = NULL)
)

aet02_3_lyt(
  armvar = .study$actualarm,
  lbl_overall = .study$lbl_overall,
  lbl_aedecod = "AEDECOD",
  deco = std_deco("AET02"),
  .study = list(actualarm = "ACTARM", lbl_overall = NULL)
)

aet02_3_pre(adam_db)

Arguments

adam_db: (dm) object containing the ADaM datasets
armvar: (character) variable used for column splitting
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
lbl_aedecod: (character) text label for AEDECOD.

Details

Numbers represent absolute numbers of patients and fraction of N, or absolute number of event when specified.
Remove zero-count rows unless overridden with prune_0 = FALSE.
Split columns by arm.
Does not include a total column by default.
Sort Dictionary-Derived Code by highest overall frequencies.

Functions

aet02_3_lyt: aet02_3 Layout
aet02_3_pre: aet02_3 Preprocessing

Examples

library(dm)

db <- syn_test_data() %>%
  aet02_3_pre()

aet02_3(adam_db = db) %>% head()
#> Adverse Events: {Specify Population}
#> Protocol: {{protocol}}
#> 
#> ————————————————————————————————————————————————————————————————————————————————————————————————————
#>                                                            A: Drug X    B: Placebo    C: Combination
#>                                                             (N=134)       (N=134)        (N=132)    
#> ————————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of patients with at least one adverse event   122 (91%)    123 (91.8%)    120 (90.9%)  
#> Overall total number of events                                609           622            703      
#> dcd D.2.1.5.3                                              47 (35.1%)   58 (43.3%)      57 (43.2%)  
#> dcd A.1.1.1.1                                              50 (37.3%)   45 (33.6%)      63 (47.7%)  
#> dcd B.2.2.3.1                                              48 (35.8%)   54 (40.3%)      51 (38.6%)  
#> dcd A.1.1.1.2                                              48 (35.8%)   48 (35.8%)      50 (37.9%)  
#> ————————————————————————————————————————————————————————————————————————————————————————————————————
#> 
#> Investigator text for AEs encoded using MedDRA version xx.x.  Percentages are based on N in the column headings. For frequency counts by preferred term, multiple occurrences of the same AE in an individual are counted only once.  For frequency counts of "Total number of events" rows, multiple occurrences of the same AE in an individual are counted separately. Standard footnote defining AEs included in table (e.g., includes AEs with onset from first dose of study drug through 7 days after last dose of study drug).

aet02_3(db, lbl_overall = "All Patients") %>% head()
#> Adverse Events: {Specify Population}
#> Protocol: {{protocol}}
#> 
#> ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#>                                                            A: Drug X    B: Placebo    C: Combination   All Patients
#>                                                             (N=134)       (N=134)        (N=132)         (N=400)   
#> ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of patients with at least one adverse event   122 (91%)    123 (91.8%)    120 (90.9%)     365 (91.2%) 
#> Overall total number of events                                609           622            703             1934    
#> dcd D.2.1.5.3                                              47 (35.1%)   58 (43.3%)      57 (43.2%)     162 (40.5%) 
#> dcd A.1.1.1.1                                              50 (37.3%)   45 (33.6%)      63 (47.7%)     158 (39.5%) 
#> dcd B.2.2.3.1                                              48 (35.8%)   54 (40.3%)      51 (38.6%)     153 (38.2%) 
#> dcd A.1.1.1.2                                              48 (35.8%)   48 (35.8%)      50 (37.9%)     146 (36.5%) 
#> ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> 
#> Investigator text for AEs encoded using MedDRA version xx.x.  Percentages are based on N in the column headings. For frequency counts by preferred term, multiple occurrences of the same AE in an individual are counted only once.  For frequency counts of "Total number of events" rows, multiple occurrences of the same AE in an individual are counted separately. Standard footnote defining AEs included in table (e.g., includes AEs with onset from first dose of study drug through 7 days after last dose of study drug).
aet02_3_lyt(
  armvar = "ACTARM",
  lbl_overall = NULL,
  lbl_aedecod = "Dictionary-Derived Term",
  deco = std_deco("AET02")
)
#> A Pre-data Table Layout
#> 
#> Column-Split Structure:
#> ACTARM (lvls) 
#> 
#> Row-Split Structure:
#> AEDECOD (** analysis **) 
#> 
syn_test_data() %>%
  aet02_3_pre()
#> ── Metadata ────────────────────────────────────────────────────────────────────
#> Tables: `adsl`, `adae`, `adaette`, `adcm`, `addv`, … (15 total)
#> Columns: 846
#> Primary keys: 2
#> Foreign keys: 1