AET02 Table 1 (Default) Adverse Events by System Organ Class and Preferred Term Table 1

The AET02 table provides an overview of the number of subjects experiencing adverse events and the number of advert events categorized by Body System and Dictionary-Derived Term.

Usage

aet02_1_main(
  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_1_lyt(
  armvar = .study$actualarm,
  lbl_overall = .study$lbl_overall,
  lbl_aebodsys = "MedDRA System Organ Class",
  lbl_aedecod = "MedDRA Preferred Term",
  deco = std_deco("AET02"),
  .study = list(actualarm = "ACTARM", lbl_overall = NULL)
)

aet02_1_pre(adam_db, ...)

aet02_1_check(
  adam_db,
  req_tables = c("adsl", "adae"),
  armvar = .study$actualarm,
  .study = list(actualarm = "ACTARM"),
  ...
)

aet02_1

Format

An object of class chevron_tlg of length 1.

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_aebodsys: (character) text label for AEBODSYS.
lbl_aedecod: (character) text label for AEDECOD.
...: not used.
req_tables: (character) names of the required tables.

Details

Numbers represent absolute numbers of subject 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 (AEDECOD) by highest overall frequencies.
Missing values in AEBODSYS, and AEDECOD are labeled by No Coding available.

Functions

aet02_1_main(): Main TLG function
aet02_1_lyt(): Layout
aet02_1_pre(): Preprocessing
aet02_1_check(): Checks

Examples

run(aet02_1, syn_test_data())
#> MedDRA System Organ Class                                    A: Drug X    B: Placebo    C: Combination
#>   MedDRA Preferred Term                                       (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      
#> cl A.1                                                                                                
#>   Total number of patients with at least one adverse event   78 (58.2%)    75 (56%)       89 (67.4%)  
#>   Total number of events                                        132           130            160      
#>   dcd A.1.1.1.1                                              50 (37.3%)   45 (33.6%)      63 (47.7%)  
#>   dcd A.1.1.1.2                                              48 (35.8%)   48 (35.8%)      50 (37.9%)  
#> cl B.2                                                                                                
#>   Total number of patients with at least one adverse event    79 (59%)    74 (55.2%)      85 (64.4%)  
#>   Total number of events                                        129           138            143      
#>   dcd B.2.2.3.1                                              48 (35.8%)   54 (40.3%)      51 (38.6%)  
#>   dcd B.2.1.2.1                                              49 (36.6%)   44 (32.8%)      52 (39.4%)  
#> cl D.1                                                                                                
#>   Total number of patients with at least one adverse event    79 (59%)     67 (50%)       80 (60.6%)  
#>   Total number of events                                        127           106            135      
#>   dcd D.1.1.1.1                                              50 (37.3%)   42 (31.3%)      51 (38.6%)  
#>   dcd D.1.1.4.2                                              48 (35.8%)   42 (31.3%)      50 (37.9%)  
#> cl D.2                                                                                                
#>   Total number of patients with at least one adverse event   47 (35.1%)   58 (43.3%)      57 (43.2%)  
#>   Total number of events                                         62           72              74      
#>   dcd D.2.1.5.3                                              47 (35.1%)   58 (43.3%)      57 (43.2%)  
#> cl B.1                                                                                                
#>   Total number of patients with at least one adverse event   47 (35.1%)   49 (36.6%)      43 (32.6%)  
#>   Total number of events                                         56           60              62      
#>   dcd B.1.1.1.1                                              47 (35.1%)   49 (36.6%)      43 (32.6%)  
#> cl C.2                                                                                                
#>   Total number of patients with at least one adverse event   35 (26.1%)   48 (35.8%)      55 (41.7%)  
#>   Total number of events                                         48           53              65      
#>   dcd C.2.1.2.1                                              35 (26.1%)   48 (35.8%)      55 (41.7%)  
#> cl C.1                                                                                                
#>   Total number of patients with at least one adverse event   43 (32.1%)   46 (34.3%)      43 (32.6%)  
#>   Total number of events                                         55           63              64      
#>   dcd C.1.1.1.3                                              43 (32.1%)   46 (34.3%)      43 (32.6%)