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,
  arm_var = "ACTARM",
  lbl_overall = NULL,
  lbl_aebodsys = "MedDRA System Organ Class",
  lbl_aedecod = "MedDRA Preferred Term",
  deco = std_deco("AET02"),
  ...
)

aet02_1_lyt(arm_var, lbl_overall, lbl_aebodsys, lbl_aedecod, deco)

aet02_1_pre(adam_db, ...)

aet02_1_check(adam_db, req_tables = c("adsl", "adae"), arm_var = "ACTARM")

aet02_1_post(tlg, prune_0 = TRUE, ...)

aet02_1

Format

An object of class chevron_t of length 1.

Arguments

adam_db: (dm) object containing the ADaM datasets
arm_var: (character) variable used for column splitting
lbl_overall: (character) label used for overall column, if set to NULL the overall column is omitted
lbl_aebodsys: (character) text label for AEBODSYS.
lbl_aedecod: (character) text label for AEDECOD.
deco: (character) decoration with title, subtitles and main_footer content
...: not used.
req_tables: (character) names of the required tables.
tlg: (TableTree, Listing or ggplot) object typically produced by a main function.
prune_0: (logical) remove 0 count rows

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
aet02_1_post(): Postprocessing

Note

adam_db object must contain an adae table with the columns "AEBODSYS" and "AEDECOD".

Examples

run(aet02_1, syn_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 (91.0%)   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 (56.0%)      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 (59.0%)    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 (59.0%)    67 (50.0%)      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%)