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The AET02_2 table provides an overview of the number of patients experiencing adverse events and the number of adverse events categorized by Body System, High Level Term and Dictionary-Derived Term.

Usage

aet02_2_main(
  adam_db,
  arm_var = "ACTARM",
  lbl_overall = NULL,
  lbl_aebodsys = "MedDRA System Organ Class",
  lbl_aedecod = "MedDRA Preferred Term",
  lbl_aehlt = "MedDRA High-Level Term",
  deco = std_deco("AET02"),
  ...
)

aet02_2_lyt(
  arm_var,
  lbl_overall = NULL,
  lbl_aebodsys,
  lbl_aedecod,
  lbl_aehlt,
  deco
)

aet02_2_pre(adam_db, ...)

aet02_2_post(tlg, prune_0 = TRUE, ...)

aet02_2

aet02_3_main(
  adam_db,
  arm_var = "ACTARM",
  lbl_overall = NULL,
  lbl_aedecod = "MedDRA Preferred Term",
  deco = std_deco("AET02"),
  ...
)

Format

An object of class chevron_t of length 1.

Arguments

adam_db

(dm) object containing the ADaM datasets

arm_var

(string) variable used for column splitting

lbl_overall

(string) 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.

lbl_aehlt

(character) text label for AEHLT.

deco

(character) decoration with title, subtitles and main_footer content

...

not used.

tlg

(TableTree, Listing or ggplot) object typically produced by a main function.

prune_0

(flag) remove 0 count rows

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 Body System or Organ Class, High Level Term and Dictionary-Derived Term hierarchically by highest overall frequencies.

  • Missing values of AEBODSYS, AEHLT and AEDECOD in adae are labeled by No Coding available.

  • 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.

  • Missing values of AEDECOD in aead are labeled by No Coding available.

Functions

  • aet02_2_main(): Main TLG function

  • aet02_2_lyt(): Layout

  • aet02_2_pre(): Preprocessing

  • aet02_2_post(): Postprocessing

  • aet02_3_main(): Main TLG function

Note

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

  • adam_db object must contain an adae table with the column "AEDECOD".

Examples

run(aet02_2, syn_data)
#>   MedDRA System Organ Class                                                                                
#>     MedDRA High-Level Term                                        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      
#>     hlt A.1.1.1                                                                                            
#>       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      
#>     hlt B.2.2.3                                                                                            
#>       Total number of patients with at least one adverse event   48 (35.8%)    54 (40.3%)      51 (38.6%)  
#>       Total number of events                                         64            76              77      
#>       dcd B.2.2.3.1                                              48 (35.8%)    54 (40.3%)      51 (38.6%)  
#>     hlt B.2.1.2                                                                                            
#>       Total number of patients with at least one adverse event   49 (36.6%)    44 (32.8%)      52 (39.4%)  
#>       Total number of events                                         65            62              66      
#>       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      
#>     hlt D.1.1.1                                                                                            
#>       Total number of patients with at least one adverse event   50 (37.3%)    42 (31.3%)      51 (38.6%)  
#>       Total number of events                                         61            51              71      
#>       dcd D.1.1.1.1                                              50 (37.3%)    42 (31.3%)      51 (38.6%)  
#>     hlt D.1.1.4                                                                                            
#>       Total number of patients with at least one adverse event   48 (35.8%)    42 (31.3%)      50 (37.9%)  
#>       Total number of events                                         66            55              64      
#>       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      
#>     hlt D.2.1.5                                                                                            
#>       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      
#>     hlt B.1.1.1                                                                                            
#>       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      
#>     hlt C.2.1.2                                                                                            
#>       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      
#>     hlt C.1.1.1                                                                                            
#>       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%)