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An adverse events table categorized by System Organ Class, Dictionary-Derived Term and Greatest intensity.

Usage

aet03_1_main(
  adam_db,
  arm_var = "ACTARM",
  lbl_overall = NULL,
  lbl_aebodsys = "MedDRA System Organ Class",
  lbl_aedecod = "MedDRA Preferred Term",
  deco = std_deco("AET03"),
  ...
)

aet03_1_lyt(
  arm_var,
  lbl_overall,
  lbl_aebodsys,
  lbl_aedecod,
  intensity_grade,
  deco
)

aet03_1_pre(adam_db, ...)

aet03_1_post(tlg, prune_0 = TRUE, ...)

aet03_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.

intensity_grade

(vector of character) describing the intensity levels present in the dataset.

tlg

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

prune_0

(logical) remove 0 count rows

Details

  • Default Adverse Events by Greatest Intensity table.

  • Numbers represent absolute numbers of patients and fraction of N.

  • Remove zero-count rows unless overridden with prune_0 = FALSE.

  • Split columns by arm.

  • Does not include a total column by default.

  • Sort by Body System or Organ Class (SOC) and Dictionary-Derived Term (PT).

Functions

  • aet03_1_main(): Main TLG function

  • aet03_1_lyt(): Layout

  • aet03_1_pre(): Preprocessing

  • aet03_1_post(): Postprocessing

Note

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

Examples

run(aet03_1, syn_data)
#>   MedDRA System Organ Class    A: Drug X    B: Placebo    C: Combination
#>     MedDRA Preferred Term       (N=134)       (N=134)        (N=132)    
#>   ——————————————————————————————————————————————————————————————————————
#>   - Any Intensity -           122 (91.0%)   123 (91.8%)    120 (90.9%)  
#>   MILD                         7 (5.2%)      9 (6.7%)        4 (3.0%)   
#>   MODERATE                    24 (17.9%)    24 (17.9%)      23 (17.4%)  
#>   SEVERE                      91 (67.9%)    90 (67.2%)      93 (70.5%)  
#>   cl A.1                                                                
#>     - Any Intensity -         78 (58.2%)    75 (56.0%)      89 (67.4%)  
#>     MILD                      30 (22.4%)    27 (20.1%)      39 (29.5%)  
#>     MODERATE                  48 (35.8%)    48 (35.8%)      50 (37.9%)  
#>     dcd A.1.1.1.1                                                       
#>       - Any Intensity -       50 (37.3%)    45 (33.6%)      63 (47.7%)  
#>       MILD                    50 (37.3%)    45 (33.6%)      63 (47.7%)  
#>     dcd A.1.1.1.2                                                       
#>       - Any Intensity -       48 (35.8%)    48 (35.8%)      50 (37.9%)  
#>       MODERATE                48 (35.8%)    48 (35.8%)      50 (37.9%)  
#>   cl B.2                                                                
#>     - Any Intensity -         79 (59.0%)    74 (55.2%)      85 (64.4%)  
#>     MILD                      30 (22.4%)    30 (22.4%)      33 (25.0%)  
#>     MODERATE                  49 (36.6%)    44 (32.8%)      52 (39.4%)  
#>     dcd B.2.2.3.1                                                       
#>       - Any Intensity -       48 (35.8%)    54 (40.3%)      51 (38.6%)  
#>       MILD                    48 (35.8%)    54 (40.3%)      51 (38.6%)  
#>     dcd B.2.1.2.1                                                       
#>       - Any Intensity -       49 (36.6%)    44 (32.8%)      52 (39.4%)  
#>       MODERATE                49 (36.6%)    44 (32.8%)      52 (39.4%)  
#>   cl D.1                                                                
#>     - Any Intensity -         79 (59.0%)    67 (50.0%)      80 (60.6%)  
#>     MODERATE                  29 (21.6%)    25 (18.7%)      29 (22.0%)  
#>     SEVERE                    50 (37.3%)    42 (31.3%)      51 (38.6%)  
#>     dcd D.1.1.1.1                                                       
#>       - Any Intensity -       50 (37.3%)    42 (31.3%)      51 (38.6%)  
#>       SEVERE                  50 (37.3%)    42 (31.3%)      51 (38.6%)  
#>     dcd D.1.1.4.2                                                       
#>       - Any Intensity -       48 (35.8%)    42 (31.3%)      50 (37.9%)  
#>       MODERATE                48 (35.8%)    42 (31.3%)      50 (37.9%)  
#>   cl D.2                                                                
#>     - Any Intensity -         47 (35.1%)    58 (43.3%)      57 (43.2%)  
#>     MILD                      47 (35.1%)    58 (43.3%)      57 (43.2%)  
#>     dcd D.2.1.5.3                                                       
#>       - Any Intensity -       47 (35.1%)    58 (43.3%)      57 (43.2%)  
#>       MILD                    47 (35.1%)    58 (43.3%)      57 (43.2%)  
#>   cl B.1                                                                
#>     - Any Intensity -         47 (35.1%)    49 (36.6%)      43 (32.6%)  
#>     SEVERE                    47 (35.1%)    49 (36.6%)      43 (32.6%)  
#>     dcd B.1.1.1.1                                                       
#>       - Any Intensity -       47 (35.1%)    49 (36.6%)      43 (32.6%)  
#>       SEVERE                  47 (35.1%)    49 (36.6%)      43 (32.6%)  
#>   cl C.2                                                                
#>     - Any Intensity -         35 (26.1%)    48 (35.8%)      55 (41.7%)  
#>     MODERATE                  35 (26.1%)    48 (35.8%)      55 (41.7%)  
#>     dcd C.2.1.2.1                                                       
#>       - Any Intensity -       35 (26.1%)    48 (35.8%)      55 (41.7%)  
#>       MODERATE                35 (26.1%)    48 (35.8%)      55 (41.7%)  
#>   cl C.1                                                                
#>     - Any Intensity -         43 (32.1%)    46 (34.3%)      43 (32.6%)  
#>     SEVERE                    43 (32.1%)    46 (34.3%)      43 (32.6%)  
#>     dcd C.1.1.1.3                                                       
#>       - Any Intensity -       43 (32.1%)    46 (34.3%)      43 (32.6%)  
#>       SEVERE                  43 (32.1%)    46 (34.3%)      43 (32.6%)