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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,
  armvar = .study$actualarm,
  prune_0 = TRUE,
  lbl_overall = .study$lbl_overall,
  deco = std_deco("AET03"),
  .study = list(actualarm = "ACTARM", lbl_overall = NULL)
)

aet03_1_lyt(
  armvar = .study$actualarm,
  lbl_aebodsys = "",
  lbl_aedecod = "",
  severity_grade = .study$severity_grade,
  lbl_overall = .study$lbl_overall,
  deco = std_deco("AET03"),
  .study = list(actualarm = "ACTARM", lbl_overall = NULL, severity_grade = c("MILD",
    "MODERATE", "SEVERE", "LIFE THREATENING"))
)

aet03_1_pre(adam_db, ...)

aet03_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

prune_0

(logical) remove 0 count rows

lbl_overall

(character) label used for overall column, if set to NULL the overall column is omitted

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.

severity_grade

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

...

not used.

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

Examples

run(aet03_1, syn_test_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%)    123 (91.8%)    120 (90.9%)  
#> MILD                         7 (5.2%)     9 (6.7%)         4 (3%)    
#> 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%)       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%)    74 (55.2%)      85 (64.4%)  
#>   MILD                      30 (22.4%)   30 (22.4%)       33 (25%)   
#>   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%)     67 (50%)       80 (60.6%)  
#>   MODERATE                  29 (21.6%)   25 (18.7%)       29 (22%)   
#>   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%)