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

Usage

aet03_main(adam_db, arm_var = "ACTARM", lbl_overall = NULL, ...)

aet03_pre(adam_db, ...)

aet03_post(tlg, prune_0 = TRUE, ...)

aet03

Format

An object of class chevron_t of length 1.

Arguments

adam_db

(list of data.frames) 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

...

not used.

tlg

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

prune_0

(flag) remove 0 count rows

Value

the main function returns an rtables object.

the preprocessing function returns a list of data.frame.

the postprocessing function returns an rtables object or an ElementaryTable (null report).

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_main(): Main TLG function

  • aet03_pre(): Preprocessing

  • aet03_post(): Postprocessing

Note

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

Examples

run(aet03, syn_data)
#>   MedDRA System Organ Class   A: Drug X    B: Placebo   C: Combination
#>     MedDRA Preferred Term       (N=15)       (N=15)         (N=15)    
#>   ————————————————————————————————————————————————————————————————————
#>   - Any Intensity -           13 (86.7%)   14 (93.3%)     15 (100%)   
#>   MILD                            0         1 (6.7%)       1 (6.7%)   
#>   MODERATE                    2 (13.3%)    3 (20.0%)      2 (13.3%)   
#>   SEVERE                      11 (73.3%)   10 (66.7%)     12 (80.0%)  
#>   cl B.2                                                              
#>     - Any Intensity -         11 (73.3%)   8 (53.3%)      10 (66.7%)  
#>     MILD                      6 (40.0%)    2 (13.3%)      5 (33.3%)   
#>     MODERATE                  5 (33.3%)    6 (40.0%)      5 (33.3%)   
#>     dcd B.2.2.3.1                                                     
#>       - Any Intensity -       8 (53.3%)    6 (40.0%)      7 (46.7%)   
#>       MILD                    8 (53.3%)    6 (40.0%)      7 (46.7%)   
#>     dcd B.2.1.2.1                                                     
#>       - Any Intensity -       5 (33.3%)    6 (40.0%)      5 (33.3%)   
#>       MODERATE                5 (33.3%)    6 (40.0%)      5 (33.3%)   
#>   cl D.1                                                              
#>     - Any Intensity -         9 (60.0%)    5 (33.3%)      11 (73.3%)  
#>     MODERATE                  5 (33.3%)     1 (6.7%)      4 (26.7%)   
#>     SEVERE                    4 (26.7%)    4 (26.7%)      7 (46.7%)   
#>     dcd D.1.1.1.1                                                     
#>       - Any Intensity -       4 (26.7%)    4 (26.7%)      7 (46.7%)   
#>       SEVERE                  4 (26.7%)    4 (26.7%)      7 (46.7%)   
#>     dcd D.1.1.4.2                                                     
#>       - Any Intensity -       6 (40.0%)    2 (13.3%)      7 (46.7%)   
#>       MODERATE                6 (40.0%)    2 (13.3%)      7 (46.7%)   
#>   cl A.1                                                              
#>     - Any Intensity -         7 (46.7%)    6 (40.0%)      10 (66.7%)  
#>     MILD                      2 (13.3%)        0          4 (26.7%)   
#>     MODERATE                  5 (33.3%)    6 (40.0%)      6 (40.0%)   
#>     dcd A.1.1.1.2                                                     
#>       - Any Intensity -       5 (33.3%)    6 (40.0%)      6 (40.0%)   
#>       MODERATE                5 (33.3%)    6 (40.0%)      6 (40.0%)   
#>     dcd A.1.1.1.1                                                     
#>       - Any Intensity -       3 (20.0%)     1 (6.7%)      6 (40.0%)   
#>       MILD                    3 (20.0%)     1 (6.7%)      6 (40.0%)   
#>   cl B.1                                                              
#>     - Any Intensity -         5 (33.3%)    6 (40.0%)      8 (53.3%)   
#>     SEVERE                    5 (33.3%)    6 (40.0%)      8 (53.3%)   
#>     dcd B.1.1.1.1                                                     
#>       - Any Intensity -       5 (33.3%)    6 (40.0%)      8 (53.3%)   
#>       SEVERE                  5 (33.3%)    6 (40.0%)      8 (53.3%)   
#>   cl C.2                                                              
#>     - Any Intensity -         6 (40.0%)    4 (26.7%)      8 (53.3%)   
#>     MODERATE                  6 (40.0%)    4 (26.7%)      8 (53.3%)   
#>     dcd C.2.1.2.1                                                     
#>       - Any Intensity -       6 (40.0%)    4 (26.7%)      8 (53.3%)   
#>       MODERATE                6 (40.0%)    4 (26.7%)      8 (53.3%)   
#>   cl D.2                                                              
#>     - Any Intensity -         2 (13.3%)    5 (33.3%)      7 (46.7%)   
#>     MILD                      2 (13.3%)    5 (33.3%)      7 (46.7%)   
#>     dcd D.2.1.5.3                                                     
#>       - Any Intensity -       2 (13.3%)    5 (33.3%)      7 (46.7%)   
#>       MILD                    2 (13.3%)    5 (33.3%)      7 (46.7%)   
#>   cl C.1                                                              
#>     - Any Intensity -         4 (26.7%)    4 (26.7%)      5 (33.3%)   
#>     SEVERE                    4 (26.7%)    4 (26.7%)      5 (33.3%)   
#>     dcd C.1.1.1.3                                                     
#>       - Any Intensity -       4 (26.7%)    4 (26.7%)      5 (33.3%)   
#>       SEVERE                  4 (26.7%)    4 (26.7%)      5 (33.3%)