AET04 Table 1 (Default) Adverse Events by Highest NCI CTACAE AE Grade Table 1.

The AET04 table provides an overview of adverse event with the highest NCI CTCAE grade per individual.

Usage

aet04_main(
  adam_db,
  arm_var = "ACTARM",
  lbl_overall = NULL,
  grade_groups = NULL,
  ...
)

aet04_pre(adam_db, ...)

aet04_post(tlg, prune_0 = TRUE, ...)

aet04

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
grade_groups: (list) putting in correspondence toxicity grades and labels.
...: 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

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.
Events with missing grading values are excluded.
Split columns by arm, typically ACTARM.
Does not include a total column by default.
Sort Body System or Organ Class and Dictionary-Derived Term by highest overall frequencies. Analysis Toxicity Grade is sorted by severity.

Functions

aet04_main(): Main TLG function
aet04_pre(): Preprocessing
aet04_post(): Postprocessing

Note

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

Examples

grade_groups <- list(
  "Grade 1-2" = c("1", "2"),
  "Grade 3-4" = c("3", "4"),
  "Grade 5" = c("5")
)
proc_data <- dunlin::log_filter(syn_data, AEBODSYS == "cl A.1", "adae")
run(aet04, proc_data, grade_groups = grade_groups)
#>   MedDRA System Organ Class                                                          
#>     MedDRA Preferred Term                     A: Drug X   B: Placebo   C: Combination
#>                               Grade            (N=15)       (N=15)         (N=15)    
#>   ———————————————————————————————————————————————————————————————————————————————————
#>   - Any adverse events -                                                             
#>                               - Any Grade -   7 (46.7%)   6 (40.0%)      10 (66.7%)  
#>                               Grade 1-2       7 (46.7%)   6 (40.0%)      10 (66.7%)  
#>                               1               2 (13.3%)       0          4 (26.7%)   
#>                               2               5 (33.3%)   6 (40.0%)      6 (40.0%)   
#>   cl A.1                                                                             
#>     - Overall -                                                                      
#>                               - Any Grade -   7 (46.7%)   6 (40.0%)      10 (66.7%)  
#>                               Grade 1-2       7 (46.7%)   6 (40.0%)      10 (66.7%)  
#>                               1               2 (13.3%)       0          4 (26.7%)   
#>                               2               5 (33.3%)   6 (40.0%)      6 (40.0%)   
#>     dcd A.1.1.1.2                                                                    
#>                               - Any Grade -   5 (33.3%)   6 (40.0%)      6 (40.0%)   
#>                               Grade 1-2       5 (33.3%)   6 (40.0%)      6 (40.0%)   
#>                               2               5 (33.3%)   6 (40.0%)      6 (40.0%)   
#>     dcd A.1.1.1.1                                                                    
#>                               - Any Grade -   3 (20.0%)    1 (6.7%)      6 (40.0%)   
#>                               Grade 1-2       3 (20.0%)    1 (6.7%)      6 (40.0%)   
#>                               1               3 (20.0%)    1 (6.7%)      6 (40.0%)