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

aet04.Rd

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

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=134)      (N=134)        (N=132)    
#>   ————————————————————————————————————————————————————————————————————————————————————
#>   - Any adverse events -                                                              
#>                               - Any Grade -   78 (58.2%)   75 (56.0%)     89 (67.4%)  
#>                               Grade 1-2       78 (58.2%)   75 (56.0%)     89 (67.4%)  
#>                               1               30 (22.4%)   27 (20.1%)     39 (29.5%)  
#>                               2               48 (35.8%)   48 (35.8%)     50 (37.9%)  
#>   cl A.1                                                                              
#>     - Overall -                                                                       
#>                               - Any Grade -   78 (58.2%)   75 (56.0%)     89 (67.4%)  
#>                               Grade 1-2       78 (58.2%)   75 (56.0%)     89 (67.4%)  
#>                               1               30 (22.4%)   27 (20.1%)     39 (29.5%)  
#>                               2               48 (35.8%)   48 (35.8%)     50 (37.9%)  
#>     dcd A.1.1.1.1                                                                     
#>                               - Any Grade -   50 (37.3%)   45 (33.6%)     63 (47.7%)  
#>                               Grade 1-2       50 (37.3%)   45 (33.6%)     63 (47.7%)  
#>                               1               50 (37.3%)   45 (33.6%)     63 (47.7%)  
#>     dcd A.1.1.1.2                                                                     
#>                               - Any Grade -   48 (35.8%)   48 (35.8%)     50 (37.9%)  
#>                               Grade 1-2       48 (35.8%)   48 (35.8%)     50 (37.9%)  
#>                               2               48 (35.8%)   48 (35.8%)     50 (37.9%)