AET02 Table 1 (Default) Adverse Events by System Organ Class and Preferred Term Table 1.

The AET02 table provides an overview of the number of subjects experiencing adverse events and the number of advert events categorized by Body System and Dictionary-Derived Term.

Usage

aet02_label

aet02_main(
  adam_db,
  arm_var = "ACTARM",
  row_split_var = "AEBODSYS",
  lbl_overall = NULL,
  summary_labels = list(all = aet02_label, TOTAL = c(nonunique =
    "Overall total number of events")),
  ...
)

aet02_pre(adam_db, row_split_var = "AEBODSYS", ...)

aet02_post(tlg, row_split_var = "AEBODSYS", prune_0 = TRUE, ...)

aet02

Format

An object of class character of length 2.

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
row_split_var: (character) additional row split variables.
lbl_overall: (string) label used for overall column, if set to NULL the overall column is omitted
summary_labels: (list) of summarize labels. See details.
...: 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 subject and fraction of N, or absolute number of event when specified.
Remove zero-count rows unless overridden with prune_0 = FALSE.
Split columns by arm.
Does not include a total column by default.
Sort Dictionary-Derived Code (AEDECOD) by highest overall frequencies.
Missing values in AEBODSYS, and AEDECOD are labeled by No Coding Available. summary_labels is used to control the summary for each level. If "all" is used, then each split will have that summary statistic with the labels. One special case is "TOTAL", this is for the overall population.

Functions

aet02_label: Default labels
aet02_main(): Main TLG function
aet02_pre(): Preprocessing
aet02_post(): Postprocessing

Note

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

Examples

run(aet02, syn_data)
#>   MedDRA System Organ Class                                    A: Drug X    B: Placebo   C: Combination
#>     MedDRA Preferred Term                                        (N=15)       (N=15)         (N=15)    
#>   —————————————————————————————————————————————————————————————————————————————————————————————————————
#>   Total number of patients with at least one adverse event     13 (86.7%)   14 (93.3%)     15 (100%)   
#>   Overall total number of events                                   58           59             99      
#>   cl B.2                                                                                               
#>     Total number of patients with at least one adverse event   11 (73.3%)   8 (53.3%)      10 (66.7%)  
#>     Total number of events                                         18           15             20      
#>     dcd B.2.2.3.1                                              8 (53.3%)    6 (40.0%)      7 (46.7%)   
#>     dcd B.2.1.2.1                                              5 (33.3%)    6 (40.0%)      5 (33.3%)   
#>   cl D.1                                                                                               
#>     Total number of patients with at least one adverse event   9 (60.0%)    5 (33.3%)      11 (73.3%)  
#>     Total number of events                                         13           9              19      
#>     dcd D.1.1.1.1                                              4 (26.7%)    4 (26.7%)      7 (46.7%)   
#>     dcd D.1.1.4.2                                              6 (40.0%)    2 (13.3%)      7 (46.7%)   
#>   cl A.1                                                                                               
#>     Total number of patients with at least one adverse event   7 (46.7%)    6 (40.0%)      10 (66.7%)  
#>     Total number of events                                         8            11             16      
#>     dcd A.1.1.1.2                                              5 (33.3%)    6 (40.0%)      6 (40.0%)   
#>     dcd A.1.1.1.1                                              3 (20.0%)     1 (6.7%)      6 (40.0%)   
#>   cl B.1                                                                                               
#>     Total number of patients with at least one adverse event   5 (33.3%)    6 (40.0%)      8 (53.3%)   
#>     Total number of events                                         6            6              12      
#>     dcd B.1.1.1.1                                              5 (33.3%)    6 (40.0%)      8 (53.3%)   
#>   cl C.2                                                                                               
#>     Total number of patients with at least one adverse event   6 (40.0%)    4 (26.7%)      8 (53.3%)   
#>     Total number of events                                         6            4              12      
#>     dcd C.2.1.2.1                                              6 (40.0%)    4 (26.7%)      8 (53.3%)   
#>   cl D.2                                                                                               
#>     Total number of patients with at least one adverse event   2 (13.3%)    5 (33.3%)      7 (46.7%)   
#>     Total number of events                                         3            5              10      
#>     dcd D.2.1.5.3                                              2 (13.3%)    5 (33.3%)      7 (46.7%)   
#>   cl C.1                                                                                               
#>     Total number of patients with at least one adverse event   4 (26.7%)    4 (26.7%)      5 (33.3%)   
#>     Total number of events                                         4            9              10      
#>     dcd C.1.1.1.3                                              4 (26.7%)    4 (26.7%)      5 (33.3%)