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

Source: R/aet02.R
aet02.Rd

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=134)       (N=134)        (N=132)    
#>   ———————————————————————————————————————————————————————————————————————————————————————————————————————
#>   Total number of patients with at least one adverse event     122 (91.0%)   123 (91.8%)    120 (90.9%)  
#>   Overall total number of events                                   609           622            703      
#>   cl A.1                                                                                                 
#>     Total number of patients with at least one adverse event   78 (58.2%)    75 (56.0%)      89 (67.4%)  
#>     Total number of events                                         132           130            160      
#>     dcd A.1.1.1.1                                              50 (37.3%)    45 (33.6%)      63 (47.7%)  
#>     dcd A.1.1.1.2                                              48 (35.8%)    48 (35.8%)      50 (37.9%)  
#>   cl B.2                                                                                                 
#>     Total number of patients with at least one adverse event   79 (59.0%)    74 (55.2%)      85 (64.4%)  
#>     Total number of events                                         129           138            143      
#>     dcd B.2.2.3.1                                              48 (35.8%)    54 (40.3%)      51 (38.6%)  
#>     dcd B.2.1.2.1                                              49 (36.6%)    44 (32.8%)      52 (39.4%)  
#>   cl D.1                                                                                                 
#>     Total number of patients with at least one adverse event   79 (59.0%)    67 (50.0%)      80 (60.6%)  
#>     Total number of events                                         127           106            135      
#>     dcd D.1.1.1.1                                              50 (37.3%)    42 (31.3%)      51 (38.6%)  
#>     dcd D.1.1.4.2                                              48 (35.8%)    42 (31.3%)      50 (37.9%)  
#>   cl D.2                                                                                                 
#>     Total number of patients with at least one adverse event   47 (35.1%)    58 (43.3%)      57 (43.2%)  
#>     Total number of events                                         62            72              74      
#>     dcd D.2.1.5.3                                              47 (35.1%)    58 (43.3%)      57 (43.2%)  
#>   cl B.1                                                                                                 
#>     Total number of patients with at least one adverse event   47 (35.1%)    49 (36.6%)      43 (32.6%)  
#>     Total number of events                                         56            60              62      
#>     dcd B.1.1.1.1                                              47 (35.1%)    49 (36.6%)      43 (32.6%)  
#>   cl C.2                                                                                                 
#>     Total number of patients with at least one adverse event   35 (26.1%)    48 (35.8%)      55 (41.7%)  
#>     Total number of events                                         48            53              65      
#>     dcd C.2.1.2.1                                              35 (26.1%)    48 (35.8%)      55 (41.7%)  
#>   cl C.1                                                                                                 
#>     Total number of patients with at least one adverse event   43 (32.1%)    46 (34.3%)      43 (32.6%)  
#>     Total number of events                                         55            63              64      
#>     dcd C.1.1.1.3                                              43 (32.1%)    46 (34.3%)      43 (32.6%)