AET01_AESI Table 1 (Default) Adverse Event of Special Interest Summary Table.

AET01_AESI Table 1 (Default) Adverse Event of Special Interest Summary Table.

Usage

aet01_aesi_main(
  adam_db,
  arm_var = "ACTARM",
  lbl_overall = NULL,
  aesi_vars = NULL,
  grade_groups = NULL,
  ...
)

aet01_aesi_pre(adam_db, ...)

aet01_aesi_post(tlg, prune_0 = FALSE, ...)

aet01_aesi

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

aesi_vars

(character) the AESI variables to be included in the summary. Defaults to NA.

grade_groups

(list) the grade groups to be displayed.

...

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

• Does not remove rows with zero counts by default.

Functions

• aet01_aesi_main(): Main TLG function

• aet01_aesi_pre(): Preprocessing

• aet01_aesi_post(): Postprocessing

Note

• adam_db object must contain an adae table with columns "AEOUT", "AEACN", "AECONTRT", "AESER", "AREL", and the column specified by arm_var.

• aesi_vars may contain any/all of the following variables to display: "ALLRESWD", "ALLRESDSM", "ALLRESCONTRT", "NOTRESWD", "NOTRESDSM", "NOTRESCONTRT", "SERWD", "SERDSM", "SERCONTRT", "RELWD", "RELDSM", "RELCONTRT", "RELSER".

• aesi_vars variable prefixes are defined as follows:

  • "ALLRES" = "all non-fatal adverse events resolved"

  • "NOTRES" = "at least one unresolved or ongoing non-fatal adverse event"

  • "SER" = "serious adverse event"

  • "REL" = "related adverse event"

• aesi_vars variable suffixes are defined as follows:

  • "WD" = "patients with study drug withdrawn"

  • "DSM" = "patients with dose modified/interrupted"

  • "CONTRT" = "patients with treatment received"

• Several aesi_vars can be added to the table at once:

  • aesi_vars = "ALL" will include all possible aesi_vars.

  • Including "ALL_XXX" in aesi_vars where XXX is one of the prefixes listed above will include all aesi_vars with that prefix.

Examples

run(aet01_aesi, syn_data)
#>                                                                                   A: Drug X    B: Placebo   C: Combination
#>                                                                                     (N=15)       (N=15)         (N=15)    
#>   ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#>   Total number of patients with at least one AE                                   13 (86.7%)   14 (93.3%)     15 (100%)   
#>   Total number of AEs                                                                 58           59             99      
#>   Total number of patients with at least one AE by worst grade                                                            
#>     Grade 1                                                                           0         1 (6.7%)       1 (6.7%)   
#>     Grade 2                                                                        1 (6.7%)     1 (6.7%)       1 (6.7%)   
#>     Grade 3                                                                        1 (6.7%)    2 (13.3%)       1 (6.7%)   
#>     Grade 4                                                                       3 (20.0%)    2 (13.3%)      2 (13.3%)   
#>     Grade 5 (fatal outcome)                                                       8 (53.3%)    8 (53.3%)      10 (66.7%)  
#>   Total number of patients with study drug withdrawn due to AE                    2 (13.3%)    3 (20.0%)      3 (20.0%)   
#>   Total number of patients with dose modified/interrupted due to AE               6 (40.0%)    9 (60.0%)      11 (73.3%)  
#>   Total number of patients with treatment received for AE                         10 (66.7%)   10 (66.7%)     14 (93.3%)  
#>   Total number of patients with all non-fatal AEs resolved                        9 (60.0%)    10 (66.7%)     12 (80.0%)  
#>   Total number of patients with at least one unresolved or ongoing non-fatal AE   10 (66.7%)   9 (60.0%)      14 (93.3%)  
#>   Total number of patients with at least one serious AE                           12 (80.0%)   12 (80.0%)     11 (73.3%)  
#>   Total number of patients with at least one related AE                           11 (73.3%)   10 (66.7%)     13 (86.7%)