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- "WD" = "patients with study drug withdrawn"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=134)       (N=134)        (N=132)    
#>   ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#>   Total number of patients with at least one AE                                   122 (91.0%)   123 (91.8%)    120 (90.9%)  
#>   Total number of AEs                                                                 609           622            703      
#>   Total number of patients with at least one AE by worst grade                                                              
#>     Grade 1                                                                        7 (5.2%)      9 (6.7%)        4 (3.0%)   
#>     Grade 2                                                                        6 (4.5%)      10 (7.5%)       7 (5.3%)   
#>     Grade 3                                                                       18 (13.4%)    14 (10.4%)      16 (12.1%)  
#>     Grade 4                                                                       15 (11.2%)    20 (14.9%)      18 (13.6%)  
#>     Grade 5 (fatal outcome)                                                       76 (56.7%)    70 (52.2%)      75 (56.8%)  
#>   Total number of patients with study drug withdrawn due to AE                    27 (20.1%)    26 (19.4%)      30 (22.7%)  
#>   Total number of patients with dose modified/interrupted due to AE               66 (49.3%)    76 (56.7%)      74 (56.1%)  
#>   Total number of patients with treatment received for AE                         98 (73.1%)    102 (76.1%)    103 (78.0%)  
#>   Total number of patients with all non-fatal AEs resolved                        84 (62.7%)    92 (68.7%)      97 (73.5%)  
#>   Total number of patients with at least one unresolved or ongoing non-fatal AE   102 (76.1%)   110 (82.1%)    107 (81.1%)  
#>   Total number of patients with at least one serious AE                           104 (77.6%)   101 (75.4%)     99 (75.0%)  
#>   Total number of patients with at least one related AE                           105 (78.4%)   108 (80.6%)    109 (82.6%)