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AET01 Table 1 (Default) Overview of Deaths and Adverse Events Summary Table 1.

Source: R/aet01.R
aet01.Rd

AET01 Table 1 (Default) Overview of Deaths and Adverse Events Summary Table 1.

Usage

aet01_main(
  adam_db,
  arm_var = "ACTARM",
  lbl_overall = NULL,
  anl_vars = list(safety_var = c("FATAL", "SER", "SERWD", "SERDSM", "RELSER", "WD",
    "DSM", "REL", "RELWD", "RELDSM", "SEV")),
  anl_lbls = "Total number of {patient_label} with at least one",
  show_wd = TRUE,
  ...
)

aet01_pre(adam_db, ...)

aet01_post(tlg, prune_0 = FALSE, ...)

aet01

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

anl_vars

Named (list) of (character) variables the safety variables to be summarized.

anl_lbls

(character) of analysis labels.

show_wd

(flag) whether to display the number of patients withdrawn from study due to an adverse event and the number of death.

...

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_main(): Main TLG function

  • aet01_pre(): Preprocessing

  • aet01_post(): Postprocessing

Note

  • adam_db object must contain an adsl table with the "DTHFL" and "DCSREAS" columns.

  • adam_db object must contain an adae table with the columns passed to anl_vars.

Examples

run(aet01, syn_data, arm_var = "ARM")
#>                                                                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 deaths                                       2 (13.3%)    4 (26.7%)      3 (20.0%)   
#>   Total number of patients withdrawn from study due to an AE       0            0           1 (6.7%)   
#>   Total number of patients with at least one                                                           
#>     AE with fatal outcome                                      8 (53.3%)    8 (53.3%)      10 (66.7%)  
#>     Serious AE                                                 12 (80.0%)   12 (80.0%)     11 (73.3%)  
#>     Serious AE leading to withdrawal from treatment                0            0          2 (13.3%)   
#>     Serious AE leading to dose modification/interruption       4 (26.7%)    3 (20.0%)      4 (26.7%)   
#>     Related Serious AE                                         8 (53.3%)    8 (53.3%)      10 (66.7%)  
#>     AE leading to withdrawal from treatment                    2 (13.3%)    3 (20.0%)      3 (20.0%)   
#>     AE leading to dose modification/interruption               6 (40.0%)    9 (60.0%)      11 (73.3%)  
#>     Related AE                                                 11 (73.3%)   10 (66.7%)     13 (86.7%)  
#>     Related AE leading to withdrawal from treatment                0        3 (20.0%)          0       
#>     Related AE leading to dose modification/interruption        1 (6.7%)    4 (26.7%)      9 (60.0%)   
#>     Severe AE (at greatest intensity)                          11 (73.3%)   10 (66.7%)     12 (80.0%)