Skip to contents

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",
  ...
)

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.

...

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   Total number of patients withdrawn from study due to an AE       0            0           1 (6.7%)   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%)