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The AET05_ALL table produces the standard adverse event rate adjusted for patient-years at risk summary considering all occurrences.

Usage

aet05_all_pre(adam_db, dataset = "adsaftte", ...)

aet05_all

Format

An object of class chevron_t of length 1.

Arguments

adam_db

(list of data.frames) object containing the ADaM datasets

dataset

(string) the name of a table in the adam_db object.

...

not used.

Value

the preprocessing function returns a list of data.frame.

Functions

  • aet05_all_pre(): Preprocessing

Examples

library(dplyr)
library(dunlin)

proc_data <- log_filter(syn_data, PARAMCD == "AETOT1" | PARAMCD == "AEREPTTE", "adsaftte")

run(aet05_all, proc_data)
#>                                                  A: Drug X        B: Placebo      C: Combination 
#>                                                    (N=15)           (N=15)            (N=15)     
#>   ———————————————————————————————————————————————————————————————————————————————————————————————
#>   Number of occurrences of any adverse event                                                     
#>     Total patient-years at risk                     44.4             44.2              44.4      
#>     Number of adverse events observed                29               49                56       
#>     AE rate per 100 patient-years                  65.32            110.78            126.16     
#>     95% CI                                     (41.55, 89.09)   (79.76, 141.79)   (93.12, 159.20)

run(aet05_all, proc_data, conf_level = 0.90, conf_type = "exact")
#>                                                  A: Drug X        B: Placebo      C: Combination 
#>                                                    (N=15)           (N=15)            (N=15)     
#>   ———————————————————————————————————————————————————————————————————————————————————————————————
#>   Number of occurrences of any adverse event                                                     
#>     Total patient-years at risk                     44.4             44.2              44.4      
#>     Number of adverse events observed                29               49                56       
#>     AE rate per 100 patient-years                  65.32            110.78            126.16     
#>     90% CI                                     (46.73, 89.06)   (86.09, 140.55)   (99.77, 157.61)