AET05_ALL Table 1 (Default) Adverse Event Rate Adjusted for Patient-Years at Risk - All Occurrences.

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, ...)

aet05_all

Format

An object of class chevron_t of length 1.

Arguments

adam_db

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

...

not used.

Functions

• aet05_all_pre(): Preprocessing

Examples

library(dplyr)
library(dunlin)

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

run(aet05_all, proc_data)
#>                                                   A: Drug X         B: Placebo       C: Combination 
#>                                                    (N=134)           (N=134)            (N=132)     
#>   ——————————————————————————————————————————————————————————————————————————————————————————————————
#>   Number of occurrences of any adverse event                                                        
#>     Total patient-years at risk                     337.9             331.8              341.6      
#>     Number of adverse events observed                343               380                397       
#>     AE rate per 100 patient-years                  101.51             114.52             116.22     
#>     95% CI                                     (90.77, 112.26)   (103.00, 126.03)   (104.79, 127.66)

run(aet05_all, proc_data, conf_level = 0.90, conf_type = "exact")
#>                                                   A: Drug X         B: Placebo       C: Combination 
#>                                                    (N=134)           (N=134)            (N=132)     
#>   ——————————————————————————————————————————————————————————————————————————————————————————————————
#>   Number of occurrences of any adverse event                                                        
#>     Total patient-years at risk                     337.9             331.8              341.6      
#>     Number of adverse events observed                343               380                397       
#>     AE rate per 100 patient-years                  101.51             114.52             116.22     
#>     90% CI                                     (92.67, 111.00)   (105.03, 124.66)   (106.80, 126.29)