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TTET01 template may be used to summarize any binary outcome or response variable at a single time point. Typical application for oncology

Usage

ttet01_main(
  adam_db,
  dataset = "adtte",
  arm_var = "ARM",
  ref_group = NULL,
  summarize_event = TRUE,
  perform_analysis = "unstrat",
  strata = NULL,
  ...
)

ttet01_pre(adam_db, dataset = "adtte", ...)

ttet01_post(tlg, prune_0 = TRUE, ...)

ttet01

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.

arm_var

(string) variable used for column splitting

ref_group

(string) The name of the reference group, the value should be identical to the values in arm_var, if not specified, it will by default use the first level or value of arm_var.

summarize_event

(flag) should the event description be displayed, default is TRUE

perform_analysis

(string) option to display statistical comparisons using stratified analyses, or unstratified analyses, or both, e.g. c("unstrat", "strat"). Only unstratified will be displayed by default

strata

(string) stratification factors, e.g. strata = c("STRATA1", "STRATA2"), by default as NULL

...

Further arguments passed to control_surv_time(), control_coxph(), control_survtp(), and surv_timepoint(). For details, see the documentation in tern. Commonly used arguments include pval_method, conf_level, conf_type, quantiles, ties, time_point, method, etc.

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

  • No overall value.

Functions

  • ttet01_main(): Main TLG function

  • ttet01_pre(): Preprocessing

  • ttet01_post(): Postprocessing

Examples

library(dplyr)
library(dunlin)

proc_data <- log_filter(syn_data, PARAMCD == "PFS", "adtte")
run(ttet01, proc_data)
#>                                        A: Drug X        B: Placebo      C: Combination 
#>                                         (N=134)           (N=134)           (N=132)    
#>   —————————————————————————————————————————————————————————————————————————————————————
#>   Patients with event (%)             86 (64.2%)        90 (67.2%)        92 (69.7%)   
#>     Earliest contributing event                                                        
#>       Death                               38                48                41       
#>       Disease Progression                 48                42                51       
#>   Patients without event (%)          48 (35.8%)        44 (32.8%)        40 (30.3%)   
#>   Time to Event (MONTHS)                                                               
#>     Median                               16.9              19.7              12.3      
#>       95% CI                         (12.8, 19.0)      (13.3, 25.2)       (8.4, 14.9)  
#>     25% and 75%-ile                    7.7, 30.0         7.2, 34.1         4.5, 25.3   
#>     Range                           0.3 to 85.8 {1}   0.1 to 83.0 {2}   0.2 to 81.8 {2}
#>   Unstratified Analysis                                                                
#>     p-value (log-rank)                                    0.4808            0.0429     
#>     Hazard Ratio                                           0.90              1.36      
#>     95% CI                                             (0.67, 1.21)      (1.01, 1.82)  
#>   6 MONTHS                                                                             
#>     Patients remaining at risk            87                92                77       
#>     Event Free Rate (%)                  77.27             77.85             67.70     
#>     95% CI                          (69.83, 84.71)    (70.59, 85.10)    (59.42, 75.99) 
#>     Difference in Event Free Rate                          0.57              -9.57     
#>       95% CI                                          (-9.82, 10.97)    (-20.70, 1.57) 
#>       p-value (Z-test)                                    0.9137            0.0921     
#>   12 MONTHS                                                                            
#>     Patients remaining at risk            65                68                51       
#>     Event Free Rate (%)                  62.83             62.69             50.16     
#>     95% CI                          (54.04, 71.63)    (53.97, 71.42)    (41.00, 59.32) 
#>     Difference in Event Free Rate                          -0.14            -12.68     
#>       95% CI                                          (-12.53, 12.25)   (-25.38, 0.03) 
#>       p-value (Z-test)                                    0.9822            0.0505     
#>   —————————————————————————————————————————————————————————————————————————————————————
#> 
#>   {1} - Censored observation: range minimum
#>   {2} - Censored observation: range maximum
#>   —————————————————————————————————————————————————————————————————————————————————————
#> 

run(ttet01, proc_data,
  summarize_event = FALSE, perform_analysis = c("unstrat", "strat"),
  strata = c("STRATA1", "STRATA2"),
  conf_type = "log-log",
  time_point = c(6, 12),
  method = "both"
)
#>                                        A: Drug X        B: Placebo      C: Combination 
#>                                         (N=134)           (N=134)           (N=132)    
#>   —————————————————————————————————————————————————————————————————————————————————————
#>   Patients with event (%)             86 (64.2%)        90 (67.2%)        92 (69.7%)   
#>   Patients without event (%)          48 (35.8%)        44 (32.8%)        40 (30.3%)   
#>   Time to Event (MONTHS)                                                               
#>     Median                               16.9              19.7              12.3      
#>       95% CI                         (12.8, 19.0)      (13.2, 25.2)       (8.4, 14.9)  
#>     25% and 75%-ile                    7.7, 30.0         7.2, 34.1         4.5, 25.3   
#>     Range                           0.3 to 85.8 {1}   0.1 to 83.0 {2}   0.2 to 81.8 {2}
#>   Unstratified Analysis                                                                
#>     p-value (log-rank)                                    0.4808            0.0429     
#>     Hazard Ratio                                           0.90              1.36      
#>     95% CI                                             (0.67, 1.21)      (1.01, 1.82)  
#>   Stratified Analysis                                                                  
#>     p-value (log-rank)                                    0.8068            0.0252     
#>     Hazard Ratio                                           0.96              1.42      
#>     95% CI                                             (0.71, 1.31)      (1.04, 1.92)  
#>   6 MONTHS                                                                             
#>     Patients remaining at risk            87                92                77       
#>     Event Free Rate (%)                  77.27             77.85             67.70     
#>     95% CI                          (68.76, 83.74)    (69.53, 84.15)    (58.64, 75.20) 
#>     Difference in Event Free Rate                          0.57              -9.57     
#>       95% CI                                          (-9.82, 10.97)    (-20.70, 1.57) 
#>       p-value (Z-test)                                    0.9137            0.0921     
#>   12 MONTHS                                                                            
#>     Patients remaining at risk            65                68                51       
#>     Event Free Rate (%)                  62.83             62.69             50.16     
#>     95% CI                          (53.36, 70.91)    (53.31, 70.71)    (40.69, 58.89) 
#>     Difference in Event Free Rate                          -0.14            -12.68     
#>       95% CI                                          (-12.53, 12.25)   (-25.38, 0.03) 
#>       p-value (Z-test)                                    0.9822            0.0505     
#>   —————————————————————————————————————————————————————————————————————————————————————
#> 
#>   {1} - Censored observation: range minimum
#>   {2} - Censored observation: range maximum
#>   —————————————————————————————————————————————————————————————————————————————————————
#>