DST01 Table 1 (Default) Patient Disposition Table 1.

The DST01 Disposition Table provides an overview of patients study completion. For patients who discontinued the study a reason is provided.

Usage

dst01_main(
  adam_db,
  arm_var = "ARM",
  lbl_overall = "All {Patient_label}",
  study_status_var = "EOSSTT",
  detail_vars = list(Discontinued = c("DCSREAS")),
  trt_status_var = NULL,
  ...
)

dst01_pre(adam_db, ...)

dst01_post(tlg, prune_0 = TRUE, ...)

dst01

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. Usually one of ARM, ACTARM, TRT01A, or TRT01A.
lbl_overall: (string) label used for overall column, if set to NULL the overall column is omitted
study_status_var: (string) variable used to define patient status. Default is EOSSTT, however can also be a variable name with the pattern EOPxxSTT where xx must be substituted by 2 digits referring to the analysis period.
detail_vars: Named (list) of grouped display of study_status_var. The names must be subset of unique levels of study_status_var.
trt_status_var: (string) variable of treatment status.
...: 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

Default patient disposition table summarizing the reasons for patients withdrawal.
Numbers represent absolute numbers of patients and fraction of N.
Remove zero-count rows.
Split columns by arm.
Include a total column by default.
Sort withdrawal reasons by alphabetic order.

Functions

dst01_main(): Main TLG function
dst01_pre(): Preprocessing
dst01_post(): Postprocessing

Note

adam_db object must contain an adsl table with the columns specified by status_var and disc_reason_var.

Examples

run(dst01, syn_data, detail_vars = list(Ongoing = "STDONS"))
#>               A: Drug X    B: Placebo   C: Combination   All Patients
#>                 (N=15)       (N=15)         (N=15)          (N=45)   
#>   ———————————————————————————————————————————————————————————————————
#>   Completed   10 (66.7%)   10 (66.7%)     10 (66.7%)      30 (66.7%) 

run(dst01, syn_data, detail_vars = list(Discontinued = "DCSREAS", Ongoing = "STDONS"))
#>                                     A: Drug X    B: Placebo   C: Combination   All Patients
#>                                       (N=15)       (N=15)         (N=15)          (N=45)   
#>   —————————————————————————————————————————————————————————————————————————————————————————
#>   Completed                         10 (66.7%)   10 (66.7%)     10 (66.7%)      30 (66.7%) 
#>   Discontinued                      5 (33.3%)    5 (33.3%)      5 (33.3%)       15 (33.3%) 
#>     ADVERSE EVENT                       0            0           1 (6.7%)        1 (2.2%)  
#>     DEATH                           2 (13.3%)    4 (26.7%)      3 (20.0%)       9 (20.0%)  
#>     LACK OF EFFICACY                2 (13.3%)        0              0            2 (4.4%)  
#>     PHYSICIAN DECISION                  0            0           1 (6.7%)        1 (2.2%)  
#>     PROTOCOL VIOLATION                  0         1 (6.7%)          0            1 (2.2%)  
#>     WITHDRAWAL BY PARENT/GUARDIAN    1 (6.7%)        0              0            1 (2.2%)  

run(
  dst01, syn_data,
  detail_vars = list(
    Discontinued = c("DCSREASGP", "DCSREAS"),
    Ongoing = "STDONS"
  )
)
#>                                       A: Drug X    B: Placebo   C: Combination   All Patients
#>                                         (N=15)       (N=15)         (N=15)          (N=45)   
#>   ———————————————————————————————————————————————————————————————————————————————————————————
#>   Completed                           10 (66.7%)   10 (66.7%)     10 (66.7%)      30 (66.7%) 
#>   Discontinued                        5 (33.3%)    5 (33.3%)      5 (33.3%)       15 (33.3%) 
#>     Safety                                                                                   
#>       ADVERSE EVENT                       0            0           1 (6.7%)        1 (2.2%)  
#>       DEATH                           2 (13.3%)    4 (26.7%)      3 (20.0%)       9 (20.0%)  
#>     Non-Safety                                                                               
#>       LACK OF EFFICACY                2 (13.3%)        0              0            2 (4.4%)  
#>       PHYSICIAN DECISION                  0            0           1 (6.7%)        1 (2.2%)  
#>       PROTOCOL VIOLATION                  0         1 (6.7%)          0            1 (2.2%)  
#>       WITHDRAWAL BY PARENT/GUARDIAN    1 (6.7%)        0              0            1 (2.2%)