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The EGT05_QTCAT table summarizes several electrocardiogram parameters and their evolution throughout the study.

Usage

egt05_qtcat_main(
  adam_db,
  arm_var = "ACTARM",
  lbl_overall = NULL,
  summaryvars = c("AVALCAT1", "CHGCAT1"),
  row_split_var = NULL,
  visitvar = "AVISIT",
  page_var = NULL,
  ...
)

egt05_qtcat_pre(adam_db, ...)

egt05_qtcat_post(tlg, prune_0 = TRUE, ...)

egt05_qtcat

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

summaryvars

(character) variables to be analyzed. The label attribute of the corresponding column in adeg table of adam_db is used as name.

row_split_var

(character) additional row split variables.

visitvar

(string) typically "AVISIT" or user-defined visit incorporating "ATPT".

page_var

(string) variable name prior to which the row split is by page.

...

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

  • The Value at Visit column, displays the categories of the specific "PARAMCD" value for patients.

  • The Change from Baseline column, displays the categories of the specific "PARAMCD" value change from baseline for patients.

  • Remove zero-count rows unless overridden with prune_0 = FALSE.

  • Split columns by arm, typically "ACTARM".

  • Does not include a total column by default.

  • Sorted based on factor level; by chronological time point given by "AVISIT" or user-defined visit incorporating "ATPT". Re-level to customize order.

  • Please note that it is preferable to convert summaryvars to factor.

Functions

  • egt05_qtcat_main(): Main TLG function

  • egt05_qtcat_pre(): Preprocessing

  • egt05_qtcat_post(): Postprocessing

Note

  • adam_db object must contain an adeg table with column specified in visitvar. For summaryvars, please make sure AVALCAT1 and CHGCAT1 columns existed in input data sets.

Examples

run(egt05_qtcat, syn_data)
#>   Parameter                                                          
#>     Analysis Visit           A: Drug X    B: Placebo   C: Combination
#>       Category                 (N=15)       (N=15)         (N=15)    
#>   ———————————————————————————————————————————————————————————————————
#>   QT Duration                                                        
#>     BASELINE                                                         
#>       Value at Visit                                                 
#>         n                        15           15             15      
#>         <=450 msec           13 (86.7%)   15 (100%)      13 (86.7%)  
#>         >450 to <=480 msec    1 (6.7%)        0              0       
#>         >480 to <=500 msec       0            0           1 (6.7%)   
#>         >500 msec             1 (6.7%)        0           1 (6.7%)   
#>     WEEK 1 DAY 8                                                     
#>       Value at Visit                                                 
#>         n                        15           15             15      
#>         <=450 msec           12 (80.0%)   9 (60.0%)      13 (86.7%)  
#>         >450 to <=480 msec    1 (6.7%)     1 (6.7%)       1 (6.7%)   
#>         >480 to <=500 msec    1 (6.7%)    3 (20.0%)       1 (6.7%)   
#>         >500 msec             1 (6.7%)    2 (13.3%)          0       
#>       Change from Baseline                                           
#>         n                        15           15             15      
#>         <=30 msec            7 (46.7%)    6 (40.0%)      9 (60.0%)   
#>         >30 to <=60 msec     2 (13.3%)     1 (6.7%)       1 (6.7%)   
#>         >60 msec             6 (40.0%)    8 (53.3%)      5 (33.3%)   
#>     WEEK 2 DAY 15                                                    
#>       Value at Visit                                                 
#>         n                        15           15             15      
#>         <=450 msec           11 (73.3%)   14 (93.3%)     12 (80.0%)  
#>         >450 to <=480 msec   2 (13.3%)        0          2 (13.3%)   
#>         >480 to <=500 msec    1 (6.7%)        0           1 (6.7%)   
#>         >500 msec             1 (6.7%)     1 (6.7%)          0       
#>       Change from Baseline                                           
#>         n                        15           15             15      
#>         <=30 msec            9 (60.0%)    12 (80.0%)     7 (46.7%)   
#>         >30 to <=60 msec     2 (13.3%)        0          3 (20.0%)   
#>         >60 msec             4 (26.7%)    3 (20.0%)      5 (33.3%)   
#>     WEEK 3 DAY 22                                                    
#>       Value at Visit                                                 
#>         n                        15           15             15      
#>         <=450 msec           12 (80.0%)   12 (80.0%)     12 (80.0%)  
#>         >450 to <=480 msec   3 (20.0%)     1 (6.7%)       1 (6.7%)   
#>         >500 msec                0        2 (13.3%)      2 (13.3%)   
#>       Change from Baseline                                           
#>         n                        15           15             15      
#>         <=30 msec            9 (60.0%)    11 (73.3%)     9 (60.0%)   
#>         >30 to <=60 msec      1 (6.7%)     1 (6.7%)          0       
#>         >60 msec             5 (33.3%)    3 (20.0%)      6 (40.0%)   
#>     WEEK 4 DAY 29                                                    
#>       Value at Visit                                                 
#>         n                        15           15             15      
#>         <=450 msec           14 (93.3%)   12 (80.0%)     13 (86.7%)  
#>         >450 to <=480 msec    1 (6.7%)     1 (6.7%)       1 (6.7%)   
#>         >480 to <=500 msec       0            0           1 (6.7%)   
#>         >500 msec                0        2 (13.3%)          0       
#>       Change from Baseline                                           
#>         n                        15           15             15      
#>         <=30 msec            6 (40.0%)    9 (60.0%)      9 (60.0%)   
#>         >30 to <=60 msec     2 (13.3%)     1 (6.7%)      2 (13.3%)   
#>         >60 msec             7 (46.7%)    5 (33.3%)      4 (26.7%)   
#>     WEEK 5 DAY 36                                                    
#>       Value at Visit                                                 
#>         n                        15           15             15      
#>         <=450 msec           12 (80.0%)   15 (100%)      15 (100%)   
#>         >450 to <=480 msec   2 (13.3%)        0              0       
#>         >500 msec             1 (6.7%)        0              0       
#>       Change from Baseline                                           
#>         n                        15           15             15      
#>         <=30 msec            9 (60.0%)    11 (73.3%)     9 (60.0%)   
#>         >30 to <=60 msec         0        3 (20.0%)      2 (13.3%)   
#>         >60 msec             6 (40.0%)     1 (6.7%)      4 (26.7%)