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The EGT05_QTCAT table 1 summarizes several electrocardiogram parameters and their evolution throughout the study.

Usage

egt05_qtcat_1_main(
  adam_db,
  arm_var = "ACTARM",
  summaryvars = list(`Value at Visit` = "AVALCAT1", `Change from Baseline` = "CHGCAT1"),
  summaryvars_lbls = get_labels(adam_db$adeg, summaryvars),
  lbl_overall = NULL,
  visitvar = "AVISIT",
  lbl_avisit = var_labels_for(adam_db$adeg, visitvar),
  paramvar = "QT",
  lbl_param = var_labels_for(adam_db$adeg, "PARAM"),
  deco = std_deco("EGT05_QTCAT"),
  lbl_cat = "Category",
  lbl_headvisit = "Analysis Visit",
  ...
)

egt05_qtcat_1_lyt(
  arm_var,
  summaryvars,
  summaryvars_lbls,
  lbl_overall,
  visitvar,
  lbl_avisit,
  lbl_param,
  deco,
  lbl_cat,
  lbl_headvisit
)

egt05_qtcat_1_pre(adam_db, ...)

egt05_qtcat_1_post(tlg, prune_0 = TRUE, ...)

egt05_qtcat_1

Format

An object of class chevron_t of length 1.

Arguments

adam_db

(dm) object containing the ADaM datasets

arm_var

(string) variable used for column splitting

summaryvars

(character) the variables to be analyzed. AVALCAT1 and CHGCAT1 by default.

summaryvars_lbls

(character) the label of the variables to be analyzed.

lbl_overall

(string) label used for overall column, if set to NULL the overall column is omitted

visitvar

(string) typically one of "AVISIT" (Default) or "ATPTN" depending on the type of time point to be displayed.

lbl_avisit

(string) label of the visitvar variable.

paramvar

(string) typically "QT" (Default). It should come from "PARAMCD".

lbl_param

(string) label of the PARAM variable.

deco

(character) decoration with title, subtitles and main_footer content

lbl_cat

(string) label of the Category of summaryvars variable. Default as Category.

lbl_headvisit

(string) label of Visits in the header. Default as Analysis Visit.

...

not used.

tlg

(TableTree, Listing or ggplot) object typically produced by a main function.

prune_0

(flag) remove 0 count rows

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 one of "AVISIT" (Default) or "ATPTN". Re-level to customize order.

Functions

  • egt05_qtcat_1_main(): Main TLG function

  • egt05_qtcat_1_lyt(): Layout

  • egt05_qtcat_1_pre(): Preprocessing

  • egt05_qtcat_1_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

db <- syn_data
run(egt05_qtcat_1, db)
#>   Parameter                                                              
#>     Analysis Visit              A: Drug X    B: Placebo    C: Combination
#>       Category                   (N=134)       (N=134)        (N=132)    
#>   ———————————————————————————————————————————————————————————————————————
#>   QT Duration                                                            
#>     BASELINE                                                             
#>       Value at Visit                                                     
#>         n                          134           134            132      
#>         <=450 msec             115 (85.8%)   117 (87.3%)    104 (78.8%)  
#>         >450 to <=480 msec      6 (4.5%)      10 (7.5%)       9 (6.8%)   
#>         >480 to <=500 msec       4 (3%)       3 (2.2%)        6 (4.5%)   
#>         >500 msec               9 (6.7%)       4 (3%)        13 (9.8%)   
#>     WEEK 1 DAY 8                                                         
#>       Value at Visit                                                     
#>         n                          134           134            132      
#>         <=450 msec             113 (84.3%)   106 (79.1%)    106 (80.3%)  
#>         >450 to <=480 msec      10 (7.5%)     10 (7.5%)      11 (8.3%)   
#>         >480 to <=500 msec       4 (3%)        4 (3%)         3 (2.3%)   
#>         >500 msec               7 (5.2%)     14 (10.4%)      12 (9.1%)   
#>       Change from Baseline                                               
#>         n                          134           134            132      
#>         <=30 msec              76 (56.7%)     75 (56%)       75 (56.8%)  
#>         >30 to <=60 msec        7 (5.2%)      13 (9.7%)      11 (8.3%)   
#>         >60 msec               51 (38.1%)    46 (34.3%)      46 (34.8%)  
#>     WEEK 2 DAY 15                                                        
#>       Value at Visit                                                     
#>         n                          134           134            132      
#>         <=450 msec             111 (82.8%)   114 (85.1%)    112 (84.8%)  
#>         >450 to <=480 msec      10 (7.5%)     9 (6.7%)        9 (6.8%)   
#>         >480 to <=500 msec      7 (5.2%)      2 (1.5%)        5 (3.8%)   
#>         >500 msec               6 (4.5%)      9 (6.7%)        6 (4.5%)   
#>       Change from Baseline                                               
#>         n                          134           134            132      
#>         <=30 msec               71 (53%)     87 (64.9%)      89 (67.4%)  
#>         >30 to <=60 msec        11 (8.2%)     9 (6.7%)        9 (6.8%)   
#>         >60 msec               52 (38.8%)    38 (28.4%)      34 (25.8%)  
#>     WEEK 3 DAY 22                                                        
#>       Value at Visit                                                     
#>         n                          134           134            132      
#>         <=450 msec             106 (79.1%)   112 (83.6%)    118 (89.4%)  
#>         >450 to <=480 msec      13 (9.7%)     7 (5.2%)        3 (2.3%)   
#>         >480 to <=500 msec       4 (3%)       5 (3.7%)        2 (1.5%)   
#>         >500 msec               11 (8.2%)     10 (7.5%)       9 (6.8%)   
#>       Change from Baseline                                               
#>         n                          134           134            132      
#>         <=30 msec               63 (47%)     80 (59.7%)      81 (61.4%)  
#>         >30 to <=60 msec       14 (10.4%)      8 (6%)        11 (8.3%)   
#>         >60 msec               57 (42.5%)    46 (34.3%)      40 (30.3%)  
#>     WEEK 4 DAY 29                                                        
#>       Value at Visit                                                     
#>         n                          134           134            132      
#>         <=450 msec             117 (87.3%)   103 (76.9%)    114 (86.4%)  
#>         >450 to <=480 msec      7 (5.2%)     14 (10.4%)       6 (4.5%)   
#>         >480 to <=500 msec       4 (3%)       7 (5.2%)        3 (2.3%)   
#>         >500 msec               6 (4.5%)      10 (7.5%)       9 (6.8%)   
#>       Change from Baseline                                               
#>         n                          134           134            132      
#>         <=30 msec               79 (59%)     80 (59.7%)      79 (59.8%)  
#>         >30 to <=60 msec        11 (8.2%)     7 (5.2%)       10 (7.6%)   
#>         >60 msec               44 (32.8%)    47 (35.1%)      43 (32.6%)  
#>     WEEK 5 DAY 36                                                        
#>       Value at Visit                                                     
#>         n                          134           134            132      
#>         <=450 msec             107 (79.9%)   117 (87.3%)    112 (84.8%)  
#>         >450 to <=480 msec     16 (11.9%)     5 (3.7%)       13 (9.8%)   
#>         >480 to <=500 msec      5 (3.7%)      9 (6.7%)        3 (2.3%)   
#>         >500 msec               6 (4.5%)      3 (2.2%)         4 (3%)    
#>       Change from Baseline                                               
#>         n                          134           134            132      
#>         <=30 msec              72 (53.7%)    82 (61.2%)      73 (55.3%)  
#>         >30 to <=60 msec        10 (7.5%)     11 (8.2%)      11 (8.3%)   
#>         >60 msec               52 (38.8%)    41 (30.6%)      48 (36.4%)  
run(egt05_qtcat_1, db, summaryvars = list("AVALCAT1", "Change" = "CHGCAT1"))
#>   Parameter                                                              
#>     Analysis Visit              A: Drug X    B: Placebo    C: Combination
#>       Category                   (N=134)       (N=134)        (N=132)    
#>   ———————————————————————————————————————————————————————————————————————
#>   QT Duration                                                            
#>     BASELINE                                                             
#>       AVALCAT1                                                           
#>         n                          134           134            132      
#>         <=450 msec             115 (85.8%)   117 (87.3%)    104 (78.8%)  
#>         >450 to <=480 msec      6 (4.5%)      10 (7.5%)       9 (6.8%)   
#>         >480 to <=500 msec       4 (3%)       3 (2.2%)        6 (4.5%)   
#>         >500 msec               9 (6.7%)       4 (3%)        13 (9.8%)   
#>     WEEK 1 DAY 8                                                         
#>       AVALCAT1                                                           
#>         n                          134           134            132      
#>         <=450 msec             113 (84.3%)   106 (79.1%)    106 (80.3%)  
#>         >450 to <=480 msec      10 (7.5%)     10 (7.5%)      11 (8.3%)   
#>         >480 to <=500 msec       4 (3%)        4 (3%)         3 (2.3%)   
#>         >500 msec               7 (5.2%)     14 (10.4%)      12 (9.1%)   
#>       Change                                                             
#>         n                          134           134            132      
#>         <=30 msec              76 (56.7%)     75 (56%)       75 (56.8%)  
#>         >30 to <=60 msec        7 (5.2%)      13 (9.7%)      11 (8.3%)   
#>         >60 msec               51 (38.1%)    46 (34.3%)      46 (34.8%)  
#>     WEEK 2 DAY 15                                                        
#>       AVALCAT1                                                           
#>         n                          134           134            132      
#>         <=450 msec             111 (82.8%)   114 (85.1%)    112 (84.8%)  
#>         >450 to <=480 msec      10 (7.5%)     9 (6.7%)        9 (6.8%)   
#>         >480 to <=500 msec      7 (5.2%)      2 (1.5%)        5 (3.8%)   
#>         >500 msec               6 (4.5%)      9 (6.7%)        6 (4.5%)   
#>       Change                                                             
#>         n                          134           134            132      
#>         <=30 msec               71 (53%)     87 (64.9%)      89 (67.4%)  
#>         >30 to <=60 msec        11 (8.2%)     9 (6.7%)        9 (6.8%)   
#>         >60 msec               52 (38.8%)    38 (28.4%)      34 (25.8%)  
#>     WEEK 3 DAY 22                                                        
#>       AVALCAT1                                                           
#>         n                          134           134            132      
#>         <=450 msec             106 (79.1%)   112 (83.6%)    118 (89.4%)  
#>         >450 to <=480 msec      13 (9.7%)     7 (5.2%)        3 (2.3%)   
#>         >480 to <=500 msec       4 (3%)       5 (3.7%)        2 (1.5%)   
#>         >500 msec               11 (8.2%)     10 (7.5%)       9 (6.8%)   
#>       Change                                                             
#>         n                          134           134            132      
#>         <=30 msec               63 (47%)     80 (59.7%)      81 (61.4%)  
#>         >30 to <=60 msec       14 (10.4%)      8 (6%)        11 (8.3%)   
#>         >60 msec               57 (42.5%)    46 (34.3%)      40 (30.3%)  
#>     WEEK 4 DAY 29                                                        
#>       AVALCAT1                                                           
#>         n                          134           134            132      
#>         <=450 msec             117 (87.3%)   103 (76.9%)    114 (86.4%)  
#>         >450 to <=480 msec      7 (5.2%)     14 (10.4%)       6 (4.5%)   
#>         >480 to <=500 msec       4 (3%)       7 (5.2%)        3 (2.3%)   
#>         >500 msec               6 (4.5%)      10 (7.5%)       9 (6.8%)   
#>       Change                                                             
#>         n                          134           134            132      
#>         <=30 msec               79 (59%)     80 (59.7%)      79 (59.8%)  
#>         >30 to <=60 msec        11 (8.2%)     7 (5.2%)       10 (7.6%)   
#>         >60 msec               44 (32.8%)    47 (35.1%)      43 (32.6%)  
#>     WEEK 5 DAY 36                                                        
#>       AVALCAT1                                                           
#>         n                          134           134            132      
#>         <=450 msec             107 (79.9%)   117 (87.3%)    112 (84.8%)  
#>         >450 to <=480 msec     16 (11.9%)     5 (3.7%)       13 (9.8%)   
#>         >480 to <=500 msec      5 (3.7%)      9 (6.7%)        3 (2.3%)   
#>         >500 msec               6 (4.5%)      3 (2.2%)         4 (3%)    
#>       Change                                                             
#>         n                          134           134            132      
#>         <=30 msec              72 (53.7%)    82 (61.2%)      73 (55.3%)  
#>         >30 to <=60 msec        10 (7.5%)     11 (8.2%)      11 (8.3%)   
#>         >60 msec               52 (38.8%)    41 (30.6%)      48 (36.4%)