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The EXT01 table provides an overview of the of the exposure of the patients in terms of Total dose administered or missed, and treatment duration.

Usage

ext01_main(
  adam_db,
  arm_var = "ACTARM",
  summaryvars = "AVAL",
  row_split_var = "PARCAT2",
  lbl_overall = NULL,
  page_var = NULL,
  map = NULL,
  ...
)

ext01_pre(adam_db, ...)

ext01_post(tlg, prune_0 = TRUE, ...)

ext01

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

summaryvars

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

row_split_var

(character) additional row split variables.

lbl_overall

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

page_var

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

map

(data.frame) of mapping for split rows.

...

not used.

tlg

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

prune_0

(flag) remove 0 count rows

Details

  • Default Exposure table

  • The n row provides the number of non-missing values. The percentages for categorical variables is based on n. The percentages for Total number of patients with at least one dose modification are based on the number of patients in the corresponding analysis population given by N.

  • Split columns by arm, typically ACTARM.

  • Does not include a total column by default.

  • Sorted by alphabetic order of the PARAM value. Transform to factor and re-level for custom order.

  • ANL01FL is not relevant subset.

Functions

  • ext01_main(): Main TLG function

  • ext01_pre(): Preprocessing

  • ext01_post(): Postprocessing

Note

  • adam_db object must contain an adex table with columns specified in summaryvars.

Examples

run(ext01, syn_data)
#>   PARCAT2                        A: Drug X        B: Placebo      C: Combination 
#>                                   (N=134)           (N=134)           (N=132)    
#>   ———————————————————————————————————————————————————————————————————————————————
#>   Drug A                                                                         
#>     Overall duration (days)                                                      
#>       n                             75                67                75       
#>       Mean (SD)                121.5 (70.7)      131.2 (78.5)      130.5 (73.1)  
#>       Median                       116.0             127.0             126.0     
#>       Min - Max                15.0 - 249.0       1.0 - 250.0       1.0 - 246.0  
#>     Total dose administered                                                      
#>       n                             75                67                75       
#>       Mean (SD)               6675.2 (1110.9)   6505.1 (1249.3)   6982.4 (1272.5)
#>       Median                      6720.0            6480.0            7200.0     
#>       Min - Max               4800.0 - 9360.0   4080.0 - 9360.0   4320.0 - 9360.0
#>   Drug B                                                                         
#>     Overall duration (days)                                                      
#>       n                             59                67                57       
#>       Mean (SD)                111.0 (69.4)      113.7 (68.9)      137.5 (74.4)  
#>       Median                       98.0              104.0             144.0     
#>       Min - Max                 9.0 - 245.0       2.0 - 247.0      15.0 - 250.0  
#>     Total dose administered                                                      
#>       n                             59                67                57       
#>       Mean (SD)               6630.5 (1334.0)   6297.3 (1291.1)   6505.3 (1080.7)
#>       Median                      6720.0            6240.0            6480.0     
#>       Min - Max               4320.0 - 8880.0   4080.0 - 9120.0   4320.0 - 8640.0
run(ext01, syn_data, summaryvars = c("AVAL", "AVALCAT1"), prune_0 = FALSE)
#>   PARCAT2                        A: Drug X        B: Placebo      C: Combination 
#>                                   (N=134)           (N=134)           (N=132)    
#>   ———————————————————————————————————————————————————————————————————————————————
#>   Drug A                                                                         
#>     Overall duration (days)                                                      
#>       n                             75                67                75       
#>       Mean (SD)                121.5 (70.7)      131.2 (78.5)      130.5 (73.1)  
#>       Median                       116.0             127.0             126.0     
#>       Min - Max                15.0 - 249.0       1.0 - 250.0       1.0 - 246.0  
#>       n                             75                67                75       
#>       < 1 month                 10 (13.3%)         6 (9.0%)          6 (8.0%)    
#>       1 to <3 months            17 (22.7%)        18 (26.9%)        20 (26.7%)   
#>       3 to <6 months            29 (38.7%)        19 (28.4%)        25 (33.3%)   
#>       >=6 months                19 (25.3%)        24 (35.8%)        24 (32.0%)   
#>       <700                           0                 0                 0       
#>       700-900                        0                 0                 0       
#>       900-1200                       0                 0                 0       
#>       >1200                          0                 0                 0       
#>       <5000                          0                 0                 0       
#>       5000-7000                      0                 0                 0       
#>       7000-9000                      0                 0                 0       
#>       >9000                          0                 0                 0       
#>       7                              0                 0                 0       
#>     Total dose administered                                                      
#>       n                             75                67                75       
#>       Mean (SD)               6675.2 (1110.9)   6505.1 (1249.3)   6982.4 (1272.5)
#>       Median                      6720.0            6480.0            7200.0     
#>       Min - Max               4800.0 - 9360.0   4080.0 - 9360.0   4320.0 - 9360.0
#>       n                             75                67                75       
#>       < 1 month                      0                 0                 0       
#>       1 to <3 months                 0                 0                 0       
#>       3 to <6 months                 0                 0                 0       
#>       >=6 months                     0                 0                 0       
#>       <700                           0                 0                 0       
#>       700-900                        0                 0                 0       
#>       900-1200                       0                 0                 0       
#>       >1200                          0                 0                 0       
#>       <5000                      2 (2.7%)          6 (9.0%)          3 (4.0%)    
#>       5000-7000                 44 (58.7%)        34 (50.7%)        34 (45.3%)   
#>       7000-9000                 27 (36.0%)        25 (37.3%)        35 (46.7%)   
#>       >9000                      2 (2.7%)          2 (3.0%)          3 (4.0%)    
#>       7                              0                 0                 0       
#>   Drug B                                                                         
#>     Overall duration (days)                                                      
#>       n                             59                67                57       
#>       Mean (SD)                111.0 (69.4)      113.7 (68.9)      137.5 (74.4)  
#>       Median                       98.0              104.0             144.0     
#>       Min - Max                 9.0 - 245.0       2.0 - 247.0      15.0 - 250.0  
#>       n                             59                67                57       
#>       < 1 month                  5 (8.5%)          7 (10.4%)         5 (8.8%)    
#>       1 to <3 months            22 (37.3%)        20 (29.9%)        14 (24.6%)   
#>       3 to <6 months            18 (30.5%)        28 (41.8%)        17 (29.8%)   
#>       >=6 months                14 (23.7%)        12 (17.9%)        21 (36.8%)   
#>       <700                           0                 0                 0       
#>       700-900                        0                 0                 0       
#>       900-1200                       0                 0                 0       
#>       >1200                          0                 0                 0       
#>       <5000                          0                 0                 0       
#>       5000-7000                      0                 0                 0       
#>       7000-9000                      0                 0                 0       
#>       >9000                          0                 0                 0       
#>       7                              0                 0                 0       
#>     Total dose administered                                                      
#>       n                             59                67                57       
#>       Mean (SD)               6630.5 (1334.0)   6297.3 (1291.1)   6505.3 (1080.7)
#>       Median                      6720.0            6240.0            6480.0     
#>       Min - Max               4320.0 - 8880.0   4080.0 - 9120.0   4320.0 - 8640.0
#>       n                             59                67                57       
#>       < 1 month                      0                 0                 0       
#>       1 to <3 months                 0                 0                 0       
#>       3 to <6 months                 0                 0                 0       
#>       >=6 months                     0                 0                 0       
#>       <700                           0                 0                 0       
#>       700-900                        0                 0                 0       
#>       900-1200                       0                 0                 0       
#>       >1200                          0                 0                 0       
#>       <5000                      8 (13.6%)        12 (17.9%)         4 (7.0%)    
#>       5000-7000                 28 (47.5%)        37 (55.2%)        37 (64.9%)   
#>       7000-9000                 23 (39.0%)        17 (25.4%)        16 (28.1%)   
#>       >9000                          0             1 (1.5%)              0       
#>       7                              0                 0                 0       
levels(syn_data$adex$AVALCAT1) <- c(levels(syn_data$adex$AVALCAT1), "12 months")
map <- data.frame(
  PARAMCD = "TDURD",
  AVALCAT1 = c("< 1 month", "1 to <3 months", ">=6 months", "3 to <6 months", "12 months")
)
run(ext01, syn_data, summaryvars = c("AVAL", "AVALCAT1"), prune_0 = FALSE, map = map)
#>   PARCAT2                        A: Drug X        B: Placebo      C: Combination 
#>                                   (N=134)           (N=134)           (N=132)    
#>   ———————————————————————————————————————————————————————————————————————————————
#>   Drug A                                                                         
#>     Overall duration (days)                                                      
#>       n                             75                67                75       
#>       Mean (SD)                121.5 (70.7)      131.2 (78.5)      130.5 (73.1)  
#>       Median                       116.0             127.0             126.0     
#>       Min - Max                15.0 - 249.0       1.0 - 250.0       1.0 - 246.0  
#>       n                             75                67                75       
#>       < 1 month                 10 (13.3%)         6 (9.0%)          6 (8.0%)    
#>       1 to <3 months            17 (22.7%)        18 (26.9%)        20 (26.7%)   
#>       >=6 months                19 (25.3%)        24 (35.8%)        24 (32.0%)   
#>       3 to <6 months            29 (38.7%)        19 (28.4%)        25 (33.3%)   
#>       12 months                      0                 0                 0       
#>     Total dose administered                                                      
#>       n                             75                67                75       
#>       Mean (SD)               6675.2 (1110.9)   6505.1 (1249.3)   6982.4 (1272.5)
#>       Median                      6720.0            6480.0            7200.0     
#>       Min - Max               4800.0 - 9360.0   4080.0 - 9360.0   4320.0 - 9360.0
#>       n                             75                67                75       
#>       <5000                      2 (2.7%)          6 (9.0%)          3 (4.0%)    
#>       5000-7000                 44 (58.7%)        34 (50.7%)        34 (45.3%)   
#>       7000-9000                 27 (36.0%)        25 (37.3%)        35 (46.7%)   
#>       >9000                      2 (2.7%)          2 (3.0%)          3 (4.0%)    
#>   Drug B                                                                         
#>     Overall duration (days)                                                      
#>       n                             59                67                57       
#>       Mean (SD)                111.0 (69.4)      113.7 (68.9)      137.5 (74.4)  
#>       Median                       98.0              104.0             144.0     
#>       Min - Max                 9.0 - 245.0       2.0 - 247.0      15.0 - 250.0  
#>       n                             59                67                57       
#>       < 1 month                  5 (8.5%)          7 (10.4%)         5 (8.8%)    
#>       1 to <3 months            22 (37.3%)        20 (29.9%)        14 (24.6%)   
#>       >=6 months                14 (23.7%)        12 (17.9%)        21 (36.8%)   
#>       3 to <6 months            18 (30.5%)        28 (41.8%)        17 (29.8%)   
#>       12 months                      0                 0                 0       
#>     Total dose administered                                                      
#>       n                             59                67                57       
#>       Mean (SD)               6630.5 (1334.0)   6297.3 (1291.1)   6505.3 (1080.7)
#>       Median                      6720.0            6240.0            6480.0     
#>       Min - Max               4320.0 - 8880.0   4080.0 - 9120.0   4320.0 - 8640.0
#>       n                             59                67                57       
#>       <5000                      8 (13.6%)        12 (17.9%)         4 (7.0%)    
#>       5000-7000                 28 (47.5%)        37 (55.2%)        37 (64.9%)   
#>       7000-9000                 23 (39.0%)        17 (25.4%)        16 (28.1%)   
#>       >9000                          0             1 (1.5%)              0