A description of the causes of death optionally with the breakdown of the OTHER category and/or post-study reporting of death.

dtht01_1(
  adam_db,
  armvar = .study$actualarm,
  time_since_last_dose = FALSE,
  other_category = FALSE,
  lbl_overall = .study$lbl_overall,
  prune_0 = TRUE,
  deco = std_deco("DTHT01"),
  .study = list(actualarm = "ACTARM", lbl_overall = NULL)
)

dtht01_1_lyt(
  armvar = .study$actualarm,
  lbl_overall = .study$lbl_overall,
  other_category = TRUE,
  deco = std_deco("DTHT01"),
  .study = list(actualarm = "ACTARM", lbl_overall = NULL)
)

dtht01_1_opt_lyt(
  armvar = .study$actualarm,
  lbl_overall = .study$lbl_overall,
  deco = std_deco("DTHT01"),
  .study = list(actualarm = "ACTARM", lbl_overall = NULL)
)

dtht01_1_pre(adam_db)

Arguments

adam_db

(dm) object containing the ADaM datasets

armvar

(character) variable used for column splitting

time_since_last_dose

(logical) should the time to event information be displayed.

other_category

(logical) should the breakdown of the OTHER category be displayed.

lbl_overall

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

prune_0

(logical) remove 0 count rows

deco

(character) decoration with title, subtitles and main_footer content

.study

(list) with default values for the arguments of the function

Details

  • Numbers represent absolute numbers of subjects and fraction of N, or absolute numbers when specified.

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

  • Does not include a total column by default.

Functions

  • dtht01_1_lyt: dtht01_1 Layout

  • dtht01_1_opt_lyt: dtht01_1 Optional Layout

  • dtht01_1_pre: dtht01_1 Preprocessing

Examples

library(dm)

db <- syn_test_data() %>%
  dm_zoom_to(adsl) %>%
  mutate(DTHCAT = tern::explicit_na(DTHCAT)) %>%
  mutate(LDDTHGR1 = tern::explicit_na(LDDTHGR1)) %>%
  dm_update_zoomed() %>%
  dtht01_1_pre()

dtht01_1(adam_db = db)
#> Deaths: {Specify Population}
#> Protocol: {{protocol}}
#> 
#> —————————————————————————————————————————————————————————————————
#>                          A: Drug X    B: Placebo   C: Combination
#>                           (N=134)      (N=134)        (N=132)    
#> —————————————————————————————————————————————————————————————————
#> Total number of deaths   22 (16.4%)   26 (19.4%)     19 (14.4%)  
#> Primary cause of death                                           
#>   n                          22           26             19      
#>   ADVERSE EVENT          6 (27.3%)    12 (46.2%)     7 (36.8%)   
#>   PROGRESSIVE DISEASE    7 (31.8%)    9 (34.6%)      8 (42.1%)   
#>   OTHER                  9 (40.9%)    5 (19.2%)      4 (21.1%)   
#> —————————————————————————————————————————————————————————————————
#> 
#> If applicable, include the footnote highlighted in grey for post-study deaths collected from public records.
dtht01_1(adam_db = db, other_category = FALSE)
#> Deaths: {Specify Population}
#> Protocol: {{protocol}}
#> 
#> —————————————————————————————————————————————————————————————————
#>                          A: Drug X    B: Placebo   C: Combination
#>                           (N=134)      (N=134)        (N=132)    
#> —————————————————————————————————————————————————————————————————
#> Total number of deaths   22 (16.4%)   26 (19.4%)     19 (14.4%)  
#> Primary cause of death                                           
#>   n                          22           26             19      
#>   ADVERSE EVENT          6 (27.3%)    12 (46.2%)     7 (36.8%)   
#>   PROGRESSIVE DISEASE    7 (31.8%)    9 (34.6%)      8 (42.1%)   
#>   OTHER                  9 (40.9%)    5 (19.2%)      4 (21.1%)   
#> —————————————————————————————————————————————————————————————————
#> 
#> If applicable, include the footnote highlighted in grey for post-study deaths collected from public records.
dtht01_1(adam_db = db, time_since_last_dose = TRUE)
#> Deaths: {Specify Population}
#> Protocol: {{protocol}}
#> 
#> ————————————————————————————————————————————————————————————————————————————————————————————————————
#>                                                             A: Drug X    B: Placebo   C: Combination
#>                                                              (N=134)      (N=134)        (N=132)    
#> ————————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of deaths                                      22 (16.4%)   26 (19.4%)     19 (14.4%)  
#> Primary cause of death                                                                              
#>   n                                                             22           26             19      
#>   ADVERSE EVENT                                             6 (27.3%)    12 (46.2%)     7 (36.8%)   
#>   PROGRESSIVE DISEASE                                       7 (31.8%)    9 (34.6%)      8 (42.1%)   
#>   OTHER                                                     9 (40.9%)    5 (19.2%)      4 (21.1%)   
#> Days from last drug administration                                                                  
#>   n                                                             22           26             19      
#>   <=30                                                      12 (54.5%)   16 (61.5%)     10 (52.6%)  
#>   >30                                                       10 (45.5%)   10 (38.5%)     9 (47.4%)   
#> Primary cause by days from last study drug administration                                           
#>   <=30                                                                                              
#>     n                                                           12           16             10      
#>     ADVERSE EVENT                                            3 (25%)     9 (56.2%)       4 (40%)    
#>     PROGRESSIVE DISEASE                                      3 (25%)      4 (25%)        3 (30%)    
#>     OTHER                                                    6 (50%)     3 (18.8%)       3 (30%)    
#>   >30                                                                                               
#>     n                                                           10           10             9       
#>     ADVERSE EVENT                                            3 (30%)      3 (30%)       3 (33.3%)   
#>     PROGRESSIVE DISEASE                                      4 (40%)      5 (50%)       5 (55.6%)   
#>     OTHER                                                    3 (30%)      2 (20%)       1 (11.1%)   
#> ————————————————————————————————————————————————————————————————————————————————————————————————————
#> 
#> If applicable, include the footnote highlighted in grey for post-study deaths collected from public records.
dtht01_1(adam_db = db, time_since_last_dose = TRUE, other_category = FALSE)
#> Deaths: {Specify Population}
#> Protocol: {{protocol}}
#> 
#> ————————————————————————————————————————————————————————————————————————————————————————————————————
#>                                                             A: Drug X    B: Placebo   C: Combination
#>                                                              (N=134)      (N=134)        (N=132)    
#> ————————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of deaths                                      22 (16.4%)   26 (19.4%)     19 (14.4%)  
#> Primary cause of death                                                                              
#>   n                                                             22           26             19      
#>   ADVERSE EVENT                                             6 (27.3%)    12 (46.2%)     7 (36.8%)   
#>   PROGRESSIVE DISEASE                                       7 (31.8%)    9 (34.6%)      8 (42.1%)   
#>   OTHER                                                     9 (40.9%)    5 (19.2%)      4 (21.1%)   
#> Days from last drug administration                                                                  
#>   n                                                             22           26             19      
#>   <=30                                                      12 (54.5%)   16 (61.5%)     10 (52.6%)  
#>   >30                                                       10 (45.5%)   10 (38.5%)     9 (47.4%)   
#> Primary cause by days from last study drug administration                                           
#>   <=30                                                                                              
#>     n                                                           12           16             10      
#>     ADVERSE EVENT                                            3 (25%)     9 (56.2%)       4 (40%)    
#>     PROGRESSIVE DISEASE                                      3 (25%)      4 (25%)        3 (30%)    
#>     OTHER                                                    6 (50%)     3 (18.8%)       3 (30%)    
#>   >30                                                                                               
#>     n                                                           10           10             9       
#>     ADVERSE EVENT                                            3 (30%)      3 (30%)       3 (33.3%)   
#>     PROGRESSIVE DISEASE                                      4 (40%)      5 (50%)       5 (55.6%)   
#>     OTHER                                                    3 (30%)      2 (20%)       1 (11.1%)   
#> ————————————————————————————————————————————————————————————————————————————————————————————————————
#> 
#> If applicable, include the footnote highlighted in grey for post-study deaths collected from public records.
dtht01_1_lyt(
  armvar = "ACTARM",
  lbl_overall = NULL
)
#> A Pre-data Table Layout
#> 
#> Column-Split Structure:
#> ACTARM (lvls) 
#> 
#> Row-Split Structure:
#> DTHFL:DTHCAT (** multivar analysis **) 
#> DTHCAT (lvls) -> DTHCAUS (** analysis **) 
#> 
dtht01_1_opt_lyt(
  armvar = "ACTARM",
  lbl_overall = NULL
)
#> A Pre-data Table Layout
#> 
#> Column-Split Structure:
#> ACTARM (lvls) 
#> 
#> Row-Split Structure:
#> LDDTHGR1 (** analysis **) 
#> LDDTHGR1 (lvls) -> DTHCAT (** analysis **) 
#> 
syn_test_data() %>%
  dtht01_1_pre()
#> ── Metadata ────────────────────────────────────────────────────────────────────
#> Tables: `adsl`, `adae`, `adaette`, `adcm`, `addv`, … (15 total)
#> Columns: 846
#> Primary keys: 2
#> Foreign keys: 1