AET01 Table 2 (Supplementary) Overview of Deaths and Adverse Events Summary Table 2. Overview of death and summary of adverse events with medical concepts.

AET01 Table 2 (Supplementary) Overview of Deaths and Adverse Events Summary Table 2. Overview of death and summary of adverse events with medical concepts.

Usage

aet01_2_main(
  adam_db,
  armvar = .study$actualarm,
  lbl_overall = .study$lbl_overall,
  prune_0 = FALSE,
  deco = std_deco("AET01"),
  safety_var = .study$safety_var,
  lbl_safety_var = NULL,
  medconcept_var = .study$medconcept_var,
  lbl_medconcept_var = NULL,
  .study = list(actualarm = "ACTARM", lbl_overall = NULL, safety_var = c("FATAL", "SER",
    "SERWD", "SERDSM", "RELSER", "WD", "DSM", "REL", "RELWD", "RELDSM", "SEV"),
    medconcept_var = c("SMQ01", "SMQ02", "CQ01"))
)

aet01_2_lyt(
  armvar = .study$actualarm,
  lbl_overall = .study$lbl_overall,
  deco = std_deco("AET01"),
  safety_var = .study$safety_var,
  lbl_safety_var = .study$lbl_safety_var,
  medconcept_var = .study$medconcept_var,
  lbl_medconcept_var = .study$lbl_medconcept_var,
  .study = list(actualarm = "ACTARM", lbl_overall = NULL, safety_var = c("FATAL", "SER",
    "SERWD", "SERDSM", "RELSER", "WD", "DSM", "REL", "RELWD", "RELDSM", "CTC35", "CTC45",
    "SEV"), lbl_safety_var = c("FATAL", "SER", "SERWD", "SERDSM", "RELSER", "WD", "DSM",
    "REL", "RELWD", "RELDSM", "CTC35", "CTC45", "SEV"), medconcept_var = c("SMQ01",
    "SMQ02", "CQ01"), lbl_medconcept_var = c("SMQ01", "SMQ02", "CQ01"))
)

aet01_2_pre(adam_db, ...)

aet01_2_check(
  adam_db,
  req_tables = c("adsl", "adae"),
  armvar = .study$actualarm,
  safety_var = .study$safety_var,
  lbl_safety_var = var_labels_for(adam_db$adae, safety_var),
  medconcept_var = .study$medconcept_var,
  lbl_medconcept_var = var_labels_for(adam_db$adae, medconcept_var),
  .study = list(actualarm = "ACTARM", lbl_overall = NULL, safety_var = c("FATAL", "SER",
    "SERWD", "SERDSM", "RELSER", "WD", "DSM", "REL", "RELWD", "RELDSM", "SEV"),
    medconcept_var = c("SMQ01", "SMQ02", "CQ01")),
  ...
)

aet01_2

Format

An object of class chevron_tlg of length 1.

Arguments

adam_db: (dm) object containing the ADaM datasets
armvar: (character) variable used for column splitting
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
safety_var: (character) the safety variables to be summarized.
lbl_safety_var: (character) the labels of the safety variables to be summarized.
medconcept_var: (character) the medical concept variables to be summarized.
lbl_medconcept_var: (character) the label of the medical concept variables to be summarized.
.study: (list) with default values for the arguments of the function
...: not used.
req_tables: (character) names of the required tables.

Details

Does not remove rows with zero counts by default.

Functions

aet01_2_main(): Main TLG function
aet01_2_lyt(): Layout
aet01_2_pre(): Preprocessing
aet01_2_check(): Checks

Examples

run(aet01_2, syn_test_data())
#>                                                               A: Drug X    B: Placebo    C: Combination
#>                                                                (N=134)       (N=134)        (N=132)    
#> ———————————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of patients with at least one AE                 122 (91%)    123 (91.8%)    120 (90.9%)  
#> Total number of AEs                                              609           622            703      
#> Total number of deaths                                       22 (16.4%)    26 (19.4%)      19 (14.4%)  
#> Total number of patients withdrawn from study due to an AE    6 (4.5%)      1 (0.7%)        2 (1.5%)   
#> Total number of patients with at least one                                                             
#>   AE with fatal outcome                                      76 (56.7%)    70 (52.2%)      75 (56.8%)  
#>   Serious AE                                                 104 (77.6%)   101 (75.4%)      99 (75%)   
#>   Serious AE leading to withdrawal from treatment              8 (6%)        8 (6%)         7 (5.3%)   
#>   Serious AE leading to dose modification/interruption       36 (26.9%)    31 (23.1%)      26 (19.7%)  
#>   Related Serious AE                                         76 (56.7%)    70 (52.2%)      75 (56.8%)  
#>   AE leading to withdrawal from treatment                    23 (17.2%)    24 (17.9%)      27 (20.5%)  
#>   AE leading to dose modification/interruption               72 (53.7%)    65 (48.5%)      76 (57.6%)  
#>   Related AE                                                 105 (78.4%)   108 (80.6%)    109 (82.6%)  
#>   Related AE leading to withdrawal from treatment             6 (4.5%)      9 (6.7%)       13 (9.8%)   
#>   Related AE leading to dose modification/interruption       31 (23.1%)    31 (23.1%)      32 (24.2%)  
#>   Severe AE (at greatest intensity)                          91 (67.9%)    90 (67.2%)      93 (70.5%)  
#> Total number of patients with at least one                                                             
#>   C.1.1.1.3/B.2.2.3.1 AESI (BROAD)                           72 (53.7%)     79 (59%)       75 (56.8%)  
#>   SMQ 02 Reference Name                                           0             0              0       
#>   D.2.1.5.3/A.1.1.1.1 AESI                                   74 (55.2%)    80 (59.7%)      87 (65.9%)