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,
  arm_var = "ACTARM",
  lbl_overall = NULL,
  deco = std_deco("AET01"),
  safety_var = list("FATAL", "SER", "SERWD", "SERDSM", "RELSER", "WD", "DSM", "REL",
    "RELWD", "RELDSM", "SEV"),
  lbl_safety_var = NULL,
  medconcept_var = list("SMQ01", "SMQ02", "CQ01"),
  lbl_medconcept_var = NULL,
  ...
)

aet01_2_lyt(
  arm_var,
  lbl_overall,
  deco,
  safety_var,
  lbl_safety_var,
  medconcept_var,
  lbl_medconcept_var
)

aet01_2_pre(adam_db, ...)

aet01_2_check(
  adam_db,
  req_tables = c("adsl", "adae"),
  arm_var = "ACTARM",
  safety_var = list("FATAL", "SER", "SERWD", "SERDSM", "RELSER", "WD", "DSM", "REL",
    "RELWD", "RELDSM", "SEV"),
  medconcept_var = list("SMQ01", "SMQ02", "CQ01")
)

aet01_2

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

Note

adam_db object must contain an adsl table with the "DTHFL" and "DCSREAS" columns.
adam_db object must contain an adae table with the columns passed to safety_var.

Examples

run(aet01_2, syn_data)
#>                                                                 A: Drug X    B: Placebo    C: Combination
#>                                                                  (N=134)       (N=134)        (N=132)    
#>   ———————————————————————————————————————————————————————————————————————————————————————————————————————
#>   Total number of patients with at least one AE                122 (91.0%)   123 (91.8%)    120 (90.9%)  
#>   Total number of AEs                                              609           622            703      
#>   Total number of deaths                                       25 (18.7%)    23 (17.2%)      22 (16.7%)  
#>   Total number of patients withdrawn from study due to an AE    3 (2.2%)      6 (4.5%)        5 (3.8%)   
#>   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 (75.0%)  
#>     Serious AE leading to withdrawal from treatment             9 (6.7%)      6 (4.5%)       11 (8.3%)   
#>     Serious AE leading to dose modification/interruption       22 (16.4%)    26 (19.4%)      29 (22.0%)  
#>     Related Serious AE                                         76 (56.7%)    70 (52.2%)      75 (56.8%)  
#>     AE leading to withdrawal from treatment                    27 (20.1%)    26 (19.4%)      30 (22.7%)  
#>     AE leading to dose modification/interruption               66 (49.3%)    76 (56.7%)      74 (56.1%)  
#>     Related AE                                                 105 (78.4%)   108 (80.6%)    109 (82.6%)  
#>     Related AE leading to withdrawal from treatment             6 (4.5%)      12 (9.0%)       8 (6.1%)   
#>     Related AE leading to dose modification/interruption       29 (21.6%)    38 (28.4%)      38 (28.8%)  
#>     Severe AE (at greatest intensity)                          91 (67.9%)    90 (67.2%)      93 (70.5%)  
#>   Total number of patients with at least one                                                             
#>     SMQ 01 Reference Name                                      72 (53.7%)    79 (59.0%)      75 (56.8%)  
#>     SMQ 02 Scope                                                    0             0              0       
#>     CQ 01 Reference Name                                       74 (55.2%)    80 (59.7%)      87 (65.9%)