Skip to contents

Counts subjects with at least one event. SOCs and PTs are sorted by decreasing frequency, with ties broken alphabetically. Denominators come from adsl when given, otherwise from adae.

Usage

tbl_ae(
  adae,
  adsl = NULL,
  trt_var = "TRT01A",
  soc_var = "AESOC",
  pt_var = "AEDECOD",
  teae_flag = "TRTEMFL",
  config = NULL
)

Arguments

adae

Adverse-event data.

adsl

Optional subject-level data for denominators.

trt_var

Treatment variable (resolved with tlf_resolve_trt()).

soc_var, pt_var

SOC and PT columns.

teae_flag

Treatment-emergent flag column ("Y" rows are kept); NULL keeps all events.

config

A tlf_config(); NULL resolves through tlf_get_config().

Value

A tlf_table.

Examples

tbl_ae(ex_adae, ex_adsl)
#> <tlf_table> 11 row(s) x 5 column(s)
#>  System Organ Class / Preferred Term    Drug 10 mg (N=20) Drug 20 mg (N=20)
#>  Subjects with at least one TEAE        16 (80.0%)        17 (85.0%)       
#>  NERVOUS SYSTEM DISORDERS               9 (45.0%)         11 (55.0%)       
#>    DIZZINESS                            6 (30.0%)         7 (35.0%)        
#>    HEADACHE                             6 (30.0%)         7 (35.0%)        
#>  GASTROINTESTINAL DISORDERS             8 (40.0%)         12 (60.0%)       
#>    DIARRHOEA                            4 (20.0%)         6 (30.0%)        
#>    NAUSEA                               4 (20.0%)         6 (30.0%)        
#>  INFECTIONS AND INFESTATIONS            6 (30.0%)         4 (20.0%)        
#>    NASOPHARYNGITIS                      6 (30.0%)         4 (20.0%)        
#>  SKIN AND SUBCUTANEOUS TISSUE DISORDERS 2 (10.0%)         2 (10.0%)        
#>    RASH                                 2 (10.0%)         2 (10.0%)        
#>  Placebo (N=20) Total (N=60)
#>  17 (85.0%)     50 (83.3%)  
#>  11 (55.0%)     31 (51.7%)  
#>  8 (40.0%)      21 (35.0%)  
#>  5 (25.0%)      18 (30.0%)  
#>  6 (30.0%)      26 (43.3%)  
#>  5 (25.0%)      15 (25.0%)  
#>  3 (15.0%)      13 (21.7%)  
#>  6 (30.0%)      16 (26.7%)  
#>  6 (30.0%)      16 (26.7%)  
#>  4 (20.0%)      8 (13.3%)   
#>  4 (20.0%)      8 (13.3%)   
#> Note: Subjects are counted once per SOC and once per preferred term.