RMPT06 Table 1 (Default) Seriousness, Outcomes, Severity, Frequency with 95% CI for Risk Management Plan.

RMPT06 Table 1 (Default) Seriousness, Outcomes, Severity, Frequency with 95% CI for Risk Management Plan.

Usage

rmpt06_main(
  adam_db,
  arm_var = "ACTARM",
  lbl_overall = NULL,
  method = "clopper-pearson",
  conf_level = 0.95,
  show_diff = FALSE,
  ref_group = NULL,
  method_diff = "wald",
  conf_level_diff = 0.95,
  grade_groups = NULL,
  ...
)

rmpt06_pre(adam_db, ...)

rmpt06_post(tlg, prune_0 = FALSE, ...)

rmpt06

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
lbl_overall: (string) label used for overall column, if set to NULL the overall column is omitted
method: (string) the method used to construct the confidence interval. See tern::estimate_proportions.
conf_level: (proportion) the confidence level of the interval. See tern::estimate_proportions.
show_diff: (flag) whether to show the difference of patient with at least one adverse event between groups.
ref_group: (string) the reference group for the difference.
method_diff: (string) the method used to construct the confidence interval for the difference between groups.
conf_level_diff: (proportion) the confidence level of the interval for the difference between groups.
grade_groups: (list) the grade groups to be displayed.
...: not used.
tlg: (TableTree, Listing or ggplot) object typically produced by a main function.
prune_0: (flag) remove 0 count rows

Value

the main function returns an rtables object.

the preprocessing function returns a list of data.frame.

the postprocessing function returns an rtables object or an ElementaryTable (null report).

Functions

rmpt06_main(): Main TLG function
rmpt06_pre(): Preprocessing
rmpt06_post(): Postprocessing

Examples

run(rmpt06, syn_data)
#>                                                                   A: Drug X      B: Placebo    C: Combination
#>                                                                    (N=134)        (N=134)         (N=132)    
#>   ———————————————————————————————————————————————————————————————————————————————————————————————————————————
#>   Number of patients with at least one adverse event             122 (91.0%)    123 (91.8%)     120 (90.9%)  
#>   95% CI for % of patients with at least one AE                  (84.9, 95.3)   (85.8, 95.8)    (84.7, 95.2) 
#>   Total number of AEs                                                609            622             703      
#>   Total number of patients with at least one AE by worst grade                                               
#>     Grade 1                                                        7 (5.2%)       9 (6.7%)        4 (3.0%)   
#>     Grade 2                                                        6 (4.5%)      10 (7.5%)        7 (5.3%)   
#>     Grade 3                                                       18 (13.4%)     14 (10.4%)      16 (12.1%)  
#>     Grade 4                                                       15 (11.2%)     20 (14.9%)      18 (13.6%)  
#>     Grade 5 (fatal outcome)                                       76 (56.7%)     70 (52.2%)      75 (56.8%)  
#>   Number of patients with at least one serious AE                104 (77.6%)    101 (75.4%)      99 (75.0%)  
#>   Number of patients with at least one AE by outcome                                                         
#>     Fatal outcome                                                 76 (62.3%)     70 (56.9%)      75 (62.5%)  
#>     Unresolved                                                    66 (54.1%)     64 (52.0%)      70 (58.3%)  
#>     Recovered/Resolved                                            73 (59.8%)     83 (67.5%)      88 (73.3%)  
#>     Resolved with sequelae                                        44 (36.1%)     40 (32.5%)      43 (35.8%)  
#>     Recovering/Resolving                                          81 (66.4%)     84 (68.3%)      88 (73.3%)  
#>     Unknown outcome                                               38 (31.1%)     49 (39.8%)      44 (36.7%)