Most of the work in creating a ‘Tplyr’ table is at the layer level, but there are a few overarching properties that are worth spending some time discussing. One of the things that we wanted to make sure we did in ‘Tplyr’ is allow you to eliminate redundant code wherever possible. Adding some processing to the tplyr_table() level allows us to do that. Furthermore, some settings simply need to be applied table wide.

Table Parameters

The tplyr_table() function has 4 parameters:

  • target: The dataset upon which summaries will be performed
  • treat_var: The variable containing treatment group assignments
  • where: The overarching table subset criteria. Each layer will use this subset by default. The where parameter at the table level will be called in addition to the layer subset criteria.
  • cols: Grouping variables used in addition to the by variables set at the layer level, but will be transposed into columns in addition to treat_var.

Let’s look at an example:

tplyr_table(adsl, TRT01P, where= SAFFL =="Y", cols = SEX) %>% 
  add_layer(
    group_count(RACE, by = "Race")
  ) %>% 
  add_layer(
    group_desc(AGE, by = "Age (Years)")
  ) %>% 
  build() %>% 
  kable()
row_label1 row_label2 var1_Placebo_F var1_Placebo_M var1_Xanomeline High Dose_F var1_Xanomeline High Dose_M var1_Xanomeline Low Dose_F var1_Xanomeline Low Dose_M ord_layer_index ord_layer_1 ord_layer_2
Race AMERICAN INDIAN OR ALASKA NATIVE 0 ( 0.0%) 0 ( 0.0%) 0 ( 0.0%) 1 ( 2.3%) 0 ( 0.0%) 0 ( 0.0%) 1 1 1
Race BLACK OR AFRICAN AMERICAN 5 ( 9.4%) 3 ( 9.1%) 6 ( 15.0%) 3 ( 6.8%) 6 ( 12.0%) 0 ( 0.0%) 1 1 2
Race WHITE 48 ( 90.6%) 30 ( 90.9%) 34 ( 85.0%) 40 ( 90.9%) 44 ( 88.0%) 34 (100.0%) 1 1 3
Age (Years) n 53 33 40 44 50 34 2 1 1
Age (Years) Mean (SD) 76.4 ( 8.73) 73.4 ( 8.15) 74.7 ( 7.67) 74.1 ( 8.16) 75.7 ( 8.09) 75.6 ( 8.69) 2 1 2
Age (Years) Median 78.0 74.0 76.0 77.0 77.5 77.5 2 1 3
Age (Years) Q1, Q3 70.0, 84.0 69.0, 80.0 72.0, 79.0 69.0, 80.2 72.0, 81.0 68.2, 82.0 2 1 4
Age (Years) Min, Max 59, 89 52, 85 56, 88 56, 86 54, 87 51, 88 2 1 5
Age (Years) Missing 0 0 0 0 0 0 2 1 6

In the example above, the where parameter is passed forward into both the RACE and AGE layers. Furthermore, note how the cols parameter works. By default, the target variables from the layers are transposed by the treat_var variables. The cols argument adds an additional variable to transpose by, and the values of these variable are added as a suffix to the variable name. You are able to use multiple cols variables just like by, by using dplyr::vars(). But use with caution - as depending on the distinct variable values in the dataset, this could get quite wide.

tplyr_table(adsl, TRT01P, where= SAFFL =="Y", cols = vars(SEX, RACE)) %>% 
  add_layer(
    group_desc(AGE, by = "Age (Years)")
  ) %>% 
  build() %>% 
  kable()
row_label1 row_label2 var1_Placebo_F_AMERICAN INDIAN OR ALASKA NATIVE var1_Placebo_F_BLACK OR AFRICAN AMERICAN var1_Placebo_F_WHITE var1_Placebo_M_AMERICAN INDIAN OR ALASKA NATIVE var1_Placebo_M_BLACK OR AFRICAN AMERICAN var1_Placebo_M_WHITE var1_Xanomeline High Dose_F_AMERICAN INDIAN OR ALASKA NATIVE var1_Xanomeline High Dose_F_BLACK OR AFRICAN AMERICAN var1_Xanomeline High Dose_F_WHITE var1_Xanomeline High Dose_M_AMERICAN INDIAN OR ALASKA NATIVE var1_Xanomeline High Dose_M_BLACK OR AFRICAN AMERICAN var1_Xanomeline High Dose_M_WHITE var1_Xanomeline Low Dose_F_AMERICAN INDIAN OR ALASKA NATIVE var1_Xanomeline Low Dose_F_BLACK OR AFRICAN AMERICAN var1_Xanomeline Low Dose_F_WHITE var1_Xanomeline Low Dose_M_AMERICAN INDIAN OR ALASKA NATIVE var1_Xanomeline Low Dose_M_BLACK OR AFRICAN AMERICAN var1_Xanomeline Low Dose_M_WHITE ord_layer_index ord_layer_1 ord_layer_2
Age (Years) n 5 48 3 30 6 34 1 3 40 6 44 34 1 1 1
Age (Years) Mean (SD) 75.2 ( 7.79) 76.5 ( 8.89) 64.7 ( 6.81) 74.2 ( 7.84) 72.2 ( 6.08) 75.1 ( 7.91) 61.0 ( ) 79.3 ( 2.52) 74.0 ( 8.16) 72.5 (11.78) 76.1 ( 7.54) 75.6 ( 8.69) 1 1 2
Age (Years) Median 80.0 78.0 67.0 74.5 73.5 76.0 61.0 79.0 76.0 75.0 78.0 77.5 1 1 3
Age (Years) Q1, Q3 70.0, 81.0 70.5, 84.0 62.0, 68.5 70.0, 80.8 68.5, 76.2 72.0, 79.8 61.0, 61.0 78.0, 80.5 69.0, 80.2 63.5, 79.8 72.0, 81.0 68.2, 82.0 1 1 4
Age (Years) Min, Max 64, 81 59, 89 57, 70 52, 85 63, 79 56, 88 61, 61 77, 82 56, 86 57, 87 54, 86 51, 88 1 1 5
Age (Years) Missing 0 0 0 0 0 0 0 0 0 0 0 0 1 1 6

Additional Treatment Groups

Another important feature that works at the table level is the addition of treatment groups. By adding additional treatment groups, you’re able to do a number of things:

  • Add a ‘treated’ group to your data so you can analyze ‘treated’ vs. ‘placebo’ when you have multiple treated cohorts
  • Add a ‘total’ group so summarize the overall study population

We’ve added the function add_treat_grps() to do this work for you. With this function, you can create new treatment groups by combining existing treatment groups from values within treat_var. Additionally, to simplify the process we added an abstraction of add_treat_grps() named add_total_group() to simplify the process of creating a “Total” group.

tplyr_table(adsl, TRT01P) %>%
  add_treat_grps('Treated' = c("Xanomeline High Dose", "Xanomeline Low Dose")) %>% 
  add_total_group() %>% 
  add_layer(
    group_desc(AGE, by = "Age (Years)")
  ) %>% 
  build() %>% 
  kable()
row_label1 row_label2 var1_Placebo var1_Total var1_Treated var1_Xanomeline High Dose var1_Xanomeline Low Dose ord_layer_index ord_layer_1 ord_layer_2
Age (Years) n 86 254 168 84 84 1 1 1
Age (Years) Mean (SD) 75.2 ( 8.59) 75.1 ( 8.25) 75.0 ( 8.09) 74.4 ( 7.89) 75.7 ( 8.29) 1 1 2
Age (Years) Median 76.0 77.0 77.0 76.0 77.5 1 1 3
Age (Years) Q1, Q3 69.2, 81.8 70.0, 81.0 71.0, 81.0 70.8, 80.0 71.0, 82.0 1 1 4
Age (Years) Min, Max 52, 89 51, 89 51, 88 56, 88 51, 88 1 1 5
Age (Years) Missing 0 0 0 0 0 1 1 6

Note how in the above example, there are two new columns added to the data - var1_Total and var1_Treated. The summaries for the individual cohorts are left unchanged.

Population Data

A last and very important aspect of table level properties in ‘Tplyr’ is the addition of a population dataset. In CDISC standards, datasets like adae only contain adverse events when the occur. This means that if a subject did not experience an adverse event, or did not experience an adverse event within the criteria that you’re subsetting for, they don’t appear in the dataset. When you’re looking at the proportion of subject who experienced an adverse event compared to the total number of subjects in that cohort, adae itself leaves you no way to calculate that total - as the subjects won’t exist in the data.

‘Tplyr’ allows you to provide a separate population dataset to overcome this. Furthermore, you are also able to provide a separate population dataset where parameter and a population treatment variable named pop_treat_var, as variable names may differ between the datasets.

t <- tplyr_table(adae, TRTA, where = AEREL != "NONE") %>% 
  set_pop_data(adsl) %>% 
  set_pop_treat_var(TRT01A) %>% 
  set_pop_where(TRUE) %>% 
  add_layer(
    group_count(AEDECOD) %>% 
      set_distinct_by(USUBJID)
  )
  
t %>% 
  build() %>% 
  kable()
row_label1 var1_Placebo var1_Xanomeline High Dose var1_Xanomeline Low Dose ord_layer_index ord_layer_1
ALOPECIA 1 ( 1.2%) 0 ( 0.0%) 0 ( 0.0%) 1 2
BLISTER 0 ( 0.0%) 1 ( 1.2%) 5 ( 6.0%) 1 3
COLD SWEAT 1 ( 1.2%) 0 ( 0.0%) 0 ( 0.0%) 1 4
DERMATITIS CONTACT 0 ( 0.0%) 0 ( 0.0%) 1 ( 1.2%) 1 6
ERYTHEMA 9 ( 10.5%) 14 ( 16.7%) 13 ( 15.5%) 1 8
HYPERHIDROSIS 2 ( 2.3%) 8 ( 9.5%) 4 ( 4.8%) 1 9
PRURITUS 8 ( 9.3%) 26 ( 31.0%) 21 ( 25.0%) 1 10
PRURITUS GENERALISED 0 ( 0.0%) 1 ( 1.2%) 1 ( 1.2%) 1 11
RASH 4 ( 4.7%) 8 ( 9.5%) 13 ( 15.5%) 1 12
RASH ERYTHEMATOUS 0 ( 0.0%) 0 ( 0.0%) 2 ( 2.4%) 1 13
RASH MACULO-PAPULAR 0 ( 0.0%) 1 ( 1.2%) 0 ( 0.0%) 1 14
RASH PAPULAR 0 ( 0.0%) 1 ( 1.2%) 0 ( 0.0%) 1 15
RASH PRURITIC 0 ( 0.0%) 2 ( 2.4%) 1 ( 1.2%) 1 16
SKIN EXFOLIATION 0 ( 0.0%) 0 ( 0.0%) 1 ( 1.2%) 1 17
SKIN IRRITATION 2 ( 2.3%) 5 ( 6.0%) 6 ( 7.1%) 1 18
SKIN ODOUR ABNORMAL 0 ( 0.0%) 1 ( 1.2%) 0 ( 0.0%) 1 19
SKIN ULCER 1 ( 1.2%) 0 ( 0.0%) 0 ( 0.0%) 1 20
URTICARIA 0 ( 0.0%) 1 ( 1.2%) 1 ( 1.2%) 1 21

In the above example, AEREL doesn’t exist in adsl, therefore we used set_pop_where() to remove the filter criteria on the population data. Setting the population dataset where parameter to TRUE removes any filter applied by the population data. If set_pop_where() is not set for the population data, it will default to the where parameter used in tplyr_table(). The same logic applies to the population treatment variable. TRTA does not exist in adsl either, so we used set_pop_treat_var() to change it to the appropriate variable in adsl.

Note the percentage values in the summary above. By setting the population data, ‘Tplyr’ now knew to use those values when calculating the percentages for the distinct counts of subjects who experienced the summarized adverse events. Furthermore, with the population data provided, ‘Tplyr’ is able to calculate your header N’s properly:

header_n(t) %>% 
  kable()
TRT01A n
Placebo 86
Xanomeline High Dose 84
Xanomeline Low Dose 84

With the table level settings under control, now you’re ready to learn more about what ‘Tplyr’ has to offer in each layer.