--- title: "Customize Columns in an AE Summary Table" output: rmarkdown::html_vignette vignette: > %\VignetteIndexEntry{Customize Columns in an AE Summary Table} %\VignetteEngine{knitr::rmarkdown} %\VignetteEncoding{UTF-8} resource_files: - rtf/ae0summary2.rtf --- ```{r, include=FALSE} knitr::opts_chunk$set( comment = "#>", collapse = TRUE, out.width = "100%", dpi = 150 ) ``` ```{r} library(metalite.ae) ``` ## Overview The `display` argument of `format_ae_summary()` selects and orders the statistics in an AE summary table. This vignette demonstrates how to include risk-difference estimates and inference results. ## Define metadata The example uses ADSL and ADAE data from the [forestly](https://merck.github.io/forestly/) package. The metadata follows the same approach used in the [AE Summary in RTF format](ae-summary-rtf.html) vignette. ```{r} adsl <- forestly::forestly_adsl adae <- forestly::forestly_adae adsl$TRT01A <- factor( adsl$TRT01A, levels = c("Xanomeline Low Dose", "Placebo"), labels = c("Low Dose", "Placebo") ) adae$TRTA <- factor( adae$TRTA, levels = c("Xanomeline Low Dose", "Placebo"), labels = c("Low Dose", "Placebo") ) analysis_plan <- metalite::plan( analysis = "ae_summary", population = "apat", observation = "wk12", parameter = "any;rel;ser" ) meta <- metalite::meta_adam(observation = adae, population = adsl) |> metalite::define_plan(analysis_plan) |> metalite::define_population( name = "apat", var = c("USUBJID", "SAFFL", "TRT01A"), group = "TRT01A", subset = SAFFL == "Y", label = "All Participants as Treated" ) |> metalite::define_observation( name = "wk12", var = c( "USUBJID", "SAFFL", "TRTA", "AEDECOD", "AEBODSYS", "AEREL", "AESER" ), group = "TRTA", subset = SAFFL == "Y", label = "Weeks 0 to 12" ) |> metalite::define_parameter( name = "any", term1 = "", term2 = "", var = "AEDECOD", soc = "AEBODSYS", label = "All AEs" ) |> metalite::define_parameter( name = "rel", term1 = "Drug-Related", term2 = "", subset = AEREL %in% c("POSSIBLE", "PROBABLE"), var = "AEDECOD", soc = "AEBODSYS", label = "Drug-related AEs" ) |> metalite::define_parameter( name = "ser", term1 = "Serious", term2 = "", subset = AESER == "Y", var = "AEDECOD", soc = "AEBODSYS", label = "Serious AEs" ) |> metalite::define_analysis( name = "ae_summary", title = "Adverse Event Summary" ) |> metalite::meta_build() ``` ## Select columns Use `extend_ae_specific_inference()` to add confidence intervals and p-values based on the Miettinen and Nurminen (M&N) method. For details, see the [rate compare vignette](https://merck.github.io/metalite.ae/articles/rate-compare.html). After extending the analysis, use `display` in `format_ae_summary()` to select statistics and set their order. Available options are: - `"n"`: number of participants with an adverse event. - `"prop"`: proportion of participants with an adverse event. - `"total"`: total columns. - `"diff"`: risk difference. - `"diff_ci"`: 95% confidence interval for the risk difference using the Miettinen and Nurminen method. - `"diff_p"`: p-value for the risk difference using the Miettinen and Nurminen method. - `"dur"`: average adverse event duration. - `"events_avg"`: average number of adverse events per participant. - `"events_count"`: number of adverse events per participant. The `"diff_ci"` and `"diff_p"` statistics are added by `extend_ae_specific_inference()`, `"dur"` is added by `extend_ae_specific_duration()`, and the event statistics are added by `extend_ae_specific_events()`. For example, include `"diff"` in addition to the number and proportion of participants with an adverse event: ```{r} rtf_dir <- if (dir.exists("vignettes/rtf")) "vignettes/rtf" else "rtf" rtf_file <- file.path(rtf_dir, "ae0summary2.rtf") prepare_ae_summary( meta, population = "apat", observation = "wk12", parameter = "any;rel;ser" ) |> extend_ae_specific_inference() |> format_ae_summary(display = c("n", "prop", "diff", "diff_ci")) |> tlf_ae_summary( source = "Source: [CDISCpilot: adam-adsl; adae]", analysis = "ae_summary", # Provide analysis type defined in meta$analysis col_rel_width = c(3, rep(1, 6)), path_outtable = rtf_file ) ``` ```{r download-rtf, results="asis", echo=FALSE} cat( "Generated RTF file: ae0summary2.rtf" ) ```