## ----setup, include = FALSE--------------------------------------------------- knitr::opts_chunk$set(collapse = TRUE, comment = "#>") has_pva <- requireNamespace("pharmaverseadam", quietly = TRUE) ## ----eval = has_pva----------------------------------------------------------- library(trialdiff) ## ----eval = has_pva----------------------------------------------------------- params <- c("ALT", "AST", "CREAT") adsl_full <- pharmaverseadam::adsl adlb_full <- subset(pharmaverseadam::adlb, PARAMCD %in% params) subjects <- unique(as.character(adsl_full$USUBJID)) new_subjects <- tail(subjects, 2) adsl_cut1 <- adsl_full[!adsl_full$USUBJID %in% new_subjects, ] adlb_cut1 <- adlb_full[!adlb_full$USUBJID %in% new_subjects, ] adsl_cut2 <- adsl_full adlb_cut2 <- adlb_full trt_subject <- adsl_cut2$USUBJID[which(adsl_cut2$TRT01P == "Placebo")[1]] for (v in c("TRT01P", "TRT01A")) { adsl_cut2[[v]][adsl_cut2$USUBJID == trt_subject] <- "Xanomeline Low Dose" } for (v in c("TRT01P", "TRTP")) { adlb_cut2[[v]][adlb_cut2$USUBJID == trt_subject] <- "Xanomeline Low Dose" } i <- which(adlb_cut2$USUBJID == trt_subject & adlb_cut2$PARAMCD == "ALT" & adlb_cut2$AVISIT == "Week 4")[1] adlb_cut2$AVAL[i] <- adlb_cut2$AVAL[i] + 7 adlb_cut2$CHG[i] <- adlb_cut2$AVAL[i] - adlb_cut2$BASE[i] j <- which(adlb_cut2$PARAMCD == "AST" & adlb_cut2$AVISIT == "Week 2")[1] adlb_cut2$AVAL[j] <- NA_real_ adlb_cut2$CHG[j] <- NA_real_ c(adsl = nrow(adsl_cut2) - nrow(adsl_cut1), adlb = nrow(adlb_cut2) - nrow(adlb_cut1)) ## ----eval = has_pva----------------------------------------------------------- metadata <- list( ds_spec = data.frame( dataset = c("ADSL", "ADLB"), label = c("Subject-Level Analysis", "Laboratory Analysis") ), ds_vars = data.frame( dataset = c("ADSL", "ADSL", "ADSL", "ADLB", "ADLB", "ADLB", "ADLB", "ADLB"), variable = c("USUBJID", "TRT01P", "SAFFL", "USUBJID", "PARAMCD", "TRT01P", "AVAL", "CHG") ), value_spec = data.frame( dataset = c("ADSL", "ADLB", "ADLB", "ADLB", "ADLB"), variable = c("TRT01P", "TRT01P", "AVAL", "BASE", "CHG"), derivation_id = c("MT.ADSL.TRT01P", "MT.ADLB.TRT01P", "MT.ADLB.AVAL", "MT.ADLB.BASE", "MT.ADLB.CHG"), where = c(NA, NA, "PARAMCD == 'ALT'", NA, NA) ), derivations = data.frame( derivation_id = c("MT.ADSL.TRT01P", "MT.ADLB.TRT01P", "MT.ADLB.AVAL", "MT.ADLB.BASE", "MT.ADLB.CHG"), derivation = c("DM.ARM", "ADSL.TRT01P", "LB.LBSTRESN", "ADLB.AVAL", "AVAL - BASE") ) ) registry <- output_registry( td_output("Lab_Summary_By_Treatment", depends_on = c("ADLB.TRT01P", "ADLB.AVAL"), type = "analysis", relationship = "summarises"), td_output("MMRM", depends_on = c("ADLB.AVAL", "ADLB.CHG")), td_output("Table_14_2_1", depends_on = "Lab_Summary_By_Treatment", type = "output"), td_output("Table_14_2_2", depends_on = "MMRM", type = "output") ) lineage <- lineage_from_metadata(metadata, overrides = registry) lineage ## ----eval = has_pva----------------------------------------------------------- lineage_provenance(lineage)[, c("from", "to", "relationship", "source")] ## ----eval = has_pva----------------------------------------------------------- adsl_diff <- compare_cut(adsl_cut1, adsl_cut2, by = "USUBJID", dataset = "ADSL") |> classify_changes() adlb_diff <- compare_cut(adlb_cut1, adlb_cut2, by = c("USUBJID", "PARAMCD", "AVISIT"), dataset = "ADLB") |> classify_changes() knitr::kable(table(adsl_diff$register$category_label), col.names = c("Category", "ADSL")) knitr::kable(table(adlb_diff$register$category_label), col.names = c("Category", "ADLB")) ## ----eval = has_pva----------------------------------------------------------- adlb_impact <- assess_impact(adlb_diff, lineage) adlb_impact$impacts[, c("node", "node_type", "level", "depth", "requires_rerun")] ## ----eval = has_pva----------------------------------------------------------- report <- report_diff(adsl_diff, impact = assess_impact(adsl_diff, lineage), output = "list") report$data$review_items