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Update label indentation
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‎R/fda-table_38.R

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@@ -87,7 +87,7 @@ make_table_38 <- function(adae,
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vars = pref_var,
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riskdiff = !is.null(risk_diff)
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) %>%
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append_topleft(paste(" ", lbl_pref_var))
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append_topleft(paste(" ", lbl_pref_var))
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tbl <- build_table(lyt, df = adae, alt_counts_df = alt_counts_df)
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if (prune_0) tbl <- prune_table(tbl)

‎tests/testthat/_snaps/fda-table_38.md

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@@ -3,24 +3,24 @@
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Code
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res
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Output
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Body System or Organ Class
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FMQ (Broad) A: Drug X B: Placebo C: Combination
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Dictionary-Derived Term (N=134) (N=134) (N=132)
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—————————————————————————————————————————————————————————————————————
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cl B.2
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FMQ1 20 (14.9%) 17 (12.7%) 22 (16.7%)
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dcd B.2.2.3.1 20 (14.9%) 17 (12.7%) 22 (16.7%)
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FMQ2 22 (16.4%) 25 (18.7%) 21 (15.9%)
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dcd B.2.2.3.1 22 (16.4%) 25 (18.7%) 21 (15.9%)
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FMQ3 18 (13.4%) 24 (17.9%) 23 (17.4%)
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dcd B.2.2.3.1 18 (13.4%) 24 (17.9%) 23 (17.4%)
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cl C.1
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FMQ1 14 (10.4%) 19 (14.2%) 21 (15.9%)
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dcd C.1.1.1.3 14 (10.4%) 19 (14.2%) 21 (15.9%)
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FMQ2 17 (12.7%) 22 (16.4%) 19 (14.4%)
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dcd C.1.1.1.3 17 (12.7%) 22 (16.4%) 19 (14.4%)
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FMQ3 20 (14.9%) 16 (11.9%) 19 (14.4%)
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dcd C.1.1.1.3 20 (14.9%) 16 (11.9%) 19 (14.4%)
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Body System or Organ Class
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FMQ (Broad) A: Drug X B: Placebo C: Combination
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Dictionary-Derived Term (N=134) (N=134) (N=132)
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——————————————————————————————————————————————————————————————————————
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cl B.2
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FMQ1 20 (14.9%) 17 (12.7%) 22 (16.7%)
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dcd B.2.2.3.1 20 (14.9%) 17 (12.7%) 22 (16.7%)
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FMQ2 22 (16.4%) 25 (18.7%) 21 (15.9%)
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dcd B.2.2.3.1 22 (16.4%) 25 (18.7%) 21 (15.9%)
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FMQ3 18 (13.4%) 24 (17.9%) 23 (17.4%)
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dcd B.2.2.3.1 18 (13.4%) 24 (17.9%) 23 (17.4%)
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cl C.1
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FMQ1 14 (10.4%) 19 (14.2%) 21 (15.9%)
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dcd C.1.1.1.3 14 (10.4%) 19 (14.2%) 21 (15.9%)
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FMQ2 17 (12.7%) 22 (16.4%) 19 (14.4%)
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dcd C.1.1.1.3 17 (12.7%) 22 (16.4%) 19 (14.4%)
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FMQ3 20 (14.9%) 16 (11.9%) 19 (14.4%)
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dcd C.1.1.1.3 20 (14.9%) 16 (11.9%) 19 (14.4%)
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# Table 38 generation works with custom values
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@@ -33,7 +33,7 @@
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————————————————————————————————————————————————————————————————————————
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Body System or Organ Class(3)
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FMQ (Narrow) A: Drug X B: Placebo C: Combination
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Dictionary-Derived Term (N=134) (N=134) (N=132)
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Dictionary-Derived Term (N=134) (N=134) (N=132)
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————————————————————————————————————————————————————————————————————————
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cl A.1
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FMQ1 32 (23.9%) 29 (21.6%) 48 (36.4%)
@@ -99,22 +99,22 @@
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Code
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res
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Output
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Body System or Organ Class
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FMQ (Broad) A: Drug X B: Placebo C: Combination Risk Difference (%) (95% CI)
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Dictionary-Derived Term (N=134) (N=134) (N=132) (N=268)
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————————————————————————————————————————————————————————————————————————————————————————————————————
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cl B.2
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FMQ1 20 (14.9%) 17 (12.7%) 22 (16.7%) -2.2 (-10.5 - 6.0)
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dcd B.2.2.3.1 20 (14.9%) 17 (12.7%) 22 (16.7%) -2.2 (-10.5 - 6.0)
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FMQ2 22 (16.4%) 25 (18.7%) 21 (15.9%) 2.2 (-6.9 - 11.3)
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dcd B.2.2.3.1 22 (16.4%) 25 (18.7%) 21 (15.9%) 2.2 (-6.9 - 11.3)
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FMQ3 18 (13.4%) 24 (17.9%) 23 (17.4%) 4.5 (-4.2 - 13.2)
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dcd B.2.2.3.1 18 (13.4%) 24 (17.9%) 23 (17.4%) 4.5 (-4.2 - 13.2)
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cl C.1
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FMQ1 14 (10.4%) 19 (14.2%) 21 (15.9%) 3.7 (-4.1 - 11.6)
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dcd C.1.1.1.3 14 (10.4%) 19 (14.2%) 21 (15.9%) 3.7 (-4.1 - 11.6)
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FMQ2 17 (12.7%) 22 (16.4%) 19 (14.4%) 3.7 (-4.7 - 12.2)
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dcd C.1.1.1.3 17 (12.7%) 22 (16.4%) 19 (14.4%) 3.7 (-4.7 - 12.2)
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FMQ3 20 (14.9%) 16 (11.9%) 19 (14.4%) -3.0 (-11.1 - 5.2)
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dcd C.1.1.1.3 20 (14.9%) 16 (11.9%) 19 (14.4%) -3.0 (-11.1 - 5.2)
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Body System or Organ Class
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FMQ (Broad) A: Drug X B: Placebo C: Combination Risk Difference (%) (95% CI)
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Dictionary-Derived Term (N=134) (N=134) (N=132) (N=268)
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—————————————————————————————————————————————————————————————————————————————————————————————————————
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cl B.2
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FMQ1 20 (14.9%) 17 (12.7%) 22 (16.7%) -2.2 (-10.5 - 6.0)
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dcd B.2.2.3.1 20 (14.9%) 17 (12.7%) 22 (16.7%) -2.2 (-10.5 - 6.0)
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FMQ2 22 (16.4%) 25 (18.7%) 21 (15.9%) 2.2 (-6.9 - 11.3)
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dcd B.2.2.3.1 22 (16.4%) 25 (18.7%) 21 (15.9%) 2.2 (-6.9 - 11.3)
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FMQ3 18 (13.4%) 24 (17.9%) 23 (17.4%) 4.5 (-4.2 - 13.2)
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dcd B.2.2.3.1 18 (13.4%) 24 (17.9%) 23 (17.4%) 4.5 (-4.2 - 13.2)
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cl C.1
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FMQ1 14 (10.4%) 19 (14.2%) 21 (15.9%) 3.7 (-4.1 - 11.6)
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dcd C.1.1.1.3 14 (10.4%) 19 (14.2%) 21 (15.9%) 3.7 (-4.1 - 11.6)
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FMQ2 17 (12.7%) 22 (16.4%) 19 (14.4%) 3.7 (-4.7 - 12.2)
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dcd C.1.1.1.3 17 (12.7%) 22 (16.4%) 19 (14.4%) 3.7 (-4.7 - 12.2)
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FMQ3 20 (14.9%) 16 (11.9%) 19 (14.4%) -3.0 (-11.1 - 5.2)
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dcd C.1.1.1.3 20 (14.9%) 16 (11.9%) 19 (14.4%) -3.0 (-11.1 - 5.2)
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‎tests/testthat/test-fda-table_38.R

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@@ -31,7 +31,8 @@ test_that("Table 38 generation works with custom values", {
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),
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main_footer = paste(
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"Source: [include Applicant source, datasets and/or software tools used]\n",
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"(1) Duration = [e.g., X week double-blind treatment period or median and a range indicating pooled trial durations].\n",
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"(1) Duration = [e.g., X week double-blind treatment period or median and a range indicating pooled trial",
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"durations].\n",
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"(2) Treatment-emergent adverse event defined as [definition]. MedDRA version X.\n",
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"(3) Each FMQ is aligned to a single SOC based on clinical judgment. However,\n",
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"please be aware that some FMQs may contain PTs from more than one SOC."

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