Laboratory Test Results Listing

Subject-Level Laboratory Results

Setup

See Prerequisites for installation instructions.

library(arframe)
library(pharmaverseadam)
library(dplyr, warn.conflicts = FALSE)

arm_levels <- c("Placebo", "Xanomeline Low Dose", "Xanomeline High Dose")

chem_params <- c("ALT", "AST", "BILI", "CREAT")

lab_listing <- pharmaverseadam::adlb |>
  blank_to_na() |>
  filter(
    SAFFL == "Y",
    TRT01A %in% arm_levels,
    PARCAT1 == "CHEMISTRY",
    PARAMCD %in% chem_params
  ) |>
  mutate(
    TRT01A = factor(TRT01A, levels = arm_levels),
    AVAL_C = if_else(is.na(AVAL), NA_character_, sprintf("%.1f", AVAL)),
    BASE_C = if_else(is.na(BASE), NA_character_, sprintf("%.1f", BASE)),
    CHG_C  = if_else(is.na(CHG),  NA_character_, sprintf("%.1f", CHG))
  ) |>
  arrange(TRT01A, USUBJID, PARAMCD, AVISITN) |>
  slice_head(n = 200) |>
  select(
    TRT01A,
    USUBJID,
    PARAM,
    AVISIT,
    AVAL_C,
    BASE_C,
    CHG_C,
    ANRIND
  )

arframe Pipeline

lab_listing |>
  fr_table() |>
  fr_titles(
    "Listing 16.2.8",
    "Laboratory Test Results - Chemistry",
    "Safety Population"
  ) |>
  fr_cols(
    TRT01A  = fr_col(visible = FALSE),
    USUBJID = fr_col("Subject ID",         width = 1.2),
    PARAM   = fr_col("Parameter",          width = 2.4),
    AVISIT  = fr_col("Visit",              width = 1.5),
    AVAL_C  = fr_col("Result",             width = 1.0, align = "decimal"),
    BASE_C  = fr_col("Baseline",           width = 1.0, align = "decimal"),
    CHG_C   = fr_col("Change from\nBaseline", width = 1.1, align = "decimal"),
    ANRIND  = fr_col("Normal\nRange Flag", width = 1.0, align = "center")
  ) |>
  fr_header(bold = TRUE, align = "center") |>
  fr_rows(page_by = "TRT01A", sort_by = c("USUBJID", "PARAM", "AVISIT"), suppress = c("USUBJID", "PARAM")) |>
  fr_footnotes(
    "Safety Population: all randomised subjects who received at least one dose of study medication.",
    "Parameters: ALT = Alanine Aminotransferase, AST = Aspartate Aminotransferase, BILI = Bilirubin, CREAT = Creatinine.",
    "Result and Baseline are in original measurement units. Change from Baseline = Result minus Baseline.",
    "Normal Range Flag (ANRIND): HIGH = above upper limit of normal, LOW = below lower limit of normal, NORMAL = within range.",
    "First 200 records shown. Sorted by treatment arm, subject identifier, parameter, and visit."
  )

Rendered Listing

Pages are separated by treatment arm using page_by. Numeric columns use align = "decimal" for alignment on the decimal point. Values are pre-formatted to one decimal place in data preparation.

Listing 16.2.8

Laboratory Test Results - Chemistry

Safety Population

Placebo

Subject ID	Parameter	Visit	Result	Baseline	Change from Baseline	Normal Range Flag
01-701-1015	Alanine Aminotransferase (U/L)	Baseline	27.0	27.0		NORMAL
		POST-BASELINE LAST	23.0	27.0	-4.0	NORMAL
		POST-BASELINE MAXIMUM	41.0	27.0	14.0	HIGH
		POST-BASELINE MINIMUM	17.0	27.0	-10.0	NORMAL
		Week 12	27.0	27.0	0.0	NORMAL
		Week 16	17.0	27.0	-10.0	NORMAL
		Week 2	41.0	27.0	14.0	HIGH
		Week 20	21.0	27.0	-6.0	NORMAL
		Week 24	23.0	27.0	-4.0	NORMAL
		Week 26	23.0	27.0	-4.0	NORMAL
		Week 4	18.0	27.0	-9.0	NORMAL
		Week 6	26.0	27.0	-1.0	NORMAL
		Week 8	22.0	27.0	-5.0	NORMAL
	Aspartate Aminotransferase (U/L)	Baseline	40.0	40.0		HIGH
		POST-BASELINE LAST	19.0	40.0	-21.0	NORMAL
		POST-BASELINE MAXIMUM	33.0	40.0	-7.0	NORMAL
		POST-BASELINE MINIMUM	19.0	40.0	-21.0	NORMAL
		Week 12	22.0	40.0	-18.0	NORMAL
		Week 16	23.0	40.0	-17.0	NORMAL
		Week 2	33.0	40.0	-7.0	NORMAL
		Week 20	19.0	40.0	-21.0	NORMAL
		Week 24	23.0	40.0	-17.0	NORMAL
		Week 26	19.0	40.0	-21.0	NORMAL
		Week 4	21.0	40.0	-19.0	NORMAL
		Week 6	26.0	40.0	-14.0	NORMAL
		Week 8	21.0	40.0	-19.0	NORMAL
	Bilirubin (umol/L)	Baseline	10.3	10.3		NORMAL
		POST-BASELINE LAST	5.1	10.3	-5.1	NORMAL
		POST-BASELINE MAXIMUM	8.5	10.3	-1.7	NORMAL
		POST-BASELINE MINIMUM	5.1	10.3	-5.1	NORMAL
		Week 12	6.8	10.3	-3.4	NORMAL
		Week 16	6.8	10.3	-3.4	NORMAL
		Week 2	8.5	10.3	-1.7	NORMAL
		Week 20	6.8	10.3	-3.4	NORMAL
		Week 24	6.8	10.3	-3.4	NORMAL
		Week 26	5.1	10.3	-5.1	NORMAL
		Week 4	6.8	10.3	-3.4	NORMAL
		Week 6	5.1	10.3	-5.1	NORMAL
		Week 8	8.5	10.3	-1.7	NORMAL
	Creatinine (umol/L)	Baseline	79.6	79.6		NORMAL
		POST-BASELINE LAST	88.4	79.6	8.8	NORMAL
		POST-BASELINE MAXIMUM	88.4	79.6	8.8	NORMAL
		POST-BASELINE MINIMUM	70.7	79.6	-8.8	NORMAL
		Week 12	79.6	79.6	0.0	NORMAL
		Week 16	88.4	79.6	8.8	NORMAL
		Week 2	88.4	79.6	8.8	NORMAL
		Week 20	79.6	79.6	0.0	NORMAL
		Week 24	79.6	79.6	0.0	NORMAL
		Week 26	88.4	79.6	8.8	NORMAL
		Week 4	70.7	79.6	-8.8	NORMAL
		Week 6	88.4	79.6	8.8	NORMAL
		Week 8	88.4	79.6	8.8	NORMAL
01-701-1023	Alanine Aminotransferase (U/L)	Baseline	23.0	23.0		NORMAL
		POST-BASELINE LAST	30.0	23.0	7.0	NORMAL
		POST-BASELINE MAXIMUM	30.0	23.0	7.0	NORMAL
		POST-BASELINE MINIMUM	30.0	23.0	7.0	NORMAL
		Week 2	30.0	23.0	7.0	NORMAL
		Week 4	38.0	23.0	15.0	NORMAL
	Aspartate Aminotransferase (U/L)	Baseline	21.0	21.0		NORMAL
		POST-BASELINE LAST	25.0	21.0	4.0	NORMAL
		POST-BASELINE MAXIMUM	25.0	21.0	4.0	NORMAL
		POST-BASELINE MINIMUM	25.0	21.0	4.0	NORMAL
		Week 2	25.0	21.0	4.0	NORMAL
		Week 4	30.0	21.0	9.0	NORMAL
	Bilirubin (umol/L)	Baseline	12.0	12.0		NORMAL
		POST-BASELINE LAST	6.8	12.0	-5.1	NORMAL
		POST-BASELINE MAXIMUM	6.8	12.0	-5.1	NORMAL
		POST-BASELINE MINIMUM	6.8	12.0	-5.1	NORMAL
		Week 2	6.8	12.0	-5.1	NORMAL
		Week 4	8.5	12.0	-3.4	NORMAL
	Creatinine (umol/L)	Baseline	123.8	123.8		NORMAL
		POST-BASELINE LAST	132.6	123.8	8.8	NORMAL
		POST-BASELINE MAXIMUM	132.6	123.8	8.8	NORMAL
		POST-BASELINE MINIMUM	132.6	123.8	8.8	NORMAL
		Week 2	132.6	123.8	8.8	NORMAL
		Week 4	114.9	123.8	-8.8	NORMAL
01-701-1047	Alanine Aminotransferase (U/L)	Baseline	22.0	22.0		NORMAL
		POST-BASELINE LAST	16.0	22.0	-6.0	NORMAL
		POST-BASELINE MAXIMUM	16.0	22.0	-6.0	NORMAL
		POST-BASELINE MINIMUM	16.0	22.0	-6.0	NORMAL
		Unscheduled 6.1	17.0	22.0	-5.0	NORMAL
		Week 2	16.0	22.0	-6.0	NORMAL
		Week 4	20.0	22.0	-2.0	NORMAL
	Aspartate Aminotransferase (U/L)	Baseline	25.0	25.0		NORMAL
		POST-BASELINE LAST	21.0	25.0	-4.0	NORMAL
		POST-BASELINE MAXIMUM	21.0	25.0	-4.0	NORMAL
		POST-BASELINE MINIMUM	21.0	25.0	-4.0	NORMAL
		Unscheduled 6.1	21.0	25.0	-4.0	NORMAL
		Week 2	21.0	25.0	-4.0	NORMAL
		Week 4	24.0	25.0	-1.0	NORMAL
	Bilirubin (umol/L)	Baseline	6.8	6.8		NORMAL
		POST-BASELINE LAST	8.5	6.8	1.7	NORMAL
		POST-BASELINE MAXIMUM	8.5	6.8	1.7	NORMAL
		POST-BASELINE MINIMUM	8.5	6.8	1.7	NORMAL
		Unscheduled 6.1	6.8	6.8	0.0	NORMAL
		Week 2	8.5	6.8	1.7	NORMAL
		Week 4	6.8	6.8	0.0	NORMAL
	Creatinine (umol/L)	Baseline	88.4	88.4		NORMAL
		POST-BASELINE LAST	88.4	88.4	0.0	NORMAL
		POST-BASELINE MAXIMUM	88.4	88.4	0.0	NORMAL
		POST-BASELINE MINIMUM	88.4	88.4	0.0	NORMAL
		Unscheduled 6.1	88.4	88.4	0.0	NORMAL
		Week 2	88.4	88.4	0.0	NORMAL
		Week 4	79.6	88.4	-8.8	NORMAL
01-701-1118	Alanine Aminotransferase (U/L)	Baseline	15.0	15.0		NORMAL
		POST-BASELINE LAST	10.0	15.0	-5.0	NORMAL
		POST-BASELINE MAXIMUM	16.0	15.0	1.0	NORMAL
		POST-BASELINE MINIMUM	7.0	15.0	-8.0	NORMAL
		Week 12	16.0	15.0	1.0	NORMAL
		Week 16	15.0	15.0	0.0	NORMAL
		Week 2	7.0	15.0	-8.0	NORMAL
		Week 20	13.0	15.0	-2.0	NORMAL
		Week 24	13.0	15.0	-2.0	NORMAL
		Week 26	10.0	15.0	-5.0	NORMAL
		Week 4	15.0	15.0	0.0	NORMAL
		Week 6	11.0	15.0	-4.0	NORMAL
		Week 8	15.0	15.0	0.0	NORMAL
	Aspartate Aminotransferase (U/L)	Baseline	15.0	15.0		NORMAL
		POST-BASELINE LAST	12.0	15.0	-3.0	NORMAL
		POST-BASELINE MAXIMUM	18.0	15.0	3.0	NORMAL
		POST-BASELINE MINIMUM	11.0	15.0	-4.0	NORMAL
		Week 12	13.0	15.0	-2.0	NORMAL
		Week 16	18.0	15.0	3.0	NORMAL
		Week 2	13.0	15.0	-2.0	NORMAL
		Week 20	14.0	15.0	-1.0	NORMAL
		Week 24	11.0	15.0	-4.0	NORMAL
		Week 26	12.0	15.0	-3.0	NORMAL
		Week 4	14.0	15.0	-1.0	NORMAL
		Week 6	15.0	15.0	0.0	NORMAL
		Week 8	18.0	15.0	3.0	NORMAL
	Bilirubin (umol/L)	Baseline	12.0	12.0		NORMAL
		POST-BASELINE LAST	8.5	12.0	-3.4	NORMAL
		POST-BASELINE MAXIMUM	10.3	12.0	-1.7	NORMAL
		POST-BASELINE MINIMUM	8.5	12.0	-3.4	NORMAL
		Week 12	8.5	12.0	-3.4	NORMAL
		Week 16	10.3	12.0	-1.7	NORMAL
		Week 2	8.5	12.0	-3.4	NORMAL
		Week 20	10.3	12.0	-1.7	NORMAL
		Week 24	8.5	12.0	-3.4	NORMAL
		Week 26	8.5	12.0	-3.4	NORMAL
		Week 4	10.3	12.0	-1.7	NORMAL
		Week 6	8.5	12.0	-3.4	NORMAL
		Week 8	10.3	12.0	-1.7	NORMAL
	Creatinine (umol/L)	Baseline	88.4	88.4		NORMAL
		POST-BASELINE LAST	97.2	88.4	8.8	NORMAL
		POST-BASELINE MAXIMUM	106.1	88.4	17.7	NORMAL
		POST-BASELINE MINIMUM	88.4	88.4	0.0	NORMAL
		Week 12	106.1	88.4	17.7	NORMAL
		Week 16	97.2	88.4	8.8	NORMAL
		Week 2	88.4	88.4	0.0	NORMAL
		Week 20	106.1	88.4	17.7	NORMAL
		Week 24	97.2	88.4	8.8	NORMAL
		Week 26	97.2	88.4	8.8	NORMAL
		Week 4	106.1	88.4	17.7	NORMAL
		Week 6	97.2	88.4	8.8	NORMAL
		Week 8	88.4	88.4	0.0	NORMAL
01-701-1130	Alanine Aminotransferase (U/L)	Baseline	15.0	15.0		NORMAL
		POST-BASELINE LAST	10.0	15.0	-5.0	NORMAL
		POST-BASELINE MAXIMUM	18.0	15.0	3.0	NORMAL
		POST-BASELINE MINIMUM	10.0	15.0	-5.0	NORMAL
		Week 12	13.0	15.0	-2.0	NORMAL
		Week 16	12.0	15.0	-3.0	NORMAL
		Week 2	14.0	15.0	-1.0	NORMAL
		Week 20	11.0	15.0	-4.0	NORMAL
		Week 24	13.0	15.0	-2.0	NORMAL
		Week 26	10.0	15.0	-5.0	NORMAL
		Week 4	18.0	15.0	3.0	NORMAL
		Week 6	13.0	15.0	-2.0	NORMAL
		Week 8	10.0	15.0	-5.0	NORMAL
	Aspartate Aminotransferase (U/L)	Baseline	24.0	24.0		NORMAL
		POST-BASELINE LAST	19.0	24.0	-5.0	NORMAL
		POST-BASELINE MAXIMUM	26.0	24.0	2.0	NORMAL
		POST-BASELINE MINIMUM	18.0	24.0	-6.0	NORMAL
		Week 12	21.0	24.0	-3.0	NORMAL
		Week 16	19.0	24.0	-5.0	NORMAL
		Week 2	26.0	24.0	2.0	NORMAL
		Week 20	19.0	24.0	-5.0	NORMAL
		Week 24	22.0	24.0	-2.0	NORMAL
		Week 26	19.0	24.0	-5.0	NORMAL
		Week 4	25.0	24.0	1.0	NORMAL
		Week 6	19.0	24.0	-5.0	NORMAL
		Week 8	18.0	24.0	-6.0	NORMAL
	Bilirubin (umol/L)	Baseline	8.5	8.5		NORMAL
		POST-BASELINE LAST	10.3	8.5	1.7	NORMAL
		POST-BASELINE MAXIMUM	12.0	8.5	3.4	NORMAL
		POST-BASELINE MINIMUM	5.1	8.5	-3.4	NORMAL
		Week 12	8.5	8.5	0.0	NORMAL
		Week 16	10.3	8.5	1.7	NORMAL
		Week 2	10.3	8.5	1.7	NORMAL
		Week 20	6.8	8.5	-1.7	NORMAL
		Week 24	12.0	8.5	3.4	NORMAL
		Week 26	10.3	8.5	1.7	NORMAL
		Week 4	5.1	8.5	-3.4	NORMAL
		Week 6	6.8	8.5	-1.7	NORMAL
		Week 8	10.3	8.5	1.7	NORMAL
	Creatinine (umol/L)	Baseline	123.8	123.8		NORMAL
		Week 2	123.8	123.8	0.0	NORMAL
		Week 4	176.8	123.8	53.0	HIGH
		Week 6	123.8	123.8	0.0	NORMAL
		Week 8	114.9	123.8	-8.8	NORMAL

Safety Population: all randomised subjects who received at least one dose of study medication.

Parameters: ALT = Alanine Aminotransferase, AST = Aspartate Aminotransferase, BILI = Bilirubin, CREAT = Creatinine.

Result and Baseline are in original measurement units. Change from Baseline = Result minus Baseline.

Normal Range Flag (ANRIND): HIGH = above upper limit of normal, LOW = below lower limit of normal, NORMAL = within range.

First 200 records shown. Sorted by treatment arm, subject identifier, parameter, and visit.

/opt/quarto/share/rmd/rmd.R 01APR2026 09:50:59