Vital Signs

Values and Change from Baseline by Visit

Setup

See Prerequisites for installation instructions.

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

# Safety population vitals (baseline + post-baseline analysis visits)
advs_saf <- pharmaverseadam::advs |>
  blank_to_na() |>
  filter(
    SAFFL   == "Y",
    TRT01A  != "Screen Failure",
    PARAMCD %in% c("SYSBP", "DIABP", "PULSE", "TEMP"),
    ANL01FL == "Y" | AVISIT == "Baseline"
  )

# Arm N from ADSL
adsl_saf <- pharmaverseadam::adsl |>
  blank_to_na() |>
  filter(SAFFL == "Y", TRT01A != "Screen Failure")

arm_n      <- adsl_saf |> count(TRT01A) |> pull(n, name = TRT01A)
arm_levels <- c("Placebo", "Xanomeline Low Dose", "Xanomeline High Dose")

# Visit ordering (include Baseline)
visit_order <- c(
  "Baseline", "Week 2", "Week 4", "Week 6", "Week 8",
  "Week 12", "Week 16", "Week 20", "Week 24",
  "Week 26", "End of Treatment"
)

advs_saf <- advs_saf |>
  mutate(
    AVISIT = factor(AVISIT, levels = visit_order),
    TRT01A = factor(TRT01A, levels = arm_levels)
  ) |>
  filter(!is.na(AVISIT))

Data Preparation

# ── Wide layout: one row per Visit × Treatment ──
# Value stats: N, Mean, SD, Median, Min, Max
# Change from Baseline stats: N, Mean, SD, Median, Min, Max

fmt1 <- function(x) ifelse(is.na(x), "", sprintf("%.1f", x))
fmt0 <- function(x) ifelse(is.na(x), "", sprintf("%.0f", x))

vs_wide <- advs_saf |>
  group_by(PARAM, PARAMCD, AVISIT, TRT01A) |>
  summarise(
    val_n      = as.character(sum(!is.na(AVAL))),
    val_mean   = fmt1(mean(AVAL, na.rm = TRUE)),
    val_sd     = fmt1(sd(AVAL, na.rm = TRUE)),
    val_median = fmt1(median(AVAL, na.rm = TRUE)),
    val_min    = fmt0(min(AVAL, na.rm = TRUE)),
    val_max    = fmt0(max(AVAL, na.rm = TRUE)),
    chg_n      = if (all(is.na(CHG))) "" else as.character(sum(!is.na(CHG))),
    chg_mean   = if (all(is.na(CHG))) "" else fmt1(mean(CHG, na.rm = TRUE)),
    chg_sd     = if (all(is.na(CHG))) "" else fmt1(sd(CHG, na.rm = TRUE)),
    chg_median = if (all(is.na(CHG))) "" else fmt1(median(CHG, na.rm = TRUE)),
    chg_min    = if (all(is.na(CHG))) "" else fmt0(min(CHG, na.rm = TRUE)),
    chg_max    = if (all(is.na(CHG))) "" else fmt0(max(CHG, na.rm = TRUE)),
    .groups    = "drop"
  ) |>
  # Handle visits with no CHG data (Baseline)
 mutate(
    across(starts_with("chg_"), ~ ifelse(.x %in% c("NaN", "NA", "Inf", "-Inf"), "", .x))
  ) |>
  arrange(PARAM, AVISIT, TRT01A) |>
  mutate(across(where(is.factor), as.character))

vs_data <- advs_saf |>
  mutate(across(where(is.factor), as.character))

vs_ard <- ard_stack(
  data  = vs_data,
  .by   = c("TRT01A", "PARAM", "AVISIT"),
  ard_continuous(
    variables = c("AVAL", "CHG"),
    statistic = ~ continuous_summary_fns(c("N", "mean", "sd", "median", "min", "max"))
  ),
  .overall = FALSE
) |>
  filter(variable %in% c("AVAL", "CHG"))

# Pivot to wide: one row per Visit × Treatment
vs_cards <- vs_ard |>
  mutate(
    stat_val = as.numeric(unlist(stat)),
    stat_name = as.character(stat_name),
    var = as.character(variable),
    arm = as.character(unlist(group1_level)),
    param = as.character(unlist(group2_level)),
    visit = as.character(unlist(group3_level))
  ) |>
  mutate(
    col_name = paste0(
      ifelse(var == "AVAL", "val_", "chg_"),
      stat_name
    )
  ) |>
  select(param, visit, arm, col_name, stat_val) |>
  pivot_wider(names_from = col_name, values_from = stat_val) |>
  mutate(across(where(is.numeric), ~ ifelse(is.na(.) | is.nan(.) | is.infinite(.), NA_real_, .)))

arframe Pipeline

The rendered table below uses the dplyr data prep (vs_wide). The cards tab produces an equivalent vs_cards — swap it in to use the cards path instead.

Each row is a treatment group at a visit, with Value and Change from Baseline statistics as columns:

vs_wide |>
  fr_table() |>
  fr_titles(
    "Table 14.3.9",
    "Summary of Vital Signs: Values and Change from Baseline",
    "Safety Population"
  ) |>
  fr_cols(
    PARAMCD    = fr_col(visible = FALSE),
    PARAM      = fr_col(visible = FALSE),
    AVISIT     = fr_col(visible = FALSE),
    TRT01A     = fr_col("", width = 1.5),
    val_n      = fr_col("N",      align = "decimal", width = 0.5),
    val_mean   = fr_col("Mean",   align = "decimal", width = 0.7),
    val_sd     = fr_col("SD",     align = "decimal", width = 0.7),
    val_median = fr_col("Median", align = "decimal", width = 0.7),
    val_min    = fr_col("Min",    align = "decimal", width = 0.5),
    val_max    = fr_col("Max",    align = "decimal", width = 0.5),
    chg_n      = fr_col("N",      align = "decimal", width = 0.5),
    chg_mean   = fr_col("Mean",   align = "decimal", width = 0.7),
    chg_sd     = fr_col("SD",     align = "decimal", width = 0.7),
    chg_median = fr_col("Median", align = "decimal", width = 0.7),
    chg_min    = fr_col("Min",    align = "decimal", width = 0.5),
    chg_max    = fr_col("Max",    align = "decimal", width = 0.5)
  ) |>
  fr_spans(
    "Value" = c("val_n", "val_mean", "val_sd", "val_median", "val_min", "val_max"),
    "Change from Baseline" = c("chg_n", "chg_mean", "chg_sd", "chg_median", "chg_min", "chg_max"),
    .gap = FALSE
  ) |>
  fr_header(bold = TRUE, align = "center") |>
  fr_rows(
    group_by    = list(cols = "AVISIT", label = "TRT01A"),
    blank_after = "AVISIT",
    page_by     = "PARAM",
    group_style = list(bold = TRUE)
  ) |>
  fr_footnotes(
    "Value = observed value at visit; Change = post-baseline value minus baseline.",
    "SD = Standard Deviation.",
    "CDISCPILOT01 Safety Population."
  )

Rendered Table

Table 14.3.9

Summary of Vital Signs: Values and Change from Baseline

Safety Population

Diastolic Blood Pressure (mmHg)

	Value						Change from Baseline
	N	Mean	SD	Median	Min	Max	N	Mean	SD	Median	Min	Max
Baseline
Placebo	340	77.1	10.7	77.7	40	110
Xanomeline Low Dose	384	76.6	9.8	76.7	48	108
Xanomeline High Dose	288	78.2	10.3	78.8	51	108

Week 2
Placebo	332	74.6	10.1	74.0	45	100	249	-2.4	9.2	-2.0		30
Xanomeline Low Dose	300	76.9	9.7	76.7	55	102	225	-0.1	8.9	0.0		32
Xanomeline High Dose	286	76.3	9.7	76.0	43	101	214	-1.9	10.7	0.0		26

Week 4
Placebo	312	75.3	11.5	76.0	39	100	234	-1.8	9.9	-2.0		30
Xanomeline Low Dose	260	75.9	9.2	76.5	50	100	195	-0.0	9.1	0.0		28
Xanomeline High Dose	268	77.1	9.5	79.0	54	100	201	-1.3	11.2	-1.0		26

Week 6
Placebo	296	74.3	10.0	74.0	48	110	222	-3.2	9.6	-2.0		26
Xanomeline Low Dose	236	74.7	9.3	76.0	50	100	177	-1.1	8.6	0.0		34
Xanomeline High Dose	224	75.5	9.6	76.3	52	98	168	-3.3	9.9	-3.0		18

Week 8
Placebo	284	75.1	9.2	76.0	49	101	213	-2.1	9.1	-2.0		24
Xanomeline Low Dose	216	75.6	10.6	74.0	52	100	162	-0.4	10.8	0.0		34
Xanomeline High Dose	204	77.0	9.2	78.0	54	98	153	-1.6	9.7	0.0		20

Week 12
Placebo	272	74.1	10.8	72.8	49	104	204	-3.0	9.2	-2.5		20
Xanomeline Low Dose	164	76.1	11.5	78.3	50	100	123	-0.7	10.7	0.0		34
Xanomeline High Dose	164	74.9	9.3	76.0	56	92	123	-3.4	10.9	-2.0		20

Week 16
Placebo	268	75.0	11.0	76.0	49	98	201	-1.9	9.7	0.0		24
Xanomeline Low Dose	128	75.6	10.3	76.0	55	98	96	-1.3	9.1	-2.5		20
Xanomeline High Dose	132	75.8	8.6	76.0	50	92	99	-1.2	10.3	0.0		27

Week 20
Placebo	248	72.8	10.2	72.0	48	98	186	-2.9	9.4	-3.5		18
Xanomeline Low Dose	108	73.9	9.0	74.3	52	98	81	-2.6	10.5	0.0		20
Xanomeline High Dose	120	74.2	10.4	72.0	54	98	90	-2.9	11.3	-2.0		28

Week 24
Placebo	236	73.8	11.7	74.0	44	117	177	-2.1	10.3	-3.0		41
Xanomeline Low Dose	100	76.0	9.9	76.0	57	98	75	-0.6	8.0	0.0		18
Xanomeline High Dose	112	75.4	10.0	76.0	50	98	84	-2.2	9.6	-4.0		22

Week 26
Placebo	204	72.9	10.6	72.0	39	98	153	-3.3	9.5	-4.0		24
Xanomeline Low Dose	84	73.3	10.2	72.3	56	92	63	-3.5	8.4	-2.0		22
Xanomeline High Dose	96	73.5	9.7	73.5	50	93	72	-3.6	10.3	-4.0		20

End of Treatment
Placebo	222	74.4	10.7	73.5	49	104	222	-3.0	9.0	-2.0		20
Xanomeline Low Dose	177	76.0	11.2	76.0	50	100	177	0.1	10.1	0.0		34
Xanomeline High Dose	168	76.0	9.9	78.0	56	98	168	-2.7	11.3	-2.0		20

Value = observed value at visit; Change = post-baseline value minus baseline.

SD = Standard Deviation.

CDISCPILOT01 Safety Population.

/opt/quarto/share/rmd/rmd.R 01APR2026 09:54:39

Table 14.3.9

Summary of Vital Signs: Values and Change from Baseline

Safety Population

Pulse Rate (beats/min)

	Value						Change from Baseline
	N	Mean	SD	Median	Min	Max	N	Mean	SD	Median	Min	Max
Baseline
Placebo	340	73.5	11.6	72.3	51	134
Xanomeline Low Dose	384	72.1	10.8	70.0	50	104
Xanomeline High Dose	288	72.4	9.7	71.7	52	100

Week 2
Placebo	332	73.3	10.1	72.3	50	106	249	-0.1	11.4	0.0		42
Xanomeline Low Dose	300	75.2	10.6	75.0	52	116	225	3.9	10.6	4.0		40
Xanomeline High Dose	286	76.3	9.1	76.0	56	102	214	3.8	9.1	4.0		32

Week 4
Placebo	312	74.1	10.7	74.7	50	120	234	0.5	8.9	0.0		30
Xanomeline Low Dose	260	73.0	10.0	73.7	48	100	195	2.4	10.4	2.0		32
Xanomeline High Dose	268	76.7	10.8	76.0	52	114	201	4.2	10.0	4.0		36

Week 6
Placebo	296	72.7	10.1	72.0	53	108	222	-0.9	12.1	0.0		40
Xanomeline Low Dose	236	72.1	9.0	72.0	52	96	177	2.3	7.7	2.0		24
Xanomeline High Dose	224	75.2	9.6	74.0	54	100	168	2.8	10.5	3.5		29

Week 8
Placebo	284	71.9	9.1	72.0	52	102	213	-1.5	10.9	-2.0		30
Xanomeline Low Dose	216	72.7	11.3	72.0	49	104	162	3.0	10.0	3.5		30
Xanomeline High Dose	204	74.3	9.1	73.3	50	104	153	1.7	9.0	2.0		26

Week 12
Placebo	272	75.1	11.4	74.8	51	106	204	1.7	10.9	0.0		36
Xanomeline Low Dose	164	74.3	9.0	74.3	54	94	123	3.9	11.2	2.0		28
Xanomeline High Dose	164	74.1	9.7	76.0	50	98	123	1.3	9.9	0.0		28

Week 16
Placebo	268	70.6	8.8	70.2	50	90	201	-2.9	10.0	-2.0		28
Xanomeline Low Dose	128	69.2	10.1	68.7	48	104	96	-1.8	10.6	-2.0		34
Xanomeline High Dose	132	73.0	9.6	72.0	51	96	99	-0.4	12.1	0.0		32

Week 20
Placebo	248	71.6	8.6	72.0	53	96	186	-0.9	12.1	-2.0		26
Xanomeline Low Dose	108	69.6	10.2	70.0	40	98	81	-2.0	11.0	0.0		20
Xanomeline High Dose	120	76.9	11.2	80.0	52	100	90	3.1	10.7	3.5		30

Week 24
Placebo	236	71.6	9.0	72.0	50	92	177	-1.1	10.3	0.0		24
Xanomeline Low Dose	100	70.2	10.0	70.5	52	96	75	-2.4	9.2	-1.0		25
Xanomeline High Dose	112	72.3	11.2	70.0	48	98	84	-2.4	11.9	-2.0		20

Week 26
Placebo	204	73.4	10.8	74.0	50	108	153	0.7	12.1	0.0		44
Xanomeline Low Dose	84	69.8	8.7	68.0	53	92	63	-3.7	10.0	-4.0		24
Xanomeline High Dose	96	73.3	11.8	72.0	53	100	72	-1.7	10.6	-2.0		24

End of Treatment
Placebo	222	75.2	11.5	74.0	51	106	222	1.6	10.7	0.0		36
Xanomeline Low Dose	177	74.1	9.4	75.0	50	94	177	4.3	10.4	4.0		28
Xanomeline High Dose	168	73.6	9.6	73.0	50	98	168	1.2	8.9	0.0		28

Value = observed value at visit; Change = post-baseline value minus baseline.

SD = Standard Deviation.

CDISCPILOT01 Safety Population.

/opt/quarto/share/rmd/rmd.R 01APR2026 09:54:39

Table 14.3.9

Summary of Vital Signs: Values and Change from Baseline

Safety Population

Systolic Blood Pressure (mmHg)

	Value						Change from Baseline
	N	Mean	SD	Median	Min	Max	N	Mean	SD	Median	Min	Max
Baseline
Placebo	340	136.8	17.6	136.3	80	184
Xanomeline Low Dose	384	137.9	18.5	138.0	100	194
Xanomeline High Dose	288	137.8	17.2	138.0	100	192

Week 2
Placebo	332	134.1	17.4	130.8	90	173	249	-3.0	14.4	-2.0		40
Xanomeline Low Dose	300	136.0	18.2	133.7	96	190	225	-2.1	15.9	-2.0		40
Xanomeline High Dose	286	131.8	14.8	131.0	96	191	214	-5.9	15.8	-6.0		40

Week 4
Placebo	312	133.7	17.7	132.3	84	202	234	-3.1	15.9	-2.0		50
Xanomeline Low Dose	260	135.3	17.8	134.0	95	180	195	-1.6	17.1	0.0		80
Xanomeline High Dose	268	132.6	15.9	132.0	95	181	201	-5.8	16.1	-6.0		40

Week 6
Placebo	296	133.4	17.9	130.0	80	210	222	-2.9	15.4	-2.0		48
Xanomeline Low Dose	236	134.0	18.4	130.8	98	195	177	-2.7	14.1	-2.0		35
Xanomeline High Dose	224	130.5	16.0	130.0	90	174	168	-8.6	17.4	-8.0		44

Week 8
Placebo	284	136.2	17.1	136.5	90	189	213	-0.1	15.2	0.0		50
Xanomeline Low Dose	216	134.9	16.5	133.5	92	180	162	-0.5	14.8	0.0		46
Xanomeline High Dose	204	134.3	15.4	133.7	91	198	153	-3.7	16.2	-4.0		50

Week 12
Placebo	272	132.5	15.0	132.0	78	168	204	-4.0	17.1	-3.5		34
Xanomeline Low Dose	164	131.7	15.9	131.0	92	170	123	-2.4	14.4	-2.0		32
Xanomeline High Dose	164	129.5	15.3	130.0	100	177	123	-8.2	15.4	-8.0		30

Week 16
Placebo	268	134.4	18.4	133.7	76	190	201	-1.9	19.3	-6.0		50
Xanomeline Low Dose	128	132.6	15.4	130.0	100	168	96	-1.4	13.8	0.0		30
Xanomeline High Dose	132	132.5	14.2	130.5	102	186	99	-5.1	17.2	-6.0		45

Week 20
Placebo	248	133.2	19.8	131.5	80	200	186	-2.3	16.7	-2.0		58
Xanomeline Low Dose	108	129.8	15.9	128.8	100	162	81	-3.0	14.1	-6.0		30
Xanomeline High Dose	120	126.7	15.7	124.0	98	185	90	-10.8	18.6	-10.5		45

Week 24
Placebo	236	134.7	17.7	131.0	90	199	177	-1.9	15.8	-2.0		50
Xanomeline Low Dose	100	132.0	17.6	131.5	92	173	75	0.1	17.4	0.0		48
Xanomeline High Dose	112	131.2	18.7	130.0	90	198	84	-7.4	18.0	-8.0		42

Week 26
Placebo	204	129.9	18.0	130.0	80	176	153	-6.2	17.7	-6.0		42
Xanomeline Low Dose	84	129.9	18.9	129.8	99	173	63	-4.3	14.6	-4.0		32
Xanomeline High Dose	96	122.6	14.7	120.5	95	179	72	-14.2	21.4	-18.0		34

End of Treatment
Placebo	222	132.7	15.4	131.0	78	172	222	-3.6	17.8	-2.5		48
Xanomeline Low Dose	177	133.0	17.1	130.0	92	178	177	-3.7	14.1	-4.0		32
Xanomeline High Dose	168	132.3	15.6	131.0	100	177	168	-6.7	15.0	-8.0		30

Value = observed value at visit; Change = post-baseline value minus baseline.

SD = Standard Deviation.

CDISCPILOT01 Safety Population.

/opt/quarto/share/rmd/rmd.R 01APR2026 09:54:39

Table 14.3.9

Summary of Vital Signs: Values and Change from Baseline

Safety Population

Temperature (C)

	Value						Change from Baseline
	N	Mean	SD	Median	Min	Max	N	Mean	SD	Median	Min	Max
Baseline
Placebo	172	36.6	0.4	36.7	35	37
Xanomeline Low Dose	190	36.5	0.4	36.6	35	37
Xanomeline High Dose	144	36.6	0.4	36.6	36	37

Week 2
Placebo	164	36.6	0.4	36.6	35	38	164	-0.0	0.4	-0.0		1
Xanomeline Low Dose	150	36.5	0.4	36.6	35	38	150	-0.0	0.4	0.0		1
Xanomeline High Dose	142	36.6	0.4	36.7	35	37	142	0.0	0.4	0.0		1

Week 4
Placebo	154	36.6	0.5	36.7	34	38	154	0.0	0.4	0.0		1
Xanomeline Low Dose	130	36.5	0.5	36.6	34	37	130	-0.1	0.5	0.0		1
Xanomeline High Dose	134	36.6	0.4	36.7	35	37	134	0.1	0.3	0.0		1

Week 6
Placebo	148	36.6	0.4	36.7	35	38	148	0.0	0.4	0.0		1
Xanomeline Low Dose	118	36.5	0.5	36.7	35	37	118	-0.0	0.4	0.0		1
Xanomeline High Dose	112	36.6	0.4	36.7	36	37	112	0.0	0.4	0.0		1

Week 8
Placebo	142	36.6	0.4	36.7	36	37	142	0.0	0.4	0.0		1
Xanomeline Low Dose	106	36.6	0.4	36.6	36	37	106	0.0	0.4	0.0		1
Xanomeline High Dose	102	36.6	0.4	36.7	36	37	102	0.0	0.4	0.0		1

Week 12
Placebo	136	36.6	0.4	36.8	35	37	136	0.1	0.4	0.0		1
Xanomeline Low Dose	82	36.6	0.5	36.7	35	38	82	0.1	0.4	0.0		2
Xanomeline High Dose	82	36.7	0.4	36.8	36	37	82	0.0	0.3	-0.1		1

Week 16
Placebo	134	36.7	0.3	36.7	36	37	134	0.1	0.5	0.0		1
Xanomeline Low Dose	62	36.6	0.4	36.6	36	37	62	0.0	0.4	0.0		1
Xanomeline High Dose	66	36.6	0.4	36.7	36	37	66	-0.0	0.4	0.0		1

Week 20
Placebo	120	36.6	0.5	36.7	35	38	120	0.1	0.5	0.0		1
Xanomeline Low Dose	54	36.7	0.5	36.6	35	38	54	0.1	0.5	0.0		1
Xanomeline High Dose	60	36.7	0.5	36.7	35	38	60	0.0	0.4	0.0		1

Week 24
Placebo	114	36.6	0.5	36.7	35	38	114	0.1	0.5	0.1		1
Xanomeline Low Dose	48	36.6	0.4	36.8	36	37	48	0.1	0.4	0.0		1
Xanomeline High Dose	54	36.7	0.4	36.8	36	38	54	-0.0	0.5	-0.0		1

Week 26
Placebo	102	36.7	0.4	36.7	35	38	102	0.1	0.4	0.1		1
Xanomeline Low Dose	42	36.6	0.5	36.7	35	37	42	-0.0	0.5	0.1		1
Xanomeline High Dose	48	36.8	0.2	36.8	36	37	48	0.0	0.4	0.0		1

End of Treatment
Placebo	74	36.7	0.4	36.8	35	37	74	0.1	0.4	0.0		1
Xanomeline Low Dose	59	36.6	0.4	36.7	35	38	59	0.1	0.4	0.0		2
Xanomeline High Dose	56	36.6	0.4	36.7	36	37	56	0.1	0.4	0.0		1

Value = observed value at visit; Change = post-baseline value minus baseline.

SD = Standard Deviation.

CDISCPILOT01 Safety Population.

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