TSFLAB07

Shift in Laboratory Values From Baseline to Worst Grade During Time Period Based on NCI-CTCAE Criteria

---

Output

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# Program Name:              tsflab07

# Prep Environment

library(envsetup)
library(tern)
library(dplyr)
library(rtables)
library(junco)

# Define script level parameters:

tblid <- "TSFLAB07"
fileid <- tblid
titles <- get_titles_from_file(input_path = '../../_data/', tblid)
string_map <- default_str_map


ad_domain <- "ADLB"

popfl <- "SAFFL"
trtvar <- "TRT01A"
ctrl_grp <- "Placebo"

# Initial processing of data

adlb_complete <- pharmaverseadamjnj::adlb

# Process Data:

adsl <- pharmaverseadamjnj::adsl %>%
  filter(.data[[popfl]] == "Y") %>%
  select(STUDYID, USUBJID, all_of(c(popfl, trtvar)))

adsl <- adsl %>%
  mutate(
    colspan_trt = factor(
      ifelse(.data[[trtvar]] == ctrl_grp, " ", "Active Study Agent"),
      levels = c("Active Study Agent", " ")
    )
  )

## to ensure the same order as on other outputs
trt_order <- as.character((unique(
  adsl %>% select("colspan_trt", all_of(trtvar))
) %>%
  arrange(colspan_trt, .data[[trtvar]]))[[trtvar]])
adsl[[trtvar]] <- factor(as.character(adsl[[trtvar]]), levels = trt_order)


availparcat56 <- c(
  "Blood and lymphatic system disorders",
  "Investigations",
  "Metabolism and nutritional disorders",
  "Renal and urinary disorders"
)

flagvars <- c("ONTRTFL", "TRTEMFL", "LVOTFL", "ABLFL")
adlb00 <- adlb_complete %>%
  filter(!is.na(ATOXGR)) %>%
  filter(!is.na(BTOXGR)) %>%
  select(
    USUBJID,
    AVISITN,
    AVISIT,
    PARAMCD,
    PARAM,
    PARAMN,
    PARCAT1,
    PARCAT3,
    PARCAT5,
    PARCAT6,
    starts_with("ATOX"),
    starts_with("BTOX"),
    starts_with("ANL"),
    all_of(flagvars),
    LBSEQ,
    AVAL,
    AVALC
  ) %>%
  inner_join(adsl) %>%
  relocate(
    .,
    USUBJID,
    ANL04FL,
    ANL05FL,
    ONTRTFL,
    TRTEMFL,
    AVISIT,
    ATOXGRL,
    ATOXGRH,
    ATOXDSCL,
    ATOXDSCH,
    ABLFL,
    BTOXGRL,
    BTOXGRH,
    PARAMCD,
    PARCAT3,
    AVISIT,
    AVAL
  )


adlb00 <- var_relabel_list(adlb00, var_labels(adlb_complete, fill = T))

filtered_adlb <- adlb00

## similar to LAB03: separate low and high and then combine
## esp as for 2 tests PARCAT5/6 is not the same for low/high direction

filtered_adlb_low <- filtered_adlb %>%
  filter(!is.na(ATOXDSCL) & !is.na(ATOXGRL)) %>%
  mutate(
    ATOXDSCLH = ATOXDSCL,
    ATOXGRLH = ATOXGRL,
    BTOXGRLH = BTOXGRL,
    ATOXDIR = "LOW",
    ANL045FL = ANL04FL
  ) %>%
  select(-c(ATOXGRL, ATOXGRH, ATOXDSCL, ATOXDSCH, BTOXGRL, BTOXGRH))

### high grades: ATOXDSCH ATOXGRH ANL05FL
filtered_adlb_high <- filtered_adlb %>%
  filter(!is.na(ATOXDSCH) & !is.na(ATOXGRH)) %>%
  mutate(
    ATOXDSCLH = ATOXDSCH,
    ATOXGRLH = ATOXGRH,
    BTOXGRLH = BTOXGRH,
    ATOXDIR = "HIGH",
    ANL045FL = ANL05FL
  ) %>%
  select(-c(ATOXGRL, ATOXGRH, ATOXDSCL, ATOXDSCH, BTOXGRL, BTOXGRH))


## combine Low and high into adlb_tox
filtered_adlb_tox <-
  bind_rows(
    filtered_adlb_low,
    filtered_adlb_high
  ) %>%
  select(-c(ATOXGR, ATOXGRN)) %>%
  inner_join(adsl)


### correction of proper category (PARCAT56) for HGB (LOW) and WBC (HIGH)
filtered_adlb_tox <-
  filtered_adlb_tox %>%
  mutate(
    PARCAT56 = case_when(
      PARAMCD == "HGB" & ATOXDIR == "LOW" ~ PARCAT6,
      PARAMCD == "WBC" & ATOXDIR == "HIGH" ~ PARCAT6,
      TRUE ~ PARCAT5
    )
  ) %>%
  mutate(
    PARCAT56 = factor(
      PARCAT56,
      levels = unique(c(
        "Blood and lymphatic system disorders",
        levels(adlb_complete$PARCAT5)
      ))
    )
  )


### filter for timepoints (either per visit or worst over a time period (overall,period,phase,...))

## here: use worst overall: ANL04FL/ANL05FL --- ANL045FL
## if worst per period/phase:use ANL07/8 and ANL9/10 --- and ensure to create a combined version ANL078FL, ANL0910FL in the above code
filtered_adlb_tox <-
  filtered_adlb_tox %>%
  filter(ANL045FL == "Y")

## add the word Grade to ATOXGRLH,BTOXGRLH, For BTOXGRLH add an extra level (for display purpose)
filtered_adlb_tox <-
  filtered_adlb_tox %>%
  mutate(
    ATOXGRLH = factor(paste("Grade", ATOXGRLH), levels = paste("Grade", 0:4)),
    BTOXGRLH = factor(
      paste("Grade", BTOXGRLH),
      levels = c("N", paste("Grade", 0:4))
    )
  )

## trick for alt_counts_df to work with col splitting
# add BNRIND to adsl, all assign to extra level N (column will be used for N counts)
adsl <- adsl %>%
  mutate(BTOXGRLH = "N") %>%
  mutate(BTOXGRLH = factor(BTOXGRLH, levels = c("N", paste("Grade", 0:4))))

## add variable for column split header
filtered_adlb_tox$BTOXGRLH_header <- "Baseline Toxicity Grade"
adsl$BTOXGRLH_header <- "Baseline Toxicity Grade"

filtered_adlb_tox$BTOXGRLH_header2 <- " " ## first column N should not appear under Baseline column span
adsl$BTOXGRLH_header2 <- " " ## first column N should not appear under Baseline column span


### Alphabetical sorting of toxicity terms
atoxdsclh_levels <- sort(as.character(unique(filtered_adlb_tox$ATOXDSCLH)))

filtered_adlb_tox <- filtered_adlb_tox %>%
  mutate(ATOXDSCLH = factor(as.character(ATOXDSCLH), levels = atoxdsclh_levels))


check_categories <- unique(
  filtered_adlb_tox %>% select(PARCAT3, PARCAT56, ATOXDSCLH)
) %>%
  arrange(PARCAT3, PARCAT56, ATOXDSCLH)

# Define layout and build table:

lyt <- basic_table(show_colcounts = FALSE) %>%
  ## to ensure N column is not under the Baseline column span header
  split_cols_by("BTOXGRLH_header2") %>%
  split_cols_by("BTOXGRLH", split_fun = keep_split_levels("N")) %>%
  split_cols_by("BTOXGRLH_header", nested = FALSE) %>%
  split_cols_by(
    "BTOXGRLH",
    split_fun = make_split_fun(
      pre = list(rm_levels(excl = "N")),
      post = list(add_overall_facet("TOTAL", "Total"))
    )
  ) %>%
  #### replace split_rows and summarize by single analyze call
  ### a_freq_j only works due to
  ### special arguments can do the trick : denomf = adslx & .stats = count_unique
  ### we want counts of treatment group coming from adsl, not from input dataset, therefor, countsource = altdf
  analyze(
    vars = trtvar,
    afun = a_freq_j,
    extra_args = list(
      restr_columns = "N",
      .stats = "count_unique",
      countsource = "altdf",
      extrablankline = TRUE
    ),
    indent_mod = -1L
  ) %>%
  ## main part of table, restart row-split so nested = FALSE

  split_rows_by(
    "PARCAT56",
    nested = FALSE,
    label_pos = "topleft",
    child_labels = "visible",
    split_label = "NCI-CTCAE Category",
    split_fun = drop_split_levels,
    section_div = " "
  ) %>%
  split_rows_by(
    "ATOXDSCLH",
    label_pos = "topleft",
    child_labels = "visible",
    split_label = "Laboratory Test",
    split_fun = drop_split_levels,
    section_div = " "
  ) %>%
  split_rows_by(
    trtvar,
    label_pos = "hidden",
    split_label = "Treatment Group",
    section_div = " "
  ) %>%
  ### a_freq_j
  ### the special statistic "n_rowdf" option does the trick here of getting the proper value for the N column
  summarize_row_groups(
    trtvar,
    cfun = a_freq_j,
    extra_args = list(
      .stats = "n_rowdf",
      restr_columns = c("N")
    ),
  ) %>%
  ## add extra level TOTAL using new_levels, rather than earlier technique
  ## advantage for denominator derivation -- n_rowdf can be used, if we'd like to present fraction as well
  ## switch .stats to count_unique_denom_fraction or count_unique_fraction
  analyze(
    "ATOXGRLH",
    var_labels = "Worst toxicity grade, n",
    show_labels = "visible",
    indent_mod = 1L,
    afun = a_freq_j,
    extra_args = list(
      .stats = "count_unique",
      denom = "n_rowdf",
      new_levels = list(
        c("Total"),
        list(c("Grade 0", "Grade 1", "Grade 2", "Grade 3", "Grade 4"))
      ),
      new_levels_after = TRUE,
      .indent_mods = 1L,
      restr_columns = c(
        c("GRADE 0", "GRADE 1", "GRADE 2", "GRADE 3", "GRADE 4", "TOTAL")
      )
    )
  )


if (nrow(filtered_adlb_tox) > 0) {
  result <- build_table(lyt, filtered_adlb_tox, alt_counts_df = adsl)
} else {
  result <- NULL
}

# Set title

result <- set_titles(result, titles)

# Convert to tbl file and output table

tt_to_tlgrtf(string_map = string_map, tt = result, file = fileid, orientation = "landscape")

TSFLAB07: Shift in Laboratory Values From Baseline to Worst Grade [During Time Period] Based on NCI-CTCAE Criteria; Safety Analysis Set (Study jjcs - core)
NCI-CTCAE Category		Baseline Toxicity Grade
Laboratory Test	N	Grade 0	Grade 1	Grade 2	Grade 3	Grade 4	Total
Xanomeline High Dose	53
Xanomeline Low Dose	73
Placebo	59
Blood and lymphatic system  disorders
Leukocytosis
Xanomeline High Dose	53
Worst toxicity grade, n
Grade 0		53	0	0	0	0	53
Grade 1		0	0	0	0	0	0
Grade 2		0	0	0	0	0	0
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		53	0	0	0	0	53
Xanomeline Low Dose	73
Worst toxicity grade, n
Grade 0		73	0	0	0	0	73
Grade 1		0	0	0	0	0	0
Grade 2		0	0	0	0	0	0
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		73	0	0	0	0	73
Placebo	59
Worst toxicity grade, n
Grade 0		59	0	0	0	0	59
Grade 1		0	0	0	0	0	0
Grade 2		0	0	0	0	0	0
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		59	0	0	0	0	59
Investigations
Alanine aminotransferase  increased
Xanomeline High Dose	53
Worst toxicity grade, n
Grade 0		49	4	0	0	0	53
Grade 1		5	4	0	0	0	9
Grade 2		1	0	0	0	0	1
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		49	4	0	0	0	53
Xanomeline Low Dose	73
Worst toxicity grade, n
Grade 0		70	1	0	0	0	71
Grade 1		7	3	0	0	0	10
Grade 2		0	0	0	0	0	0
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		70	3	0	0	0	73
Placebo	59
Worst toxicity grade, n
Grade 0		57	2	0	0	0	59
Grade 1		0	2	0	0	0	2
Grade 2		1	0	0	0	0	1
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		57	2	0	0	0	59
Alkaline phosphatase  increased
Xanomeline High Dose	53
Worst toxicity grade, n
Grade 0		53	0	0	0	0	53
Grade 1		4	0	0	0	0	4
Grade 2		0	0	0	0	0	0
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		53	0	0	0	0	53
Xanomeline Low Dose	73
Worst toxicity grade, n
Grade 0		70	1	0	0	0	71
Grade 1		3	3	0	0	0	6
Grade 2		0	0	0	0	0	0
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		70	3	0	0	0	73
Placebo	59
Worst toxicity grade, n
Grade 0		59	0	0	0	0	59
Grade 1		4	0	0	0	0	4
Grade 2		1	0	0	0	0	1
Grade 3		1	0	0	0	0	1
Grade 4		0	0	0	0	0	0
Total		59	0	0	0	0	59
Aspartate aminotransferase  increased
Xanomeline High Dose	53
Worst toxicity grade, n
Grade 0		50	3	0	0	0	53
Grade 1		4	3	0	0	0	7
Grade 2		1	0	0	0	0	1
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		50	3	0	0	0	53
Xanomeline Low Dose	73
Worst toxicity grade, n
Grade 0		66	4	0	0	0	70
Grade 1		6	7	0	0	0	13
Grade 2		0	1	0	0	0	1
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		66	7	0	0	0	73
Placebo	59
Worst toxicity grade, n
Grade 0		57	2	0	0	0	59
Grade 1		4	2	0	0	0	6
Grade 2		1	0	0	0	0	1
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		57	2	0	0	0	59
Blood bilirubin increased
Xanomeline High Dose	53
Worst toxicity grade, n
Grade 0		51	1	1	0	0	53
Grade 1		1	1	1	0	0	3
Grade 2		0	1	1	0	0	2
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		51	1	1	0	0	53
Xanomeline Low Dose	73
Worst toxicity grade, n
Grade 0		70	3	0	0	0	73
Grade 1		1	3	0	0	0	4
Grade 2		0	1	0	0	0	1
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		70	3	0	0	0	73
Placebo	59
Worst toxicity grade, n
Grade 0		59	0	0	0	0	59
Grade 1		3	0	0	0	0	3
Grade 2		0	0	0	0	0	0
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		59	0	0	0	0	59
Cholesterol high
Xanomeline High Dose	53
Worst toxicity grade, n
Grade 0		51	0	2	0	0	53
Grade 1		3	0	0	0	0	3
Grade 2		0	0	2	0	0	2
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		51	0	2	0	0	53
Xanomeline Low Dose	73
Worst toxicity grade, n
Grade 0		73	0	0	0	0	73
Grade 1		1	0	0	0	0	1
Grade 2		2	0	0	0	0	2
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		73	0	0	0	0	73
Placebo	59
Worst toxicity grade, n
Grade 0		57	0	1	0	0	58
Grade 1		1	0	0	0	0	1
Grade 2		1	0	2	0	0	3
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		57	0	2	0	0	59
Creatinine increased
Xanomeline High Dose	53
Worst toxicity grade, n
Grade 0		49	1	0	0	0	50
Grade 1		42	4	0	0	0	46
Grade 2		0	0	0	0	0	0
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		49	4	0	0	0	53
Xanomeline Low Dose	73
Worst toxicity grade, n
Grade 0		68	2	0	0	0	70
Grade 1		41	5	0	0	0	46
Grade 2		0	0	0	0	0	0
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		68	5	0	0	0	73
Placebo	59
Worst toxicity grade, n
Grade 0		58	1	0	0	0	59
Grade 1		40	1	0	0	0	41
Grade 2		0	0	0	0	0	0
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		58	1	0	0	0	59
Platelet count decreased
Xanomeline High Dose	53
Worst toxicity grade, n
Grade 0		52	1	0	0	0	53
Grade 1		43	1	0	0	0	44
Grade 2		38	0	0	0	0	38
Grade 3		10	0	0	0	0	10
Grade 4		3	0	0	0	0	3
Total		52	1	0	0	0	53
Xanomeline Low Dose	72
Worst toxicity grade, n
Grade 0		67	2	0	0	0	69
Grade 1		48	1	0	0	0	49
Grade 2		35	1	0	0	0	36
Grade 3		25	0	0	0	0	25
Grade 4		1	0	0	0	0	1
Total		70	2	0	0	0	72
Placebo	59
Worst toxicity grade, n
Grade 0		59	0	0	0	0	59
Grade 1		52	0	0	0	0	52
Grade 2		37	0	0	0	0	37
Grade 3		22	0	0	0	0	22
Grade 4		1	0	0	0	0	1
Total		59	0	0	0	0	59
White blood cell decreased
Xanomeline High Dose	53
Worst toxicity grade, n
Grade 0		53	0	0	0	0	53
Grade 1		45	0	0	0	0	45
Grade 2		33	0	0	0	0	33
Grade 3		18	0	0	0	0	18
Grade 4		1	0	0	0	0	1
Total		53	0	0	0	0	53
Xanomeline Low Dose	73
Worst toxicity grade, n
Grade 0		67	3	0	0	0	70
Grade 1		50	3	0	0	0	53
Grade 2		32	1	0	0	0	33
Grade 3		21	0	0	0	0	21
Grade 4		1	0	0	0	0	1
Total		70	3	0	0	0	73
Placebo	59
Worst toxicity grade, n
Grade 0		59	0	0	0	0	59
Grade 1		52	0	0	0	0	52
Grade 2		42	0	0	0	0	42
Grade 3		21	0	0	0	0	21
Grade 4		4	0	0	0	0	4
Total		59	0	0	0	0	59
Metabolism and nutritional  disorders
CD4 lymphocytes decreased
Xanomeline High Dose	51
Worst toxicity grade, n
Grade 0		51	0	0	0	0	51
Grade 1		47	0	0	0	0	47
Grade 2		28	0	0	0	0	28
Grade 3		15	0	0	0	0	15
Grade 4		6	0	0	0	0	6
Total		51	0	0	0	0	51
Xanomeline Low Dose	72
Worst toxicity grade, n
Grade 0		66	2	0	0	0	68
Grade 1		46	1	0	0	0	47
Grade 2		37	0	0	0	0	37
Grade 3		18	0	0	0	0	18
Grade 4		3	1	0	0	0	4
Total		70	2	0	0	0	72
Placebo	57
Worst toxicity grade, n
Grade 0		56	1	0	0	0	57
Grade 1		48	1	0	0	0	49
Grade 2		43	1	0	0	0	44
Grade 3		27	0	0	0	0	27
Grade 4		3	0	0	0	0	3
Total		56	1	0	0	0	57
Hyperglycemia
Xanomeline High Dose	53
Worst toxicity grade, n
Grade 0		53	0	0	0	0	53
Grade 1		0	0	0	0	0	0
Grade 2		0	0	0	0	0	0
Grade 3		6	0	0	0	0	6
Grade 4		0	0	0	0	0	0
Total		53	0	0	0	0	53
Xanomeline Low Dose	73
Worst toxicity grade, n
Grade 0		73	0	0	0	0	73
Grade 1		0	0	0	0	0	0
Grade 2		0	0	0	0	0	0
Grade 3		1	0	0	0	0	1
Grade 4		0	0	0	0	0	0
Total		73	0	0	0	0	73
Placebo	59
Worst toxicity grade, n
Grade 0		59	0	0	0	0	59
Grade 1		0	0	0	0	0	0
Grade 2		0	0	0	0	0	0
Grade 3		1	0	0	0	0	1
Grade 4		0	0	0	0	0	0
Total		59	0	0	0	0	59
Hyperkalemia
Xanomeline High Dose	53
Worst toxicity grade, n
Grade 0		53	0	0	0	0	53
Grade 1		1	0	0	0	0	1
Grade 2		1	0	0	0	0	1
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		53	0	0	0	0	53
Xanomeline Low Dose	73
Worst toxicity grade, n
Grade 0		73	0	0	0	0	73
Grade 1		0	0	0	0	0	0
Grade 2		0	0	0	0	0	0
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		73	0	0	0	0	73
Placebo	59
Worst toxicity grade, n
Grade 0		58	0	1	0	0	59
Grade 1		0	0	1	0	0	1
Grade 2		0	0	1	0	0	1
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		58	0	1	0	0	59
Hypernatremia
Xanomeline High Dose	53
Worst toxicity grade, n
Grade 0		51	2	0	0	0	53
Grade 1		5	2	0	0	0	7
Grade 2		2	0	0	0	0	2
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		51	2	0	0	0	53
Xanomeline Low Dose	73
Worst toxicity grade, n
Grade 0		73	0	0	0	0	73
Grade 1		6	0	0	0	0	6
Grade 2		0	0	0	0	0	0
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		73	0	0	0	0	73
Placebo	59
Worst toxicity grade, n
Grade 0		56	3	0	0	0	59
Grade 1		7	3	0	0	0	10
Grade 2		0	0	0	0	0	0
Grade 3		0	0	0	0	0	0
Grade 4		0	0	0	0	0	0
Total		56	3	0	0	0	59
Hypoalbuminemia
Xanomeline High Dose	53
Worst toxicity grade, n
Grade 0		53	0	0	0	0	53
Grade 1		48	0	0	0	0	48
Grade 2		34	0	0	0	0	34
Grade 3		23	0	0	0	0	23
Grade 4		2	0	0	0	0	2
Total		53	0	0	0	0	53
Xanomeline Low Dose	73
Worst toxicity grade, n
Grade 0		69	2	0	0	0	71
Grade 1		50	2	0	0	0	52
Grade 2		41	0	0	0	0	41
Grade 3		19	0	0	0	0	19
Grade 4		2	0	0	0	0	2
Total		71	2	0	0	0	73
Placebo	59
Worst toxicity grade, n
Grade 0		59	0	0	0	0	59
Grade 1		49	0	0	0	0	49
Grade 2		40	0	0	0	0	40
Grade 3		21	0	0	0	0	21
Grade 4		3	0	0	0	0	3
Total		59	0	0	0	0	59
Hypoglycemia
Xanomeline High Dose	53
Worst toxicity grade, n
Grade 0		53	0	0	0	0	53
Grade 1		41	0	0	0	0	41
Grade 2		38	0	0	0	0	38
Grade 3		21	0	0	0	0	21
Grade 4		5	0	0	0	0	5
Total		53	0	0	0	0	53
Xanomeline Low Dose	73
Worst toxicity grade, n
Grade 0		69	0	1	0	0	70
Grade 1		50	0	0	0	0	50
Grade 2		35	0	0	0	0	35
Grade 3		25	0	0	0	0	25
Grade 4		2	0	0	0	0	2
Total		71	0	1	0	0	72
Placebo	59
Worst toxicity grade, n
Grade 0		58	0	0	0	0	58
Grade 1		55	0	0	0	0	55
Grade 2		37	0	0	0	0	37
Grade 3		23	0	0	0	0	23
Grade 4		3	0	0	0	0	3
Total		59	0	0	0	0	59
Hypokalemia
Xanomeline High Dose	53
Worst toxicity grade, n
Grade 0		53	0	0	0	0	53
Grade 1		45	0	0	0	0	45
Grade 2		38	0	0	0	0	38
Grade 3		25	0	0	0	0	25
Grade 4		5	0	0	0	0	5
Total		53	0	0	0	0	53
Xanomeline Low Dose	73
Worst toxicity grade, n
Grade 0		71	0	0	0	0	71
Grade 1		49	0	0	0	0	49
Grade 2		38	0	0	0	0	38
Grade 3		23	0	0	0	0	23
Grade 4		6	0	0	0	0	6
Total		73	0	0	0	0	73
Placebo	59
Worst toxicity grade, n
Grade 0		57	0	0	0	0	57
Grade 1		51	0	0	0	0	51
Grade 2		38	0	0	0	0	38
Grade 3		28	0	0	0	0	28
Grade 4		4	0	0	0	0	4
Total		59	0	0	0	0	59
Hyponatremia
Xanomeline High Dose	53
Worst toxicity grade, n
Grade 0		53	0	0	0	0	53
Grade 1		47	0	0	0	0	47
Grade 2		36	0	0	0	0	36
Grade 3		21	0	0	0	0	21
Grade 4		5	0	0	0	0	5
Total		53	0	0	0	0	53
Xanomeline Low Dose	73
Worst toxicity grade, n
Grade 0		64	2	0	0	0	66
Grade 1		52	1	0	0	0	53
Grade 2		36	1	0	0	0	37
Grade 3		28	0	0	0	0	28
Grade 4		1	0	0	0	0	1
Total		71	2	0	0	0	73
Placebo	59
Worst toxicity grade, n
Grade 0		58	1	0	0	0	59
Grade 1		50	1	0	0	0	51
Grade 2		39	1	0	0	0	40
Grade 3		25	0	0	0	0	25
Grade 4		0	0	0	0	0	0
Total		58	1	0	0	0	59
Note: N is the number of subjects with non-missing values for the specific lab test at baseline and at least 1 postbaseline visit within the time period.
Note: NCI-CTCAE grades (version 5.0.) are based on the laboratory result and do not take into account the clinical component, if applicable.

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