library(arframe)
library(pharmaverseadam)
library(dplyr, warn.conflicts = FALSE)
library(tidyr)
library(cards)
adsl_saf <- pharmaverseadam::adsl |>
blank_to_na() |>
filter(SAFFL == "Y", TRT01A != "Screen Failure")
adae_teae <- pharmaverseadam::adae |>
blank_to_na() |>
filter(TRTEMFL == "Y", TRT01A != "Screen Failure")
arm_levels <- c("Placebo", "Xanomeline Low Dose", "Xanomeline High Dose")
arm_n <- adsl_saf |>
filter(TRT01A %in% arm_levels) |>
count(TRT01A) |>
pull(n, name = TRT01A)
arm_n <- arm_n[arm_levels]
N_total <- nrow(adsl_saf)
n_vec <- c(arm_n, Total = N_total)Adverse Events with Event Counts
Summary of Treatment-Emergent Adverse Events with Event Counts
Setup
See Prerequisites for installation instructions.
Data Preparation
# Format: "n_subjects (n_events)"
subj_events <- function(n_subj, n_events) {
sprintf("%d (%d)", n_subj, n_events)
}
# ── Any TEAE (overall row) ──
any_subj_arm <- adae_teae |>
filter(TRT01A %in% arm_levels) |>
distinct(USUBJID, TRT01A) |>
count(TRT01A, name = "n_subj")
any_events_arm <- adae_teae |>
filter(TRT01A %in% arm_levels) |>
count(TRT01A, name = "n_events")
any_arm <- left_join(any_subj_arm, any_events_arm, by = "TRT01A") |>
mutate(value = mapply(subj_events, n_subj, n_events)) |>
select(TRT01A, value) |>
pivot_wider(names_from = TRT01A, values_from = value)
any_total <- tibble(
Total = subj_events(
n_distinct(adae_teae$USUBJID),
nrow(adae_teae)
)
)
any_row <- bind_cols(
tibble(soc = "Any TEAE", pt = "Any TEAE", row_type = "overall"),
any_arm,
any_total
)
# ── SOC-level: subjects and events ──
soc_subj_arm <- adae_teae |>
filter(TRT01A %in% arm_levels) |>
distinct(USUBJID, TRT01A, AEBODSYS) |>
count(TRT01A, AEBODSYS, name = "n_subj")
soc_events_arm <- adae_teae |>
filter(TRT01A %in% arm_levels) |>
count(TRT01A, AEBODSYS, name = "n_events")
soc_arm <- left_join(soc_subj_arm, soc_events_arm, by = c("TRT01A", "AEBODSYS")) |>
mutate(value = mapply(subj_events, n_subj, n_events)) |>
select(TRT01A, AEBODSYS, value) |>
pivot_wider(names_from = TRT01A, values_from = value)
soc_subj_total <- adae_teae |>
distinct(USUBJID, AEBODSYS) |>
count(AEBODSYS, name = "n_subj")
soc_events_total <- adae_teae |>
count(AEBODSYS, name = "n_events")
soc_total <- left_join(soc_subj_total, soc_events_total, by = "AEBODSYS") |>
mutate(Total = mapply(subj_events, n_subj, n_events)) |>
select(AEBODSYS, Total)
soc_wide <- left_join(soc_arm, soc_total, by = "AEBODSYS") |>
mutate(
soc = AEBODSYS,
pt = AEBODSYS,
row_type = "soc",
.before = 1
) |>
select(-AEBODSYS)
# ── PT-level: subjects and events ──
pt_subj_arm <- adae_teae |>
filter(TRT01A %in% arm_levels) |>
distinct(USUBJID, TRT01A, AEBODSYS, AEDECOD) |>
count(TRT01A, AEBODSYS, AEDECOD, name = "n_subj")
pt_events_arm <- adae_teae |>
filter(TRT01A %in% arm_levels) |>
count(TRT01A, AEBODSYS, AEDECOD, name = "n_events")
pt_arm <- left_join(pt_subj_arm, pt_events_arm, by = c("TRT01A", "AEBODSYS", "AEDECOD")) |>
mutate(value = mapply(subj_events, n_subj, n_events)) |>
select(TRT01A, AEBODSYS, AEDECOD, value) |>
pivot_wider(names_from = TRT01A, values_from = value)
pt_subj_total <- adae_teae |>
distinct(USUBJID, AEBODSYS, AEDECOD) |>
count(AEBODSYS, AEDECOD, name = "n_subj")
pt_events_total <- adae_teae |>
count(AEBODSYS, AEDECOD, name = "n_events")
pt_total <- left_join(pt_subj_total, pt_events_total, by = c("AEBODSYS", "AEDECOD")) |>
mutate(Total = mapply(subj_events, n_subj, n_events)) |>
select(AEBODSYS, AEDECOD, Total)
pt_wide <- left_join(pt_arm, pt_total, by = c("AEBODSYS", "AEDECOD")) |>
mutate(
soc = AEBODSYS,
pt = AEDECOD,
row_type = "pt",
.before = 1
) |>
select(-AEBODSYS, -AEDECOD)
# ── Sort by descending subject frequency ──
soc_order <- adae_teae |>
distinct(USUBJID, AEBODSYS) |>
count(AEBODSYS, name = "soc_n") |>
arrange(desc(soc_n)) |>
pull(AEBODSYS)
pt_sorted <- adae_teae |>
distinct(USUBJID, AEBODSYS, AEDECOD) |>
count(AEBODSYS, AEDECOD, name = "pt_n") |>
arrange(match(AEBODSYS, soc_order), desc(pt_n))
pt_wide <- pt_sorted |>
select(soc = AEBODSYS, pt = AEDECOD) |>
left_join(pt_wide, by = c("soc", "pt"))
# ── Interleave ──
ae_events_wide <- bind_rows(
any_row,
bind_rows(
lapply(soc_order, function(s) {
bind_rows(
filter(soc_wide, soc == s),
filter(pt_wide, soc == s)
)
})
)
) |>
mutate(across(
where(is.character) & !c(soc, pt, row_type),
~ replace_na(.x, "0 (0)")
))# cards ard_stack_hierarchical provides subject counts
# We supplement with event counts via manual aggregation
ae_subj_ard <- ard_stack_hierarchical(
data = adae_teae |> filter(TRT01A %in% arm_levels),
variables = c(AEBODSYS, AEDECOD),
by = TRT01A,
denominator = adsl_saf,
id = USUBJID,
overall = TRUE,
over_variables = FALSE
) |>
sort_ard_hierarchical(sort = "descending")
# Note: cards output has subject counts only (no event counts)
# Use a separate variable to avoid overwriting the dplyr output
ae_events_cards <- fr_wide_ard(
ae_subj_ard,
statistic = "{n}",
label = c(
AEBODSYS = "System Organ Class",
AEDECOD = "Preferred Term"
)
)arframe Pipeline
The rendered table below uses the dplyr data prep (ae_events_wide, with subject + event counts). The cards tab produces ae_events_cards (subject counts only) — swap it in to use the cards path instead.
ae_events_wide |>
fr_table() |>
fr_titles(
"Table 14.3.2",
"Summary of Treatment-Emergent Adverse Events with Event Counts",
"Safety Population"
) |>
fr_cols(
soc = fr_col(visible = FALSE),
pt = fr_col("System Organ Class\n Preferred Term", width = 3.5),
row_type = fr_col(visible = FALSE),
!!!setNames(
lapply(arm_levels, function(a) fr_col(a, align = "decimal")),
arm_levels
),
Total = fr_col("Total", align = "decimal"),
.n = n_vec
) |>
fr_header(bold = TRUE, align = "center") |>
fr_rows(
group_by = "soc",
indent_by = "pt"
) |>
fr_styles(
fr_row_style(rows = fr_rows_matches("row_type", value = "soc"), bold = TRUE),
fr_row_style(rows = fr_rows_matches("row_type", value = "overall"), bold = TRUE)
) |>
fr_footnotes(
"TEAE = Treatment-Emergent Adverse Event.",
"Values displayed as: n_subjects (n_events).",
"Subjects are counted once per SOC and once per PT; events are total occurrences.",
"Percentages not shown \u2014 denominators differ for subjects vs events.",
"SOC and PT sorted by descending subject frequency."
)Rendered Table
Table 14.3.2
Summary of Treatment-Emergent Adverse Events with Event Counts
Safety Population
| System Organ Class Preferred Term | Placebo (N=86) | Xanomeline High Dose (N=72) | Xanomeline Low Dose (N=96) | Total (N=254) |
|---|---|---|---|---|
| Any TEAE | 65 (281) | 68 (414) | 84 (427) | 217 (1122) |
| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | 21 ( 46) | 36 (118) | 51 (124) | 108 ( 288) |
| APPLICATION SITE PRURITUS | 6 ( 10) | 21 ( 34) | 23 ( 33) | 50 ( 77) |
| APPLICATION SITE ERYTHEMA | 3 ( 3) | 14 ( 22) | 13 ( 21) | 30 ( 46) |
| APPLICATION SITE DERMATITIS | 5 ( 9) | 7 ( 12) | 9 ( 15) | 21 ( 36) |
| APPLICATION SITE IRRITATION | 3 ( 7) | 9 ( 16) | 9 ( 18) | 21 ( 41) |
| APPLICATION SITE VESICLES | 1 ( 2) | 5 ( 5) | 5 ( 6) | 11 ( 13) |
| FATIGUE | 1 ( 2) | 5 ( 5) | 5 ( 5) | 11 ( 12) |
| OEDEMA PERIPHERAL | 2 ( 3) | 2 ( 3) | 1 ( 1) | 5 ( 7) |
| APPLICATION SITE SWELLING | 0 | 2 ( 3) | 1 ( 1) | 3 ( 4) |
| APPLICATION SITE URTICARIA | 0 | 1 ( 1) | 2 ( 2) | 3 ( 3) |
| CHILLS | 1 ( 3) | 1 ( 1) | 1 ( 2) | 3 ( 6) |
| MALAISE | 0 | 2 ( 3) | 1 ( 2) | 3 ( 5) |
| PYREXIA | 2 ( 2) | 0 | 1 ( 1) | 3 ( 3) |
| APPLICATION SITE PAIN | 0 | 2 ( 2) | 0 | 2 ( 2) |
| APPLICATION SITE PERSPIRATION | 0 | 2 ( 3) | 0 | 2 ( 3) |
| APPLICATION SITE REACTION | 1 ( 2) | 1 ( 1) | 0 | 2 ( 3) |
| ASTHENIA | 1 ( 2) | 0 | 1 ( 1) | 2 ( 3) |
| CHEST DISCOMFORT | 0 | 1 ( 1) | 1 ( 1) | 2 ( 2) |
| CHEST PAIN | 0 | 2 ( 2) | 0 | 2 ( 2) |
| OEDEMA | 0 | 0 | 2 ( 2) | 2 ( 2) |
| PAIN | 0 | 1 ( 1) | 1 ( 2) | 2 ( 3) |
| APPLICATION SITE BLEEDING | 0 | 0 | 1 ( 1) | 1 ( 1) |
| APPLICATION SITE DESQUAMATION | 0 | 0 | 1 ( 1) | 1 ( 1) |
| APPLICATION SITE DISCHARGE | 0 | 1 ( 1) | 0 | 1 ( 1) |
| APPLICATION SITE DISCOLOURATION | 0 | 0 | 1 ( 1) | 1 ( 1) |
| APPLICATION SITE INDURATION | 1 ( 1) | 0 | 0 | 1 ( 1) |
| APPLICATION SITE WARMTH | 0 | 0 | 1 ( 2) | 1 ( 2) |
| FEELING ABNORMAL | 0 | 1 ( 1) | 0 | 1 ( 1) |
| FEELING COLD | 0 | 1 ( 1) | 0 | 1 ( 1) |
| INFLAMMATION | 0 | 0 | 1 ( 1) | 1 ( 1) |
| SECRETION DISCHARGE | 0 | 0 | 1 ( 2) | 1 ( 2) |
| SUDDEN DEATH | 0 | 0 | 1 ( 1) | 1 ( 1) |
| SWELLING | 0 | 0 | 1 ( 1) | 1 ( 1) |
| ULCER | 0 | 0 | 1 ( 1) | 1 ( 1) |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 20 ( 45) | 39 (100) | 39 (111) | 98 ( 256) |
| PRURITUS | 8 ( 11) | 25 ( 36) | 21 ( 31) | 54 ( 78) |
| ERYTHEMA | 8 ( 12) | 14 ( 22) | 14 ( 22) | 36 ( 56) |
| RASH | 5 ( 9) | 8 ( 13) | 13 ( 18) | 26 ( 40) |
| HYPERHIDROSIS | 2 ( 2) | 8 ( 10) | 4 ( 5) | 14 ( 17) |
| SKIN IRRITATION | 3 ( 4) | 5 ( 8) | 6 ( 13) | 14 ( 25) |
| BLISTER | 0 | 1 ( 2) | 5 ( 8) | 6 ( 10) |
| RASH PRURITIC | 0 | 2 ( 3) | 1 ( 2) | 3 ( 5) |
| PRURITUS GENERALISED | 0 | 1 ( 1) | 1 ( 4) | 2 ( 5) |
| URTICARIA | 0 | 1 ( 2) | 1 ( 3) | 2 ( 5) |
| ACTINIC KERATOSIS | 0 | 1 ( 1) | 0 | 1 ( 1) |
| ALOPECIA | 1 ( 1) | 0 | 0 | 1 ( 1) |
| COLD SWEAT | 1 ( 3) | 0 | 0 | 1 ( 3) |
| DERMATITIS CONTACT | 0 | 0 | 1 ( 2) | 1 ( 2) |
| DRUG ERUPTION | 1 ( 1) | 0 | 0 | 1 ( 1) |
| RASH ERYTHEMATOUS | 0 | 0 | 1 ( 1) | 1 ( 1) |
| RASH MACULO-PAPULAR | 0 | 1 ( 1) | 0 | 1 ( 1) |
| SKIN EXFOLIATION | 0 | 0 | 1 ( 2) | 1 ( 2) |
| SKIN ODOUR ABNORMAL | 0 | 1 ( 1) | 0 | 1 ( 1) |
| SKIN ULCER | 1 ( 2) | 0 | 0 | 1 ( 2) |
| NERVOUS SYSTEM DISORDERS | 8 ( 11) | 23 ( 39) | 22 ( 42) | 53 ( 92) |
| DIZZINESS | 2 ( 3) | 10 ( 14) | 9 ( 14) | 21 ( 31) |
| HEADACHE | 3 ( 3) | 5 ( 8) | 3 ( 4) | 11 ( 15) |
| SYNCOPE | 0 | 2 ( 3) | 5 ( 7) | 7 ( 10) |
| SOMNOLENCE | 2 ( 3) | 1 ( 1) | 3 ( 5) | 6 ( 9) |
| TRANSIENT ISCHAEMIC ATTACK | 0 | 1 ( 1) | 2 ( 3) | 3 ( 4) |
| BURNING SENSATION | 0 | 2 ( 2) | 0 | 2 ( 2) |
| LETHARGY | 0 | 1 ( 1) | 1 ( 1) | 2 ( 2) |
| AMNESIA | 0 | 1 ( 2) | 0 | 1 ( 2) |
| BALANCE DISORDER | 0 | 0 | 1 ( 3) | 1 ( 3) |
| COGNITIVE DISORDER | 0 | 1 ( 1) | 0 | 1 ( 1) |
| COMPLEX PARTIAL SEIZURES | 0 | 0 | 1 ( 1) | 1 ( 1) |
| COORDINATION ABNORMAL | 0 | 0 | 1 ( 1) | 1 ( 1) |
| HEMIANOPIA HOMONYMOUS | 0 | 0 | 1 ( 1) | 1 ( 1) |
| HYPERSOMNIA | 0 | 1 ( 1) | 0 | 1 ( 1) |
| PARAESTHESIA | 0 | 1 ( 1) | 0 | 1 ( 1) |
| PARAESTHESIA ORAL | 0 | 0 | 1 ( 1) | 1 ( 1) |
| PARKINSON'S DISEASE | 1 ( 1) | 0 | 0 | 1 ( 1) |
| PAROSMIA | 0 | 1 ( 2) | 0 | 1 ( 2) |
| PARTIAL SEIZURES WITH SECONDARY GENERALISATION | 0 | 1 ( 1) | 0 | 1 ( 1) |
| PSYCHOMOTOR HYPERACTIVITY | 1 ( 1) | 0 | 0 | 1 ( 1) |
| STUPOR | 0 | 0 | 1 ( 1) | 1 ( 1) |
| SYNCOPE VASOVAGAL | 0 | 1 ( 1) | 0 | 1 ( 1) |
| GASTROINTESTINAL DISORDERS | 17 ( 26) | 19 ( 34) | 15 ( 24) | 51 ( 84) |
| DIARRHOEA | 9 ( 10) | 3 ( 3) | 5 ( 6) | 17 ( 19) |
| VOMITING | 3 ( 3) | 6 ( 8) | 4 ( 5) | 13 ( 16) |
| NAUSEA | 3 ( 3) | 6 ( 13) | 3 ( 5) | 12 ( 21) |
| ABDOMINAL PAIN | 1 ( 1) | 1 ( 2) | 3 ( 3) | 5 ( 6) |
| SALIVARY HYPERSECRETION | 0 | 4 ( 5) | 0 | 4 ( 5) |
| DYSPEPSIA | 1 ( 2) | 0 | 1 ( 2) | 2 ( 4) |
| ABDOMINAL DISCOMFORT | 0 | 1 ( 1) | 0 | 1 ( 1) |
| CONSTIPATION | 1 ( 1) | 0 | 0 | 1 ( 1) |
| DYSPHAGIA | 0 | 0 | 1 ( 1) | 1 ( 1) |
| FLATULENCE | 1 ( 2) | 0 | 0 | 1 ( 2) |
| GASTROINTESTINAL HAEMORRHAGE | 0 | 1 ( 1) | 0 | 1 ( 1) |
| GASTROOESOPHAGEAL REFLUX DISEASE | 1 ( 1) | 0 | 0 | 1 ( 1) |
| GLOSSITIS | 1 ( 1) | 0 | 0 | 1 ( 1) |
| HIATUS HERNIA | 1 ( 2) | 0 | 0 | 1 ( 2) |
| RECTAL HAEMORRHAGE | 0 | 0 | 1 ( 2) | 1 ( 2) |
| STOMACH DISCOMFORT | 0 | 1 ( 1) | 0 | 1 ( 1) |
| CARDIAC DISORDERS | 12 ( 26) | 14 ( 28) | 14 ( 32) | 40 ( 86) |
| SINUS BRADYCARDIA | 2 ( 2) | 8 ( 12) | 7 ( 10) | 17 ( 24) |
| MYOCARDIAL INFARCTION | 4 ( 4) | 4 ( 8) | 2 ( 4) | 10 ( 16) |
| ATRIAL FIBRILLATION | 1 ( 1) | 2 ( 3) | 2 ( 3) | 5 ( 7) |
| SUPRAVENTRICULAR EXTRASYSTOLES | 1 ( 2) | 1 ( 1) | 1 ( 2) | 3 ( 5) |
| VENTRICULAR EXTRASYSTOLES | 0 | 1 ( 1) | 2 ( 4) | 3 ( 5) |
| ATRIAL FLUTTER | 0 | 1 ( 2) | 1 ( 1) | 2 ( 3) |
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | 1 ( 1) | 0 | 1 ( 1) | 2 ( 2) |
| BUNDLE BRANCH BLOCK RIGHT | 1 ( 2) | 0 | 1 ( 1) | 2 ( 3) |
| PALPITATIONS | 0 | 0 | 2 ( 2) | 2 ( 2) |
| ATRIAL HYPERTROPHY | 1 ( 2) | 0 | 0 | 1 ( 2) |
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | 1 ( 1) | 0 | 0 | 1 ( 1) |
| BRADYCARDIA | 1 ( 4) | 0 | 0 | 1 ( 4) |
| BUNDLE BRANCH BLOCK LEFT | 1 ( 1) | 0 | 0 | 1 ( 1) |
| CARDIAC DISORDER | 0 | 1 ( 1) | 0 | 1 ( 1) |
| CARDIAC FAILURE CONGESTIVE | 1 ( 1) | 0 | 0 | 1 ( 1) |
| SINUS ARRHYTHMIA | 1 ( 2) | 0 | 0 | 1 ( 2) |
| SUPRAVENTRICULAR TACHYCARDIA | 0 | 0 | 1 ( 2) | 1 ( 2) |
| TACHYCARDIA | 1 ( 2) | 0 | 0 | 1 ( 2) |
| VENTRICULAR HYPERTROPHY | 1 ( 1) | 0 | 0 | 1 ( 1) |
| WOLFF-PARKINSON-WHITE SYNDROME | 0 | 0 | 1 ( 2) | 1 ( 2) |
| INFECTIONS AND INFESTATIONS | 16 ( 35) | 13 ( 20) | 9 ( 16) | 38 ( 71) |
| NASOPHARYNGITIS | 2 ( 4) | 6 ( 8) | 4 ( 9) | 12 ( 21) |
| UPPER RESPIRATORY TRACT INFECTION | 6 ( 12) | 3 ( 5) | 1 ( 2) | 10 ( 19) |
| INFLUENZA | 1 ( 2) | 1 ( 1) | 1 ( 1) | 3 ( 4) |
| URINARY TRACT INFECTION | 2 ( 4) | 1 ( 1) | 0 | 3 ( 5) |
| CYSTITIS | 1 ( 1) | 1 ( 1) | 0 | 2 ( 2) |
| EAR INFECTION | 2 ( 4) | 0 | 0 | 2 ( 4) |
| BRONCHITIS | 1 ( 1) | 0 | 0 | 1 ( 1) |
| CELLULITIS | 0 | 0 | 1 ( 1) | 1 ( 1) |
| CERVICITIS | 1 ( 2) | 0 | 0 | 1 ( 2) |
| GASTROENTERITIS VIRAL | 1 ( 1) | 0 | 0 | 1 ( 1) |
| HORDEOLUM | 0 | 1 ( 1) | 0 | 1 ( 1) |
| LOCALISED INFECTION | 1 ( 2) | 0 | 0 | 1 ( 2) |
| LOWER RESPIRATORY TRACT INFECTION | 0 | 1 ( 2) | 0 | 1 ( 2) |
| PNEUMONIA | 0 | 0 | 1 ( 2) | 1 ( 2) |
| RHINITIS | 0 | 1 ( 1) | 0 | 1 ( 1) |
| VAGINAL MYCOSIS | 1 ( 2) | 0 | 0 | 1 ( 2) |
| VIRAL INFECTION | 0 | 0 | 1 ( 1) | 1 ( 1) |
| PSYCHIATRIC DISORDERS | 10 ( 12) | 7 ( 10) | 11 ( 15) | 28 ( 37) |
| CONFUSIONAL STATE | 2 ( 2) | 1 ( 1) | 3 ( 3) | 6 ( 6) |
| AGITATION | 2 ( 2) | 0 | 3 ( 3) | 5 ( 5) |
| INSOMNIA | 2 ( 3) | 2 ( 2) | 0 | 4 ( 5) |
| ANXIETY | 0 | 0 | 3 ( 4) | 3 ( 4) |
| DELUSION | 1 ( 1) | 1 ( 1) | 0 | 2 ( 2) |
| IRRITABILITY | 1 ( 2) | 0 | 1 ( 1) | 2 ( 3) |
| COMPLETED SUICIDE | 1 ( 1) | 0 | 0 | 1 ( 1) |
| DELIRIUM | 0 | 1 ( 1) | 0 | 1 ( 1) |
| DEPRESSED MOOD | 0 | 0 | 1 ( 2) | 1 ( 2) |
| DISORIENTATION | 1 ( 1) | 0 | 0 | 1 ( 1) |
| HALLUCINATION | 0 | 1 ( 1) | 0 | 1 ( 1) |
| HALLUCINATION, VISUAL | 0 | 1 ( 1) | 0 | 1 ( 1) |
| LIBIDO DECREASED | 0 | 1 ( 1) | 0 | 1 ( 1) |
| LISTLESS | 0 | 1 ( 1) | 0 | 1 ( 1) |
| NIGHTMARE | 0 | 1 ( 1) | 0 | 1 ( 1) |
| RESTLESSNESS | 0 | 0 | 1 ( 2) | 1 ( 2) |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | 8 ( 12) | 10 ( 22) | 9 ( 14) | 27 ( 48) |
| COUGH | 1 ( 1) | 5 ( 7) | 5 ( 7) | 11 ( 15) |
| NASAL CONGESTION | 3 ( 3) | 3 ( 4) | 1 ( 1) | 7 ( 8) |
| DYSPNOEA | 1 ( 1) | 1 ( 1) | 1 ( 1) | 3 ( 3) |
| EPISTAXIS | 0 | 2 ( 2) | 1 ( 1) | 3 ( 3) |
| PHARYNGOLARYNGEAL PAIN | 0 | 1 ( 1) | 1 ( 1) | 2 ( 2) |
| RHINORRHOEA | 0 | 1 ( 2) | 1 ( 2) | 2 ( 4) |
| ALLERGIC GRANULOMATOUS ANGIITIS | 0 | 1 ( 1) | 0 | 1 ( 1) |
| DYSPHONIA | 0 | 0 | 1 ( 1) | 1 ( 1) |
| EMPHYSEMA | 1 ( 1) | 0 | 0 | 1 ( 1) |
| HAEMOPTYSIS | 1 ( 2) | 0 | 0 | 1 ( 2) |
| PHARYNGEAL ERYTHEMA | 0 | 1 ( 2) | 0 | 1 ( 2) |
| POSTNASAL DRIP | 1 ( 2) | 0 | 0 | 1 ( 2) |
| PRODUCTIVE COUGH | 0 | 1 ( 1) | 0 | 1 ( 1) |
| RALES | 1 ( 2) | 0 | 0 | 1 ( 2) |
| RESPIRATORY TRACT CONGESTION | 0 | 1 ( 1) | 0 | 1 ( 1) |
| INVESTIGATIONS | 10 ( 19) | 5 ( 6) | 7 ( 9) | 22 ( 34) |
| ELECTROCARDIOGRAM ST SEGMENT DEPRESSION | 4 ( 4) | 0 | 1 ( 2) | 5 ( 6) |
| ELECTROCARDIOGRAM T WAVE INVERSION | 2 ( 3) | 1 ( 1) | 1 ( 1) | 4 ( 5) |
| BLOOD GLUCOSE INCREASED | 0 | 1 ( 2) | 1 ( 1) | 2 ( 3) |
| ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED | 1 ( 1) | 0 | 1 ( 1) | 2 ( 2) |
| BIOPSY | 0 | 1 ( 1) | 0 | 1 ( 1) |
| BIOPSY PROSTATE | 0 | 1 ( 1) | 0 | 1 ( 1) |
| BLOOD ALKALINE PHOSPHATASE INCREASED | 1 ( 1) | 0 | 0 | 1 ( 1) |
| BLOOD CHOLESTEROL INCREASED | 0 | 1 ( 1) | 0 | 1 ( 1) |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | 1 ( 2) | 0 | 0 | 1 ( 2) |
| BLOOD URINE PRESENT | 1 ( 1) | 0 | 0 | 1 ( 1) |
| BODY TEMPERATURE INCREASED | 0 | 0 | 1 ( 1) | 1 ( 1) |
| CYSTOSCOPY | 1 ( 1) | 0 | 0 | 1 ( 1) |
| HEART RATE INCREASED | 1 ( 2) | 0 | 0 | 1 ( 2) |
| HEART RATE IRREGULAR | 1 ( 4) | 0 | 0 | 1 ( 4) |
| NASAL MUCOSA BIOPSY | 0 | 0 | 1 ( 1) | 1 ( 1) |
| WEIGHT DECREASED | 0 | 0 | 1 ( 2) | 1 ( 2) |
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | 4 ( 6) | 7 ( 10) | 7 ( 10) | 18 ( 26) |
| BACK PAIN | 1 ( 2) | 3 ( 4) | 1 ( 1) | 5 ( 7) |
| ARTHRALGIA | 1 ( 1) | 1 ( 1) | 2 ( 4) | 4 ( 6) |
| SHOULDER PAIN | 1 ( 2) | 0 | 2 ( 2) | 3 ( 4) |
| MUSCLE SPASMS | 0 | 1 ( 2) | 1 ( 1) | 2 ( 3) |
| ARTHRITIS | 0 | 1 ( 1) | 0 | 1 ( 1) |
| FLANK PAIN | 0 | 1 ( 1) | 0 | 1 ( 1) |
| MUSCULAR WEAKNESS | 0 | 0 | 1 ( 2) | 1 ( 2) |
| MYALGIA | 0 | 1 ( 1) | 0 | 1 ( 1) |
| PAIN IN EXTREMITY | 1 ( 1) | 0 | 0 | 1 ( 1) |
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS | 4 ( 9) | 5 ( 8) | 5 ( 12) | 14 ( 29) |
| CONTUSION | 1 ( 1) | 2 ( 3) | 1 ( 3) | 4 ( 7) |
| EXCORIATION | 2 ( 3) | 1 ( 1) | 1 ( 2) | 4 ( 6) |
| FALL | 1 ( 2) | 1 ( 1) | 2 ( 2) | 4 ( 5) |
| HIP FRACTURE | 1 ( 2) | 2 ( 2) | 0 | 3 ( 4) |
| SKIN LACERATION | 1 ( 1) | 0 | 2 ( 2) | 3 ( 3) |
| FACIAL BONES FRACTURE | 0 | 1 ( 1) | 0 | 1 ( 1) |
| JOINT DISLOCATION | 0 | 0 | 1 ( 1) | 1 ( 1) |
| WOUND | 0 | 0 | 1 ( 2) | 1 ( 2) |
| RENAL AND URINARY DISORDERS | 4 ( 5) | 3 ( 4) | 3 ( 3) | 10 ( 12) |
| MICTURITION URGENCY | 1 ( 1) | 1 ( 2) | 1 ( 1) | 3 ( 4) |
| DYSURIA | 1 ( 1) | 0 | 1 ( 1) | 2 ( 2) |
| NEPHROLITHIASIS | 1 ( 1) | 1 ( 1) | 0 | 2 ( 2) |
| CALCULUS URETHRAL | 0 | 1 ( 1) | 0 | 1 ( 1) |
| INCONTINENCE | 0 | 0 | 1 ( 1) | 1 ( 1) |
| POLLAKIURIA | 1 ( 2) | 0 | 0 | 1 ( 2) |
| METABOLISM AND NUTRITION DISORDERS | 6 ( 8) | 2 ( 4) | 1 ( 1) | 9 ( 13) |
| DECREASED APPETITE | 1 ( 2) | 1 ( 2) | 0 | 2 ( 4) |
| FOOD CRAVING | 1 ( 1) | 0 | 1 ( 1) | 2 ( 2) |
| INCREASED APPETITE | 1 ( 2) | 1 ( 2) | 0 | 2 ( 4) |
| DEHYDRATION | 1 ( 1) | 0 | 0 | 1 ( 1) |
| DIABETES MELLITUS | 1 ( 1) | 0 | 0 | 1 ( 1) |
| HYPONATRAEMIA | 1 ( 1) | 0 | 0 | 1 ( 1) |
| VASCULAR DISORDERS | 3 ( 7) | 1 ( 1) | 3 ( 3) | 7 ( 11) |
| HYPOTENSION | 2 ( 3) | 0 | 1 ( 1) | 3 ( 4) |
| HYPERTENSION | 1 ( 2) | 0 | 1 ( 1) | 2 ( 3) |
| HOT FLUSH | 0 | 0 | 1 ( 1) | 1 ( 1) |
| ORTHOSTATIC HYPOTENSION | 1 ( 2) | 0 | 0 | 1 ( 2) |
| WOUND HAEMORRHAGE | 0 | 1 ( 1) | 0 | 1 ( 1) |
| EYE DISORDERS | 2 ( 5) | 1 ( 2) | 2 ( 2) | 5 ( 9) |
| VISION BLURRED | 0 | 1 ( 2) | 1 ( 1) | 2 ( 3) |
| CONJUNCTIVAL HAEMORRHAGE | 0 | 0 | 1 ( 1) | 1 ( 1) |
| CONJUNCTIVITIS | 1 ( 2) | 0 | 0 | 1 ( 2) |
| EYE ALLERGY | 1 ( 1) | 0 | 0 | 1 ( 1) |
| EYE PRURITUS | 1 ( 1) | 0 | 0 | 1 ( 1) |
| EYE SWELLING | 1 ( 1) | 0 | 0 | 1 ( 1) |
| SURGICAL AND MEDICAL PROCEDURES | 2 ( 2) | 2 ( 2) | 1 ( 1) | 5 ( 5) |
| CATARACT OPERATION | 1 ( 1) | 0 | 1 ( 1) | 2 ( 2) |
| ACROCHORDON EXCISION | 0 | 1 ( 1) | 0 | 1 ( 1) |
| EYE LASER SURGERY | 1 ( 1) | 0 | 0 | 1 ( 1) |
| SKIN LESION EXCISION | 0 | 1 ( 1) | 0 | 1 ( 1) |
| EAR AND LABYRINTH DISORDERS | 1 ( 2) | 1 ( 1) | 2 ( 2) | 4 ( 5) |
| VERTIGO | 0 | 1 ( 1) | 1 ( 1) | 2 ( 2) |
| CERUMEN IMPACTION | 0 | 0 | 1 ( 1) | 1 ( 1) |
| EAR PAIN | 1 ( 2) | 0 | 0 | 1 ( 2) |
| CONGENITAL, FAMILIAL AND GENETIC DISORDERS | 0 | 2 ( 2) | 1 ( 1) | 3 ( 3) |
| VENTRICULAR SEPTAL DEFECT | 0 | 2 ( 2) | 1 ( 1) | 3 ( 3) |
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) | 0 | 1 ( 1) | 2 ( 3) | 3 ( 4) |
| COLON CANCER | 0 | 0 | 1 ( 1) | 1 ( 1) |
| MALIGNANT FIBROUS HISTIOCYTOMA | 0 | 0 | 1 ( 2) | 1 ( 2) |
| PROSTATE CANCER | 0 | 1 ( 1) | 0 | 1 ( 1) |
| REPRODUCTIVE SYSTEM AND BREAST DISORDERS | 2 ( 4) | 1 ( 1) | 0 | 3 ( 5) |
| BENIGN PROSTATIC HYPERPLASIA | 1 ( 2) | 1 ( 1) | 0 | 2 ( 3) |
| PELVIC PAIN | 1 ( 2) | 0 | 0 | 1 ( 2) |
| HEPATOBILIARY DISORDERS | 1 ( 1) | 0 | 0 | 1 ( 1) |
| HYPERBILIRUBINAEMIA | 1 ( 1) | 0 | 0 | 1 ( 1) |
| IMMUNE SYSTEM DISORDERS | 0 | 0 | 1 ( 2) | 1 ( 2) |
| HYPERSENSITIVITY | 0 | 0 | 1 ( 2) | 1 ( 2) |
| SOCIAL CIRCUMSTANCES | 0 | 1 ( 1) | 0 | 1 ( 1) |
| ALCOHOL USE | 0 | 1 ( 1) | 0 | 1 ( 1) |
TEAE = Treatment-Emergent Adverse Event.
Values displayed as: n_subjects (n_events).
Subjects are counted once per SOC and once per PT; events are total occurrences.
Percentages not shown — denominators differ for subjects vs events.
SOC and PT sorted by descending subject frequency.
/opt/quarto/share/rmd/rmd.R
01APR2026 09:51:55