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]Adverse Events by System Organ Class and Preferred Term
Summary of Treatment-Emergent Adverse Events by SOC and PT
Setup
See Prerequisites for installation instructions.
Data Preparation
# ── Helper: n (%) string ──
n_pct <- function(n, denom) sprintf("%d (%.1f)", n, n / denom * 100)
# ── Denominators ──
N_total <- nrow(adsl_saf)
N_arm <- arm_n
# ── Any TEAE (overall row) ──
any_teae_arm <- adae_teae |>
distinct(USUBJID, TRT01A) |>
count(TRT01A) |>
filter(TRT01A %in% arm_levels) |>
mutate(value = mapply(n_pct, n, N_arm[TRT01A])) |>
select(TRT01A, value) |>
pivot_wider(names_from = TRT01A, values_from = value)
any_teae_total <- adae_teae |>
distinct(USUBJID) |>
nrow() |>
(\(n) tibble(Total = n_pct(n, N_total)))()
any_teae_row <- bind_cols(
tibble(soc = "TOTAL SUBJECTS WITH AN EVENT", pt = "TOTAL SUBJECTS WITH AN EVENT", row_type = "overall"),
any_teae_arm,
any_teae_total
)
# ── SOC-level summary (one subject counted once per SOC) ──
soc_arm <- adae_teae |>
distinct(USUBJID, TRT01A, AEBODSYS) |>
count(TRT01A, AEBODSYS) |>
filter(TRT01A %in% arm_levels) |>
mutate(value = mapply(n_pct, n, N_arm[TRT01A])) |>
select(TRT01A, AEBODSYS, value) |>
pivot_wider(names_from = TRT01A, values_from = value)
soc_total <- adae_teae |>
distinct(USUBJID, AEBODSYS) |>
count(AEBODSYS) |>
mutate(Total = n_pct(n, N_total)) |>
select(AEBODSYS, Total)
soc_arm <- soc_arm |>
mutate(across(all_of(arm_levels), ~ replace_na(.x, "0 (0.0)")))
soc_wide <- left_join(soc_arm, soc_total, by = "AEBODSYS") |>
mutate(
soc = AEBODSYS,
pt = AEBODSYS,
row_type = "soc",
.before = 1
) |>
select(-AEBODSYS)
# ── PT-level summary (one subject counted once per SOC/PT) ──
pt_arm <- adae_teae |>
distinct(USUBJID, TRT01A, AEBODSYS, AEDECOD) |>
count(TRT01A, AEBODSYS, AEDECOD) |>
filter(TRT01A %in% arm_levels) |>
mutate(value = mapply(n_pct, n, N_arm[TRT01A])) |>
select(TRT01A, AEBODSYS, AEDECOD, value) |>
pivot_wider(names_from = TRT01A, values_from = value)
pt_total <- adae_teae |>
distinct(USUBJID, AEBODSYS, AEDECOD) |>
count(AEBODSYS, AEDECOD) |>
mutate(Total = n_pct(n, N_total)) |>
select(AEBODSYS, AEDECOD, Total)
pt_arm <- pt_arm |>
mutate(across(all_of(arm_levels), ~ replace_na(.x, "0 (0.0)")))
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)
# ── Compute sort order: SOC frequency descending, PT frequency descending ──
soc_order <- soc_wide |>
left_join(
adae_teae |>
distinct(USUBJID, AEBODSYS) |>
count(AEBODSYS, name = "soc_n"),
by = c("soc" = "AEBODSYS")
) |>
arrange(desc(soc_n)) |>
pull(soc)
pt_order <- pt_wide |>
left_join(
adae_teae |>
distinct(USUBJID, AEBODSYS, AEDECOD) |>
count(AEBODSYS, AEDECOD, name = "pt_n"),
by = c("soc" = "AEBODSYS", "pt" = "AEDECOD")
) |>
arrange(match(soc, soc_order), desc(pt_n)) |>
select(-pt_n)
# ── Interleave SOC header row + PT rows, sorted ──
ae_wide <- bind_rows(
any_teae_row,
bind_rows(
lapply(soc_order, function(s) {
soc_row <- filter(soc_wide, soc == s)
pt_rows <- filter(pt_order, soc == s)
bind_rows(soc_row, pt_rows)
})
)
) |>
mutate(across(
where(is.character) & !c(soc, pt, row_type),
~ replace_na(.x, "0 (0.0)")
))
n_vec <- c(arm_n, Total = N_total)ae_ard <- ard_stack_hierarchical(
data = adae_teae,
variables = c(AEBODSYS, AEDECOD),
by = TRT01A,
denominator = adsl_saf,
id = USUBJID,
overall = TRUE,
over_variables = TRUE
) |>
sort_ard_hierarchical(sort = "descending")
ae_wide_cards <- fr_wide_ard(
ae_ard,
statistic = "{n} ({p}%)",
decimals = c(p = 1),
label = c(
"..ard_hierarchical_overall.." = "TOTAL SUBJECTS WITH AN EVENT",
AEBODSYS = "System Organ Class",
AEDECOD = "Preferred Term"
)
)arframe Pipeline
The rendered table below uses the dplyr data prep (ae_wide). The cards tab produces an equivalent ae_wide_cards — swap it in to use the cards path instead.
ae_wide |>
fr_table() |>
fr_titles(
"Table 14.3.1",
"Summary of Treatment-Emergent Adverse Events by System Organ Class and Preferred Term",
"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. Subjects are counted once per SOC and once per PT.",
"Percentages based on N per treatment arm (Safety Population).",
"SOC rows sorted by descending subject frequency; PT rows sorted within SOC by descending frequency."
)Rendered Table
Table 14.3.1
Summary of Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
Safety Population
| System Organ Class Preferred Term | Placebo (N=86) | Xanomeline High Dose (N=72) | Xanomeline Low Dose (N=96) | Total (N=254) |
|---|---|---|---|---|
| TOTAL SUBJECTS WITH AN EVENT | 65 (75.6) | 68 (94.4) | 84 (87.5) | 217 (85.4) |
| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | 21 (24.4) | 36 (50.0) | 51 (53.1) | 108 (42.5) |
| APPLICATION SITE PRURITUS | 6 ( 7.0) | 21 (29.2) | 23 (24.0) | 50 (19.7) |
| APPLICATION SITE ERYTHEMA | 3 ( 3.5) | 14 (19.4) | 13 (13.5) | 30 (11.8) |
| APPLICATION SITE DERMATITIS | 5 ( 5.8) | 7 ( 9.7) | 9 ( 9.4) | 21 ( 8.3) |
| APPLICATION SITE IRRITATION | 3 ( 3.5) | 9 (12.5) | 9 ( 9.4) | 21 ( 8.3) |
| APPLICATION SITE VESICLES | 1 ( 1.2) | 5 ( 6.9) | 5 ( 5.2) | 11 ( 4.3) |
| FATIGUE | 1 ( 1.2) | 5 ( 6.9) | 5 ( 5.2) | 11 ( 4.3) |
| OEDEMA PERIPHERAL | 2 ( 2.3) | 2 ( 2.8) | 1 ( 1.0) | 5 ( 2.0) |
| CHILLS | 1 ( 1.2) | 1 ( 1.4) | 1 ( 1.0) | 3 ( 1.2) |
| PYREXIA | 2 ( 2.3) | 0 | 1 ( 1.0) | 3 ( 1.2) |
| APPLICATION SITE SWELLING | 0 | 2 ( 2.8) | 1 ( 1.0) | 3 ( 1.2) |
| APPLICATION SITE URTICARIA | 0 | 1 ( 1.4) | 2 ( 2.1) | 3 ( 1.2) |
| MALAISE | 0 | 2 ( 2.8) | 1 ( 1.0) | 3 ( 1.2) |
| APPLICATION SITE REACTION | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| ASTHENIA | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| APPLICATION SITE PAIN | 0 | 2 ( 2.8) | 0 | 2 ( 0.8) |
| APPLICATION SITE PERSPIRATION | 0 | 2 ( 2.8) | 0 | 2 ( 0.8) |
| CHEST DISCOMFORT | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| CHEST PAIN | 0 | 2 ( 2.8) | 0 | 2 ( 0.8) |
| PAIN | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| OEDEMA | 0 | 0 | 2 ( 2.1) | 2 ( 0.8) |
| APPLICATION SITE INDURATION | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| APPLICATION SITE DISCHARGE | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| FEELING ABNORMAL | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| FEELING COLD | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| APPLICATION SITE BLEEDING | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| APPLICATION SITE DESQUAMATION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| APPLICATION SITE DISCOLOURATION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| APPLICATION SITE WARMTH | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| INFLAMMATION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| SECRETION DISCHARGE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| SUDDEN DEATH | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| SWELLING | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| ULCER | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 20 (23.3) | 39 (54.2) | 39 (40.6) | 98 (38.6) |
| PRURITUS | 8 ( 9.3) | 25 (34.7) | 21 (21.9) | 54 (21.3) |
| ERYTHEMA | 8 ( 9.3) | 14 (19.4) | 14 (14.6) | 36 (14.2) |
| RASH | 5 ( 5.8) | 8 (11.1) | 13 (13.5) | 26 (10.2) |
| HYPERHIDROSIS | 2 ( 2.3) | 8 (11.1) | 4 ( 4.2) | 14 ( 5.5) |
| SKIN IRRITATION | 3 ( 3.5) | 5 ( 6.9) | 6 ( 6.2) | 14 ( 5.5) |
| BLISTER | 0 | 1 ( 1.4) | 5 ( 5.2) | 6 ( 2.4) |
| RASH PRURITIC | 0 | 2 ( 2.8) | 1 ( 1.0) | 3 ( 1.2) |
| PRURITUS GENERALISED | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| URTICARIA | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| ALOPECIA | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| COLD SWEAT | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| DRUG ERUPTION | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| SKIN ULCER | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| ACTINIC KERATOSIS | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| RASH MACULO-PAPULAR | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| SKIN ODOUR ABNORMAL | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| DERMATITIS CONTACT | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| RASH ERYTHEMATOUS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| SKIN EXFOLIATION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| NERVOUS SYSTEM DISORDERS | 8 ( 9.3) | 23 (31.9) | 22 (22.9) | 53 (20.9) |
| DIZZINESS | 2 ( 2.3) | 10 (13.9) | 9 ( 9.4) | 21 ( 8.3) |
| HEADACHE | 3 ( 3.5) | 5 ( 6.9) | 3 ( 3.1) | 11 ( 4.3) |
| SYNCOPE | 0 | 2 ( 2.8) | 5 ( 5.2) | 7 ( 2.8) |
| SOMNOLENCE | 2 ( 2.3) | 1 ( 1.4) | 3 ( 3.1) | 6 ( 2.4) |
| TRANSIENT ISCHAEMIC ATTACK | 0 | 1 ( 1.4) | 2 ( 2.1) | 3 ( 1.2) |
| BURNING SENSATION | 0 | 2 ( 2.8) | 0 | 2 ( 0.8) |
| LETHARGY | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| PARKINSON'S DISEASE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| PSYCHOMOTOR HYPERACTIVITY | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| AMNESIA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| COGNITIVE DISORDER | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| HYPERSOMNIA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| PARAESTHESIA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| PAROSMIA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| PARTIAL SEIZURES WITH SECONDARY GENERALISATION | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| SYNCOPE VASOVAGAL | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| BALANCE DISORDER | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| COMPLEX PARTIAL SEIZURES | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| COORDINATION ABNORMAL | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| HEMIANOPIA HOMONYMOUS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| PARAESTHESIA ORAL | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| STUPOR | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| GASTROINTESTINAL DISORDERS | 17 (19.8) | 19 (26.4) | 15 (15.6) | 51 (20.1) |
| DIARRHOEA | 9 (10.5) | 3 ( 4.2) | 5 ( 5.2) | 17 ( 6.7) |
| VOMITING | 3 ( 3.5) | 6 ( 8.3) | 4 ( 4.2) | 13 ( 5.1) |
| NAUSEA | 3 ( 3.5) | 6 ( 8.3) | 3 ( 3.1) | 12 ( 4.7) |
| ABDOMINAL PAIN | 1 ( 1.2) | 1 ( 1.4) | 3 ( 3.1) | 5 ( 2.0) |
| SALIVARY HYPERSECRETION | 0 | 4 ( 5.6) | 0 | 4 ( 1.6) |
| DYSPEPSIA | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| CONSTIPATION | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| FLATULENCE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| GASTROOESOPHAGEAL REFLUX DISEASE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| GLOSSITIS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| HIATUS HERNIA | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| ABDOMINAL DISCOMFORT | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| GASTROINTESTINAL HAEMORRHAGE | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| STOMACH DISCOMFORT | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| DYSPHAGIA | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| RECTAL HAEMORRHAGE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| CARDIAC DISORDERS | 12 (14.0) | 14 (19.4) | 14 (14.6) | 40 (15.7) |
| SINUS BRADYCARDIA | 2 ( 2.3) | 8 (11.1) | 7 ( 7.3) | 17 ( 6.7) |
| MYOCARDIAL INFARCTION | 4 ( 4.7) | 4 ( 5.6) | 2 ( 2.1) | 10 ( 3.9) |
| ATRIAL FIBRILLATION | 1 ( 1.2) | 2 ( 2.8) | 2 ( 2.1) | 5 ( 2.0) |
| SUPRAVENTRICULAR EXTRASYSTOLES | 1 ( 1.2) | 1 ( 1.4) | 1 ( 1.0) | 3 ( 1.2) |
| VENTRICULAR EXTRASYSTOLES | 0 | 1 ( 1.4) | 2 ( 2.1) | 3 ( 1.2) |
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| BUNDLE BRANCH BLOCK RIGHT | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| ATRIAL FLUTTER | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| PALPITATIONS | 0 | 0 | 2 ( 2.1) | 2 ( 0.8) |
| ATRIAL HYPERTROPHY | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| BRADYCARDIA | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| BUNDLE BRANCH BLOCK LEFT | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| CARDIAC FAILURE CONGESTIVE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| SINUS ARRHYTHMIA | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| TACHYCARDIA | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| VENTRICULAR HYPERTROPHY | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| CARDIAC DISORDER | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| SUPRAVENTRICULAR TACHYCARDIA | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| WOLFF-PARKINSON-WHITE SYNDROME | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| INFECTIONS AND INFESTATIONS | 16 (18.6) | 13 (18.1) | 9 ( 9.4) | 38 (15.0) |
| NASOPHARYNGITIS | 2 ( 2.3) | 6 ( 8.3) | 4 ( 4.2) | 12 ( 4.7) |
| UPPER RESPIRATORY TRACT INFECTION | 6 ( 7.0) | 3 ( 4.2) | 1 ( 1.0) | 10 ( 3.9) |
| INFLUENZA | 1 ( 1.2) | 1 ( 1.4) | 1 ( 1.0) | 3 ( 1.2) |
| URINARY TRACT INFECTION | 2 ( 2.3) | 1 ( 1.4) | 0 | 3 ( 1.2) |
| CYSTITIS | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| EAR INFECTION | 2 ( 2.3) | 0 | 0 | 2 ( 0.8) |
| BRONCHITIS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| CERVICITIS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| GASTROENTERITIS VIRAL | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| LOCALISED INFECTION | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| VAGINAL MYCOSIS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| HORDEOLUM | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| LOWER RESPIRATORY TRACT INFECTION | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| RHINITIS | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| CELLULITIS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| PNEUMONIA | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| VIRAL INFECTION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| PSYCHIATRIC DISORDERS | 10 (11.6) | 7 ( 9.7) | 11 (11.5) | 28 (11.0) |
| CONFUSIONAL STATE | 2 ( 2.3) | 1 ( 1.4) | 3 ( 3.1) | 6 ( 2.4) |
| AGITATION | 2 ( 2.3) | 0 | 3 ( 3.1) | 5 ( 2.0) |
| INSOMNIA | 2 ( 2.3) | 2 ( 2.8) | 0 | 4 ( 1.6) |
| ANXIETY | 0 | 0 | 3 ( 3.1) | 3 ( 1.2) |
| DELUSION | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| IRRITABILITY | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| COMPLETED SUICIDE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| DISORIENTATION | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| DELIRIUM | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| HALLUCINATION | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| HALLUCINATION, VISUAL | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| LIBIDO DECREASED | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| LISTLESS | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| NIGHTMARE | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| DEPRESSED MOOD | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| RESTLESSNESS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | 8 ( 9.3) | 10 (13.9) | 9 ( 9.4) | 27 (10.6) |
| COUGH | 1 ( 1.2) | 5 ( 6.9) | 5 ( 5.2) | 11 ( 4.3) |
| NASAL CONGESTION | 3 ( 3.5) | 3 ( 4.2) | 1 ( 1.0) | 7 ( 2.8) |
| DYSPNOEA | 1 ( 1.2) | 1 ( 1.4) | 1 ( 1.0) | 3 ( 1.2) |
| EPISTAXIS | 0 | 2 ( 2.8) | 1 ( 1.0) | 3 ( 1.2) |
| PHARYNGOLARYNGEAL PAIN | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| RHINORRHOEA | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| EMPHYSEMA | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| HAEMOPTYSIS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| POSTNASAL DRIP | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| RALES | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| ALLERGIC GRANULOMATOUS ANGIITIS | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| PHARYNGEAL ERYTHEMA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| PRODUCTIVE COUGH | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| RESPIRATORY TRACT CONGESTION | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| DYSPHONIA | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| INVESTIGATIONS | 10 (11.6) | 5 ( 6.9) | 7 ( 7.3) | 22 ( 8.7) |
| ELECTROCARDIOGRAM ST SEGMENT DEPRESSION | 4 ( 4.7) | 0 | 1 ( 1.0) | 5 ( 2.0) |
| ELECTROCARDIOGRAM T WAVE INVERSION | 2 ( 2.3) | 1 ( 1.4) | 1 ( 1.0) | 4 ( 1.6) |
| ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| BLOOD GLUCOSE INCREASED | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| BLOOD ALKALINE PHOSPHATASE INCREASED | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| BLOOD URINE PRESENT | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| CYSTOSCOPY | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| HEART RATE INCREASED | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| HEART RATE IRREGULAR | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| BIOPSY | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| BIOPSY PROSTATE | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| BLOOD CHOLESTEROL INCREASED | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| BODY TEMPERATURE INCREASED | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| NASAL MUCOSA BIOPSY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| WEIGHT DECREASED | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | 4 ( 4.7) | 7 ( 9.7) | 7 ( 7.3) | 18 ( 7.1) |
| BACK PAIN | 1 ( 1.2) | 3 ( 4.2) | 1 ( 1.0) | 5 ( 2.0) |
| ARTHRALGIA | 1 ( 1.2) | 1 ( 1.4) | 2 ( 2.1) | 4 ( 1.6) |
| SHOULDER PAIN | 1 ( 1.2) | 0 | 2 ( 2.1) | 3 ( 1.2) |
| MUSCLE SPASMS | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| PAIN IN EXTREMITY | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| ARTHRITIS | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| FLANK PAIN | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| MYALGIA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| MUSCULAR WEAKNESS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS | 4 ( 4.7) | 5 ( 6.9) | 5 ( 5.2) | 14 ( 5.5) |
| CONTUSION | 1 ( 1.2) | 2 ( 2.8) | 1 ( 1.0) | 4 ( 1.6) |
| EXCORIATION | 2 ( 2.3) | 1 ( 1.4) | 1 ( 1.0) | 4 ( 1.6) |
| FALL | 1 ( 1.2) | 1 ( 1.4) | 2 ( 2.1) | 4 ( 1.6) |
| HIP FRACTURE | 1 ( 1.2) | 2 ( 2.8) | 0 | 3 ( 1.2) |
| SKIN LACERATION | 1 ( 1.2) | 0 | 2 ( 2.1) | 3 ( 1.2) |
| FACIAL BONES FRACTURE | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| JOINT DISLOCATION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| WOUND | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| RENAL AND URINARY DISORDERS | 4 ( 4.7) | 3 ( 4.2) | 3 ( 3.1) | 10 ( 3.9) |
| MICTURITION URGENCY | 1 ( 1.2) | 1 ( 1.4) | 1 ( 1.0) | 3 ( 1.2) |
| DYSURIA | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| NEPHROLITHIASIS | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| POLLAKIURIA | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| CALCULUS URETHRAL | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| INCONTINENCE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| METABOLISM AND NUTRITION DISORDERS | 6 ( 7.0) | 2 ( 2.8) | 1 ( 1.0) | 9 ( 3.5) |
| DECREASED APPETITE | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| FOOD CRAVING | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| INCREASED APPETITE | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| DEHYDRATION | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| DIABETES MELLITUS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| HYPONATRAEMIA | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| VASCULAR DISORDERS | 3 ( 3.5) | 1 ( 1.4) | 3 ( 3.1) | 7 ( 2.8) |
| HYPOTENSION | 2 ( 2.3) | 0 | 1 ( 1.0) | 3 ( 1.2) |
| HYPERTENSION | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| ORTHOSTATIC HYPOTENSION | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| WOUND HAEMORRHAGE | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| HOT FLUSH | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| EYE DISORDERS | 2 ( 2.3) | 1 ( 1.4) | 2 ( 2.1) | 5 ( 2.0) |
| VISION BLURRED | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| CONJUNCTIVITIS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| EYE ALLERGY | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| EYE PRURITUS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| EYE SWELLING | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| CONJUNCTIVAL HAEMORRHAGE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| SURGICAL AND MEDICAL PROCEDURES | 2 ( 2.3) | 2 ( 2.8) | 1 ( 1.0) | 5 ( 2.0) |
| CATARACT OPERATION | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| EYE LASER SURGERY | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| ACROCHORDON EXCISION | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| SKIN LESION EXCISION | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| EAR AND LABYRINTH DISORDERS | 1 ( 1.2) | 1 ( 1.4) | 2 ( 2.1) | 4 ( 1.6) |
| VERTIGO | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| EAR PAIN | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| CERUMEN IMPACTION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| REPRODUCTIVE SYSTEM AND BREAST DISORDERS | 2 ( 2.3) | 1 ( 1.4) | 0 | 3 ( 1.2) |
| BENIGN PROSTATIC HYPERPLASIA | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| PELVIC PAIN | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| CONGENITAL, FAMILIAL AND GENETIC DISORDERS | 0 | 2 ( 2.8) | 1 ( 1.0) | 3 ( 1.2) |
| VENTRICULAR SEPTAL DEFECT | 0 | 2 ( 2.8) | 1 ( 1.0) | 3 ( 1.2) |
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) | 0 | 1 ( 1.4) | 2 ( 2.1) | 3 ( 1.2) |
| PROSTATE CANCER | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| COLON CANCER | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| MALIGNANT FIBROUS HISTIOCYTOMA | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| HEPATOBILIARY DISORDERS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| HYPERBILIRUBINAEMIA | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| SOCIAL CIRCUMSTANCES | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| ALCOHOL USE | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| IMMUNE SYSTEM DISORDERS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| HYPERSENSITIVITY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
TEAE = Treatment-Emergent Adverse Event. Subjects are counted once per SOC and once per PT.
Percentages based on N per treatment arm (Safety Population).
SOC rows sorted by descending subject frequency; PT rows sorted within SOC by descending frequency.
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01APR2026 09:52:26