library(arframe)
library(pharmaverseadam)
library(dplyr, warn.conflicts = FALSE)
library(tidyr)
adsl_saf <- pharmaverseadam::adsl |>
blank_to_na() |>
filter(SAFFL == "Y", TRT01A != "Screen Failure")
adae_teae <- pharmaverseadam::adae |>
blank_to_na() |>
filter(SAFFL == "Y", TRTEMFL == "Y")
# Total study duration per subject from ADEX (TDURD = total duration in days)
adex_tdurd <- pharmaverseadam::adex |>
blank_to_na() |>
filter(SAFFL == "Y", TRT01A != "Screen Failure", PARAMCD == "TDURD")
arm_levels <- c("Placebo", "Xanomeline Low Dose", "Xanomeline High Dose")Exposure-Adjusted Adverse Events
Incidence Rate per 100 Patient-Years
Setup
See Prerequisites for installation instructions.
Data Preparation
# ── Patient-years per arm: sum subject durations / 365.25 ──
py_by_arm <- adex_tdurd |>
filter(TRT01A %in% arm_levels) |>
group_by(TRT01A) |>
summarise(patient_years = sum(AVAL, na.rm = TRUE) / 365.25, .groups = "drop")
# ── Subjects with at least one TEAE per SOC/PT per arm ──
subj_soc_pt <- adae_teae |>
distinct(USUBJID, TRT01A, AEBODSYS, AEDECOD) |>
filter(TRT01A %in% arm_levels) |>
count(TRT01A, AEBODSYS, AEDECOD, name = "n_subj")
# ── Subjects per SOC (deduplicated) ──
subj_soc <- adae_teae |>
distinct(USUBJID, TRT01A, AEBODSYS) |>
filter(TRT01A %in% arm_levels) |>
count(TRT01A, AEBODSYS, name = "n_subj")
# ── Helper: build n / PY / Rate columns for one dataset ──
build_ea_cols <- function(count_df, by_vars, py_df) {
count_df |>
left_join(py_df, by = "TRT01A") |>
mutate(
n_col = as.character(n_subj),
py_col = sprintf("%.1f", patient_years),
rate_col = sprintf("%.2f", n_subj / patient_years * 100)
) |>
select(all_of(by_vars), TRT01A, n_col, py_col, rate_col)
}
# ── SOC-level ──
soc_ea <- build_ea_cols(subj_soc, c("AEBODSYS"), py_by_arm) |>
pivot_wider(
names_from = TRT01A,
values_from = c(n_col, py_col, rate_col),
names_glue = "{TRT01A}__{.value}"
) |>
mutate(
soc = AEBODSYS,
pt = AEBODSYS,
row_type = "soc",
.before = 1
) |>
select(-AEBODSYS)
# ── PT-level ──
pt_ea <- build_ea_cols(subj_soc_pt, c("AEBODSYS", "AEDECOD"), py_by_arm) |>
pivot_wider(
names_from = TRT01A,
values_from = c(n_col, py_col, rate_col),
names_glue = "{TRT01A}__{.value}"
) |>
mutate(
soc = AEBODSYS,
pt = AEDECOD,
row_type = "pt",
.before = 1
) |>
select(-AEBODSYS, -AEDECOD)
# ── Sort order: SOC by descending subject count (Placebo + active combined) ──
soc_order <- adae_teae |>
filter(TRT01A %in% arm_levels) |>
distinct(USUBJID, AEBODSYS) |>
count(AEBODSYS, name = "soc_n") |>
arrange(desc(soc_n)) |>
pull(AEBODSYS)
pt_order <- adae_teae |>
filter(TRT01A %in% arm_levels) |>
distinct(USUBJID, AEBODSYS, AEDECOD) |>
count(AEBODSYS, AEDECOD, name = "pt_n") |>
arrange(match(AEBODSYS, soc_order), desc(pt_n))
# ── Interleave SOC rows + PT rows ──
ae_ea_wide <- bind_rows(
lapply(soc_order, function(s) {
soc_row <- filter(soc_ea, soc == s)
pt_rows <- filter(pt_ea, soc == s) |>
left_join(
pt_order |> filter(AEBODSYS == s) |> select(pt = AEDECOD, pt_n),
by = "pt"
) |>
arrange(desc(pt_n)) |>
select(-pt_n)
bind_rows(soc_row, pt_rows)
})
) |>
mutate(across(
where(is.character) & !c(soc, pt, row_type),
~ replace_na(.x, "0")
))arframe Pipeline
# Build fr_col() specs in arm-grouped order: n, PY, Rate per arm
arm_col_specs <- unlist(
lapply(arm_levels, function(a) {
setNames(
list(
fr_col("n", align = "decimal", width = 0.55),
fr_col("PY", align = "decimal", width = 0.65),
fr_col("Rate", align = "decimal", width = 0.65)
),
c(paste0(a, "__n_col"), paste0(a, "__py_col"), paste0(a, "__rate_col"))
)
}),
recursive = FALSE
)
ae_ea_wide |>
fr_table() |>
fr_titles(
"Exposure-Adjusted Adverse Events",
"Incidence Rate per 100 Patient-Years",
"Safety Population"
) |>
fr_cols(
soc = fr_col(visible = FALSE),
pt = fr_col("System Organ Class\n Preferred Term", width = 3.0),
row_type = fr_col(visible = FALSE),
!!!arm_col_specs
) |>
fr_spans(
!!!setNames(
lapply(arm_levels, function(a) {
c(paste0(a, "__n_col"), paste0(a, "__py_col"), paste0(a, "__rate_col"))
}),
arm_levels
)
) |>
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_footnotes(
"n = number of subjects with at least one event in the category.",
"PY = patient-years of exposure (total duration in days / 365.25).",
"Rate = (n / PY) x 100. Subjects counted once per SOC and once per PT.",
"SOC rows sorted by descending subject frequency across all arms."
)Rendered Table
Exposure-Adjusted Adverse Events
Incidence Rate per 100 Patient-Years
Safety Population
| Placebo | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| System Organ Class Preferred Term | n | n | n | PY | PY | PY | Rate | Rate | Rate |
| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | 21 | 36 | 51 | 34.8 | 22.1 | 22.6 | 60.34 | 162.74 | 225.87 |
| APPLICATION SITE PRURITUS | 6 | 21 | 23 | 34.8 | 22.1 | 22.6 | 17.24 | 94.93 | 101.86 |
| APPLICATION SITE ERYTHEMA | 3 | 14 | 13 | 34.8 | 22.1 | 22.6 | 8.62 | 63.29 | 57.58 |
| APPLICATION SITE DERMATITIS | 5 | 7 | 9 | 34.8 | 22.1 | 22.6 | 14.37 | 31.64 | 39.86 |
| APPLICATION SITE IRRITATION | 3 | 9 | 9 | 34.8 | 22.1 | 22.6 | 8.62 | 40.68 | 39.86 |
| APPLICATION SITE VESICLES | 1 | 5 | 5 | 34.8 | 22.1 | 22.6 | 2.87 | 22.60 | 22.14 |
| FATIGUE | 1 | 5 | 5 | 34.8 | 22.1 | 22.6 | 2.87 | 22.60 | 22.14 |
| OEDEMA PERIPHERAL | 2 | 2 | 1 | 34.8 | 22.1 | 22.6 | 5.75 | 9.04 | 4.43 |
| CHILLS | 1 | 1 | 1 | 34.8 | 22.1 | 22.6 | 2.87 | 4.52 | 4.43 |
| PYREXIA | 2 | 0 | 1 | 34.8 | 0 | 22.6 | 5.75 | 0 | 4.43 |
| APPLICATION SITE SWELLING | 0 | 2 | 1 | 0 | 22.1 | 22.6 | 0 | 9.04 | 4.43 |
| APPLICATION SITE URTICARIA | 0 | 1 | 2 | 0 | 22.1 | 22.6 | 0 | 4.52 | 8.86 |
| MALAISE | 0 | 2 | 1 | 0 | 22.1 | 22.6 | 0 | 9.04 | 4.43 |
| APPLICATION SITE REACTION | 1 | 1 | 0 | 34.8 | 22.1 | 0 | 2.87 | 4.52 | 0 |
| ASTHENIA | 1 | 0 | 1 | 34.8 | 0 | 22.6 | 2.87 | 0 | 4.43 |
| APPLICATION SITE PAIN | 0 | 2 | 0 | 0 | 22.1 | 0 | 0 | 9.04 | 0 |
| APPLICATION SITE PERSPIRATION | 0 | 2 | 0 | 0 | 22.1 | 0 | 0 | 9.04 | 0 |
| CHEST DISCOMFORT | 0 | 1 | 1 | 0 | 22.1 | 22.6 | 0 | 4.52 | 4.43 |
| CHEST PAIN | 0 | 2 | 0 | 0 | 22.1 | 0 | 0 | 9.04 | 0 |
| PAIN | 0 | 1 | 1 | 0 | 22.1 | 22.6 | 0 | 4.52 | 4.43 |
| OEDEMA | 0 | 0 | 2 | 0 | 0 | 22.6 | 0 | 0 | 8.86 |
| APPLICATION SITE INDURATION | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| APPLICATION SITE DISCHARGE | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| FEELING ABNORMAL | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| FEELING COLD | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| APPLICATION SITE BLEEDING | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| APPLICATION SITE DESQUAMATION | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| APPLICATION SITE DISCOLOURATION | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| APPLICATION SITE WARMTH | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| INFLAMMATION | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| SECRETION DISCHARGE | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| SUDDEN DEATH | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| SWELLING | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| ULCER | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 20 | 39 | 39 | 34.8 | 22.1 | 22.6 | 57.47 | 176.30 | 172.73 |
| PRURITUS | 8 | 25 | 21 | 34.8 | 22.1 | 22.6 | 22.99 | 113.01 | 93.01 |
| ERYTHEMA | 8 | 14 | 14 | 34.8 | 22.1 | 22.6 | 22.99 | 63.29 | 62.00 |
| RASH | 5 | 8 | 13 | 34.8 | 22.1 | 22.6 | 14.37 | 36.16 | 57.58 |
| HYPERHIDROSIS | 2 | 8 | 4 | 34.8 | 22.1 | 22.6 | 5.75 | 36.16 | 17.72 |
| SKIN IRRITATION | 3 | 5 | 6 | 34.8 | 22.1 | 22.6 | 8.62 | 22.60 | 26.57 |
| BLISTER | 0 | 1 | 5 | 0 | 22.1 | 22.6 | 0 | 4.52 | 22.14 |
| RASH PRURITIC | 0 | 2 | 1 | 0 | 22.1 | 22.6 | 0 | 9.04 | 4.43 |
| PRURITUS GENERALISED | 0 | 1 | 1 | 0 | 22.1 | 22.6 | 0 | 4.52 | 4.43 |
| URTICARIA | 0 | 1 | 1 | 0 | 22.1 | 22.6 | 0 | 4.52 | 4.43 |
| ALOPECIA | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| COLD SWEAT | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| DRUG ERUPTION | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| SKIN ULCER | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| ACTINIC KERATOSIS | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| RASH MACULO-PAPULAR | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| SKIN ODOUR ABNORMAL | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| DERMATITIS CONTACT | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| RASH ERYTHEMATOUS | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| SKIN EXFOLIATION | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| NERVOUS SYSTEM DISORDERS | 8 | 23 | 22 | 34.8 | 22.1 | 22.6 | 22.99 | 103.97 | 97.44 |
| DIZZINESS | 2 | 10 | 9 | 34.8 | 22.1 | 22.6 | 5.75 | 45.20 | 39.86 |
| HEADACHE | 3 | 5 | 3 | 34.8 | 22.1 | 22.6 | 8.62 | 22.60 | 13.29 |
| SYNCOPE | 0 | 2 | 5 | 0 | 22.1 | 22.6 | 0 | 9.04 | 22.14 |
| SOMNOLENCE | 2 | 1 | 3 | 34.8 | 22.1 | 22.6 | 5.75 | 4.52 | 13.29 |
| TRANSIENT ISCHAEMIC ATTACK | 0 | 1 | 2 | 0 | 22.1 | 22.6 | 0 | 4.52 | 8.86 |
| BURNING SENSATION | 0 | 2 | 0 | 0 | 22.1 | 0 | 0 | 9.04 | 0 |
| LETHARGY | 0 | 1 | 1 | 0 | 22.1 | 22.6 | 0 | 4.52 | 4.43 |
| PARKINSON'S DISEASE | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| PSYCHOMOTOR HYPERACTIVITY | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| AMNESIA | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| COGNITIVE DISORDER | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| HYPERSOMNIA | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| PARAESTHESIA | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| PAROSMIA | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| PARTIAL SEIZURES WITH SECONDARY GENERALISATION | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| SYNCOPE VASOVAGAL | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| BALANCE DISORDER | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| COMPLEX PARTIAL SEIZURES | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| COORDINATION ABNORMAL | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| HEMIANOPIA HOMONYMOUS | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| PARAESTHESIA ORAL | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| STUPOR | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| GASTROINTESTINAL DISORDERS | 17 | 19 | 15 | 34.8 | 22.1 | 22.6 | 48.85 | 85.89 | 66.43 |
| DIARRHOEA | 9 | 3 | 5 | 34.8 | 22.1 | 22.6 | 25.86 | 13.56 | 22.14 |
| VOMITING | 3 | 6 | 4 | 34.8 | 22.1 | 22.6 | 8.62 | 27.12 | 17.72 |
| NAUSEA | 3 | 6 | 3 | 34.8 | 22.1 | 22.6 | 8.62 | 27.12 | 13.29 |
| ABDOMINAL PAIN | 1 | 1 | 3 | 34.8 | 22.1 | 22.6 | 2.87 | 4.52 | 13.29 |
| SALIVARY HYPERSECRETION | 0 | 4 | 0 | 0 | 22.1 | 0 | 0 | 18.08 | 0 |
| DYSPEPSIA | 1 | 0 | 1 | 34.8 | 0 | 22.6 | 2.87 | 0 | 4.43 |
| CONSTIPATION | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| FLATULENCE | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| GASTROOESOPHAGEAL REFLUX DISEASE | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| GLOSSITIS | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| HIATUS HERNIA | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| ABDOMINAL DISCOMFORT | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| GASTROINTESTINAL HAEMORRHAGE | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| STOMACH DISCOMFORT | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| DYSPHAGIA | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| RECTAL HAEMORRHAGE | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| CARDIAC DISORDERS | 12 | 14 | 14 | 34.8 | 22.1 | 22.6 | 34.48 | 63.29 | 62.00 |
| SINUS BRADYCARDIA | 2 | 8 | 7 | 34.8 | 22.1 | 22.6 | 5.75 | 36.16 | 31.00 |
| MYOCARDIAL INFARCTION | 4 | 4 | 2 | 34.8 | 22.1 | 22.6 | 11.49 | 18.08 | 8.86 |
| ATRIAL FIBRILLATION | 1 | 2 | 2 | 34.8 | 22.1 | 22.6 | 2.87 | 9.04 | 8.86 |
| SUPRAVENTRICULAR EXTRASYSTOLES | 1 | 1 | 1 | 34.8 | 22.1 | 22.6 | 2.87 | 4.52 | 4.43 |
| VENTRICULAR EXTRASYSTOLES | 0 | 1 | 2 | 0 | 22.1 | 22.6 | 0 | 4.52 | 8.86 |
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | 1 | 0 | 1 | 34.8 | 0 | 22.6 | 2.87 | 0 | 4.43 |
| BUNDLE BRANCH BLOCK RIGHT | 1 | 0 | 1 | 34.8 | 0 | 22.6 | 2.87 | 0 | 4.43 |
| ATRIAL FLUTTER | 0 | 1 | 1 | 0 | 22.1 | 22.6 | 0 | 4.52 | 4.43 |
| PALPITATIONS | 0 | 0 | 2 | 0 | 0 | 22.6 | 0 | 0 | 8.86 |
| ATRIAL HYPERTROPHY | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| BRADYCARDIA | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| BUNDLE BRANCH BLOCK LEFT | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| CARDIAC FAILURE CONGESTIVE | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| SINUS ARRHYTHMIA | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| TACHYCARDIA | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| VENTRICULAR HYPERTROPHY | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| CARDIAC DISORDER | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| SUPRAVENTRICULAR TACHYCARDIA | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| WOLFF-PARKINSON-WHITE SYNDROME | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| INFECTIONS AND INFESTATIONS | 16 | 13 | 9 | 34.8 | 22.1 | 22.6 | 45.98 | 58.77 | 39.86 |
| NASOPHARYNGITIS | 2 | 6 | 4 | 34.8 | 22.1 | 22.6 | 5.75 | 27.12 | 17.72 |
| UPPER RESPIRATORY TRACT INFECTION | 6 | 3 | 1 | 34.8 | 22.1 | 22.6 | 17.24 | 13.56 | 4.43 |
| INFLUENZA | 1 | 1 | 1 | 34.8 | 22.1 | 22.6 | 2.87 | 4.52 | 4.43 |
| URINARY TRACT INFECTION | 2 | 1 | 0 | 34.8 | 22.1 | 0 | 5.75 | 4.52 | 0 |
| CYSTITIS | 1 | 1 | 0 | 34.8 | 22.1 | 0 | 2.87 | 4.52 | 0 |
| EAR INFECTION | 2 | 0 | 0 | 34.8 | 0 | 0 | 5.75 | 0 | 0 |
| BRONCHITIS | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| CERVICITIS | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| GASTROENTERITIS VIRAL | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| LOCALISED INFECTION | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| VAGINAL MYCOSIS | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| HORDEOLUM | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| LOWER RESPIRATORY TRACT INFECTION | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| RHINITIS | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| CELLULITIS | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| PNEUMONIA | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| VIRAL INFECTION | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| PSYCHIATRIC DISORDERS | 10 | 7 | 11 | 34.8 | 22.1 | 22.6 | 28.73 | 31.64 | 48.72 |
| CONFUSIONAL STATE | 2 | 1 | 3 | 34.8 | 22.1 | 22.6 | 5.75 | 4.52 | 13.29 |
| AGITATION | 2 | 0 | 3 | 34.8 | 0 | 22.6 | 5.75 | 0 | 13.29 |
| INSOMNIA | 2 | 2 | 0 | 34.8 | 22.1 | 0 | 5.75 | 9.04 | 0 |
| ANXIETY | 0 | 0 | 3 | 0 | 0 | 22.6 | 0 | 0 | 13.29 |
| DELUSION | 1 | 1 | 0 | 34.8 | 22.1 | 0 | 2.87 | 4.52 | 0 |
| IRRITABILITY | 1 | 0 | 1 | 34.8 | 0 | 22.6 | 2.87 | 0 | 4.43 |
| COMPLETED SUICIDE | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| DISORIENTATION | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| DELIRIUM | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| HALLUCINATION | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| HALLUCINATION, VISUAL | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| LIBIDO DECREASED | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| LISTLESS | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| NIGHTMARE | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| DEPRESSED MOOD | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| RESTLESSNESS | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | 8 | 10 | 9 | 34.8 | 22.1 | 22.6 | 22.99 | 45.20 | 39.86 |
| COUGH | 1 | 5 | 5 | 34.8 | 22.1 | 22.6 | 2.87 | 22.60 | 22.14 |
| NASAL CONGESTION | 3 | 3 | 1 | 34.8 | 22.1 | 22.6 | 8.62 | 13.56 | 4.43 |
| DYSPNOEA | 1 | 1 | 1 | 34.8 | 22.1 | 22.6 | 2.87 | 4.52 | 4.43 |
| EPISTAXIS | 0 | 2 | 1 | 0 | 22.1 | 22.6 | 0 | 9.04 | 4.43 |
| PHARYNGOLARYNGEAL PAIN | 0 | 1 | 1 | 0 | 22.1 | 22.6 | 0 | 4.52 | 4.43 |
| RHINORRHOEA | 0 | 1 | 1 | 0 | 22.1 | 22.6 | 0 | 4.52 | 4.43 |
| EMPHYSEMA | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| HAEMOPTYSIS | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| POSTNASAL DRIP | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| RALES | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| ALLERGIC GRANULOMATOUS ANGIITIS | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| PHARYNGEAL ERYTHEMA | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| PRODUCTIVE COUGH | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| RESPIRATORY TRACT CONGESTION | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| DYSPHONIA | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| INVESTIGATIONS | 10 | 5 | 7 | 34.8 | 22.1 | 22.6 | 28.73 | 22.60 | 31.00 |
| ELECTROCARDIOGRAM ST SEGMENT DEPRESSION | 4 | 0 | 1 | 34.8 | 0 | 22.6 | 11.49 | 0 | 4.43 |
| ELECTROCARDIOGRAM T WAVE INVERSION | 2 | 1 | 1 | 34.8 | 22.1 | 22.6 | 5.75 | 4.52 | 4.43 |
| ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED | 1 | 0 | 1 | 34.8 | 0 | 22.6 | 2.87 | 0 | 4.43 |
| BLOOD GLUCOSE INCREASED | 0 | 1 | 1 | 0 | 22.1 | 22.6 | 0 | 4.52 | 4.43 |
| BLOOD ALKALINE PHOSPHATASE INCREASED | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| BLOOD URINE PRESENT | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| CYSTOSCOPY | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| HEART RATE INCREASED | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| HEART RATE IRREGULAR | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| BIOPSY | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| BIOPSY PROSTATE | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| BLOOD CHOLESTEROL INCREASED | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| BODY TEMPERATURE INCREASED | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| NASAL MUCOSA BIOPSY | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| WEIGHT DECREASED | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | 4 | 7 | 7 | 34.8 | 22.1 | 22.6 | 11.49 | 31.64 | 31.00 |
| BACK PAIN | 1 | 3 | 1 | 34.8 | 22.1 | 22.6 | 2.87 | 13.56 | 4.43 |
| ARTHRALGIA | 1 | 1 | 2 | 34.8 | 22.1 | 22.6 | 2.87 | 4.52 | 8.86 |
| SHOULDER PAIN | 1 | 0 | 2 | 34.8 | 0 | 22.6 | 2.87 | 0 | 8.86 |
| MUSCLE SPASMS | 0 | 1 | 1 | 0 | 22.1 | 22.6 | 0 | 4.52 | 4.43 |
| PAIN IN EXTREMITY | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| ARTHRITIS | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| FLANK PAIN | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| MYALGIA | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| MUSCULAR WEAKNESS | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS | 4 | 5 | 5 | 34.8 | 22.1 | 22.6 | 11.49 | 22.60 | 22.14 |
| CONTUSION | 1 | 2 | 1 | 34.8 | 22.1 | 22.6 | 2.87 | 9.04 | 4.43 |
| EXCORIATION | 2 | 1 | 1 | 34.8 | 22.1 | 22.6 | 5.75 | 4.52 | 4.43 |
| FALL | 1 | 1 | 2 | 34.8 | 22.1 | 22.6 | 2.87 | 4.52 | 8.86 |
| HIP FRACTURE | 1 | 2 | 0 | 34.8 | 22.1 | 0 | 2.87 | 9.04 | 0 |
| SKIN LACERATION | 1 | 0 | 2 | 34.8 | 0 | 22.6 | 2.87 | 0 | 8.86 |
| FACIAL BONES FRACTURE | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| JOINT DISLOCATION | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| WOUND | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| RENAL AND URINARY DISORDERS | 4 | 3 | 3 | 34.8 | 22.1 | 22.6 | 11.49 | 13.56 | 13.29 |
| MICTURITION URGENCY | 1 | 1 | 1 | 34.8 | 22.1 | 22.6 | 2.87 | 4.52 | 4.43 |
| DYSURIA | 1 | 0 | 1 | 34.8 | 0 | 22.6 | 2.87 | 0 | 4.43 |
| NEPHROLITHIASIS | 1 | 1 | 0 | 34.8 | 22.1 | 0 | 2.87 | 4.52 | 0 |
| POLLAKIURIA | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| CALCULUS URETHRAL | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| INCONTINENCE | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| METABOLISM AND NUTRITION DISORDERS | 6 | 2 | 1 | 34.8 | 22.1 | 22.6 | 17.24 | 9.04 | 4.43 |
| DECREASED APPETITE | 1 | 1 | 0 | 34.8 | 22.1 | 0 | 2.87 | 4.52 | 0 |
| FOOD CRAVING | 1 | 0 | 1 | 34.8 | 0 | 22.6 | 2.87 | 0 | 4.43 |
| INCREASED APPETITE | 1 | 1 | 0 | 34.8 | 22.1 | 0 | 2.87 | 4.52 | 0 |
| DEHYDRATION | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| DIABETES MELLITUS | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| HYPONATRAEMIA | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| VASCULAR DISORDERS | 3 | 1 | 3 | 34.8 | 22.1 | 22.6 | 8.62 | 4.52 | 13.29 |
| HYPOTENSION | 2 | 0 | 1 | 34.8 | 0 | 22.6 | 5.75 | 0 | 4.43 |
| HYPERTENSION | 1 | 0 | 1 | 34.8 | 0 | 22.6 | 2.87 | 0 | 4.43 |
| ORTHOSTATIC HYPOTENSION | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| WOUND HAEMORRHAGE | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| HOT FLUSH | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| EYE DISORDERS | 2 | 1 | 2 | 34.8 | 22.1 | 22.6 | 5.75 | 4.52 | 8.86 |
| VISION BLURRED | 0 | 1 | 1 | 0 | 22.1 | 22.6 | 0 | 4.52 | 4.43 |
| CONJUNCTIVITIS | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| EYE ALLERGY | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| EYE PRURITUS | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| EYE SWELLING | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| CONJUNCTIVAL HAEMORRHAGE | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| SURGICAL AND MEDICAL PROCEDURES | 2 | 2 | 1 | 34.8 | 22.1 | 22.6 | 5.75 | 9.04 | 4.43 |
| CATARACT OPERATION | 1 | 0 | 1 | 34.8 | 0 | 22.6 | 2.87 | 0 | 4.43 |
| EYE LASER SURGERY | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| ACROCHORDON EXCISION | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| SKIN LESION EXCISION | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| EAR AND LABYRINTH DISORDERS | 1 | 1 | 2 | 34.8 | 22.1 | 22.6 | 2.87 | 4.52 | 8.86 |
| VERTIGO | 0 | 1 | 1 | 0 | 22.1 | 22.6 | 0 | 4.52 | 4.43 |
| EAR PAIN | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| CERUMEN IMPACTION | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| CONGENITAL, FAMILIAL AND GENETIC DISORDERS | 0 | 2 | 1 | 0 | 22.1 | 22.6 | 0 | 9.04 | 4.43 |
| VENTRICULAR SEPTAL DEFECT | 0 | 2 | 1 | 0 | 22.1 | 22.6 | 0 | 9.04 | 4.43 |
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) | 0 | 1 | 2 | 0 | 22.1 | 22.6 | 0 | 4.52 | 8.86 |
| PROSTATE CANCER | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| COLON CANCER | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| MALIGNANT FIBROUS HISTIOCYTOMA | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| REPRODUCTIVE SYSTEM AND BREAST DISORDERS | 2 | 1 | 0 | 34.8 | 22.1 | 0 | 5.75 | 4.52 | 0 |
| BENIGN PROSTATIC HYPERPLASIA | 1 | 1 | 0 | 34.8 | 22.1 | 0 | 2.87 | 4.52 | 0 |
| PELVIC PAIN | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| HEPATOBILIARY DISORDERS | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| HYPERBILIRUBINAEMIA | 1 | 0 | 0 | 34.8 | 0 | 0 | 2.87 | 0 | 0 |
| IMMUNE SYSTEM DISORDERS | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| HYPERSENSITIVITY | 0 | 0 | 1 | 0 | 0 | 22.6 | 0 | 0 | 4.43 |
| SOCIAL CIRCUMSTANCES | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
| ALCOHOL USE | 0 | 1 | 0 | 0 | 22.1 | 0 | 0 | 4.52 | 0 |
n = number of subjects with at least one event in the category.
PY = patient-years of exposure (total duration in days / 365.25).
Rate = (n / PY) x 100. Subjects counted once per SOC and once per PT.
SOC rows sorted by descending subject frequency across all arms.
/opt/quarto/share/rmd/rmd.R
01APR2026 09:51:59