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")
admh <- pharmaverseadam::admh |>
blank_to_na() |>
filter(SAFFL == "Y")
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)Medical History
Summary of Medical History by System Organ Class and Preferred Term
Setup
See Prerequisites for installation instructions.
Data Preparation
n_pct <- function(n, denom) sprintf("%d (%.1f)", n, n / denom * 100)
# ── Overall: subjects with at least one MH condition ──
any_mh_arm <- admh |>
distinct(USUBJID, TRT01A) |>
count(TRT01A) |>
filter(TRT01A %in% arm_levels) |>
mutate(value = mapply(n_pct, n, arm_n[TRT01A])) |>
select(TRT01A, value) |>
pivot_wider(names_from = TRT01A, values_from = value)
any_mh_total <- n_distinct(admh$USUBJID)
any_mh_row <- bind_cols(
tibble(soc = "ANY MEDICAL HISTORY", pt = "ANY MEDICAL HISTORY",
row_type = "overall"),
any_mh_arm,
tibble(Total = n_pct(any_mh_total, N_total))
)
# ── SOC-level (MHBODSYS) ──
soc_arm <- admh |>
distinct(USUBJID, TRT01A, MHBODSYS) |>
count(TRT01A, MHBODSYS) |>
filter(TRT01A %in% arm_levels) |>
mutate(value = mapply(n_pct, n, arm_n[TRT01A])) |>
select(TRT01A, MHBODSYS, value) |>
pivot_wider(names_from = TRT01A, values_from = value)
soc_total <- admh |>
distinct(USUBJID, MHBODSYS) |>
count(MHBODSYS) |>
mutate(Total = n_pct(n, N_total)) |>
select(MHBODSYS, Total)
soc_wide <- left_join(soc_arm, soc_total, by = "MHBODSYS") |>
mutate(soc = MHBODSYS, pt = MHBODSYS, row_type = "soc", .before = 1) |>
select(-MHBODSYS)
# ── PT-level (MHDECOD) ──
pt_arm <- admh |>
distinct(USUBJID, TRT01A, MHBODSYS, MHDECOD) |>
count(TRT01A, MHBODSYS, MHDECOD) |>
filter(TRT01A %in% arm_levels) |>
mutate(value = mapply(n_pct, n, arm_n[TRT01A])) |>
select(TRT01A, MHBODSYS, MHDECOD, value) |>
pivot_wider(names_from = TRT01A, values_from = value)
pt_total <- admh |>
distinct(USUBJID, MHBODSYS, MHDECOD) |>
count(MHBODSYS, MHDECOD) |>
mutate(Total = n_pct(n, N_total)) |>
select(MHBODSYS, MHDECOD, Total)
pt_wide <- left_join(pt_arm, pt_total, by = c("MHBODSYS", "MHDECOD")) |>
mutate(soc = MHBODSYS, pt = MHDECOD, row_type = "pt", .before = 1) |>
select(-MHBODSYS, -MHDECOD)
# ── Sort by frequency and interleave ──
soc_order <- admh |>
distinct(USUBJID, MHBODSYS) |>
count(MHBODSYS, name = "soc_n") |>
arrange(desc(soc_n)) |>
pull(MHBODSYS)
mh_wide <- bind_rows(
any_mh_row,
bind_rows(lapply(soc_order, function(s) {
bind_rows(
filter(soc_wide, soc == s),
filter(pt_wide, soc == s) |>
left_join(
admh |> distinct(USUBJID, MHBODSYS, MHDECOD) |>
count(MHBODSYS, MHDECOD, name = "pt_n"),
by = c("soc" = "MHBODSYS", "pt" = "MHDECOD")
) |> arrange(desc(pt_n)) |> select(-pt_n)
)
}))
) |>
mutate(across(where(is.character) & !c(soc, pt, row_type),
~ replace_na(.x, "0 (0.0)")))mh_ard <- ard_stack_hierarchical(
data = admh,
variables = c(MHBODSYS, MHDECOD),
by = TRT01A,
denominator = adsl_saf,
id = USUBJID,
overall = TRUE,
over_variables = TRUE
) |>
sort_ard_hierarchical(sort = "descending")
mh_wide_cards <- fr_wide_ard(
mh_ard,
statistic = "{n} ({p}%)",
decimals = c(p = 1),
label = c(
"..ard_hierarchical_overall.." = "ANY MEDICAL HISTORY",
MHBODSYS = "System Organ Class",
MHDECOD = "Preferred Term"
)
)arframe Pipeline
The rendered table below uses the dplyr data prep (mh_wide). The cards tab produces an equivalent mh_wide_cards — swap it in to use the cards path instead.
mh_wide |>
fr_table() |>
fr_titles(
"Table 14.1.7",
"Summary of Medical History",
"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(
"Subjects counted once per SOC and once per PT.",
"Percentages based on N per treatment arm (Safety Population).",
"SOC sorted by descending frequency; PT sorted within SOC by descending frequency."
)Rendered Table
Table 14.1.7
Summary of Medical History
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) |
|---|---|---|---|---|
| ANY MEDICAL HISTORY | 86 (100.0) | 72 (100.0) | 96 (100.0) | 254 (100.0) |
| SURGICAL AND MEDICAL PROCEDURES | 45 ( 52.3) | 46 ( 63.9) | 68 ( 70.8) | 159 ( 62.6) |
| HYSTERECTOMY | 9 ( 10.5) | 9 ( 12.5) | 16 ( 16.7) | 34 ( 13.4) |
| APPENDICECTOMY | 8 ( 9.3) | 10 ( 13.9) | 5 ( 5.2) | 23 ( 9.1) |
| TONSILLECTOMY | 7 ( 8.1) | 4 ( 5.6) | 10 ( 10.4) | 21 ( 8.3) |
| CATARACT OPERATION | 10 ( 11.6) | 4 ( 5.6) | 6 ( 6.2) | 20 ( 7.9) |
| HERNIA REPAIR | 5 ( 5.8) | 6 ( 8.3) | 4 ( 4.2) | 15 ( 5.9) |
| CHOLECYSTECTOMY | 4 ( 4.7) | 2 ( 2.8) | 4 ( 4.2) | 10 ( 3.9) |
| HIP ARTHROPLASTY | 4 ( 4.7) | 2 ( 2.8) | 3 ( 3.1) | 9 ( 3.5) |
| TRANSURETHRAL PROSTATECTOMY | 1 ( 1.2) | 3 ( 4.2) | 5 ( 5.2) | 9 ( 3.5) |
| SKIN NEOPLASM EXCISION | 4 ( 4.7) | 0 | 3 ( 3.1) | 7 ( 2.8) |
| HAEMORRHOID OPERATION | 0 | 4 ( 5.6) | 3 ( 3.1) | 7 ( 2.8) |
| INGUINAL HERNIA REPAIR | 3 ( 3.5) | 1 ( 1.4) | 2 ( 2.1) | 6 ( 2.4) |
| TOOTH EXTRACTION | 2 ( 2.3) | 2 ( 2.8) | 2 ( 2.1) | 6 ( 2.4) |
| SURGERY | 0 | 3 ( 4.2) | 3 ( 3.1) | 6 ( 2.4) |
| KNEE ARTHROPLASTY | 2 ( 2.3) | 3 ( 4.2) | 0 | 5 ( 2.0) |
| LENS IMPLANT | 0 | 3 ( 4.2) | 2 ( 2.1) | 5 ( 2.0) |
| CARDIAC PACEMAKER INSERTION | 1 ( 1.2) | 0 | 3 ( 3.1) | 4 ( 1.6) |
| MASTECTOMY | 1 ( 1.2) | 1 ( 1.4) | 2 ( 2.1) | 4 ( 1.6) |
| COLECTOMY | 1 ( 1.2) | 0 | 2 ( 2.1) | 3 ( 1.2) |
| FRACTURE TREATMENT | 1 ( 1.2) | 1 ( 1.4) | 1 ( 1.0) | 3 ( 1.2) |
| VASCULAR BYPASS GRAFT | 1 ( 1.2) | 2 ( 2.8) | 0 | 3 ( 1.2) |
| CORONARY ARTERY SURGERY | 0 | 0 | 3 ( 3.1) | 3 ( 1.2) |
| EAR OPERATION | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| INTESTINAL POLYPECTOMY | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| KNEE OPERATION | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| MALIGNANT TUMOUR EXCISION | 2 ( 2.3) | 0 | 0 | 2 ( 0.8) |
| RADICAL MASTECTOMY | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| SKIN GRAFT | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| UMBILICAL HERNIA REPAIR | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| AORTIC ANEURYSM REPAIR | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| BREAST LUMP REMOVAL | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| CAROTID ENDARTERECTOMY | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| CARPAL TUNNEL DECOMPRESSION | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| GASTRIC ULCER SURGERY | 0 | 2 ( 2.8) | 0 | 2 ( 0.8) |
| HIP SURGERY | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| OOPHORECTOMY PARTIAL | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| ORCHIDECTOMY | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| SINUS OPERATION | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| INTERVERTEBRAL DISC OPERATION | 0 | 0 | 2 ( 2.1) | 2 ( 0.8) |
| PROSTATIC OPERATION | 0 | 0 | 2 ( 2.1) | 2 ( 0.8) |
| SPINAL LAMINECTOMY | 0 | 0 | 2 ( 2.1) | 2 ( 0.8) |
| ABSCESS DRAINAGE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| AORTIC VALVE REPLACEMENT | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| BENIGN TUMOUR EXCISION | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| BRAIN OPERATION | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| CORNEAL TRANSPLANT | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| DETACHED RETINA REPAIR | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| EYE LASER SURGERY | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| EYE OPERATION | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| GLAUCOMA SURGERY | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| PENILE PROSTHESIS INSERTION | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| PROSTATECTOMY | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| RENAL STONE REMOVAL | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| SHOULDER ARTHROPLASTY | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| SKIN LESION EXCISION | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| SPINAL FUSION SURGERY | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| TENDON REPAIR | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| THYROID OPERATION | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| THYROIDECTOMY PARTIAL | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| TONGUE OPERATION | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| VAGOTOMY | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| BLADDER NEOPLASM SURGERY | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| CAESAREAN SECTION | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| CHEMOTHERAPY | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| COLON POLYPECTOMY | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| CORNEAL OPERATION | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| DENTAL OPERATION | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| ENDODONTIC PROCEDURE | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| FACE LIFT | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| FOOT OPERATION | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| INTERNAL FIXATION OF FRACTURE | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| INTESTINAL ADHESION LYSIS | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| LARYNGEAL POLYPECTOMY | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| LIPECTOMY | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| MASS EXCISION | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| TRIPLE VESSEL BYPASS GRAFT | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| TUBAL LIGATION | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| VASECTOMY | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| ANGIOPLASTY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| BENIGN BREAST LUMP REMOVAL | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| BLADDER REPAIR | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| BREAST COSMETIC SURGERY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| CORONARY ANGIOPLASTY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| CYST REMOVAL | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| CYSTOPEXY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| FINGER AMPUTATION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| GASTRECTOMY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| GINGIVAL OPERATION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| HAND REPAIR OPERATION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| ILEOSTOMY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| JOINT ARTHROPLASTY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| MASTOIDECTOMY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| NASAL CYST REMOVAL | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| NEPHRECTOMY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| OESOPHAGEAL OPERATION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| SEBACEOUS CYST EXCISION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| SHOULDER OPERATION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| STENT PLACEMENT | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| THROMBECTOMY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| THYROIDECTOMY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| TOE OPERATION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| TUMOUR EXCISION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| URETHRAL OPERATION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| UTERINE DILATION AND CURETTAGE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| UTERINE TUMOUR EXCISION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| VARICOSE VEINS STRIPPING | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| WISDOM TEETH REMOVAL | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | 37 ( 43.0) | 35 ( 48.6) | 46 ( 47.9) | 118 ( 46.5) |
| ARTHRITIS | 14 ( 16.3) | 13 ( 18.1) | 20 ( 20.8) | 47 ( 18.5) |
| OSTEOARTHRITIS | 7 ( 8.1) | 5 ( 6.9) | 8 ( 8.3) | 20 ( 7.9) |
| POLYARTHRITIS | 3 ( 3.5) | 5 ( 6.9) | 5 ( 5.2) | 13 ( 5.1) |
| BACK PAIN | 4 ( 4.7) | 4 ( 5.6) | 3 ( 3.1) | 11 ( 4.3) |
| ARTHRALGIA | 3 ( 3.5) | 2 ( 2.8) | 2 ( 2.1) | 7 ( 2.8) |
| OSTEOPOROSIS | 2 ( 2.3) | 1 ( 1.4) | 3 ( 3.1) | 6 ( 2.4) |
| KYPHOSIS | 2 ( 2.3) | 0 | 2 ( 2.1) | 4 ( 1.6) |
| MYALGIA | 2 ( 2.3) | 2 ( 2.8) | 0 | 4 ( 1.6) |
| PAIN IN EXTREMITY | 1 ( 1.2) | 2 ( 2.8) | 1 ( 1.0) | 4 ( 1.6) |
| INTERVERTEBRAL DISC PROTRUSION | 0 | 2 ( 2.8) | 2 ( 2.1) | 4 ( 1.6) |
| GANGLION | 2 ( 2.3) | 0 | 1 ( 1.0) | 3 ( 1.2) |
| MUSCLE SPASMS | 1 ( 1.2) | 1 ( 1.4) | 1 ( 1.0) | 3 ( 1.2) |
| RHEUMATOID ARTHRITIS | 2 ( 2.3) | 0 | 1 ( 1.0) | 3 ( 1.2) |
| BUNION | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| OSTEITIS DEFORMANS | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| SCOLIOSIS | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| SHOULDER PAIN | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| DUPUYTREN'S CONTRACTURE | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| JOINT SWELLING | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| SPINAL OSTEOARTHRITIS | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| MONARTHRITIS | 0 | 0 | 2 ( 2.1) | 2 ( 0.8) |
| RHEUMATIC FEVER | 0 | 0 | 2 ( 2.1) | 2 ( 0.8) |
| SPONDYLITIS | 0 | 0 | 2 ( 2.1) | 2 ( 0.8) |
| JOINT CONTRACTURE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| NECK PAIN | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| SPINAL COLUMN STENOSIS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| BURSITIS | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| EXOSTOSIS | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| FIBROMYALGIA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| KYPHOSCOLIOSIS | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| MUSCLE TWITCHING | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| CHONDROPATHY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| FINGER DEFORMITY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| FOOT DEFORMITY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| LUMBAR SPINAL STENOSIS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| OSTEOPOROTIC FRACTURE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| PERIARTHRITIS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| GASTROINTESTINAL DISORDERS | 29 ( 33.7) | 22 ( 30.6) | 35 ( 36.5) | 86 ( 33.9) |
| CONSTIPATION | 6 ( 7.0) | 7 ( 9.7) | 7 ( 7.3) | 20 ( 7.9) |
| DYSPEPSIA | 10 ( 11.6) | 5 ( 6.9) | 2 ( 2.1) | 17 ( 6.7) |
| HAEMORRHOIDS | 4 ( 4.7) | 3 ( 4.2) | 3 ( 3.1) | 10 ( 3.9) |
| HIATUS HERNIA | 4 ( 4.7) | 2 ( 2.8) | 2 ( 2.1) | 8 ( 3.1) |
| DUODENAL ULCER | 2 ( 2.3) | 1 ( 1.4) | 3 ( 3.1) | 6 ( 2.4) |
| DIARRHOEA | 0 | 3 ( 4.2) | 3 ( 3.1) | 6 ( 2.4) |
| DIVERTICULUM | 2 ( 2.3) | 2 ( 2.8) | 1 ( 1.0) | 5 ( 2.0) |
| INGUINAL HERNIA | 2 ( 2.3) | 2 ( 2.8) | 1 ( 1.0) | 5 ( 2.0) |
| GASTRIC ULCER | 0 | 1 ( 1.4) | 4 ( 4.2) | 5 ( 2.0) |
| RECTAL HAEMORRHAGE | 1 ( 1.2) | 2 ( 2.8) | 1 ( 1.0) | 4 ( 1.6) |
| PEPTIC ULCER | 1 ( 1.2) | 1 ( 1.4) | 1 ( 1.0) | 3 ( 1.2) |
| GASTRITIS | 2 ( 2.3) | 0 | 0 | 2 ( 0.8) |
| GASTROOESOPHAGEAL REFLUX DISEASE | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| INTESTINAL OBSTRUCTION | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| OESOPHAGEAL SPASM | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| ABDOMINAL DISCOMFORT | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| ABDOMINAL PAIN | 0 | 2 ( 2.8) | 0 | 2 ( 0.8) |
| ANAL FISTULA | 0 | 2 ( 2.8) | 0 | 2 ( 0.8) |
| ABDOMINAL HERNIA | 0 | 0 | 2 ( 2.1) | 2 ( 0.8) |
| UMBILICAL HERNIA | 0 | 0 | 2 ( 2.1) | 2 ( 0.8) |
| DYSPHAGIA | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| INTESTINAL ULCER | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| ABDOMINAL ADHESIONS | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| BOWEL MOVEMENT IRREGULARITY | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| INTESTINAL POLYP | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| OESOPHAGEAL STENOSIS | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| PAINFUL DEFAECATION | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| SMALL INTESTINE ULCER | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| COLITIS ULCERATIVE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| COLONIC POLYP | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| FLATULENCE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| GASTROINTESTINAL PAIN | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| GASTROINTESTINAL ULCER | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| GINGIVITIS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| LARGE INTESTINAL ULCER | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| MALABSORPTION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| RECTAL POLYP | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| TOOTHACHE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| EYE DISORDERS | 26 ( 30.2) | 24 ( 33.3) | 30 ( 31.2) | 80 ( 31.5) |
| GLAUCOMA | 7 ( 8.1) | 6 ( 8.3) | 6 ( 6.2) | 19 ( 7.5) |
| CATARACT | 6 ( 7.0) | 2 ( 2.8) | 10 ( 10.4) | 18 ( 7.1) |
| HYPERMETROPIA | 2 ( 2.3) | 5 ( 6.9) | 4 ( 4.2) | 11 ( 4.3) |
| PRESBYOPIA | 4 ( 4.7) | 1 ( 1.4) | 4 ( 4.2) | 9 ( 3.5) |
| MACULAR DEGENERATION | 5 ( 5.8) | 2 ( 2.8) | 1 ( 1.0) | 8 ( 3.1) |
| MYOPIA | 2 ( 2.3) | 3 ( 4.2) | 3 ( 3.1) | 8 ( 3.1) |
| ASTIGMATISM | 3 ( 3.5) | 1 ( 1.4) | 0 | 4 ( 1.6) |
| RETINAL DETACHMENT | 1 ( 1.2) | 1 ( 1.4) | 1 ( 1.0) | 3 ( 1.2) |
| DIABETIC RETINOPATHY | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| BLINDNESS UNILATERAL | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| CONJUNCTIVAL DISCOLOURATION | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| STRABISMUS | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| DRY EYE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| VISUAL ACUITY REDUCED | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| VASCULAR DISORDERS | 22 ( 25.6) | 22 ( 30.6) | 25 ( 26.0) | 69 ( 27.2) |
| HYPERTENSION | 21 ( 24.4) | 20 ( 27.8) | 21 ( 21.9) | 62 ( 24.4) |
| VARICOSE VEIN | 1 ( 1.2) | 2 ( 2.8) | 2 ( 2.1) | 5 ( 2.0) |
| RAYNAUD'S PHENOMENON | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| VASODILATATION | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| AORTIC ATHEROSCLEROSIS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| AORTIC STENOSIS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| ARTERIOSCLEROSIS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| ATHEROSCLEROSIS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| VENOUS INSUFFICIENCY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| NERVOUS SYSTEM DISORDERS | 20 ( 23.3) | 21 ( 29.2) | 20 ( 20.8) | 61 ( 24.0) |
| HEADACHE | 9 ( 10.5) | 9 ( 12.5) | 11 ( 11.5) | 29 ( 11.4) |
| DIZZINESS | 3 ( 3.5) | 7 ( 9.7) | 6 ( 6.2) | 16 ( 6.3) |
| HYPOAESTHESIA | 4 ( 4.7) | 1 ( 1.4) | 0 | 5 ( 2.0) |
| HYPOREFLEXIA | 1 ( 1.2) | 2 ( 2.8) | 0 | 3 ( 1.2) |
| MIGRAINE | 2 ( 2.3) | 0 | 1 ( 1.0) | 3 ( 1.2) |
| PARAESTHESIA | 2 ( 2.3) | 1 ( 1.4) | 0 | 3 ( 1.2) |
| AREFLEXIA | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| CONVULSION | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| LOSS OF CONSCIOUSNESS | 2 ( 2.3) | 0 | 0 | 2 ( 0.8) |
| NERVE COMPRESSION | 0 | 0 | 2 ( 2.1) | 2 ( 0.8) |
| CEREBRAL HAEMORRHAGE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| DIABETIC NEUROPATHY | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| DIZZINESS POSTURAL | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| HEMIPLEGIA | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| SCIATICA | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| SINUS HEADACHE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| TREMOR | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| ANOSMIA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| ESSENTIAL TREMOR | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| GLOBAL AMNESIA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| INTENTION TREMOR | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| MIGRAINE WITH AURA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| NEURALGIA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| BALANCE DISORDER | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| CERVICAL MYELOPATHY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| CERVICOBRACHIAL SYNDROME | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| NEUROPATHY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| SENSORY LOSS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| SYNCOPE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| TRANSIENT ISCHAEMIC ATTACK | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| CARDIAC DISORDERS | 17 ( 19.8) | 15 ( 20.8) | 25 ( 26.0) | 57 ( 22.4) |
| MYOCARDIAL INFARCTION | 7 ( 8.1) | 5 ( 6.9) | 10 ( 10.4) | 22 ( 8.7) |
| ANGINA PECTORIS | 4 ( 4.7) | 2 ( 2.8) | 3 ( 3.1) | 9 ( 3.5) |
| BUNDLE BRANCH BLOCK RIGHT | 2 ( 2.3) | 0 | 3 ( 3.1) | 5 ( 2.0) |
| SINUS BRADYCARDIA | 0 | 3 ( 4.2) | 2 ( 2.1) | 5 ( 2.0) |
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | 2 ( 2.3) | 1 ( 1.4) | 0 | 3 ( 1.2) |
| BUNDLE BRANCH BLOCK LEFT | 1 ( 1.2) | 0 | 2 ( 2.1) | 3 ( 1.2) |
| CORONARY ARTERY DISEASE | 1 ( 1.2) | 1 ( 1.4) | 1 ( 1.0) | 3 ( 1.2) |
| PALPITATIONS | 2 ( 2.3) | 1 ( 1.4) | 0 | 3 ( 1.2) |
| ATRIAL HYPERTROPHY | 0 | 1 ( 1.4) | 2 ( 2.1) | 3 ( 1.2) |
| BRADYCARDIA | 0 | 1 ( 1.4) | 2 ( 2.1) | 3 ( 1.2) |
| EXTRASYSTOLES | 0 | 2 ( 2.8) | 1 ( 1.0) | 3 ( 1.2) |
| ARRHYTHMIA | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| ATRIOVENTRICULAR BLOCK | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| CYANOSIS | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| MITRAL VALVE PROLAPSE | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| CARDIAC FAILURE CONGESTIVE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| ATRIAL FIBRILLATION | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| CARDIAC DISORDER | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| MYOCARDIAL ISCHAEMIA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| TACHYCARDIA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| VENTRICULAR HYPERTROPHY | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| ATRIAL TACHYCARDIA | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| CARDIAC VALVE DISEASE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| CARDIOVASCULAR DISORDER | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| MITRAL VALVE DISEASE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| SUPRAVENTRICULAR EXTRASYSTOLES | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| EAR AND LABYRINTH DISORDERS | 16 ( 18.6) | 17 ( 23.6) | 17 ( 17.7) | 50 ( 19.7) |
| DEAFNESS | 4 ( 4.7) | 6 ( 8.3) | 4 ( 4.2) | 14 ( 5.5) |
| HYPOACUSIS | 5 ( 5.8) | 3 ( 4.2) | 4 ( 4.2) | 12 ( 4.7) |
| TINNITUS | 1 ( 1.2) | 3 ( 4.2) | 6 ( 6.2) | 10 ( 3.9) |
| DEAFNESS BILATERAL | 0 | 4 ( 5.6) | 2 ( 2.1) | 6 ( 2.4) |
| VERTIGO | 2 ( 2.3) | 1 ( 1.4) | 2 ( 2.1) | 5 ( 2.0) |
| DEAFNESS UNILATERAL | 1 ( 1.2) | 1 ( 1.4) | 1 ( 1.0) | 3 ( 1.2) |
| CERUMEN IMPACTION | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| DEAFNESS NEUROSENSORY | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| EAR PAIN | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| MENIERE'S DISEASE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| INFECTIONS AND INFESTATIONS | 16 ( 18.6) | 12 ( 16.7) | 17 ( 17.7) | 45 ( 17.7) |
| SINUSITIS | 5 ( 5.8) | 3 ( 4.2) | 4 ( 4.2) | 12 ( 4.7) |
| PNEUMONIA | 7 ( 8.1) | 1 ( 1.4) | 2 ( 2.1) | 10 ( 3.9) |
| BRONCHITIS | 1 ( 1.2) | 1 ( 1.4) | 2 ( 2.1) | 4 ( 1.6) |
| CYSTITIS | 2 ( 2.3) | 1 ( 1.4) | 1 ( 1.0) | 4 ( 1.6) |
| TUBERCULOSIS | 0 | 1 ( 1.4) | 3 ( 3.1) | 4 ( 1.6) |
| UPPER RESPIRATORY TRACT INFECTION | 1 ( 1.2) | 1 ( 1.4) | 1 ( 1.0) | 3 ( 1.2) |
| HERPES SIMPLEX | 0 | 1 ( 1.4) | 2 ( 2.1) | 3 ( 1.2) |
| URINARY TRACT INFECTION | 0 | 1 ( 1.4) | 2 ( 2.1) | 3 ( 1.2) |
| NASOPHARYNGITIS | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| OTITIS EXTERNA | 2 ( 2.3) | 0 | 0 | 2 ( 0.8) |
| DIVERTICULITIS | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| GONORRHOEA | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| HERPES ZOSTER | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| APPENDICITIS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| CELLULITIS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| GROIN ABSCESS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| MASTOIDITIS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| POLIOMYELITIS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| HEPATITIS C | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| ONYCHOMYCOSIS | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| PYELONEPHRITIS | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| DIPHTHERIA | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| HORDEOLUM | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| LABYRINTHITIS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| LOCALISED INFECTION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| PNEUMONIA PRIMARY ATYPICAL | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| RHINITIS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| YAWS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS | 16 ( 18.6) | 10 ( 13.9) | 17 ( 17.7) | 43 ( 16.9) |
| HEAD INJURY | 1 ( 1.2) | 3 ( 4.2) | 3 ( 3.1) | 7 ( 2.8) |
| UPPER LIMB FRACTURE | 3 ( 3.5) | 0 | 2 ( 2.1) | 5 ( 2.0) |
| LIMB INJURY | 1 ( 1.2) | 1 ( 1.4) | 2 ( 2.1) | 4 ( 1.6) |
| LOWER LIMB FRACTURE | 1 ( 1.2) | 2 ( 2.8) | 1 ( 1.0) | 4 ( 1.6) |
| FALL | 2 ( 2.3) | 1 ( 1.4) | 0 | 3 ( 1.2) |
| PAIN TRAUMA ACTIVATED | 2 ( 2.3) | 0 | 1 ( 1.0) | 3 ( 1.2) |
| SKIN LACERATION | 2 ( 2.3) | 0 | 1 ( 1.0) | 3 ( 1.2) |
| WRIST FRACTURE | 1 ( 1.2) | 1 ( 1.4) | 1 ( 1.0) | 3 ( 1.2) |
| FOOT FRACTURE | 0 | 1 ( 1.4) | 2 ( 2.1) | 3 ( 1.2) |
| THERMAL BURN | 0 | 1 ( 1.4) | 2 ( 2.1) | 3 ( 1.2) |
| CONTUSION | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| HIP FRACTURE | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| ANKLE FRACTURE | 0 | 2 ( 2.8) | 0 | 2 ( 0.8) |
| JOINT INJURY | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| RIB FRACTURE | 0 | 0 | 2 ( 2.1) | 2 ( 0.8) |
| ACCIDENT | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| CERVICAL VERTEBRAL FRACTURE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| CLAVICLE FRACTURE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| FEMUR FRACTURE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| GUN SHOT WOUND | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| PATELLA FRACTURE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| SPLENIC RUPTURE | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| WHIPLASH INJURY | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| COMPRESSION FRACTURE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| FRACTURED COCCYX | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| HAND FRACTURE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| JAW FRACTURE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| JOINT DISLOCATION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| LACERATION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| PELVIC FRACTURE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| POLYTRAUMATISM | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| SKELETAL INJURY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| TENDON INJURY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| WOUND | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| INVESTIGATIONS | 7 ( 8.1) | 18 ( 25.0) | 14 ( 14.6) | 39 ( 15.4) |
| CARDIAC MURMUR | 3 ( 3.5) | 7 ( 9.7) | 3 ( 3.1) | 13 ( 5.1) |
| BLOOD CHOLESTEROL INCREASED | 1 ( 1.2) | 3 ( 4.2) | 0 | 4 ( 1.6) |
| BIOPSY BREAST NORMAL | 0 | 1 ( 1.4) | 3 ( 3.1) | 4 ( 1.6) |
| ELECTROCARDIOGRAM ST SEGMENT DEPRESSION | 0 | 3 ( 4.2) | 1 ( 1.0) | 4 ( 1.6) |
| BIOPSY PROSTATE NORMAL | 0 | 2 ( 2.8) | 1 ( 1.0) | 3 ( 1.2) |
| ELECTROCARDIOGRAM T WAVE INVERSION | 0 | 2 ( 2.8) | 1 ( 1.0) | 3 ( 1.2) |
| HEART RATE IRREGULAR | 0 | 1 ( 1.4) | 2 ( 2.1) | 3 ( 1.2) |
| CAROTID BRUIT | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| WEIGHT DECREASED | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| ELECTROCARDIOGRAM ST SEGMENT ELEVATION | 0 | 2 ( 2.8) | 0 | 2 ( 0.8) |
| BIOPSY LUNG | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| BIOPSY PROSTATE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| PROSTATIC SPECIFIC ANTIGEN INCREASED | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| ANGIOGRAM | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| BIOPSY BREAST | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| BLOOD PRESSURE INCREASED | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| INTRAOCULAR PRESSURE INCREASED | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| ARTHROSCOPY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| BIOPSY SKIN | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| CATHETERISATION CARDIAC | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| LAPAROSCOPY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| PLATELET COUNT DECREASED | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| METABOLISM AND NUTRITION DISORDERS | 12 ( 14.0) | 12 ( 16.7) | 12 ( 12.5) | 36 ( 14.2) |
| HYPERCHOLESTEROLAEMIA | 7 ( 8.1) | 5 ( 6.9) | 4 ( 4.2) | 16 ( 6.3) |
| DIABETES MELLITUS | 1 ( 1.2) | 7 ( 9.7) | 1 ( 1.0) | 9 ( 3.5) |
| DIABETES MELLITUS NON-INSULIN-DEPENDENT | 1 ( 1.2) | 1 ( 1.4) | 3 ( 3.1) | 5 ( 2.0) |
| VITAMIN B12 DEFICIENCY | 2 ( 2.3) | 0 | 3 ( 3.1) | 5 ( 2.0) |
| GOUT | 0 | 2 ( 2.8) | 2 ( 2.1) | 4 ( 1.6) |
| GLUCOSE TOLERANCE IMPAIRED | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| HYPERLIPIDAEMIA | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| ANOREXIA | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| DEHYDRATION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | 15 ( 17.4) | 5 ( 6.9) | 14 ( 14.6) | 34 ( 13.4) |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 3 ( 3.5) | 2 ( 2.8) | 2 ( 2.1) | 7 ( 2.8) |
| COUGH | 2 ( 2.3) | 0 | 5 ( 5.2) | 7 ( 2.8) |
| ASTHMA | 2 ( 2.3) | 1 ( 1.4) | 1 ( 1.0) | 4 ( 1.6) |
| DYSPNOEA | 1 ( 1.2) | 1 ( 1.4) | 2 ( 2.1) | 4 ( 1.6) |
| DYSPNOEA EXERTIONAL | 2 ( 2.3) | 0 | 0 | 2 ( 0.8) |
| EMPHYSEMA | 2 ( 2.3) | 0 | 0 | 2 ( 0.8) |
| PHARYNGOLARYNGEAL PAIN | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| PLEURISY | 0 | 0 | 2 ( 2.1) | 2 ( 0.8) |
| EPISTAXIS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| PNEUMOTHORAX | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| PULMONARY FIBROSIS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| RALES | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| RHINORRHOEA | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| WHEEZING | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| CHOKING | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| EOSINOPHILIC PNEUMONIA | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| NASAL CONGESTION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| RESPIRATION ABNORMAL | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| RHINITIS ALLERGIC | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| SINUS POLYP | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| SLEEP APNOEA SYNDROME | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 11 ( 12.8) | 8 ( 11.1) | 13 ( 13.5) | 32 ( 12.6) |
| DRY SKIN | 2 ( 2.3) | 1 ( 1.4) | 3 ( 3.1) | 6 ( 2.4) |
| ACTINIC KERATOSIS | 2 ( 2.3) | 1 ( 1.4) | 1 ( 1.0) | 4 ( 1.6) |
| SEBORRHOEIC DERMATITIS | 0 | 1 ( 1.4) | 2 ( 2.1) | 3 ( 1.2) |
| ECZEMA | 2 ( 2.3) | 0 | 0 | 2 ( 0.8) |
| PRURITUS | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| PSORIASIS | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| RASH | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| SKIN ULCER | 0 | 0 | 2 ( 2.1) | 2 ( 0.8) |
| DERMATITIS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| DERMATITIS ATOPIC | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| INCREASED TENDENCY TO BRUISE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| NAIL DISCOLOURATION | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| ALOPECIA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| HYPERHIDROSIS | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| LIVEDO RETICULARIS | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| RASH MACULO-PAPULAR | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| ALOPECIA AREATA | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| ERYTHEMA | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| HYPERKERATOSIS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| SKIN NODULE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| URTICARIA | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) | 13 ( 15.1) | 6 ( 8.3) | 12 ( 12.5) | 31 ( 12.2) |
| BASAL CELL CARCINOMA | 4 ( 4.7) | 2 ( 2.8) | 2 ( 2.1) | 8 ( 3.1) |
| PROSTATE CANCER | 3 ( 3.5) | 0 | 2 ( 2.1) | 5 ( 2.0) |
| LIPOMA | 1 ( 1.2) | 1 ( 1.4) | 2 ( 2.1) | 4 ( 1.6) |
| BREAST CANCER | 2 ( 2.3) | 0 | 1 ( 1.0) | 3 ( 1.2) |
| LUNG NEOPLASM | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| SKIN CANCER | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| LIP AND/OR ORAL CAVITY CANCER | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| NASOPHARYNGEAL CANCER | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| NEUROMA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| OSTEOCHONDROMA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| UTERINE LEIOMYOMA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| ACROCHORDON | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| BENIGN NEOPLASM OF EYE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| MENINGIOMA | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| THYROID GLAND CANCER | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | 10 ( 11.6) | 5 ( 6.9) | 14 ( 14.6) | 29 ( 11.4) |
| OEDEMA PERIPHERAL | 7 ( 8.1) | 0 | 8 ( 8.3) | 15 ( 5.9) |
| OEDEMA | 1 ( 1.2) | 1 ( 1.4) | 3 ( 3.1) | 5 ( 2.0) |
| CHEST PAIN | 0 | 4 ( 5.6) | 1 ( 1.0) | 5 ( 2.0) |
| GAIT DISTURBANCE | 2 ( 2.3) | 0 | 0 | 2 ( 0.8) |
| ULCER | 2 ( 2.3) | 0 | 0 | 2 ( 0.8) |
| CYST | 0 | 0 | 2 ( 2.1) | 2 ( 0.8) |
| PITTING OEDEMA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| IMPAIRED HEALING | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| LOCALISED OEDEMA | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| MALAISE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| ENDOCRINE DISORDERS | 7 ( 8.1) | 8 ( 11.1) | 10 ( 10.4) | 25 ( 9.8) |
| HYPOTHYROIDISM | 6 ( 7.0) | 7 ( 9.7) | 8 ( 8.3) | 21 ( 8.3) |
| HYPERTHYROIDISM | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| PITUITARY CYST | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| GOITRE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| THYROID CYST | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| REPRODUCTIVE SYSTEM AND BREAST DISORDERS | 7 ( 8.1) | 7 ( 9.7) | 11 ( 11.5) | 25 ( 9.8) |
| BENIGN PROSTATIC HYPERPLASIA | 5 ( 5.8) | 6 ( 8.3) | 7 ( 7.3) | 18 ( 7.1) |
| ERECTILE DYSFUNCTION | 0 | 1 ( 1.4) | 1 ( 1.0) | 2 ( 0.8) |
| UTERINE PROLAPSE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| VAGINAL HAEMORRHAGE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| BREAST CYST | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| MENOPAUSAL SYMPTOMS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| PROSTATIC DISORDER | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| PROSTATITIS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| RENAL AND URINARY DISORDERS | 5 ( 5.8) | 7 ( 9.7) | 12 ( 12.5) | 24 ( 9.4) |
| NEPHROLITHIASIS | 0 | 3 ( 4.2) | 4 ( 4.2) | 7 ( 2.8) |
| URINARY INCONTINENCE | 2 ( 2.3) | 1 ( 1.4) | 2 ( 2.1) | 5 ( 2.0) |
| NOCTURIA | 0 | 1 ( 1.4) | 2 ( 2.1) | 3 ( 1.2) |
| POLLAKIURIA | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| BLADDER PROLAPSE | 0 | 2 ( 2.8) | 0 | 2 ( 0.8) |
| INCONTINENCE | 0 | 0 | 2 ( 2.1) | 2 ( 0.8) |
| HAEMATURIA | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| RENAL DISORDER | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| DYSURIA | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| ENURESIS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| MICTURITION URGENCY | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| STRESS INCONTINENCE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| SOCIAL CIRCUMSTANCES | 7 ( 8.1) | 7 ( 9.7) | 10 ( 10.4) | 24 ( 9.4) |
| DENTURE WEARER | 3 ( 3.5) | 2 ( 2.8) | 4 ( 4.2) | 9 ( 3.5) |
| MENOPAUSE | 3 ( 3.5) | 2 ( 2.8) | 3 ( 3.1) | 8 ( 3.1) |
| HEARING AID USER | 1 ( 1.2) | 3 ( 4.2) | 1 ( 1.0) | 5 ( 2.0) |
| CORRECTIVE LENS USER | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| WALKING AID USER | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| PSYCHIATRIC DISORDERS | 6 ( 7.0) | 8 ( 11.1) | 8 ( 8.3) | 22 ( 8.7) |
| DEPRESSION | 2 ( 2.3) | 3 ( 4.2) | 2 ( 2.1) | 7 ( 2.8) |
| INSOMNIA | 1 ( 1.2) | 1 ( 1.4) | 3 ( 3.1) | 5 ( 2.0) |
| ANXIETY | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| CONFUSIONAL STATE | 1 ( 1.2) | 0 | 1 ( 1.0) | 2 ( 0.8) |
| CLAUSTROPHOBIA | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| DEPRESSED MOOD | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| LIBIDO INCREASED | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| TIC | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| EATING DISORDER | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| HALLUCINATION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| IMMUNE SYSTEM DISORDERS | 3 ( 3.5) | 4 ( 5.6) | 4 ( 4.2) | 11 ( 4.3) |
| SEASONAL ALLERGY | 2 ( 2.3) | 3 ( 4.2) | 2 ( 2.1) | 7 ( 2.8) |
| MULTIPLE ALLERGIES | 0 | 1 ( 1.4) | 2 ( 2.1) | 3 ( 1.2) |
| HYPERSENSITIVITY | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| BLOOD AND LYMPHATIC SYSTEM DISORDERS | 2 ( 2.3) | 2 ( 2.8) | 3 ( 3.1) | 7 ( 2.8) |
| ANAEMIA | 2 ( 2.3) | 0 | 2 ( 2.1) | 4 ( 1.6) |
| JAUNDICE ACHOLURIC | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| THROMBOCYTOPENIA | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| IRON DEFICIENCY ANAEMIA | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| HEPATOBILIARY DISORDERS | 2 ( 2.3) | 3 ( 4.2) | 2 ( 2.1) | 7 ( 2.8) |
| CHOLELITHIASIS | 1 ( 1.2) | 2 ( 2.8) | 1 ( 1.0) | 4 ( 1.6) |
| HEPATITIS | 1 ( 1.2) | 1 ( 1.4) | 0 | 2 ( 0.8) |
| JAUNDICE | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| CONGENITAL, FAMILIAL AND GENETIC DISORDERS | 3 ( 3.5) | 2 ( 2.8) | 1 ( 1.0) | 6 ( 2.4) |
| VENTRICULAR SEPTAL DEFECT | 1 ( 1.2) | 1 ( 1.4) | 1 ( 1.0) | 3 ( 1.2) |
| EPIDERMAL NAEVUS | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| HYDROCELE | 1 ( 1.2) | 0 | 0 | 1 ( 0.4) |
| PIGMENTED NAEVUS | 0 | 1 ( 1.4) | 0 | 1 ( 0.4) |
| PREGNANCY, PUERPERIUM AND PERINATAL CONDITIONS | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
| ABORTION | 0 | 0 | 1 ( 1.0) | 1 ( 0.4) |
Subjects counted once per SOC and once per PT.
Percentages based on N per treatment arm (Safety Population).
SOC sorted by descending frequency; PT sorted within SOC by descending frequency.
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01APR2026 09:54:18