TSFAE24C

Subjects With Treatment-emergent Adverse Events and Related Treatment-emergent Adverse Events by System Organ Class and Preferred Term

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Output

Preview

# Program Name:              tsfae24c.R

# Prep environment:

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

# Define script level parameters:

tblid <- "TSFAE24c"
fileid <- tblid
popfl <- "SAFFL"
trtvar <- "TRT01A"
tab_titles <- get_titles_from_file(input_path = '../../_data/', tblid)
string_map <- default_str_map

# Process data:

adsl <- pharmaverseadamjnj::adsl %>%
  filter(!!rlang::sym(popfl) == "Y") %>%
  create_colspan_var(
    non_active_grp = "Placebo",
    non_active_grp_span_lbl = " ",
    active_grp_span_lbl = "Active Study Agent",
    colspan_var = "colspan_trt",
    trt_var = trtvar
  ) %>%
  mutate(COLSPAN_REL = "AEs") %>%
  select(
    USUBJID,
    !!rlang::sym(popfl),
    !!rlang::sym(trtvar),
    colspan_trt,
    COLSPAN_REL
  )

adae <- pharmaverseadamjnj::adae %>%
  filter(TRTEMFL == "Y") %>%
  select(USUBJID, TRTEMFL, AEBODSYS, AEDECOD, AEREL)

adae <- inner_join(adae, adsl, by = c("USUBJID"))

# Define layout and build table:

colspan_trt_map <- create_colspan_map(
  adsl,
  non_active_grp = "Placebo",
  non_active_grp_span_lbl = " ",
  active_grp_span_lbl = "Active Study Agent",
  colspan_var = "colspan_trt",
  trt_var = trtvar
)

combodf <- tribble(
  ~valname  , ~label        , ~levelcombo , ~exargs ,
  "RELATED" , "Related AEs" , c("AEs")    , list()
)

extra_args1 <- list(
  .stats = c("count_unique_fraction"),
  subcol_split = "RELATED",
  subcol_var = "AEREL",
  subcol_val = "RELATED"
)

lyt <- basic_table(
  show_colcounts = TRUE,
  colcount_format = "N=xx",
  top_level_section_div = " "
) %>%
  split_cols_by(
    "COLSPAN_REL",
    split_fun = add_combo_levels(combodf, trim = TRUE)
  ) %>%
  split_cols_by(
    "colspan_trt",
    split_fun = trim_levels_to_map(map = colspan_trt_map)
  ) %>%
  split_cols_by(trtvar) %>%
  analyze(
    "TRTEMFL",
    afun = a_freq_subcol_j,
    extra_args = append(
      extra_args1,
      list(
        label = "Subjects with >= 1 AE",
        val = "Y"
      )
    )
  ) %>%
  split_rows_by(
    "AEBODSYS",
    split_label = "System Organ Class",
    label_pos = "topleft",
    split_fun = trim_levels_in_group("AEDECOD"),
    section_div = " ",
    nested = FALSE
  ) %>%
  summarize_row_groups(
    "AEBODSYS",
    cfun = a_freq_subcol_j,
    extra_args = extra_args1
  ) %>%
  analyze("AEDECOD", afun = a_freq_subcol_j, extra_args = extra_args1) %>%
  append_topleft(" Preferred Term, n (%)")

result <- build_table(lyt, adae, alt_counts_df = adsl)

# Post-Processing:

result <- result %>%
  sort_at_path(
    path = c("AEBODSYS"),
    scorefun = cont_n_onecol("AEs.Active Study Agent.Xanomeline High Dose")
  ) %>%
  sort_at_path(
    path = c("AEBODSYS", "*", "AEDECOD"),
    scorefun = score_occurrences_cols(
      "AEs.Active Study Agent.Xanomeline High Dose"
    )
  )

# Add titles and footnotes:

result <- set_titles(result, tab_titles)

# Convert to tbl file and output table:

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

TSFAE24c: Subjects With Treatment-emergent Adverse Events and Related Treatment-emergent Adverse Events by System Organ Class and Preferred Term; Safety Analysis Set (Study jjcs - core)
	AEs			Related AEs
	Active Study Agent			Active Study Agent
System Organ Class	Xanomeline High Dose	Xanomeline Low Dose	Placebo	Xanomeline High Dose	Xanomeline Low Dose	Placebo
Preferred Term, n (%)	N=53	N=73	N=59	N=53	N=73	N=59
Subjects with ≥ 1 AE	51 (96.2%)	62 (84.9%)	42 (71.2%)	15 (28.3%)	19 (26.0%)	19 (32.2%)
Skin and subcutaneous tissue  disorders	34 (64.2%)	28 (38.4%)	16 (27.1%)	1 (1.9%)	0	4 (6.8%)
PRURITUS	20 (37.7%)	14 (19.2%)	6 (10.2%)	0	0	1 (1.7%)
ERYTHEMA	12 (22.6%)	8 (11.0%)	6 (10.2%)	0	0	0
HYPERHIDROSIS	8 (15.1%)	4 (5.5%)	2 (3.4%)	0	0	1 (1.7%)
RASH	5 (9.4%)	9 (12.3%)	4 (6.8%)	0	0	1 (1.7%)
SKIN IRRITATION	4 (7.5%)	4 (5.5%)	3 (5.1%)	0	0	0
RASH PRURITIC	2 (3.8%)	1 (1.4%)	0	0	0	0
ACTINIC KERATOSIS	1 (1.9%)	0	0	0	0	0
BLISTER	1 (1.9%)	2 (2.7%)	0	0	0	0
PRURITUS GENERALISED	1 (1.9%)	0	0	0	0	0
RASH MACULO-PAPULAR	1 (1.9%)	0	0	0	0	0
SKIN ODOUR ABNORMAL	1 (1.9%)	0	0	1 (1.9%)	0	0
URTICARIA	1 (1.9%)	1 (1.4%)	0	0	0	0
ALOPECIA	0	0	1 (1.7%)	0	0	1 (1.7%)
DRUG ERUPTION	0	0	1 (1.7%)	0	0	0
RASH ERYTHEMATOUS	0	1 (1.4%)	0	0	0	0
SKIN ULCER	0	0	1 (1.7%)	0	0	0
General disorders and  administration site conditions	26 (49.1%)	38 (52.1%)	16 (27.1%)	5 (9.4%)	6 (8.2%)	1 (1.7%)
APPLICATION SITE PRURITUS	13 (24.5%)	18 (24.7%)	4 (6.8%)	0	0	0
APPLICATION SITE ERYTHEMA	10 (18.9%)	11 (15.1%)	2 (3.4%)	0	0	0
APPLICATION SITE IRRITATION	8 (15.1%)	7 (9.6%)	2 (3.4%)	0	0	0
FATIGUE	5 (9.4%)	5 (6.8%)	0	1 (1.9%)	3 (4.1%)	0
APPLICATION SITE DERMATITIS	4 (7.5%)	7 (9.6%)	5 (8.5%)	0	0	0
APPLICATION SITE VESICLES	4 (7.5%)	4 (5.5%)	0	0	0	0
APPLICATION SITE PAIN	2 (3.8%)	0	0	0	0	0
APPLICATION SITE  PERSPIRATION	2 (3.8%)	0	0	0	0	0
APPLICATION SITE SWELLING	2 (3.8%)	1 (1.4%)	0	0	0	0
CHEST PAIN	2 (3.8%)	0	0	2 (3.8%)	0	0
MALAISE	2 (3.8%)	1 (1.4%)	0	1 (1.9%)	0	0
APPLICATION SITE REACTION	1 (1.9%)	0	1 (1.7%)	0	0	0
CHEST DISCOMFORT	1 (1.9%)	1 (1.4%)	0	0	0	0
CHILLS	1 (1.9%)	0	0	1 (1.9%)	0	0
FEELING ABNORMAL	1 (1.9%)	0	0	0	0	0
FEELING COLD	1 (1.9%)	0	0	0	0	0
OEDEMA PERIPHERAL	1 (1.9%)	1 (1.4%)	2 (3.4%)	0	1 (1.4%)	1 (1.7%)
PAIN	1 (1.9%)	0	0	0	0	0
APPLICATION SITE BLEEDING	0	1 (1.4%)	0	0	0	0
APPLICATION SITE  DESQUAMATION	0	1 (1.4%)	0	0	0	0
APPLICATION SITE INDURATION	0	0	1 (1.7%)	0	0	0
APPLICATION SITE URTICARIA	0	2 (2.7%)	0	0	0	0
ASTHENIA	0	1 (1.4%)	1 (1.7%)	0	1 (1.4%)	0
OEDEMA	0	1 (1.4%)	0	0	0	0
PYREXIA	0	1 (1.4%)	2 (3.4%)	0	1 (1.4%)	0
SECRETION DISCHARGE	0	1 (1.4%)	0	0	0	0
SUDDEN DEATH	0	1 (1.4%)	0	0	0	0
ULCER	0	1 (1.4%)	0	0	0	0
Nervous system disorders	18 (34.0%)	18 (24.7%)	5 (8.5%)	6 (11.3%)	5 (6.8%)	1 (1.7%)
DIZZINESS	8 (15.1%)	8 (11.0%)	0	4 (7.5%)	2 (2.7%)	0
HEADACHE	5 (9.4%)	3 (4.1%)	2 (3.4%)	2 (3.8%)	1 (1.4%)	0
BURNING SENSATION	1 (1.9%)	0	0	0	0	0
COGNITIVE DISORDER	1 (1.9%)	0	0	0	0	0
HYPERSOMNIA	1 (1.9%)	0	0	0	0	0
PARAESTHESIA	1 (1.9%)	0	0	0	0	0
PAROSMIA	1 (1.9%)	0	0	0	0	0
PARTIAL SEIZURES WITH  SECONDARY  GENERALISATION	1 (1.9%)	0	0	0	0	0
SOMNOLENCE	1 (1.9%)	2 (2.7%)	1 (1.7%)	1 (1.9%)	1 (1.4%)	0
SYNCOPE	1 (1.9%)	3 (4.1%)	0	0	0	0
SYNCOPE VASOVAGAL	1 (1.9%)	0	0	0	0	0
TRANSIENT ISCHAEMIC  ATTACK	1 (1.9%)	2 (2.7%)	0	0	1 (1.4%)	0
BALANCE DISORDER	0	1 (1.4%)	0	0	0	0
COMPLEX PARTIAL SEIZURES	0	1 (1.4%)	0	0	0	0
COORDINATION ABNORMAL	0	1 (1.4%)	0	0	0	0
HEMIANOPIA HOMONYMOUS	0	1 (1.4%)	0	0	0	0
LETHARGY	0	1 (1.4%)	0	0	0	0
PARAESTHESIA ORAL	0	1 (1.4%)	0	0	0	0
PARKINSON'S DISEASE	0	0	1 (1.7%)	0	0	0
PSYCHOMOTOR  HYPERACTIVITY	0	0	1 (1.7%)	0	0	1 (1.7%)
STUPOR	0	1 (1.4%)	0	0	0	0
Gastrointestinal disorders	14 (26.4%)	10 (13.7%)	7 (11.9%)	4 (7.5%)	2 (2.7%)	2 (3.4%)
NAUSEA	5 (9.4%)	2 (2.7%)	0	2 (3.8%)	0	0
VOMITING	5 (9.4%)	2 (2.7%)	0	2 (3.8%)	0	0
SALIVARY HYPERSECRETION	4 (7.5%)	0	0	0	0	0
DIARRHOEA	2 (3.8%)	3 (4.1%)	3 (5.1%)	1 (1.9%)	1 (1.4%)	1 (1.7%)
ABDOMINAL DISCOMFORT	1 (1.9%)	0	0	1 (1.9%)	0	0
STOMACH DISCOMFORT	1 (1.9%)	0	0	0	0	0
ABDOMINAL PAIN	0	2 (2.7%)	1 (1.7%)	0	1 (1.4%)	1 (1.7%)
CONSTIPATION	0	0	1 (1.7%)	0	0	1 (1.7%)
DYSPEPSIA	0	1 (1.4%)	1 (1.7%)	0	0	0
GASTROOESOPHAGEAL REFLUX  DISEASE	0	0	1 (1.7%)	0	0	0
GLOSSITIS	0	0	1 (1.7%)	0	0	0
HIATUS HERNIA	0	0	1 (1.7%)	0	0	0
RECTAL HAEMORRHAGE	0	1 (1.4%)	0	0	0	0
Cardiac disorders	11 (20.8%)	11 (15.1%)	7 (11.9%)	2 (3.8%)	3 (4.1%)	3 (5.1%)
SINUS BRADYCARDIA	7 (13.2%)	4 (5.5%)	0	2 (3.8%)	1 (1.4%)	0
MYOCARDIAL INFARCTION	3 (5.7%)	1 (1.4%)	3 (5.1%)	0	0	2 (3.4%)
ATRIAL FIBRILLATION	1 (1.9%)	2 (2.7%)	0	0	0	0
ATRIAL FLUTTER	1 (1.9%)	1 (1.4%)	0	0	0	0
CARDIAC DISORDER	1 (1.9%)	0	0	0	0	0
VENTRICULAR EXTRASYSTOLES	1 (1.9%)	2 (2.7%)	0	0	1 (1.4%)	0
ATRIOVENTRICULAR BLOCK  FIRST DEGREE	0	1 (1.4%)	0	0	0	0
ATRIOVENTRICULAR BLOCK  SECOND DEGREE	0	0	1 (1.7%)	0	0	0
BUNDLE BRANCH BLOCK LEFT	0	0	1 (1.7%)	0	0	0
BUNDLE BRANCH BLOCK RIGHT	0	1 (1.4%)	1 (1.7%)	0	0	1 (1.7%)
PALPITATIONS	0	2 (2.7%)	0	0	1 (1.4%)	0
SINUS ARRHYTHMIA	0	0	1 (1.7%)	0	0	0
SUPRAVENTRICULAR  EXTRASYSTOLES	0	1 (1.4%)	1 (1.7%)	0	0	1 (1.7%)
SUPRAVENTRICULAR  TACHYCARDIA	0	1 (1.4%)	0	0	0	0
TACHYCARDIA	0	0	1 (1.7%)	0	0	1 (1.7%)
WOLFF-PARKINSON-WHITE  SYNDROME	0	1 (1.4%)	0	0	0	0
Infections and infestations	9 (17.0%)	6 (8.2%)	14 (23.7%)	0	0	4 (6.8%)
NASOPHARYNGITIS	3 (5.7%)	3 (4.1%)	2 (3.4%)	0	0	0
UPPER RESPIRATORY TRACT  INFECTION	2 (3.8%)	0	5 (8.5%)	0	0	3 (5.1%)
HORDEOLUM	1 (1.9%)	0	0	0	0	0
INFLUENZA	1 (1.9%)	1 (1.4%)	1 (1.7%)	0	0	0
LOWER RESPIRATORY TRACT  INFECTION	1 (1.9%)	0	0	0	0	0
RHINITIS	1 (1.9%)	0	0	0	0	0
URINARY TRACT INFECTION	1 (1.9%)	0	2 (3.4%)	0	0	1 (1.7%)
BRONCHITIS	0	0	1 (1.7%)	0	0	0
CELLULITIS	0	1 (1.4%)	0	0	0	0
CERVICITIS	0	0	1 (1.7%)	0	0	1 (1.7%)
EAR INFECTION	0	0	2 (3.4%)	0	0	0
GASTROENTERITIS VIRAL	0	0	1 (1.7%)	0	0	1 (1.7%)
LOCALISED INFECTION	0	0	1 (1.7%)	0	0	0
PNEUMONIA	0	1 (1.4%)	0	0	0	0
VAGINAL MYCOSIS	0	0	1 (1.7%)	0	0	1 (1.7%)
Respiratory, thoracic and  mediastinal disorders	7 (13.2%)	6 (8.2%)	5 (8.5%)	2 (3.8%)	2 (2.7%)	2 (3.4%)
COUGH	3 (5.7%)	4 (5.5%)	1 (1.7%)	0	1 (1.4%)	1 (1.7%)
NASAL CONGESTION	3 (5.7%)	0	2 (3.4%)	1 (1.9%)	0	1 (1.7%)
EPISTAXIS	2 (3.8%)	0	0	1 (1.9%)	0	0
ALLERGIC GRANULOMATOUS  ANGIITIS	1 (1.9%)	0	0	0	0	0
PHARYNGOLARYNGEAL PAIN	1 (1.9%)	0	0	0	0	0
PRODUCTIVE COUGH	1 (1.9%)	0	0	0	0	0
RESPIRATORY TRACT  CONGESTION	1 (1.9%)	0	0	0	0	0
RHINORRHOEA	1 (1.9%)	1 (1.4%)	0	0	1 (1.4%)	0
DYSPHONIA	0	1 (1.4%)	0	0	1 (1.4%)	0
DYSPNOEA	0	1 (1.4%)	0	0	0	0
EMPHYSEMA	0	0	1 (1.7%)	0	0	0
POSTNASAL DRIP	0	0	1 (1.7%)	0	0	0
Psychiatric disorders	6 (11.3%)	8 (11.0%)	7 (11.9%)	2 (3.8%)	0	5 (8.5%)
CONFUSIONAL STATE	1 (1.9%)	3 (4.1%)	2 (3.4%)	1 (1.9%)	0	1 (1.7%)
DELIRIUM	1 (1.9%)	0	0	0	0	0
DELUSION	1 (1.9%)	0	1 (1.7%)	0	0	1 (1.7%)
HALLUCINATION	1 (1.9%)	0	0	0	0	0
HALLUCINATION, VISUAL	1 (1.9%)	0	0	0	0	0
INSOMNIA	1 (1.9%)	0	1 (1.7%)	0	0	0
LIBIDO DECREASED	1 (1.9%)	0	0	0	0	0
LISTLESS	1 (1.9%)	0	0	0	0	0
NIGHTMARE	1 (1.9%)	0	0	1 (1.9%)	0	0
AGITATION	0	2 (2.7%)	1 (1.7%)	0	0	1 (1.7%)
ANXIETY	0	1 (1.4%)	0	0	0	0
DEPRESSED MOOD	0	1 (1.4%)	0	0	0	0
DISORIENTATION	0	0	1 (1.7%)	0	0	1 (1.7%)
DISTURBANCE IN SEXUAL  AROUSAL	0	0	1 (1.7%)	0	0	1 (1.7%)
IRRITABILITY	0	1 (1.4%)	0	0	0	0
RESTLESSNESS	0	1 (1.4%)	0	0	0	0
Investigations	5 (9.4%)	7 (9.6%)	7 (11.9%)	0	1 (1.4%)	3 (5.1%)
BIOPSY	1 (1.9%)	0	0	0	0	0
BIOPSY PROSTATE	1 (1.9%)	0	0	0	0	0
BLOOD CHOLESTEROL  INCREASED	1 (1.9%)	0	0	0	0	0
BLOOD GLUCOSE INCREASED	1 (1.9%)	1 (1.4%)	0	0	0	0
ELECTROCARDIOGRAM T WAVE  INVERSION	1 (1.9%)	1 (1.4%)	2 (3.4%)	0	0	2 (3.4%)
BLOOD ALKALINE  PHOSPHATASE INCREASED	0	0	1 (1.7%)	0	0	0
BLOOD CREATINE  PHOSPHOKINASE INCREASED	0	0	1 (1.7%)	0	0	0
BLOOD URINE PRESENT	0	0	1 (1.7%)	0	0	0
BODY TEMPERATURE  INCREASED	0	1 (1.4%)	0	0	0	0
CYSTOSCOPY	0	0	1 (1.7%)	0	0	0
ELECTROCARDIOGRAM ST  SEGMENT DEPRESSION	0	1 (1.4%)	3 (5.1%)	0	0	2 (3.4%)
ELECTROCARDIOGRAM T WAVE  AMPLITUDE DECREASED	0	1 (1.4%)	1 (1.7%)	0	1 (1.4%)	1 (1.7%)
NASAL MUCOSA BIOPSY	0	1 (1.4%)	0	0	0	0
WEIGHT DECREASED	0	1 (1.4%)	0	0	0	0
Musculoskeletal and connective  tissue disorders	4 (7.5%)	5 (6.8%)	2 (3.4%)	1 (1.9%)	0	0
BACK PAIN	2 (3.8%)	1 (1.4%)	1 (1.7%)	1 (1.9%)	0	0
ARTHRALGIA	1 (1.9%)	1 (1.4%)	0	0	0	0
FLANK PAIN	1 (1.9%)	0	0	0	0	0
MYALGIA	1 (1.9%)	0	0	0	0	0
MUSCLE SPASMS	0	1 (1.4%)	0	0	0	0
MUSCULAR WEAKNESS	0	1 (1.4%)	0	0	0	0
SHOULDER PAIN	0	1 (1.4%)	1 (1.7%)	0	0	0
Injury, poisoning and  procedural complications	3 (5.7%)	5 (6.8%)	2 (3.4%)	1 (1.9%)	1 (1.4%)	0
CONTUSION	2 (3.8%)	1 (1.4%)	0	1 (1.9%)	1 (1.4%)	0
EXCORIATION	1 (1.9%)	1 (1.4%)	0	0	0	0
FACIAL BONES FRACTURE	1 (1.9%)	0	0	0	0	0
FALL	1 (1.9%)	2 (2.7%)	1 (1.7%)	0	1 (1.4%)	0
HIP FRACTURE	0	0	1 (1.7%)	0	0	0
JOINT DISLOCATION	0	1 (1.4%)	0	0	0	0
SKIN LACERATION	0	2 (2.7%)	0	0	0	0
WOUND	0	1 (1.4%)	0	0	0	0
Reproductive system and breast  disorders	3 (5.7%)	0	3 (5.1%)	0	0	0
ABNORMAL UTERINE BLEEDING	1 (1.9%)	0	0	0	0	0
BENIGN PROSTATIC  HYPERPLASIA	1 (1.9%)	0	1 (1.7%)	0	0	0
ERECTILE DYSFUNCTION	1 (1.9%)	0	1 (1.7%)	0	0	0
PELVIC PAIN	0	0	1 (1.7%)	0	0	0
Renal and urinary disorders	2 (3.8%)	3 (4.1%)	2 (3.4%)	0	1 (1.4%)	1 (1.7%)
CALCULUS URETHRAL	1 (1.9%)	0	0	0	0	0
NEPHROLITHIASIS	1 (1.9%)	0	0	0	0	0
DYSURIA	0	1 (1.4%)	1 (1.7%)	0	1 (1.4%)	1 (1.7%)
INCONTINENCE	0	1 (1.4%)	0	0	0	0
MICTURITION URGENCY	0	1 (1.4%)	1 (1.7%)	0	0	0
Congenital, familial and genetic  disorders	1 (1.9%)	1 (1.4%)	0	0	0	0
VENTRICULAR SEPTAL DEFECT	1 (1.9%)	1 (1.4%)	0	0	0	0
Ear and labyrinth disorders	1 (1.9%)	2 (2.7%)	1 (1.7%)	0	0	0
VERTIGO	1 (1.9%)	1 (1.4%)	0	0	0	0
CERUMEN IMPACTION	0	1 (1.4%)	0	0	0	0
EAR PAIN	0	0	1 (1.7%)	0	0	0
Eye disorders	1 (1.9%)	2 (2.7%)	2 (3.4%)	0	1 (1.4%)	2 (3.4%)
VISION BLURRED	1 (1.9%)	1 (1.4%)	0	0	0	0
CONJUNCTIVAL HAEMORRHAGE	0	1 (1.4%)	0	0	1 (1.4%)	0
CONJUNCTIVITIS	0	0	1 (1.7%)	0	0	1 (1.7%)
EYE ALLERGY	0	0	1 (1.7%)	0	0	0
EYE PRURITUS	0	0	1 (1.7%)	0	0	1 (1.7%)
EYE SWELLING	0	0	1 (1.7%)	0	0	0
Metabolism and nutrition  disorders	1 (1.9%)	0	2 (3.4%)	1 (1.9%)	0	0
INCREASED APPETITE	1 (1.9%)	0	0	1 (1.9%)	0	0
DECREASED APPETITE	0	0	1 (1.7%)	0	0	0
DEHYDRATION	0	0	1 (1.7%)	0	0	0
Neoplasms benign, malignant  and unspecified (incl cysts  and polyps)	1 (1.9%)	1 (1.4%)	0	0	0	0
PROSTATE CANCER	1 (1.9%)	0	0	0	0	0
COLON CANCER	0	1 (1.4%)	0	0	0	0
Surgical and medical  procedures	1 (1.9%)	0	2 (3.4%)	0	0	0
ACROCHORDON EXCISION	1 (1.9%)	0	0	0	0	0
CATARACT OPERATION	0	0	1 (1.7%)	0	0	0
EYE LASER SURGERY	0	0	1 (1.7%)	0	0	0
Vascular disorders	1 (1.9%)	3 (4.1%)	3 (5.1%)	0	0	2 (3.4%)
WOUND HAEMORRHAGE	1 (1.9%)	0	0	0	0	0
HOT FLUSH	0	1 (1.4%)	0	0	0	0
HYPERTENSION	0	1 (1.4%)	1 (1.7%)	0	0	1 (1.7%)
HYPOTENSION	0	1 (1.4%)	2 (3.4%)	0	0	1 (1.7%)
ORTHOSTATIC HYPOTENSION	0	0	1 (1.7%)	0	0	0
Endocrine disorders	0	1 (1.4%)	1 (1.7%)	0	0	1 (1.7%)
BLEEDING ANOVULATORY	0	1 (1.4%)	1 (1.7%)	0	0	1 (1.7%)
Note: Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event. An AE is assessed by the investigator as related.
Note: Adverse events are coded using MedDRA version 26.0.

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