TSFAE13

Exposure-adjusted Incidence Rate Analysis by Preferred Term

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Code

# Program Name:              tsfae13.R

# Prep environment:

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

# Define script level parameters:

tblid <- "TSFAE13"
fileid <- tblid
popfl <- "SAFFL"
trtvar <- "TRT01A"
ctrl_grp <- "Placebo"
tab_titles <- get_titles_from_file(input_path = '../../_data/', tblid)
string_map <- default_str_map

# Process data:

adexsum <- pharmaverseadamjnj::adexsum %>%
  filter(!!rlang::sym(popfl) == "Y" & PARAMCD == "TRTDURY") %>%
  create_colspan_var(
    non_active_grp = ctrl_grp,
    non_active_grp_span_lbl = " ",
    active_grp_span_lbl = "Active Study Agent",
    colspan_var = "colspan_trt",
    trt_var = trtvar
  ) %>%
  mutate(
    rrisk_header = "Risk Difference (95% CI)",
    rrisk_label = paste(!!rlang::sym(trtvar), "vs", ctrl_grp),
    TRTDURY = AVAL
  ) %>%
  select(
    USUBJID,
    !!rlang::sym(trtvar),
    colspan_trt,
    rrisk_header,
    rrisk_label,
    TRTDURY
  )

adae <- pharmaverseadamjnj::adae %>%
  filter(TRTEMFL == "Y" & AOCCPFL == "Y") %>%
  select(USUBJID, AEDECOD, ASTDY, AOCCPFL)

#  join -- -- subjects without ae will be handled via alt_counts_df dataframe
aefup <- right_join(adae, adexsum, by = "USUBJID")

colspan_trt_map <- create_colspan_map(
  adexsum,
  non_active_grp = ctrl_grp,
  non_active_grp_span_lbl = " ",
  active_grp_span_lbl = "Active Study Agent",
  colspan_var = "colspan_trt",
  trt_var = trtvar
)
ref_path <- c("colspan_trt", " ", trtvar, ctrl_grp)

# Define layout and build table:

lyt <- basic_table(
  show_colcounts = TRUE,
  colcount_format = "N=xx",
  top_level_section_div = " "
) %>%
  split_cols_by(
    "colspan_trt",
    split_fun = trim_levels_to_map(map = colspan_trt_map)
  ) %>%
  split_cols_by(trtvar) %>%
  split_cols_by("rrisk_header", nested = FALSE) %>%
  split_cols_by(
    trtvar,
    labels_var = "rrisk_label",
    split_fun = remove_split_levels(ctrl_grp)
  ) %>%
  analyze(
    "TRTDURY",
    nested = FALSE,
    show_labels = "hidden",
    afun = a_patyrs_j,
    extra_args = list(.labels = c(patyrs = "Subject years\u1D43"))
  ) %>%
  analyze(
    vars = "AEDECOD",
    nested = FALSE,
    afun = a_eair100_j,
    extra_args = list(
      fup_var = "TRTDURY",
      occ_var = "AOCCPFL",
      occ_dy = "ASTDY",
      ref_path = ref_path,
      drop_levels = TRUE
    )
  ) %>%
  append_topleft("Preferred Term, EAIR Per 100 SY")


result <- build_table(lyt, aefup, alt_counts_df = adexsum)

# Post-Processing:

result <- result %>%
  sort_at_path(
    path = c("AEDECOD"),
    scorefun = jj_complex_scorefun(colpath = "Xanomeline High Dose")
  )

result <- remove_col_count(result)

# 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")

TSFAE13: Exposure-adjusted Incidence Rate Analysis by Preferred Term; Safety Analysis Set (Study jjcs - core)
	Active Study Agent			Risk Difference (95% CI)
	Xanomeline High Dose	Xanomeline Low Dose	Placebo	Xanomeline High Dose vs Placebo	Xanomeline Low Dose vs Placebo
Preferred Term, EAIR Per 100 SY	N=53	N=73	N=59
Subject yearsᵃ	92.1	126.5	99.8

PRURITUS	30.4	13.9	6.7	23.77 (9.41, 38.12)	7.28 (-1.75, 16.31)
APPLICATION SITE PRURITUS	18.4	16.3	4.2	14.18 (3.39, 24.97)	12.09 (3.34, 20.84)
ERYTHEMA	16.0	7.3	6.6	9.31 (-1.16, 19.79)	0.68 (-6.67, 8.02)
APPLICATION SITE ERYTHEMA	13.1	10.0	2.1	11.06 (2.43, 19.68)	7.96 (1.38, 14.55)
HYPERHIDROSIS	10.7	3.3	2.1	8.62 (0.67, 16.56)	1.19 (-3.11, 5.49)
APPLICATION SITE IRRITATION	10.3	6.2	2.1	8.21 (0.55, 15.87)	4.11 (-1.27, 9.50)
DIZZINESS	9.1	6.9	0.0	9.08 (2.35, 15.80)	6.88 (2.11, 11.65)
SINUS BRADYCARDIA	8.7	3.3	0.0	8.66 (2.24, 15.07)	3.35 (0.07, 6.63)
HEADACHE	6.2	2.5	2.1	4.12 (-2.00, 10.24)	0.40 (-3.58, 4.38)
VOMITING	6.1	1.6	0.0	6.12 (0.76, 11.48)	1.60 (-0.62, 3.81)
RASH	6.0	8.1	4.3	1.70 (-4.99, 8.39)	3.86 (-2.90, 10.61)
FATIGUE	5.9	4.3	0.0	5.93 (0.73, 11.12)	4.30 (0.53, 8.07)
NAUSEA	5.8	1.7	0.0	5.84 (0.72, 10.97)	1.65 (-0.64, 3.94)
SKIN IRRITATION	4.7	3.3	3.1	1.67 (-4.12, 7.47)	0.28 (-4.49, 5.05)
APPLICATION SITE DERMATITIS	4.7	6.0	5.5	-0.77 (-7.42, 5.89)	0.57 (-5.99, 7.13)
APPLICATION SITE VESICLES	4.6	3.3	0.0	4.58 (0.09, 9.07)	3.31 (0.07, 6.55)
SALIVARY HYPERSECRETION	4.4	0.0	0.0	4.42 (0.09, 8.76)	0.00 (0.00, 0.00)
NASAL CONGESTION	3.5	0.0	2.0	1.44 (-3.40, 6.28)	-2.04 (-4.86, 0.79)
MYOCARDIAL INFARCTION	3.4	0.8	3.1	0.30 (-4.94, 5.55)	-2.33 (-6.19, 1.53)
COUGH	3.4	3.4	1.0	2.38 (-1.94, 6.71)	2.35 (-1.49, 6.20)
NASOPHARYNGITIS	3.4	2.5	2.1	1.24 (-3.59, 6.07)	0.36 (-3.73, 4.44)
MALAISE	2.3	0.8	0.0	2.32 (-0.90, 5.55)	0.81 (-0.77, 2.38)
RASH PRURITIC	2.3	0.8	0.0	2.32 (-0.89, 5.53)	0.80 (-0.77, 2.37)
APPLICATION SITE PERSPIRATION	2.3	0.0	0.0	2.31 (-0.89, 5.51)	0.00 (0.00, 0.00)
BACK PAIN	2.3	0.8	1.0	1.28 (-2.45, 5.02)	-0.20 (-2.72, 2.33)
DIARRHOEA	2.3	2.4	3.1	-0.82 (-5.55, 3.90)	-0.66 (-5.13, 3.80)
CONTUSION	2.3	0.8	0.0	2.27 (-0.87, 5.40)	0.80 (-0.77, 2.36)
EPISTAXIS	2.3	0.0	0.0	2.26 (-0.87, 5.40)	0.00 (0.00, 0.00)
UPPER RESPIRATORY TRACT INFECTION	2.3	0.0	5.3	-3.01 (-8.59, 2.58)	-5.27 (-9.89, -0.65)
APPLICATION SITE PAIN	2.3	0.0	0.0	2.26 (-0.87, 5.38)	0.00 (0.00, 0.00)
APPLICATION SITE SWELLING	2.2	0.8	0.0	2.25 (-0.87, 5.37)	0.80 (-0.77, 2.36)
CHEST PAIN	2.2	0.0	0.0	2.22 (-0.86, 5.30)	0.00 (0.00, 0.00)
DELIRIUM	1.1	0.0	0.0	1.13 (-1.08, 3.33)	0.00 (0.00, 0.00)
STOMACH DISCOMFORT	1.1	0.0	0.0	1.12 (-1.08, 3.33)	0.00 (0.00, 0.00)
PAIN	1.1	0.0	0.0	1.12 (-1.08, 3.33)	0.00 (0.00, 0.00)
URTICARIA	1.1	0.8	0.0	1.12 (-1.08, 3.33)	0.81 (-0.77, 2.39)
MYALGIA	1.1	0.0	0.0	1.12 (-1.08, 3.33)	0.00 (0.00, 0.00)
PHARYNGOLARYNGEAL PAIN	1.1	0.0	0.0	1.12 (-1.08, 3.33)	0.00 (0.00, 0.00)
PRODUCTIVE COUGH	1.1	0.0	0.0	1.12 (-1.08, 3.33)	0.00 (0.00, 0.00)
ABDOMINAL DISCOMFORT	1.1	0.0	0.0	1.12 (-1.08, 3.32)	0.00 (0.00, 0.00)
RESPIRATORY TRACT CONGESTION	1.1	0.0	0.0	1.12 (-1.08, 3.32)	0.00 (0.00, 0.00)
RHINITIS	1.1	0.0	0.0	1.12 (-1.08, 3.32)	0.00 (0.00, 0.00)
FEELING ABNORMAL	1.1	0.0	0.0	1.12 (-1.08, 3.32)	0.00 (0.00, 0.00)
LIBIDO DECREASED	1.1	0.0	0.0	1.12 (-1.08, 3.32)	0.00 (0.00, 0.00)
LISTLESS	1.1	0.0	0.0	1.12 (-1.08, 3.32)	0.00 (0.00, 0.00)
VISION BLURRED	1.1	0.8	0.0	1.12 (-1.08, 3.32)	0.79 (-0.76, 2.35)
COGNITIVE DISORDER	1.1	0.0	0.0	1.12 (-1.08, 3.32)	0.00 (0.00, 0.00)
INCREASED APPETITE	1.1	0.0	0.0	1.12 (-1.08, 3.32)	0.00 (0.00, 0.00)
CHILLS	1.1	0.0	0.0	1.12 (-1.08, 3.32)	0.00 (0.00, 0.00)
ABNORMAL UTERINE BLEEDING	1.1	0.0	0.0	1.12 (-1.08, 3.32)	0.00 (0.00, 0.00)
CONFUSIONAL STATE	1.1	2.5	2.1	-0.93 (-4.53, 2.66)	0.42 (-3.57, 4.41)
INSOMNIA	1.1	0.0	1.0	0.11 (-2.84, 3.07)	-1.01 (-2.99, 0.97)
SOMNOLENCE	1.1	1.6	1.0	0.09 (-2.89, 3.07)	0.58 (-2.43, 3.60)
PRURITUS GENERALISED	1.1	0.0	0.0	1.12 (-1.08, 3.32)	0.00 (0.00, 0.00)
BURNING SENSATION	1.1	0.0	0.0	1.12 (-1.07, 3.31)	0.00 (0.00, 0.00)
VENTRICULAR EXTRASYSTOLES	1.1	1.6	0.0	1.12 (-1.07, 3.31)	1.64 (-0.63, 3.91)
NIGHTMARE	1.1	0.0	0.0	1.12 (-1.07, 3.31)	0.00 (0.00, 0.00)
BIOPSY	1.1	0.0	0.0	1.12 (-1.07, 3.31)	0.00 (0.00, 0.00)
BLOOD CHOLESTEROL INCREASED	1.1	0.0	0.0	1.12 (-1.07, 3.31)	0.00 (0.00, 0.00)
ALLERGIC GRANULOMATOUS ANGIITIS	1.1	0.0	0.0	1.12 (-1.07, 3.31)	0.00 (0.00, 0.00)
FEELING COLD	1.1	0.0	0.0	1.12 (-1.07, 3.30)	0.00 (0.00, 0.00)
OEDEMA PERIPHERAL	1.1	0.8	1.0	0.10 (-2.86, 3.06)	-0.23 (-2.76, 2.30)
CHEST DISCOMFORT	1.1	0.8	0.0	1.11 (-1.07, 3.30)	0.79 (-0.76, 2.35)
WOUND HAEMORRHAGE	1.1	0.0	0.0	1.11 (-1.07, 3.30)	0.00 (0.00, 0.00)
HALLUCINATION, VISUAL	1.1	0.0	0.0	1.11 (-1.07, 3.29)	0.00 (0.00, 0.00)
PARTIAL SEIZURES WITH SECONDARY GENERALISATION	1.1	0.0	0.0	1.11 (-1.07, 3.29)	0.00 (0.00, 0.00)
BIOPSY PROSTATE	1.1	0.0	0.0	1.11 (-1.07, 3.29)	0.00 (0.00, 0.00)
BENIGN PROSTATIC HYPERPLASIA	1.1	0.0	1.0	0.08 (-2.88, 3.05)	-1.03 (-3.04, 0.98)
ELECTROCARDIOGRAM T WAVE INVERSION	1.1	0.8	2.1	-0.97 (-4.57, 2.63)	-1.28 (-4.55, 1.99)
VERTIGO	1.1	0.8	0.0	1.10 (-1.06, 3.27)	0.80 (-0.77, 2.38)
SKIN ODOUR ABNORMAL	1.1	0.0	0.0	1.10 (-1.06, 3.26)	0.00 (0.00, 0.00)
TRANSIENT ISCHAEMIC ATTACK	1.1	1.6	0.0	1.10 (-1.06, 3.26)	1.60 (-0.62, 3.81)
ARTHRALGIA	1.1	0.8	0.0	1.10 (-1.06, 3.26)	0.80 (-0.77, 2.37)
VENTRICULAR SEPTAL DEFECT	1.1	0.8	0.0	1.10 (-1.06, 3.26)	0.81 (-0.77, 2.39)
HORDEOLUM	1.1	0.0	0.0	1.10 (-1.06, 3.25)	0.00 (0.00, 0.00)
SYNCOPE VASOVAGAL	1.1	0.0	0.0	1.10 (-1.06, 3.25)	0.00 (0.00, 0.00)
CARDIAC DISORDER	1.1	0.0	0.0	1.10 (-1.06, 3.25)	0.00 (0.00, 0.00)
INFLUENZA	1.1	0.8	1.0	0.08 (-2.87, 3.02)	-0.21 (-2.77, 2.34)
NEPHROLITHIASIS	1.1	0.0	0.0	1.10 (-1.05, 3.25)	0.00 (0.00, 0.00)
URINARY TRACT INFECTION	1.1	0.0	2.1	-0.99 (-4.60, 2.62)	-2.09 (-4.99, 0.81)
LOWER RESPIRATORY TRACT INFECTION	1.1	0.0	0.0	1.10 (-1.05, 3.25)	0.00 (0.00, 0.00)
ACROCHORDON EXCISION	1.1	0.0	0.0	1.10 (-1.05, 3.24)	0.00 (0.00, 0.00)
FLANK PAIN	1.1	0.0	0.0	1.10 (-1.05, 3.24)	0.00 (0.00, 0.00)
HYPERSOMNIA	1.1	0.0	0.0	1.10 (-1.05, 3.24)	0.00 (0.00, 0.00)
CALCULUS URETHRAL	1.1	0.0	0.0	1.10 (-1.05, 3.24)	0.00 (0.00, 0.00)
SYNCOPE	1.1	2.4	0.0	1.09 (-1.05, 3.24)	2.42 (-0.32, 5.17)
FACIAL BONES FRACTURE	1.1	0.0	0.0	1.09 (-1.05, 3.24)	0.00 (0.00, 0.00)
FALL	1.1	1.6	1.0	0.09 (-2.83, 3.00)	0.60 (-2.38, 3.58)
ACTINIC KERATOSIS	1.1	0.0	0.0	1.09 (-1.05, 3.24)	0.00 (0.00, 0.00)
APPLICATION SITE REACTION	1.1	0.0	1.0	0.06 (-2.88, 3.01)	-1.03 (-3.05, 0.99)
ERECTILE DYSFUNCTION	1.1	0.0	1.0	0.07 (-2.86, 3.00)	-1.02 (-3.02, 0.98)
ATRIAL FLUTTER	1.1	0.8	0.0	1.09 (-1.05, 3.23)	0.81 (-0.77, 2.39)
ATRIAL FIBRILLATION	1.1	1.6	0.0	1.09 (-1.05, 3.23)	1.63 (-0.63, 3.90)
EXCORIATION	1.1	0.8	0.0	1.09 (-1.05, 3.23)	0.81 (-0.78, 2.39)
BLISTER	1.1	1.6	0.0	1.09 (-1.05, 3.23)	1.62 (-0.62, 3.86)
PARAESTHESIA	1.1	0.0	0.0	1.09 (-1.05, 3.23)	0.00 (0.00, 0.00)
DELUSION	1.1	0.0	1.0	0.08 (-2.84, 2.99)	-1.01 (-2.99, 0.97)
HALLUCINATION	1.1	0.0	0.0	1.09 (-1.05, 3.22)	0.00 (0.00, 0.00)
BLOOD GLUCOSE INCREASED	1.1	0.8	0.0	1.09 (-1.05, 3.22)	0.80 (-0.77, 2.37)
PROSTATE CANCER	1.1	0.0	0.0	1.09 (-1.04, 3.22)	0.00 (0.00, 0.00)
PAROSMIA	1.1	0.0	0.0	1.09 (-1.04, 3.21)	0.00 (0.00, 0.00)
RHINORRHOEA	1.1	0.8	0.0	1.08 (-1.04, 3.20)	0.81 (-0.78, 2.39)
ABDOMINAL PAIN	0.0	1.6	1.0	-1.03 (-3.04, 0.98)	0.58 (-2.42, 3.57)
AGITATION	0.0	1.6	1.0	-1.01 (-2.98, 0.97)	0.59 (-2.38, 3.56)
ALOPECIA	0.0	0.0	1.0	-1.00 (-2.97, 0.96)	-1.00 (-2.97, 0.96)
ANXIETY	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.81 (-0.78, 2.39)
APPLICATION SITE BLEEDING	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.76, 2.36)
APPLICATION SITE DESQUAMATION	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.76, 2.36)
APPLICATION SITE INDURATION	0.0	0.0	1.0	-1.01 (-2.99, 0.97)	-1.01 (-2.99, 0.97)
APPLICATION SITE URTICARIA	0.0	1.6	0.0	0.00 (0.00, 0.00)	1.64 (-0.63, 3.91)
ASTHENIA	0.0	0.8	1.0	-1.03 (-3.06, 0.99)	-0.23 (-2.79, 2.33)
ATRIOVENTRICULAR BLOCK FIRST DEGREE	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.81 (-0.77, 2.39)
ATRIOVENTRICULAR BLOCK SECOND DEGREE	0.0	0.0	1.0	-1.02 (-3.02, 0.98)	-1.02 (-3.02, 0.98)
BALANCE DISORDER	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.36)
BLEEDING ANOVULATORY	0.0	0.8	1.0	-1.01 (-2.98, 0.97)	-0.21 (-2.73, 2.31)
BLOOD ALKALINE PHOSPHATASE INCREASED	0.0	0.0	1.0	-1.01 (-3.00, 0.97)	-1.01 (-3.00, 0.97)
BLOOD CREATINE PHOSPHOKINASE INCREASED	0.0	0.0	1.0	-1.01 (-2.99, 0.97)	-1.01 (-2.99, 0.97)
BLOOD URINE PRESENT	0.0	0.0	1.0	-1.03 (-3.04, 0.98)	-1.03 (-3.04, 0.98)
BODY TEMPERATURE INCREASED	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.76, 2.36)
BRONCHITIS	0.0	0.0	1.0	-1.02 (-3.00, 0.97)	-1.02 (-3.00, 0.97)
BUNDLE BRANCH BLOCK LEFT	0.0	0.0	1.0	-1.00 (-2.97, 0.96)	-1.00 (-2.97, 0.96)
BUNDLE BRANCH BLOCK RIGHT	0.0	0.8	1.0	-1.02 (-3.01, 0.98)	-0.21 (-2.75, 2.33)
CATARACT OPERATION	0.0	0.0	1.0	-1.02 (-3.03, 0.98)	-1.02 (-3.03, 0.98)
CELLULITIS	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.37)
CERUMEN IMPACTION	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.37)
CERVICITIS	0.0	0.0	1.0	-1.03 (-3.05, 0.99)	-1.03 (-3.05, 0.99)
COLON CANCER	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.79 (-0.76, 2.35)
COMPLEX PARTIAL SEIZURES	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.76, 2.36)
CONJUNCTIVAL HAEMORRHAGE	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.37)
CONJUNCTIVITIS	0.0	0.0	1.0	-1.01 (-2.98, 0.97)	-1.01 (-2.98, 0.97)
CONSTIPATION	0.0	0.0	1.0	-1.03 (-3.04, 0.98)	-1.03 (-3.04, 0.98)
COORDINATION ABNORMAL	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.76, 2.36)
CYSTOSCOPY	0.0	0.0	1.0	-1.03 (-3.04, 0.98)	-1.03 (-3.04, 0.98)
DECREASED APPETITE	0.0	0.0	1.0	-1.02 (-3.02, 0.98)	-1.02 (-3.02, 0.98)
DEHYDRATION	0.0	0.0	1.0	-1.02 (-3.03, 0.98)	-1.02 (-3.03, 0.98)
DEPRESSED MOOD	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.37)
DISORIENTATION	0.0	0.0	1.0	-1.02 (-3.02, 0.98)	-1.02 (-3.02, 0.98)
DISTURBANCE IN SEXUAL AROUSAL	0.0	0.0	1.0	-1.00 (-2.96, 0.96)	-1.00 (-2.96, 0.96)
DRUG ERUPTION	0.0	0.0	1.0	-1.01 (-2.98, 0.97)	-1.01 (-2.98, 0.97)
DYSPEPSIA	0.0	0.8	1.0	-1.03 (-3.06, 0.99)	-0.22 (-2.80, 2.36)
DYSPHONIA	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.37)
DYSPNOEA	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.37)
DYSURIA	0.0	0.8	1.0	-1.03 (-3.06, 0.99)	-0.24 (-2.79, 2.30)
EAR INFECTION	0.0	0.0	2.0	-2.05 (-4.89, 0.79)	-2.05 (-4.89, 0.79)
EAR PAIN	0.0	0.0	1.0	-1.01 (-3.00, 0.97)	-1.01 (-3.00, 0.97)
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION	0.0	0.8	3.1	-3.11 (-6.62, 0.41)	-2.30 (-6.16, 1.55)
ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED	0.0	0.8	1.0	-1.02 (-3.02, 0.98)	-0.21 (-2.76, 2.33)
EMPHYSEMA	0.0	0.0	1.0	-1.03 (-3.04, 0.99)	-1.03 (-3.04, 0.99)
EYE ALLERGY	0.0	0.0	1.0	-1.01 (-3.00, 0.97)	-1.01 (-3.00, 0.97)
EYE LASER SURGERY	0.0	0.0	1.0	-1.03 (-3.06, 0.99)	-1.03 (-3.06, 0.99)
EYE PRURITUS	0.0	0.0	1.0	-1.01 (-2.99, 0.97)	-1.01 (-2.99, 0.97)
EYE SWELLING	0.0	0.0	1.0	-1.01 (-3.00, 0.97)	-1.01 (-3.00, 0.97)
GASTROENTERITIS VIRAL	0.0	0.0	1.0	-1.03 (-3.06, 0.99)	-1.03 (-3.06, 0.99)
GASTROOESOPHAGEAL REFLUX DISEASE	0.0	0.0	1.0	-1.03 (-3.06, 0.99)	-1.03 (-3.06, 0.99)
GLOSSITIS	0.0	0.0	1.0	-1.01 (-2.98, 0.97)	-1.01 (-2.98, 0.97)
HEMIANOPIA HOMONYMOUS	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.81 (-0.78, 2.39)
HIATUS HERNIA	0.0	0.0	1.0	-1.00 (-2.97, 0.96)	-1.00 (-2.97, 0.96)
HIP FRACTURE	0.0	0.0	1.0	-1.01 (-3.00, 0.97)	-1.01 (-3.00, 0.97)
HOT FLUSH	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.81 (-0.78, 2.40)
HYPERTENSION	0.0	0.8	1.0	-1.03 (-3.04, 0.99)	-0.23 (-2.78, 2.32)
HYPOTENSION	0.0	0.8	2.1	-2.07 (-4.93, 0.80)	-1.26 (-4.53, 2.00)
INCONTINENCE	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.38)
IRRITABILITY	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.81 (-0.78, 2.39)
JOINT DISLOCATION	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.38)
LETHARGY	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.38)
LOCALISED INFECTION	0.0	0.0	1.0	-1.03 (-3.04, 0.99)	-1.03 (-3.04, 0.99)
MICTURITION URGENCY	0.0	0.8	1.0	-1.02 (-3.03, 0.98)	-0.22 (-2.77, 2.32)
MUSCLE SPASMS	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.81 (-0.78, 2.40)
MUSCULAR WEAKNESS	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.37)
NASAL MUCOSA BIOPSY	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.37)
OEDEMA	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.81 (-0.78, 2.40)
ORTHOSTATIC HYPOTENSION	0.0	0.0	1.0	-1.02 (-3.03, 0.98)	-1.02 (-3.03, 0.98)
PALPITATIONS	0.0	1.6	0.0	0.00 (0.00, 0.00)	1.62 (-0.62, 3.86)
PARAESTHESIA ORAL	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.37)
PARKINSON'S DISEASE	0.0	0.0	1.0	-1.03 (-3.05, 0.99)	-1.03 (-3.05, 0.99)
PELVIC PAIN	0.0	0.0	1.0	-1.03 (-3.06, 0.99)	-1.03 (-3.06, 0.99)
PNEUMONIA	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.37)
POSTNASAL DRIP	0.0	0.0	1.0	-1.01 (-2.99, 0.97)	-1.01 (-2.99, 0.97)
PSYCHOMOTOR HYPERACTIVITY	0.0	0.0	1.0	-1.01 (-2.99, 0.97)	-1.01 (-2.99, 0.97)
PYREXIA	0.0	0.8	2.1	-2.07 (-4.95, 0.80)	-1.27 (-4.55, 2.01)
RASH ERYTHEMATOUS	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.36)
RECTAL HAEMORRHAGE	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.37)
RESTLESSNESS	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.38)
SECRETION DISCHARGE	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.37)
SHOULDER PAIN	0.0	0.8	1.0	-1.01 (-2.99, 0.97)	-0.21 (-2.74, 2.32)
SINUS ARRHYTHMIA	0.0	0.0	1.0	-1.01 (-2.99, 0.97)	-1.01 (-2.99, 0.97)
SKIN LACERATION	0.0	1.6	0.0	0.00 (0.00, 0.00)	1.62 (-0.62, 3.86)
SKIN ULCER	0.0	0.0	1.0	-1.03 (-3.06, 0.99)	-1.03 (-3.06, 0.99)
STUPOR	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.79 (-0.76, 2.35)
SUDDEN DEATH	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.37)
SUPRAVENTRICULAR EXTRASYSTOLES	0.0	0.8	1.0	-1.02 (-3.01, 0.98)	-0.22 (-2.75, 2.32)
SUPRAVENTRICULAR TACHYCARDIA	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.81 (-0.77, 2.39)
TACHYCARDIA	0.0	0.0	1.0	-1.01 (-2.99, 0.97)	-1.01 (-2.99, 0.97)
ULCER	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.76, 2.35)
VAGINAL MYCOSIS	0.0	0.0	1.0	-1.03 (-3.05, 0.99)	-1.03 (-3.05, 0.99)
WEIGHT DECREASED	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.79 (-0.76, 2.35)
WOLFF-PARKINSON-WHITE SYNDROME	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.80 (-0.77, 2.38)
WOUND	0.0	0.8	0.0	0.00 (0.00, 0.00)	0.81 (-0.77, 2.39)

Key: EAIR=exposure-adjusted incidence rate, SY=subject years
a Subject years is the sum of all exposures per treatment group.
Note: EAIR is defined for each event as the number or subjects with an event divided by the sum of the at-risk exposure time. At-risk exposure time is calculated from [Day 1 to first onset of a specified event; for subjects with no event, it is the time from Day 1 to treatment discontinuation /completion date].
Note: Adverse events are coded using MedDRA version 26.0.

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