TSFAE24F

Subjects With Treatment-emergent Adverse Events With Frequency =x% in Any Treatment Group by System Organ Class and Preferred Term and Onset Time

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Output

Preview

# Program Name:              tsfae24f.R

# Prep environment:

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

# Define script level parameters:

tblid <- "TSFAE24f"
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(
    months = (TRTEDY + 30) / 30.4375,
    ACAT1 = case_when(
      months <= 3 ~ "Within 3 months",
      months > 3 & months <= 6 ~ "4 to 6 months",
      months > 6 & months <= 9 ~ "7 to 9 months",
      months > 9 & months <= 12 ~ "10 to 12 months",
      months > 12 ~ "Beyond 13 months",
      .default = NA_character_
    ),
    ACAT1 = factor(
      ACAT1,
      levels = c(
        "Within 3 months",
        "4 to 6 months",
        "7 to 9 months",
        "10 to 12 months",
        "Beyond 13 months"
      )
    )
  ) %>%
  select(
    USUBJID,
    !!rlang::sym(popfl),
    !!rlang::sym(trtvar),
    colspan_trt,
    TRTEDY,
    ACAT1
  )

adae <- pharmaverseadamjnj::adae %>%
  filter(TRTEMFL == "Y") %>%
  select(
    USUBJID,
    TRTEMFL,
    AEBODSYS,
    AEDECOD,
    ASTDT,
    ACAT1,
    AOCCFL,
    AOCCPFL,
    AOCCSFL
  ) %>%
  mutate(
    ACAT1 = forcats::fct_na_value_to_level(factor(
      ACAT1,
      levels = c(
        "Within 3 months",
        "4 to 6 months",
        "7 to 9 months",
        "10 to 12 months",
        "Beyond 13 months"
      )
    ))
  ) %>%
  arrange(USUBJID, AEBODSYS, AEDECOD, ASTDT)

adae <- inner_join(adae, adsl %>% select(-ACAT1), by = c("USUBJID"))

adae$TRTEMFL <- factor(adae$TRTEMFL)

# 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
)

# This df generates facets with cumulative counts for .N_col. Note: These extra
# records must then be removed from the numerator by a_freq_combos_j function.
combodf <- tribble(
  ~valname         , ~label             , ~levelcombo                                                                                                , ~exargs ,
  "Total"          , "Total"            , c("Within 3 months", "4 to 6 months", "7 to 9 months", "10 to 12 months", "Beyond 13 months", "(Missing)") , list()  ,
  "Thru 3 months"  , "Within 3 months"  , c("Within 3 months", "4 to 6 months", "7 to 9 months", "10 to 12 months", "Beyond 13 months")              , list()  ,
  "Thru 6 months"  , "4 to 6 months"    , c("4 to 6 months", "7 to 9 months", "10 to 12 months", "Beyond 13 months")                                 , list()  ,
  "Thru 9 months"  , "7 to 9 months"    , c("7 to 9 months", "10 to 12 months", "Beyond 13 months")                                                  , list()  ,
  "Thru 12 months" , "10 to 12 months"  , c("10 to 12 months", "Beyond 13 months")                                                                   , list()  ,
  "Over 13 months" , "Beyond 13 months" , c("Beyond 13 months")                                                                                      , list()
)


extra_args1 <- list(
  combosdf = combodf,
  filter_var = "ACAT1",
  do_not_filter = "Total",
  .stats = "count_unique_fraction"
)

lyt <- basic_table(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(
    "ACAT1",
    split_fun = add_combo_levels(
      combosdf = combodf,
      trim = FALSE,
      keep_levels = combodf$valname
    )
  ) %>%
  analyze(
    popfl,
    show_labels = "hidden",
    afun = a_freq_j,
    extra_args = list(
      label = "Analysis set: Safety",
      .stats = "n_altdf"
    )
  ) %>%
  analyze(
    "TRTEMFL",
    nested = FALSE,
    show_labels = "hidden",
    afun = a_freq_combos_j,
    extra_args = append(
      extra_args1,
      list(
        val = "Y",
        label = "Subjects with >= 1 AE",
        flag_var = NULL
      )
    )
  ) %>%
  split_rows_by(
    "AEBODSYS",
    split_label = "System Organ Class",
    label_pos = "topleft",
    split_fun = trim_levels_in_group("AEDECOD"),
    section_div = c(" ")
  ) %>%
  summarize_row_groups(
    "AEBODSYS",
    cfun = a_freq_combos_j,
    extra_args = append(
      extra_args1,
      list(flag_var = NULL)
    )
  ) %>%
  analyze(
    "AEDECOD",
    afun = a_freq_combos_j,
    extra_args = append(
      extra_args1,
      list(flag_var = NULL)
    )
  ) %>%
  append_topleft("  Preferred Term, n (%)")

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

# Prune & sort results

result <- safe_prune_table(result, prune_func = bspt_pruner())

result <- result %>%
  sort_at_path(
    path = c("root", "AEBODSYS"),
    scorefun = jj_complex_scorefun(colpath = "Total")
  ) %>%
  sort_at_path(
    path = c("root", "AEBODSYS", "*", "AEDECOD"),
    scorefun = jj_complex_scorefun(colpath = "Total")
  )

# 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",
  nosplitin = list(cols = c(trtvar))
)

TSFAE24f: Subjects With [Treatment-emergent Adverse Events] With Frequency =[x]% in [Any Treatment Group] by System Organ Class and Preferred Term and Onset Time; Safety Analysis Set (Study jjcs - core)
	Active Study Agent
System Organ Class	Xanomeline High Dose						Xanomeline Low Dose						Placebo
Preferred Term, n (%)	Total	Within 3 months	4 to 6 months	7 to 9 months	10 to 12 months	Beyond 13 months	Total	Within 3 months	4 to 6 months	7 to 9 months	10 to 12 months	Beyond 13 months	Total	Within 3 months	4 to 6 months	7 to 9 months	10 to 12 months	Beyond 13 months
Analysis set: Safety	53	53	49	38	30	14	73	73	55	39	24	12	59	59	44	34	22	8
Subjects with ≥ 1 AE	51 (96.2%)	4 (7.5%)	11 (22.4%)	7 (18.4%)	15 (50.0%)	14 (100.0%)	62 (84.9%)	14 (19.2%)	15 (27.3%)	14 (35.9%)	10 (41.7%)	9 (75.0%)	42 (71.2%)	11 (18.6%)	6 (13.6%)	9 (26.5%)	13 (59.1%)	3 (37.5%)
Skin and subcutaneous tissue  disorders	34 (64.2%)	4 (7.5%)	5 (10.2%)	6 (15.8%)	10 (33.3%)	9 (64.3%)	28 (38.4%)	8 (11.0%)	7 (12.7%)	2 (5.1%)	6 (25.0%)	5 (41.7%)	16 (27.1%)	5 (8.5%)	3 (6.8%)	4 (11.8%)	3 (13.6%)	1 (12.5%)
PRURITUS	20 (37.7%)	1 (1.9%)	2 (4.1%)	6 (15.8%)	5 (16.7%)	6 (42.9%)	14 (19.2%)	4 (5.5%)	3 (5.5%)	0	4 (16.7%)	3 (25.0%)	6 (10.2%)	1 (1.7%)	2 (4.5%)	2 (5.9%)	1 (4.5%)	0
ERYTHEMA	12 (22.6%)	1 (1.9%)	2 (4.1%)	4 (10.5%)	3 (10.0%)	2 (14.3%)	8 (11.0%)	4 (5.5%)	1 (1.8%)	0	2 (8.3%)	1 (8.3%)	6 (10.2%)	2 (3.4%)	1 (2.3%)	2 (5.9%)	1 (4.5%)	0
HYPERHIDROSIS	8 (15.1%)	1 (1.9%)	1 (2.0%)	0	3 (10.0%)	3 (21.4%)	4 (5.5%)	1 (1.4%)	2 (3.6%)	1 (2.6%)	0	0	2 (3.4%)	0	1 (2.3%)	0	1 (4.5%)	0
RASH	5 (9.4%)	1 (1.9%)	0	1 (2.6%)	2 (6.7%)	1 (7.1%)	9 (12.3%)	2 (2.7%)	3 (5.5%)	0	3 (12.5%)	1 (8.3%)	4 (6.8%)	1 (1.7%)	0	2 (5.9%)	0	1 (12.5%)
SKIN IRRITATION	4 (7.5%)	1 (1.9%)	1 (2.0%)	0	1 (3.3%)	1 (7.1%)	4 (5.5%)	2 (2.7%)	1 (1.8%)	0	0	1 (8.3%)	3 (5.1%)	1 (1.7%)	0	2 (5.9%)	0	0
RASH PRURITIC	2 (3.8%)	1 (1.9%)	0	0	0	1 (7.1%)	1 (1.4%)	0	0	1 (2.6%)	0	0	0	0	0	0	0	0
BLISTER	1 (1.9%)	0	0	0	1 (3.3%)	0	2 (2.7%)	0	0	0	1 (4.2%)	1 (8.3%)	0	0	0	0	0	0
PRURITUS GENERALISED	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
SKIN ODOUR ABNORMAL	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
RASH ERYTHEMATOUS	0	0	0	0	0	0	1 (1.4%)	0	0	0	0	1 (8.3%)	0	0	0	0	0	0
General disorders and  administration site conditions	26 (49.1%)	1 (1.9%)	7 (14.3%)	2 (5.3%)	8 (26.7%)	8 (57.1%)	38 (52.1%)	10 (13.7%)	11 (20.0%)	6 (15.4%)	5 (20.8%)	6 (50.0%)	16 (27.1%)	3 (5.1%)	2 (4.5%)	4 (11.8%)	6 (27.3%)	1 (12.5%)
APPLICATION SITE PRURITUS	13 (24.5%)	1 (1.9%)	5 (10.2%)	1 (2.6%)	3 (10.0%)	3 (21.4%)	18 (24.7%)	6 (8.2%)	5 (9.1%)	3 (7.7%)	1 (4.2%)	3 (25.0%)	4 (6.8%)	2 (3.4%)	0	1 (2.9%)	1 (4.5%)	0
APPLICATION SITE ERYTHEMA	10 (18.9%)	0	4 (8.2%)	2 (5.3%)	1 (3.3%)	3 (21.4%)	11 (15.1%)	5 (6.8%)	2 (3.6%)	1 (2.6%)	1 (4.2%)	2 (16.7%)	2 (3.4%)	0	0	1 (2.9%)	1 (4.5%)	0
APPLICATION SITE IRRITATION	8 (15.1%)	0	2 (4.1%)	0	1 (3.3%)	5 (35.7%)	7 (9.6%)	1 (1.4%)	3 (5.5%)	0	1 (4.2%)	2 (16.7%)	2 (3.4%)	1 (1.7%)	0	0	1 (4.5%)	0
FATIGUE	5 (9.4%)	0	0	0	2 (6.7%)	3 (21.4%)	5 (6.8%)	3 (4.1%)	0	0	1 (4.2%)	1 (8.3%)	0	0	0	0	0	0
APPLICATION SITE DERMATITIS	4 (7.5%)	1 (1.9%)	1 (2.0%)	0	2 (6.7%)	0	7 (9.6%)	0	2 (3.6%)	3 (7.7%)	0	2 (16.7%)	5 (8.5%)	1 (1.7%)	0	2 (5.9%)	1 (4.5%)	1 (12.5%)
APPLICATION SITE VESICLES	4 (7.5%)	0	1 (2.0%)	0	1 (3.3%)	2 (14.3%)	4 (5.5%)	1 (1.4%)	2 (3.6%)	1 (2.6%)	0	0	0	0	0	0	0	0
APPLICATION SITE PAIN	2 (3.8%)	0	0	0	0	2 (14.3%)	0	0	0	0	0	0	0	0	0	0	0	0
APPLICATION SITE  PERSPIRATION	2 (3.8%)	0	1 (2.0%)	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
CHEST PAIN	2 (3.8%)	0	0	0	1 (3.3%)	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
MALAISE	2 (3.8%)	0	0	0	1 (3.3%)	1 (7.1%)	1 (1.4%)	0	0	0	1 (4.2%)	0	0	0	0	0	0	0
APPLICATION SITE REACTION	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	1 (1.7%)	1 (1.7%)	0	0	0	0
CHEST DISCOMFORT	1 (1.9%)	0	0	0	0	1 (7.1%)	1 (1.4%)	0	0	1 (2.6%)	0	0	0	0	0	0	0	0
FEELING ABNORMAL	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
OEDEMA PERIPHERAL	1 (1.9%)	0	1 (2.0%)	0	0	0	1 (1.4%)	0	1 (1.8%)	0	0	0	2 (3.4%)	0	0	0	2 (9.1%)	0
PAIN	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
ASTHENIA	0	0	0	0	0	0	1 (1.4%)	0	0	0	0	1 (8.3%)	1 (1.7%)	0	1 (2.3%)	0	0	0
Nervous system disorders	18 (34.0%)	0	4 (8.2%)	2 (5.3%)	8 (26.7%)	4 (28.6%)	18 (24.7%)	2 (2.7%)	6 (10.9%)	5 (12.8%)	3 (12.5%)	2 (16.7%)	5 (8.5%)	1 (1.7%)	1 (2.3%)	0	2 (9.1%)	1 (12.5%)
DIZZINESS	8 (15.1%)	0	2 (4.1%)	1 (2.6%)	4 (13.3%)	1 (7.1%)	8 (11.0%)	1 (1.4%)	2 (3.6%)	1 (2.6%)	2 (8.3%)	2 (16.7%)	0	0	0	0	0	0
HEADACHE	5 (9.4%)	0	1 (2.0%)	1 (2.6%)	1 (3.3%)	2 (14.3%)	3 (4.1%)	0	0	1 (2.6%)	0	2 (16.7%)	2 (3.4%)	0	0	0	1 (4.5%)	1 (12.5%)
COGNITIVE DISORDER	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
PARTIAL SEIZURES WITH  SECONDARY  GENERALISATION	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
SYNCOPE	1 (1.9%)	0	0	0	1 (3.3%)	0	3 (4.1%)	0	1 (1.8%)	2 (5.1%)	0	0	0	0	0	0	0	0
TRANSIENT ISCHAEMIC ATTACK	1 (1.9%)	0	0	0	1 (3.3%)	0	2 (2.7%)	0	1 (1.8%)	0	0	1 (8.3%)	0	0	0	0	0	0
STUPOR	0	0	0	0	0	0	1 (1.4%)	0	0	0	0	1 (8.3%)	0	0	0	0	0	0
Gastrointestinal disorders	14 (26.4%)	0	6 (12.2%)	0	5 (16.7%)	3 (21.4%)	10 (13.7%)	2 (2.7%)	2 (3.6%)	3 (7.7%)	2 (8.3%)	1 (8.3%)	7 (11.9%)	2 (3.4%)	2 (4.5%)	0	2 (9.1%)	1 (12.5%)
NAUSEA	5 (9.4%)	0	3 (6.1%)	0	0	2 (14.3%)	2 (2.7%)	0	1 (1.8%)	0	1 (4.2%)	0	0	0	0	0	0	0
VOMITING	5 (9.4%)	0	3 (6.1%)	0	2 (6.7%)	0	2 (2.7%)	0	0	2 (5.1%)	0	0	0	0	0	0	0	0
SALIVARY HYPERSECRETION	4 (7.5%)	0	3 (6.1%)	0	1 (3.3%)	0	0	0	0	0	0	0	0	0	0	0	0	0
DIARRHOEA	2 (3.8%)	0	0	0	2 (6.7%)	0	3 (4.1%)	0	1 (1.8%)	2 (5.1%)	0	0	3 (5.1%)	1 (1.7%)	1 (2.3%)	0	1 (4.5%)	0
STOMACH DISCOMFORT	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
GLOSSITIS	0	0	0	0	0	0	0	0	0	0	0	0	1 (1.7%)	0	0	0	0	1 (12.5%)
RECTAL HAEMORRHAGE	0	0	0	0	0	0	1 (1.4%)	0	0	0	0	1 (8.3%)	0	0	0	0	0	0
Cardiac disorders	11 (20.8%)	0	2 (4.1%)	1 (2.6%)	6 (20.0%)	2 (14.3%)	11 (15.1%)	1 (1.4%)	1 (1.8%)	6 (15.4%)	1 (4.2%)	2 (16.7%)	7 (11.9%)	4 (6.8%)	0	1 (2.9%)	1 (4.5%)	1 (12.5%)
SINUS BRADYCARDIA	7 (13.2%)	0	1 (2.0%)	0	5 (16.7%)	1 (7.1%)	4 (5.5%)	1 (1.4%)	1 (1.8%)	1 (2.6%)	1 (4.2%)	0	0	0	0	0	0	0
MYOCARDIAL INFARCTION	3 (5.7%)	0	2 (4.1%)	1 (2.6%)	0	0	1 (1.4%)	0	0	0	0	1 (8.3%)	3 (5.1%)	1 (1.7%)	0	0	1 (4.5%)	1 (12.5%)
ATRIAL FIBRILLATION	1 (1.9%)	0	0	0	1 (3.3%)	0	2 (2.7%)	0	0	1 (2.6%)	0	1 (8.3%)	0	0	0	0	0	0
VENTRICULAR EXTRASYSTOLES	1 (1.9%)	0	0	0	0	1 (7.1%)	2 (2.7%)	0	0	2 (5.1%)	0	0	0	0	0	0	0	0
ATRIOVENTRICULAR BLOCK  FIRST DEGREE	0	0	0	0	0	0	1 (1.4%)	0	0	0	0	1 (8.3%)	0	0	0	0	0	0
PALPITATIONS	0	0	0	0	0	0	2 (2.7%)	0	0	2 (5.1%)	0	0	0	0	0	0	0	0
SUPRAVENTRICULAR  TACHYCARDIA	0	0	0	0	0	0	1 (1.4%)	0	0	0	0	1 (8.3%)	0	0	0	0	0	0
TACHYCARDIA	0	0	0	0	0	0	0	0	0	0	0	0	1 (1.7%)	0	0	0	0	1 (12.5%)
Infections and infestations	9 (17.0%)	1 (1.9%)	1 (2.0%)	1 (2.6%)	4 (13.3%)	2 (14.3%)	6 (8.2%)	3 (4.1%)	0	3 (7.7%)	0	0	14 (23.7%)	3 (5.1%)	3 (6.8%)	1 (2.9%)	5 (22.7%)	2 (25.0%)
NASOPHARYNGITIS	3 (5.7%)	1 (1.9%)	0	0	2 (6.7%)	0	3 (4.1%)	1 (1.4%)	0	2 (5.1%)	0	0	2 (3.4%)	0	0	1 (2.9%)	1 (4.5%)	0
UPPER RESPIRATORY TRACT  INFECTION	2 (3.8%)	0	0	0	1 (3.3%)	1 (7.1%)	0	0	0	0	0	0	5 (8.5%)	2 (3.4%)	0	0	2 (9.1%)	1 (12.5%)
HORDEOLUM	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
RHINITIS	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
EAR INFECTION	0	0	0	0	0	0	0	0	0	0	0	0	2 (3.4%)	0	1 (2.3%)	0	0	1 (12.5%)
Respiratory, thoracic and  mediastinal disorders	7 (13.2%)	0	3 (6.1%)	0	2 (6.7%)	2 (14.3%)	6 (8.2%)	3 (4.1%)	0	2 (5.1%)	0	1 (8.3%)	5 (8.5%)	0	1 (2.3%)	4 (11.8%)	0	0
COUGH	3 (5.7%)	0	1 (2.0%)	0	1 (3.3%)	1 (7.1%)	4 (5.5%)	1 (1.4%)	0	2 (5.1%)	0	1 (8.3%)	1 (1.7%)	0	0	1 (2.9%)	0	0
NASAL CONGESTION	3 (5.7%)	0	1 (2.0%)	0	1 (3.3%)	1 (7.1%)	0	0	0	0	0	0	2 (3.4%)	0	1 (2.3%)	1 (2.9%)	0	0
EPISTAXIS	2 (3.8%)	0	1 (2.0%)	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
PHARYNGOLARYNGEAL PAIN	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
PRODUCTIVE COUGH	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
RESPIRATORY TRACT  CONGESTION	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
Psychiatric disorders	6 (11.3%)	0	0	0	1 (3.3%)	5 (35.7%)	8 (11.0%)	4 (5.5%)	2 (3.6%)	2 (5.1%)	0	0	7 (11.9%)	1 (1.7%)	2 (4.5%)	2 (5.9%)	2 (9.1%)	0
CONFUSIONAL STATE	1 (1.9%)	0	0	0	0	1 (7.1%)	3 (4.1%)	1 (1.4%)	1 (1.8%)	1 (2.6%)	0	0	2 (3.4%)	1 (1.7%)	1 (2.3%)	0	0	0
DELIRIUM	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
DELUSION	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	1 (1.7%)	0	1 (2.3%)	0	0	0
HALLUCINATION	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
HALLUCINATION, VISUAL	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
INSOMNIA	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	1 (1.7%)	0	0	1 (2.9%)	0	0
LIBIDO DECREASED	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
LISTLESS	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
Investigations	5 (9.4%)	1 (1.9%)	0	1 (2.6%)	1 (3.3%)	2 (14.3%)	7 (9.6%)	1 (1.4%)	1 (1.8%)	3 (7.7%)	0	2 (16.7%)	7 (11.9%)	2 (3.4%)	1 (2.3%)	1 (2.9%)	3 (13.6%)	0
BLOOD GLUCOSE INCREASED	1 (1.9%)	0	0	0	0	1 (7.1%)	1 (1.4%)	0	0	1 (2.6%)	0	0	0	0	0	0	0	0
ELECTROCARDIOGRAM T WAVE  INVERSION	1 (1.9%)	0	0	0	0	1 (7.1%)	1 (1.4%)	0	0	0	0	1 (8.3%)	2 (3.4%)	1 (1.7%)	1 (2.3%)	0	0	0
ELECTROCARDIOGRAM ST  SEGMENT DEPRESSION	0	0	0	0	0	0	1 (1.4%)	0	0	1 (2.6%)	0	0	3 (5.1%)	1 (1.7%)	0	0	2 (9.1%)	0
ELECTROCARDIOGRAM T WAVE  AMPLITUDE DECREASED	0	0	0	0	0	0	1 (1.4%)	0	0	0	0	1 (8.3%)	1 (1.7%)	0	1 (2.3%)	0	0	0
Musculoskeletal and connective  tissue disorders	4 (7.5%)	0	1 (2.0%)	0	1 (3.3%)	2 (14.3%)	5 (6.8%)	3 (4.1%)	0	2 (5.1%)	0	0	2 (3.4%)	1 (1.7%)	0	1 (2.9%)	0	0
BACK PAIN	2 (3.8%)	0	0	0	1 (3.3%)	1 (7.1%)	1 (1.4%)	1 (1.4%)	0	0	0	0	1 (1.7%)	1 (1.7%)	0	0	0	0
MYALGIA	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
Injury, poisoning and  procedural complications	3 (5.7%)	0	0	0	2 (6.7%)	1 (7.1%)	5 (6.8%)	3 (4.1%)	1 (1.8%)	1 (2.6%)	0	0	2 (3.4%)	0	1 (2.3%)	1 (2.9%)	0	0
CONTUSION	2 (3.8%)	0	0	0	1 (3.3%)	1 (7.1%)	1 (1.4%)	0	1 (1.8%)	0	0	0	0	0	0	0	0	0
Eye disorders	1 (1.9%)	0	0	1 (2.6%)	0	0	2 (2.7%)	0	0	1 (2.6%)	0	1 (8.3%)	2 (3.4%)	0	1 (2.3%)	1 (2.9%)	0	0
VISION BLURRED	1 (1.9%)	0	0	1 (2.6%)	0	0	1 (1.4%)	0	0	0	0	1 (8.3%)	0	0	0	0	0	0
Metabolism and nutrition  disorders	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	2 (3.4%)	0	0	0	2 (9.1%)	0
INCREASED APPETITE	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
Neoplasms benign, malignant  and unspecified (incl cysts  and polyps)	1 (1.9%)	0	0	0	0	1 (7.1%)	1 (1.4%)	0	0	0	1 (4.2%)	0	0	0	0	0	0	0
PROSTATE CANCER	1 (1.9%)	0	0	0	0	1 (7.1%)	0	0	0	0	0	0	0	0	0	0	0	0
Vascular disorders	1 (1.9%)	1 (1.9%)	0	0	0	0	3 (4.1%)	1 (1.4%)	1 (1.8%)	1 (2.6%)	0	0	3 (5.1%)	1 (1.7%)	0	0	1 (4.5%)	1 (12.5%)
HYPOTENSION	0	0	0	0	0	0	1 (1.4%)	1 (1.4%)	0	0	0	0	2 (3.4%)	0	0	0	1 (4.5%)	1 (12.5%)
Note: Subjects are counted only once for any given event within a time category, regardless of the number of times they actually experienced the event. The event experienced by the subject with the first onset relative to [the start of [study treatment]] is summarized. If a subject has all adverse events with missing onset date, the subject is only counted in the total column. Percentages are calculated using the number of subjects at each time category as the denominator.
Note: Adverse events are coded using MedDRA version 26.0.

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