# Program Name: tsfae21c.R# Prep Environmentlibrary(envsetup)library(tern)library(dplyr)library(rtables)library(junco)# Define script level parameters:# - Define output ID and file locationtblid <-"TSFAE21c"fileid <- tblidtab_titles <-get_titles_from_file(input_path ='../../_data/', tblid)string_map <- default_str_maptrtvar <-"TRT01A"popfl <-"SAFFL"combined_colspan_trt <-TRUEif (combined_colspan_trt ==TRUE) {# Set up levels and label for the required combined columns add_combo <-add_combo_facet("Combined",label ="Combined",levels =c("Xanomeline High Dose", "Xanomeline Low Dose") )# choose if any facets need to be removed - e.g remove the combined column for placebo rm_combo_from_placebo <-cond_rm_facets(facets ="Combined",ancestor_pos =NA,value =" ",split ="colspan_trt" ) mysplit <-make_split_fun(post =list(add_combo, rm_combo_from_placebo))}# Process Data:adsl <- pharmaverseadamjnj::adsl %>%filter(!!rlang::sym(popfl) =="Y") %>%select(STUDYID, USUBJID, all_of(trtvar), all_of(popfl))adae <- pharmaverseadamjnj::adae %>%filter(TRTEMFL =="Y") %>%select(USUBJID, AEBODSYS, AEDECOD, TRTEMFL, AESEV)# Take maximum severityadaemax <- adae %>%mutate(AESEVN =case_when(toupper(AESEV) =="MILD"~3,toupper(AESEV) =="MODERATE"~2,toupper(AESEV) =="SEVERE"~1,.default =99 ) ) %>%arrange(USUBJID, AEBODSYS, AEDECOD, AESEVN) %>%group_by(USUBJID, AEBODSYS, AEDECOD) %>%slice(1) %>%ungroup()adsl$colspan_trt <-factor(ifelse(adsl[[trtvar]] =="Placebo", " ", "Active Study Agent"),levels =c("Active Study Agent", " "))colspan_trt_map <-create_colspan_map( adsl,non_active_grp ="Placebo",non_active_grp_span_lbl =" ",active_grp_span_lbl ="Active Study Agent",colspan_var ="colspan_trt",trt_var = trtvar)# join data togetherae <-inner_join(adaemax, adsl, by =c("USUBJID"))ae <- ae %>%mutate(AESEV2 =as.factor(ifelse(is.na(AESEV), "Missing", AESEV)))if (length(adae$TRTEMFL) ==0) { ae <-right_join(adaemax, adsl, by =c("USUBJID")) ae <- ae %>%mutate(AESEV2 =as.factor(ifelse(is.na(AESEV), "Missing", AESEV)))}levels(ae$AESEV2) <-c(levels(ae$AESEV), "Missing")# Define layout and build table:extra_args_1 <-list(denom ="n_altdf",.stats =c("count_unique_fraction"))lyt <-basic_table(top_level_section_div =" ",show_colcounts =TRUE,colcount_format ="N=xx") %>%split_cols_by("colspan_trt",split_fun =trim_levels_to_map(map = colspan_trt_map) )if (combined_colspan_trt ==TRUE) { lyt <- lyt %>%split_cols_by(trtvar, split_fun = mysplit)} else { lyt <- lyt %>%split_cols_by(trtvar)}lyt <- lyt %>%analyze("TRTEMFL",afun = a_freq_j,show_labels ="hidden",extra_args =append( extra_args_1,list(label ="Subjects with >=1 AE", val ="Y") ) ) %>%split_rows_by("AEBODSYS",split_label ="System Organ Class",split_fun =trim_levels_in_group("AEDECOD"),label_pos ="topleft",section_div =c(" "),nested =FALSE ) %>%summarize_row_groups("AEBODSYS",cfun = a_freq_j,extra_args = extra_args_1 ) %>%split_rows_by("AEDECOD",split_label ="Preferred Term, n (%)",section_div =c(" "),nested =TRUE ) %>%summarize_row_groups("AEDECOD",cfun = a_freq_j,extra_args = extra_args_1 ) %>%analyze("AESEV2", afun = a_freq_j, extra_args = extra_args_1) %>%append_topleft(" Preferred Term, n (%)")result <-build_table(lyt, ae, alt_counts_df = adsl)# Post-Processing step to sort by descending count on chosen active treatment columns.if (length(adae$TRTEMFL) !=0) { result <-sort_at_path( result,c("root", "AEBODSYS"),scorefun =jj_complex_scorefun() ) result <-sort_at_path( result,c("root", "AEBODSYS", "*", "AEDECOD"),scorefun =jj_complex_scorefun() )########################################################################################## Post-Processing step to remove all rows where counts are 0######################################################################################### result <-safe_prune_table(result, prune_func = prune_empty_level)}# Add titles and footnotes:result <-set_titles(result, tab_titles)# Convert to tbl file and output tablett_to_tlgrtf(string_map = string_map, tt = result,file = fileid,orientation ="portrait",label_width_ins =1.5)
TSFAE21c:Subjects With Treatment-emergent Adverse Events by System Organ Class, Preferred Term, and Severity; Safety Analysis Set (Study jjcs - core)
Active Study Agent
System Organ Class
Xanomeline High Dose
Xanomeline Low Dose
Combined
Placebo
Preferred Term, n (%)
N=53
N=73
N=126
N=59
Subjects with ≥1 AE
51 (96.2%)
62 (84.9%)
113 (89.7%)
42 (71.2%)
General disorders and administration site conditions
26 (49.1%)
38 (52.1%)
64 (50.8%)
16 (27.1%)
APPLICATION SITE PRURITUS
13 (24.5%)
18 (24.7%)
31 (24.6%)
4 (6.8%)
Mild
7 (13.2%)
11 (15.1%)
18 (14.3%)
3 (5.1%)
Moderate
6 (11.3%)
7 (9.6%)
13 (10.3%)
1 (1.7%)
APPLICATION SITE ERYTHEMA
10 (18.9%)
11 (15.1%)
21 (16.7%)
2 (3.4%)
Mild
7 (13.2%)
4 (5.5%)
11 (8.7%)
2 (3.4%)
Moderate
3 (5.7%)
6 (8.2%)
9 (7.1%)
0
Severe
0
1 (1.4%)
1 (0.8%)
0
APPLICATION SITE IRRITATION
8 (15.1%)
7 (9.6%)
15 (11.9%)
2 (3.4%)
Mild
3 (5.7%)
2 (2.7%)
5 (4.0%)
0
Moderate
5 (9.4%)
3 (4.1%)
8 (6.3%)
2 (3.4%)
Severe
0
2 (2.7%)
2 (1.6%)
0
APPLICATION SITE DERMATITIS
4 (7.5%)
7 (9.6%)
11 (8.7%)
5 (8.5%)
Mild
2 (3.8%)
3 (4.1%)
5 (4.0%)
5 (8.5%)
Moderate
2 (3.8%)
4 (5.5%)
6 (4.8%)
0
FATIGUE
5 (9.4%)
5 (6.8%)
10 (7.9%)
0
Mild
5 (9.4%)
3 (4.1%)
8 (6.3%)
0
Moderate
0
2 (2.7%)
2 (1.6%)
0
APPLICATION SITE VESICLES
4 (7.5%)
4 (5.5%)
8 (6.3%)
0
Mild
2 (3.8%)
2 (2.7%)
4 (3.2%)
0
Moderate
2 (3.8%)
2 (2.7%)
4 (3.2%)
0
APPLICATION SITE SWELLING
2 (3.8%)
1 (1.4%)
3 (2.4%)
0
Mild
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
Moderate
1 (1.9%)
0
1 (0.8%)
0
MALAISE
2 (3.8%)
1 (1.4%)
3 (2.4%)
0
Mild
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
Moderate
1 (1.9%)
0
1 (0.8%)
0
APPLICATION SITE PAIN
2 (3.8%)
0
2 (1.6%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
Moderate
1 (1.9%)
0
1 (0.8%)
0
APPLICATION SITE PERSPIRATION
2 (3.8%)
0
2 (1.6%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
Moderate
1 (1.9%)
0
1 (0.8%)
0
APPLICATION SITE URTICARIA
0
2 (2.7%)
2 (1.6%)
0
Mild
0
2 (2.7%)
2 (1.6%)
0
CHEST DISCOMFORT
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
Mild
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
CHEST PAIN
2 (3.8%)
0
2 (1.6%)
0
Mild
2 (3.8%)
0
2 (1.6%)
0
OEDEMA PERIPHERAL
1 (1.9%)
1 (1.4%)
2 (1.6%)
2 (3.4%)
Mild
0
0
0
2 (3.4%)
Moderate
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
APPLICATION SITE BLEEDING
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
APPLICATION SITE DESQUAMATION
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
APPLICATION SITE REACTION
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
Moderate
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
ASTHENIA
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
Moderate
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
CHILLS
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
FEELING ABNORMAL
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
FEELING COLD
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
OEDEMA
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
PAIN
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
PYREXIA
0
1 (1.4%)
1 (0.8%)
2 (3.4%)
Mild
0
1 (1.4%)
1 (0.8%)
2 (3.4%)
SECRETION DISCHARGE
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
SUDDEN DEATH
0
1 (1.4%)
1 (0.8%)
0
Severe
0
1 (1.4%)
1 (0.8%)
0
ULCER
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
APPLICATION SITE INDURATION
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
Skin and subcutaneous tissue disorders
34 (64.2%)
28 (38.4%)
62 (49.2%)
16 (27.1%)
PRURITUS
20 (37.7%)
14 (19.2%)
34 (27.0%)
6 (10.2%)
Mild
13 (24.5%)
6 (8.2%)
19 (15.1%)
5 (8.5%)
Moderate
7 (13.2%)
7 (9.6%)
14 (11.1%)
1 (1.7%)
Severe
0
1 (1.4%)
1 (0.8%)
0
ERYTHEMA
12 (22.6%)
8 (11.0%)
20 (15.9%)
6 (10.2%)
Mild
8 (15.1%)
3 (4.1%)
11 (8.7%)
2 (3.4%)
Moderate
4 (7.5%)
5 (6.8%)
9 (7.1%)
4 (6.8%)
RASH
5 (9.4%)
9 (12.3%)
14 (11.1%)
4 (6.8%)
Mild
4 (7.5%)
5 (6.8%)
9 (7.1%)
1 (1.7%)
Moderate
1 (1.9%)
3 (4.1%)
4 (3.2%)
3 (5.1%)
Severe
0
1 (1.4%)
1 (0.8%)
0
HYPERHIDROSIS
8 (15.1%)
4 (5.5%)
12 (9.5%)
2 (3.4%)
Mild
8 (15.1%)
1 (1.4%)
9 (7.1%)
2 (3.4%)
Moderate
0
3 (4.1%)
3 (2.4%)
0
SKIN IRRITATION
4 (7.5%)
4 (5.5%)
8 (6.3%)
3 (5.1%)
Mild
3 (5.7%)
1 (1.4%)
4 (3.2%)
2 (3.4%)
Moderate
1 (1.9%)
2 (2.7%)
3 (2.4%)
1 (1.7%)
Severe
0
1 (1.4%)
1 (0.8%)
0
BLISTER
1 (1.9%)
2 (2.7%)
3 (2.4%)
0
Mild
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
Severe
0
1 (1.4%)
1 (0.8%)
0
RASH PRURITIC
2 (3.8%)
1 (1.4%)
3 (2.4%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
Moderate
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
URTICARIA
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
ACTINIC KERATOSIS
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
PRURITUS GENERALISED
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
RASH ERYTHEMATOUS
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
RASH MACULO-PAPULAR
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
SKIN ODOUR ABNORMAL
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
ALOPECIA
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
DRUG ERUPTION
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
SKIN ULCER
0
0
0
1 (1.7%)
Moderate
0
0
0
1 (1.7%)
Nervous system disorders
18 (34.0%)
18 (24.7%)
36 (28.6%)
5 (8.5%)
DIZZINESS
8 (15.1%)
8 (11.0%)
16 (12.7%)
0
Mild
5 (9.4%)
5 (6.8%)
10 (7.9%)
0
Moderate
3 (5.7%)
3 (4.1%)
6 (4.8%)
0
HEADACHE
5 (9.4%)
3 (4.1%)
8 (6.3%)
2 (3.4%)
Mild
4 (7.5%)
2 (2.7%)
6 (4.8%)
2 (3.4%)
Moderate
1 (1.9%)
0
1 (0.8%)
0
Severe
0
1 (1.4%)
1 (0.8%)
0
SYNCOPE
1 (1.9%)
3 (4.1%)
4 (3.2%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
Moderate
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
Severe
0
1 (1.4%)
1 (0.8%)
0
SOMNOLENCE
1 (1.9%)
2 (2.7%)
3 (2.4%)
1 (1.7%)
Mild
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
TRANSIENT ISCHAEMIC ATTACK
1 (1.9%)
2 (2.7%)
3 (2.4%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
Severe
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
BALANCE DISORDER
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
BURNING SENSATION
1 (1.9%)
0
1 (0.8%)
0
Moderate
1 (1.9%)
0
1 (0.8%)
0
COGNITIVE DISORDER
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
COMPLEX PARTIAL SEIZURES
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
COORDINATION ABNORMAL
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
HEMIANOPIA HOMONYMOUS
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
HYPERSOMNIA
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
LETHARGY
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
PARAESTHESIA
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
PARAESTHESIA ORAL
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
PAROSMIA
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
PARTIAL SEIZURES WITH SECONDARY GENERALISATION
1 (1.9%)
0
1 (0.8%)
0
Severe
1 (1.9%)
0
1 (0.8%)
0
STUPOR
0
1 (1.4%)
1 (0.8%)
0
Severe
0
1 (1.4%)
1 (0.8%)
0
SYNCOPE VASOVAGAL
1 (1.9%)
0
1 (0.8%)
0
Moderate
1 (1.9%)
0
1 (0.8%)
0
PARKINSON'S DISEASE
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
PSYCHOMOTOR HYPERACTIVITY
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
Gastrointestinal disorders
14 (26.4%)
10 (13.7%)
24 (19.0%)
7 (11.9%)
NAUSEA
5 (9.4%)
2 (2.7%)
7 (5.6%)
0
Mild
5 (9.4%)
2 (2.7%)
7 (5.6%)
0
VOMITING
5 (9.4%)
2 (2.7%)
7 (5.6%)
0
Mild
4 (7.5%)
1 (1.4%)
5 (4.0%)
0
Moderate
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
DIARRHOEA
2 (3.8%)
3 (4.1%)
5 (4.0%)
3 (5.1%)
Mild
2 (3.8%)
2 (2.7%)
4 (3.2%)
3 (5.1%)
Moderate
0
1 (1.4%)
1 (0.8%)
0
SALIVARY HYPERSECRETION
4 (7.5%)
0
4 (3.2%)
0
Mild
4 (7.5%)
0
4 (3.2%)
0
ABDOMINAL PAIN
0
2 (2.7%)
2 (1.6%)
1 (1.7%)
Mild
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
Moderate
0
1 (1.4%)
1 (0.8%)
0
ABDOMINAL DISCOMFORT
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
DYSPEPSIA
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
Mild
0
0
0
1 (1.7%)
Moderate
0
1 (1.4%)
1 (0.8%)
0
RECTAL HAEMORRHAGE
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
STOMACH DISCOMFORT
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
CONSTIPATION
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
GASTROOESOPHAGEAL REFLUX DISEASE
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
GLOSSITIS
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
HIATUS HERNIA
0
0
0
1 (1.7%)
Moderate
0
0
0
1 (1.7%)
Cardiac disorders
11 (20.8%)
11 (15.1%)
22 (17.5%)
7 (11.9%)
SINUS BRADYCARDIA
7 (13.2%)
4 (5.5%)
11 (8.7%)
0
Mild
3 (5.7%)
3 (4.1%)
6 (4.8%)
0
Moderate
4 (7.5%)
1 (1.4%)
5 (4.0%)
0
MYOCARDIAL INFARCTION
3 (5.7%)
1 (1.4%)
4 (3.2%)
3 (5.1%)
Mild
2 (3.8%)
1 (1.4%)
3 (2.4%)
1 (1.7%)
Moderate
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
Severe
0
0
0
1 (1.7%)
ATRIAL FIBRILLATION
1 (1.9%)
2 (2.7%)
3 (2.4%)
0
Mild
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
VENTRICULAR EXTRASYSTOLES
1 (1.9%)
2 (2.7%)
3 (2.4%)
0
Mild
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
ATRIAL FLUTTER
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
PALPITATIONS
0
2 (2.7%)
2 (1.6%)
0
Moderate
0
2 (2.7%)
2 (1.6%)
0
ATRIOVENTRICULAR BLOCK FIRST DEGREE
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
BUNDLE BRANCH BLOCK RIGHT
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
Mild
0
0
0
1 (1.7%)
Moderate
0
1 (1.4%)
1 (0.8%)
0
CARDIAC DISORDER
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
SUPRAVENTRICULAR EXTRASYSTOLES
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
Mild
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
SUPRAVENTRICULAR TACHYCARDIA
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
WOLFF-PARKINSON-WHITE SYNDROME
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
ATRIOVENTRICULAR BLOCK SECOND DEGREE
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
BUNDLE BRANCH BLOCK LEFT
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
SINUS ARRHYTHMIA
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
TACHYCARDIA
0
0
0
1 (1.7%)
Moderate
0
0
0
1 (1.7%)
Infections and infestations
9 (17.0%)
6 (8.2%)
15 (11.9%)
14 (23.7%)
NASOPHARYNGITIS
3 (5.7%)
3 (4.1%)
6 (4.8%)
2 (3.4%)
Mild
3 (5.7%)
2 (2.7%)
5 (4.0%)
1 (1.7%)
Moderate
0
0
0
1 (1.7%)
Severe
0
1 (1.4%)
1 (0.8%)
0
INFLUENZA
1 (1.9%)
1 (1.4%)
2 (1.6%)
1 (1.7%)
Mild
1 (1.9%)
1 (1.4%)
2 (1.6%)
1 (1.7%)
UPPER RESPIRATORY TRACT INFECTION
2 (3.8%)
0
2 (1.6%)
5 (8.5%)
Mild
2 (3.8%)
0
2 (1.6%)
4 (6.8%)
Moderate
0
0
0
1 (1.7%)
CELLULITIS
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
HORDEOLUM
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
LOWER RESPIRATORY TRACT INFECTION
1 (1.9%)
0
1 (0.8%)
0
Moderate
1 (1.9%)
0
1 (0.8%)
0
PNEUMONIA
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
RHINITIS
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
URINARY TRACT INFECTION
1 (1.9%)
0
1 (0.8%)
2 (3.4%)
Mild
1 (1.9%)
0
1 (0.8%)
2 (3.4%)
BRONCHITIS
0
0
0
1 (1.7%)
Moderate
0
0
0
1 (1.7%)
CERVICITIS
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
EAR INFECTION
0
0
0
2 (3.4%)
Mild
0
0
0
2 (3.4%)
GASTROENTERITIS VIRAL
0
0
0
1 (1.7%)
Moderate
0
0
0
1 (1.7%)
LOCALISED INFECTION
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
VAGINAL MYCOSIS
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
Psychiatric disorders
6 (11.3%)
8 (11.0%)
14 (11.1%)
7 (11.9%)
CONFUSIONAL STATE
1 (1.9%)
3 (4.1%)
4 (3.2%)
2 (3.4%)
Mild
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
Moderate
0
3 (4.1%)
3 (2.4%)
1 (1.7%)
AGITATION
0
2 (2.7%)
2 (1.6%)
1 (1.7%)
Mild
0
0
0
1 (1.7%)
Moderate
0
1 (1.4%)
1 (0.8%)
0
Severe
0
1 (1.4%)
1 (0.8%)
0
ANXIETY
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
DELIRIUM
1 (1.9%)
0
1 (0.8%)
0
Moderate
1 (1.9%)
0
1 (0.8%)
0
DELUSION
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
Mild
0
0
0
1 (1.7%)
Moderate
1 (1.9%)
0
1 (0.8%)
0
DEPRESSED MOOD
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
HALLUCINATION
1 (1.9%)
0
1 (0.8%)
0
Moderate
1 (1.9%)
0
1 (0.8%)
0
HALLUCINATION, VISUAL
1 (1.9%)
0
1 (0.8%)
0
Moderate
1 (1.9%)
0
1 (0.8%)
0
INSOMNIA
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
Mild
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
IRRITABILITY
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
LIBIDO DECREASED
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
LISTLESS
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
NIGHTMARE
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
RESTLESSNESS
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
DISORIENTATION
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
DISTURBANCE IN SEXUAL AROUSAL
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
Respiratory, thoracic and mediastinal disorders
7 (13.2%)
6 (8.2%)
13 (10.3%)
5 (8.5%)
COUGH
3 (5.7%)
4 (5.5%)
7 (5.6%)
1 (1.7%)
Mild
2 (3.8%)
3 (4.1%)
5 (4.0%)
1 (1.7%)
Moderate
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
NASAL CONGESTION
3 (5.7%)
0
3 (2.4%)
2 (3.4%)
Mild
3 (5.7%)
0
3 (2.4%)
2 (3.4%)
EPISTAXIS
2 (3.8%)
0
2 (1.6%)
0
Mild
2 (3.8%)
0
2 (1.6%)
0
RHINORRHOEA
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
Mild
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
ALLERGIC GRANULOMATOUS ANGIITIS
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
DYSPHONIA
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
DYSPNOEA
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
PHARYNGOLARYNGEAL PAIN
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
PRODUCTIVE COUGH
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
RESPIRATORY TRACT CONGESTION
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
EMPHYSEMA
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
POSTNASAL DRIP
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
Investigations
5 (9.4%)
7 (9.6%)
12 (9.5%)
7 (11.9%)
BLOOD GLUCOSE INCREASED
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
Mild
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
ELECTROCARDIOGRAM T WAVE INVERSION
1 (1.9%)
1 (1.4%)
2 (1.6%)
2 (3.4%)
Mild
1 (1.9%)
1 (1.4%)
2 (1.6%)
2 (3.4%)
BIOPSY
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
BIOPSY PROSTATE
1 (1.9%)
0
1 (0.8%)
0
Moderate
1 (1.9%)
0
1 (0.8%)
0
BLOOD CHOLESTEROL INCREASED
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
BODY TEMPERATURE INCREASED
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION
0
1 (1.4%)
1 (0.8%)
3 (5.1%)
Mild
0
1 (1.4%)
1 (0.8%)
3 (5.1%)
ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
Mild
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
NASAL MUCOSA BIOPSY
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
WEIGHT DECREASED
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
BLOOD ALKALINE PHOSPHATASE INCREASED
0
0
0
1 (1.7%)
Moderate
0
0
0
1 (1.7%)
BLOOD CREATINE PHOSPHOKINASE INCREASED
0
0
0
1 (1.7%)
Moderate
0
0
0
1 (1.7%)
BLOOD URINE PRESENT
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
CYSTOSCOPY
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
Musculoskeletal and connective tissue disorders
4 (7.5%)
5 (6.8%)
9 (7.1%)
2 (3.4%)
BACK PAIN
2 (3.8%)
1 (1.4%)
3 (2.4%)
1 (1.7%)
Mild
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
Moderate
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
ARTHRALGIA
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
Moderate
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
FLANK PAIN
1 (1.9%)
0
1 (0.8%)
0
Moderate
1 (1.9%)
0
1 (0.8%)
0
MUSCLE SPASMS
0
1 (1.4%)
1 (0.8%)
0
Severe
0
1 (1.4%)
1 (0.8%)
0
MUSCULAR WEAKNESS
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
MYALGIA
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
SHOULDER PAIN
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
Mild
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
0
0
1 (1.7%)
Injury, poisoning and procedural complications
3 (5.7%)
5 (6.8%)
8 (6.3%)
2 (3.4%)
CONTUSION
2 (3.8%)
1 (1.4%)
3 (2.4%)
0
Mild
2 (3.8%)
0
2 (1.6%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
FALL
1 (1.9%)
2 (2.7%)
3 (2.4%)
1 (1.7%)
Mild
1 (1.9%)
1 (1.4%)
2 (1.6%)
1 (1.7%)
Moderate
0
1 (1.4%)
1 (0.8%)
0
EXCORIATION
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
Moderate
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
SKIN LACERATION
0
2 (2.7%)
2 (1.6%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
FACIAL BONES FRACTURE
1 (1.9%)
0
1 (0.8%)
0
Moderate
1 (1.9%)
0
1 (0.8%)
0
JOINT DISLOCATION
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
WOUND
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
HIP FRACTURE
0
0
0
1 (1.7%)
Severe
0
0
0
1 (1.7%)
Renal and urinary disorders
2 (3.8%)
3 (4.1%)
5 (4.0%)
2 (3.4%)
CALCULUS URETHRAL
1 (1.9%)
0
1 (0.8%)
0
Moderate
1 (1.9%)
0
1 (0.8%)
0
DYSURIA
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
Mild
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
INCONTINENCE
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
MICTURITION URGENCY
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
Mild
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
NEPHROLITHIASIS
1 (1.9%)
0
1 (0.8%)
0
Moderate
1 (1.9%)
0
1 (0.8%)
0
Vascular disorders
1 (1.9%)
3 (4.1%)
4 (3.2%)
3 (5.1%)
HOT FLUSH
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
HYPERTENSION
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
Mild
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
0
0
1 (1.7%)
HYPOTENSION
0
1 (1.4%)
1 (0.8%)
2 (3.4%)
Mild
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
Moderate
0
0
0
1 (1.7%)
WOUND HAEMORRHAGE
1 (1.9%)
0
1 (0.8%)
0
Moderate
1 (1.9%)
0
1 (0.8%)
0
ORTHOSTATIC HYPOTENSION
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
Ear and labyrinth disorders
1 (1.9%)
2 (2.7%)
3 (2.4%)
1 (1.7%)
VERTIGO
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
Moderate
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
CERUMEN IMPACTION
0
1 (1.4%)
1 (0.8%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
EAR PAIN
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
Eye disorders
1 (1.9%)
2 (2.7%)
3 (2.4%)
2 (3.4%)
VISION BLURRED
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
Mild
0
1 (1.4%)
1 (0.8%)
0
Moderate
1 (1.9%)
0
1 (0.8%)
0
CONJUNCTIVAL HAEMORRHAGE
0
1 (1.4%)
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
CONJUNCTIVITIS
0
0
0
1 (1.7%)
Moderate
0
0
0
1 (1.7%)
EYE ALLERGY
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
EYE PRURITUS
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
EYE SWELLING
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
Reproductive system and breast disorders
3 (5.7%)
0
3 (2.4%)
3 (5.1%)
ABNORMAL UTERINE BLEEDING
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
BENIGN PROSTATIC HYPERPLASIA
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
Moderate
1 (1.9%)
0
1 (0.8%)
0
Severe
0
0
0
1 (1.7%)
ERECTILE DYSFUNCTION
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
Mild
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
PELVIC PAIN
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
Congenital, familial and genetic disorders
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
VENTRICULAR SEPTAL DEFECT
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
Moderate
0
1 (1.4%)
1 (0.8%)
0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
COLON CANCER
0
1 (1.4%)
1 (0.8%)
0
Severe
0
1 (1.4%)
1 (0.8%)
0
PROSTATE CANCER
1 (1.9%)
0
1 (0.8%)
0
Severe
1 (1.9%)
0
1 (0.8%)
0
Endocrine disorders
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
BLEEDING ANOVULATORY
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
Mild
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
Metabolism and nutrition disorders
1 (1.9%)
0
1 (0.8%)
2 (3.4%)
INCREASED APPETITE
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
DECREASED APPETITE
0
0
0
1 (1.7%)
Moderate
0
0
0
1 (1.7%)
DEHYDRATION
0
0
0
1 (1.7%)
Mild
0
0
0
1 (1.7%)
Surgical and medical procedures
1 (1.9%)
0
1 (0.8%)
2 (3.4%)
ACROCHORDON EXCISION
1 (1.9%)
0
1 (0.8%)
0
Mild
1 (1.9%)
0
1 (0.8%)
0
CATARACT OPERATION
0
0
0
1 (1.7%)
Moderate
0
0
0
1 (1.7%)
EYE LASER SURGERY
0
0
0
1 (1.7%)
Mild
0
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. The event experienced by the subject with the worst severity is used.
Note: Adverse events are coded using MedDRA version 26.0.