# Program Name: tsfae12.R# Prep Environmentlibrary(envsetup)library(tern)library(dplyr)library(rtables)library(junco)# Define script level parameters:# - Define output ID and file locationtblid <-"TSFAE12"fileid <- tblidtab_titles <-get_titles_from_file(input_path ='../../_data/', tblid)string_map <- default_str_maptrtvar <-"TRT01A"popfl <-"SAFFL"combined_colspan_trt <-TRUErisk_diff <-TRUErr_method <-"wald"ctrl_grp <-"Placebo"if (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%filter( TRTEMFL =="Y"&!(AEACN %in%c("",NA_character_,"DRUG WITHDRAWN","DOSE NOT CHANGED","UNKNOWN","NOT APPLICABLE" )) ) %>%select(USUBJID, TRTEMFL, AEACN, AEBODSYS, AEDECOD)adsl$colspan_trt <-factor(ifelse(adsl[[trtvar]] =="Placebo", " ", "Active Study Agent"),levels =c("Active Study Agent", " "))if (risk_diff ==TRUE) { adsl$rrisk_header <-"Risk Difference (%) (95% CI)" adsl$rrisk_label <-paste(adsl[[trtvar]], paste("vs", ctrl_grp))}# join data togetherae <- adae %>%right_join(., adsl, by =c("USUBJID"))colspan_trt_map <-create_colspan_map( adsl,non_active_grp = ctrl_grp,non_active_grp_span_lbl =" ",active_grp_span_lbl ="Active Study Agent",colspan_var ="colspan_trt",trt_var = trtvar)# Define layout and build table:ref_path <-c("colspan_trt", " ", trtvar, ctrl_grp)extra_args_rr <-list(method = rr_method,ref_path = ref_path,.stats =c("count_unique_fraction"))lyt <-basic_table(top_level_section_div =" ",show_colcounts =TRUE,colcount_format ="N=xx") %>%split_cols_by("colspan_trt",split_fun =trim_levels_to_map(map = colspan_trt_map) )if (combined_colspan_trt ==TRUE) { lyt <- lyt %>%split_cols_by(trtvar, split_fun = mysplit)} else { lyt <- lyt %>%split_cols_by(trtvar)}if (risk_diff ==TRUE) { lyt <- lyt %>%split_cols_by("rrisk_header", nested =FALSE) %>%split_cols_by( trtvar,labels_var ="rrisk_label",split_fun =remove_split_levels("Placebo") )}lyt <- lyt %>%analyze("TRTEMFL",afun = a_freq_j,show_labels ="hidden",extra_args =append( extra_args_rr,list(label ="Subjects with >=1 AE", NULL) ) ) %>%split_rows_by("AEBODSYS",split_label ="System Organ Class",split_fun =trim_levels_in_group("AEDECOD"),label_pos ="topleft",section_div =c(" "),nested =FALSE ) %>%summarize_row_groups("AEBODSYS",cfun = a_freq_j,extra_args =append(extra_args_rr, NULL) ) %>%analyze("AEDECOD",afun = a_freq_j,extra_args =append(extra_args_rr, NULL) ) %>%append_topleft(" Preferred Term, n (%)")result <-build_table(lyt, ae, alt_counts_df = adsl)# Post-Processing step to sort by descending count on chosen active treatment columns.if (length(adae$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() )}## Remove the N=xx column headers for the risk difference columnsresult <-remove_col_count(result)# If there is no data remove top row and display "No data to display" textif (length(adae$TRTEMFL) ==0) { result <-safe_prune_table( result,prune_func =remove_rows(removerowtext ="Subjects with >=1 AE") )}# 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 ="landscape")
TSFAE12:Subjects With Treatment-emergent Adverse Events Leading to [Dose Modification of Study Treatment] by System Organ Class and Preferred Term; Safety Analysis Set (Study jjcs - core)
Active Study Agent
Risk Difference (%) (95% CI)
System Organ Class
Xanomeline High Dose
Xanomeline Low Dose
Combined
Placebo
Xanomeline High Dose vs Placebo
Xanomeline Low Dose vs Placebo
Preferred Term, n (%)
N=53
N=73
N=126
N=59
Subjects with ≥1 AE
49 (92.5%)
53 (72.6%)
102 (81.0%)
39 (66.1%)
26.4 (12.3, 40.4)
6.5 (-9.3, 22.3)
Skin and subcutaneous tissue disorders
26 (49.1%)
23 (31.5%)
49 (38.9%)
12 (20.3%)
28.7 (11.8, 45.6)
11.2 (-3.6, 26.0)
PRURITUS
14 (26.4%)
12 (16.4%)
26 (20.6%)
4 (6.8%)
19.6 (6.1, 33.1)
9.7 (-1.0, 20.3)
ERYTHEMA
8 (15.1%)
6 (8.2%)
14 (11.1%)
5 (8.5%)
6.6 (-5.4, 18.6)
-0.3 (-9.8, 9.2)
HYPERHIDROSIS
7 (13.2%)
2 (2.7%)
9 (7.1%)
1 (1.7%)
11.5 (1.8, 21.2)
1.0 (-3.9, 6.0)
RASH
4 (7.5%)
5 (6.8%)
9 (7.1%)
3 (5.1%)
2.5 (-6.6, 11.5)
1.8 (-6.3, 9.8)
SKIN IRRITATION
1 (1.9%)
3 (4.1%)
4 (3.2%)
2 (3.4%)
-1.5 (-7.4, 4.4)
0.7 (-5.8, 7.2)
BLISTER
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
RASH PRURITIC
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
URTICARIA
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
RASH ERYTHEMATOUS
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
RASH MACULO-PAPULAR
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
General disorders and administration site conditions
23 (43.4%)
23 (31.5%)
46 (36.5%)
12 (20.3%)
23.1 (6.2, 39.9)
11.2 (-3.6, 26.0)
APPLICATION SITE PRURITUS
9 (17.0%)
11 (15.1%)
20 (15.9%)
4 (6.8%)
10.2 (-1.8, 22.2)
8.3 (-2.1, 18.7)
APPLICATION SITE ERYTHEMA
9 (17.0%)
6 (8.2%)
15 (11.9%)
0
17.0 (6.9, 27.1)
8.2 (1.9, 14.5)
APPLICATION SITE IRRITATION
8 (15.1%)
5 (6.8%)
13 (10.3%)
2 (3.4%)
11.7 (1.0, 22.4)
3.5 (-3.9, 10.9)
FATIGUE
4 (7.5%)
3 (4.1%)
7 (5.6%)
0
7.5 (0.4, 14.7)
4.1 (-0.4, 8.7)
APPLICATION SITE DERMATITIS
2 (3.8%)
4 (5.5%)
6 (4.8%)
3 (5.1%)
-1.3 (-8.9, 6.3)
0.4 (-7.3, 8.1)
APPLICATION SITE VESICLES
2 (3.8%)
3 (4.1%)
5 (4.0%)
0
3.8 (-1.4, 8.9)
4.1 (-0.4, 8.7)
MALAISE
2 (3.8%)
1 (1.4%)
3 (2.4%)
0
3.8 (-1.4, 8.9)
1.4 (-1.3, 4.0)
APPLICATION SITE PERSPIRATION
2 (3.8%)
0
2 (1.6%)
0
3.8 (-1.4, 8.9)
0.0 (0.0, 0.0)
APPLICATION SITE SWELLING
2 (3.8%)
0
2 (1.6%)
0
3.8 (-1.4, 8.9)
0.0 (0.0, 0.0)
APPLICATION SITE BLEEDING
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
APPLICATION SITE DESQUAMATION
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
CHEST PAIN
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
CHILLS
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
FEELING ABNORMAL
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
FEELING COLD
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
OEDEMA PERIPHERAL
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
-1.7 (-5.0, 1.6)
-0.3 (-4.6, 3.9)
PYREXIA
0
1 (1.4%)
1 (0.8%)
2 (3.4%)
-3.4 (-8.0, 1.2)
-2.0 (-7.4, 3.3)
SUDDEN DEATH
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
ASTHENIA
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Nervous system disorders
8 (15.1%)
10 (13.7%)
18 (14.3%)
4 (6.8%)
8.3 (-3.3, 19.9)
6.9 (-3.2, 17.1)
DIZZINESS
4 (7.5%)
4 (5.5%)
8 (6.3%)
0
7.5 (0.4, 14.7)
5.5 (0.3, 10.7)
HEADACHE
3 (5.7%)
2 (2.7%)
5 (4.0%)
2 (3.4%)
2.3 (-5.5, 10.0)
-0.7 (-6.6, 5.3)
TRANSIENT ISCHAEMIC ATTACK
0
2 (2.7%)
2 (1.6%)
0
0.0 (0.0, 0.0)
2.7 (-1.0, 6.5)
BALANCE DISORDER
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
BURNING SENSATION
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
HEMIANOPIA HOMONYMOUS
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
PARAESTHESIA ORAL
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
SOMNOLENCE
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
-1.7 (-5.0, 1.6)
-0.3 (-4.6, 3.9)
STUPOR
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
PSYCHOMOTOR HYPERACTIVITY
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Cardiac disorders
8 (15.1%)
9 (12.3%)
17 (13.5%)
6 (10.2%)
4.9 (-7.4, 17.3)
2.2 (-8.6, 12.9)
SINUS BRADYCARDIA
6 (11.3%)
1 (1.4%)
7 (5.6%)
0
11.3 (2.8, 19.9)
1.4 (-1.3, 4.0)
ATRIAL FIBRILLATION
0
2 (2.7%)
2 (1.6%)
0
0.0 (0.0, 0.0)
2.7 (-1.0, 6.5)
MYOCARDIAL INFARCTION
1 (1.9%)
1 (1.4%)
2 (1.6%)
3 (5.1%)
-3.2 (-9.9, 3.5)
-3.7 (-9.9, 2.5)
VENTRICULAR EXTRASYSTOLES
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
ATRIAL FLUTTER
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
BUNDLE BRANCH BLOCK RIGHT
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
-1.7 (-5.0, 1.6)
-0.3 (-4.6, 3.9)
PALPITATIONS
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
SUPRAVENTRICULAR EXTRASYSTOLES
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
-1.7 (-5.0, 1.6)
-0.3 (-4.6, 3.9)
SUPRAVENTRICULAR TACHYCARDIA
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
WOLFF-PARKINSON-WHITE SYNDROME
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
BUNDLE BRANCH BLOCK LEFT
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
SINUS ARRHYTHMIA
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
TACHYCARDIA
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Gastrointestinal disorders
9 (17.0%)
4 (5.5%)
13 (10.3%)
4 (6.8%)
10.2 (-1.8, 22.2)
-1.3 (-9.6, 7.0)
NAUSEA
3 (5.7%)
2 (2.7%)
5 (4.0%)
0
5.7 (-0.6, 11.9)
2.7 (-1.0, 6.5)
VOMITING
4 (7.5%)
0
4 (3.2%)
0
7.5 (0.4, 14.7)
0.0 (0.0, 0.0)
DIARRHOEA
2 (3.8%)
1 (1.4%)
3 (2.4%)
2 (3.4%)
0.4 (-6.5, 7.3)
-2.0 (-7.4, 3.3)
SALIVARY HYPERSECRETION
3 (5.7%)
0
3 (2.4%)
0
5.7 (-0.6, 11.9)
0.0 (0.0, 0.0)
ABDOMINAL PAIN
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
CONSTIPATION
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
DYSPEPSIA
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
GASTROOESOPHAGEAL REFLUX DISEASE
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Infections and infestations
5 (9.4%)
5 (6.8%)
10 (7.9%)
7 (11.9%)
-2.4 (-13.8, 9.0)
-5.0 (-15.1, 5.1)
NASOPHARYNGITIS
2 (3.8%)
2 (2.7%)
4 (3.2%)
1 (1.7%)
2.1 (-4.0, 8.2)
1.0 (-3.9, 6.0)
UPPER RESPIRATORY TRACT INFECTION
2 (3.8%)
0
2 (1.6%)
3 (5.1%)
-1.3 (-8.9, 6.3)
-5.1 (-10.7, 0.5)
CELLULITIS
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
HORDEOLUM
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
INFLUENZA
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
LOWER RESPIRATORY TRACT INFECTION
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
PNEUMONIA
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
BRONCHITIS
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
CERVICITIS
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
EAR INFECTION
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
GASTROENTERITIS VIRAL
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
URINARY TRACT INFECTION
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
VAGINAL MYCOSIS
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Psychiatric disorders
3 (5.7%)
6 (8.2%)
9 (7.1%)
4 (6.8%)
-1.1 (-10.1, 7.8)
1.4 (-7.6, 10.4)
CONFUSIONAL STATE
0
3 (4.1%)
3 (2.4%)
1 (1.7%)
-1.7 (-5.0, 1.6)
2.4 (-3.2, 8.0)
AGITATION
0
2 (2.7%)
2 (1.6%)
0
0.0 (0.0, 0.0)
2.7 (-1.0, 6.5)
DELUSION
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
0.2 (-4.7, 5.1)
-1.7 (-5.0, 1.6)
HALLUCINATION
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
HALLUCINATION, VISUAL
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
INSOMNIA
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
0.2 (-4.7, 5.1)
-1.7 (-5.0, 1.6)
RESTLESSNESS
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
DISTURBANCE IN SEXUAL AROUSAL
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Respiratory, thoracic and mediastinal disorders
4 (7.5%)
4 (5.5%)
8 (6.3%)
3 (5.1%)
2.5 (-6.6, 11.5)
0.4 (-7.3, 8.1)
COUGH
1 (1.9%)
4 (5.5%)
5 (4.0%)
1 (1.7%)
0.2 (-4.7, 5.1)
3.8 (-2.4, 10.0)
NASAL CONGESTION
2 (3.8%)
0
2 (1.6%)
1 (1.7%)
2.1 (-4.0, 8.2)
-1.7 (-5.0, 1.6)
PRODUCTIVE COUGH
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
RHINORRHOEA
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
EMPHYSEMA
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Injury, poisoning and procedural complications
2 (3.8%)
5 (6.8%)
7 (5.6%)
2 (3.4%)
0.4 (-6.5, 7.3)
3.5 (-3.9, 10.9)
EXCORIATION
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
FALL
1 (1.9%)
1 (1.4%)
2 (1.6%)
1 (1.7%)
0.2 (-4.7, 5.1)
-0.3 (-4.6, 3.9)
CONTUSION
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
FACIAL BONES FRACTURE
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
JOINT DISLOCATION
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
SKIN LACERATION
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
WOUND
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
HIP FRACTURE
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Investigations
3 (5.7%)
3 (4.1%)
6 (4.8%)
3 (5.1%)
0.6 (-7.8, 8.9)
-1.0 (-8.2, 6.2)
ELECTROCARDIOGRAM T WAVE INVERSION
1 (1.9%)
1 (1.4%)
2 (1.6%)
1 (1.7%)
0.2 (-4.7, 5.1)
-0.3 (-4.6, 3.9)
BIOPSY
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
BIOPSY PROSTATE
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
BODY TEMPERATURE INCREASED
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
NASAL MUCOSA BIOPSY
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
BLOOD ALKALINE PHOSPHATASE INCREASED
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Musculoskeletal and connective tissue disorders
3 (5.7%)
3 (4.1%)
6 (4.8%)
2 (3.4%)
2.3 (-5.5, 10.0)
0.7 (-5.8, 7.2)
BACK PAIN
2 (3.8%)
1 (1.4%)
3 (2.4%)
1 (1.7%)
2.1 (-4.0, 8.2)
-0.3 (-4.6, 3.9)
ARTHRALGIA
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
MUSCULAR WEAKNESS
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
MYALGIA
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
SHOULDER PAIN
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
-1.7 (-5.0, 1.6)
-0.3 (-4.6, 3.9)
Eye disorders
1 (1.9%)
2 (2.7%)
3 (2.4%)
2 (3.4%)
-1.5 (-7.4, 4.4)
-0.7 (-6.6, 5.3)
VISION BLURRED
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
CONJUNCTIVAL HAEMORRHAGE
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
CONJUNCTIVITIS
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
EYE ALLERGY
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Congenital, familial and genetic disorders
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
VENTRICULAR SEPTAL DEFECT
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
Ear and labyrinth disorders
0
2 (2.7%)
2 (1.6%)
0
0.0 (0.0, 0.0)
2.7 (-1.0, 6.5)
CERUMEN IMPACTION
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
VERTIGO
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Vascular disorders
0
2 (2.7%)
2 (1.6%)
2 (3.4%)
-3.4 (-8.0, 1.2)
-0.7 (-6.6, 5.3)
HOT FLUSH
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
HYPOTENSION
0
1 (1.4%)
1 (0.8%)
2 (3.4%)
-3.4 (-8.0, 1.2)
-2.0 (-7.4, 3.3)
ORTHOSTATIC HYPOTENSION
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Endocrine disorders
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
BLEEDING ANOVULATORY
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Metabolism and nutrition disorders
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
0.2 (-4.7, 5.1)
-1.7 (-5.0, 1.6)
INCREASED APPETITE
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
DEHYDRATION
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Renal and urinary disorders
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
-1.7 (-5.0, 1.6)
-0.3 (-4.6, 3.9)
DYSURIA
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
MICTURITION URGENCY
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Reproductive system and breast disorders
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
0.2 (-4.7, 5.1)
-1.7 (-5.0, 1.6)
BENIGN PROSTATIC HYPERPLASIA
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
PELVIC PAIN
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Surgical and medical procedures
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
EYE LASER SURGERY
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Note: Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event.
Note: Adverse events are coded using MedDRA version 26.0.