# Program Name: tsfae17c.R# Prep Environmentlibrary(envsetup)library(tern)library(dplyr)library(rtables)library(junco)# Define script level parameters:# - Define output ID and file locationtblid <-"TSFAE17c"fileid <- tblidtab_titles <-get_titles_from_file(input_path ='../../_data/', tblid)string_map <- default_str_maptrtvar <-"TRT01A"popfl <-"SAFFL"ocmqclass <-"Narrow"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::adaeocmq %>%filter(TRTEMFL =="Y"& OCMQCLSS == ocmqclass) %>%select(USUBJID, TRTEMFL, OCMQSOC, OCMQNAM, 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", " ", "TRT01A", "Placebo")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 %>%split_rows_by("OCMQSOC",split_label ="Organ System~[super a]",split_fun =trim_levels_in_group("OCMQNAM"),label_pos ="topleft",section_div =c(" "),nested =FALSE ) %>%summarize_row_groups("OCMQSOC",cfun = a_freq_j,extra_args =append(extra_args_rr, NULL) ) %>%split_rows_by("OCMQNAM",split_label =paste0("OCMQ (", ocmqclass, ")"),split_fun =trim_levels_in_group("AEDECOD"),label_pos ="topleft",nested =TRUE ) %>%summarize_row_groups("OCMQNAM",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)## Remove the N=xx column headers for the risk difference columnsresult <-remove_col_count(result)# If there is no data display "No data to display" textif (nrow(adae) ==0) { result <-safe_prune_table(result)}# Post-Processing step to sort by descending count on chosen active treatment columns.if (nrow(adae) !=0) { result <-sort_at_path( result,c("root", "OCMQSOC"),scorefun =jj_complex_scorefun() ) result <-sort_at_path( result,c("root", "OCMQSOC", "*", "OCMQNAM"),scorefun =jj_complex_scorefun() ) result <-sort_at_path( result,c("root", "OCMQSOC", "*", "OCMQNAM", "*", "AEDECOD"),scorefun =jj_complex_scorefun() )}# 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")
TSFAE17c:Subjects With Treatment-emergent Adverse Events by System Organ Class, FDA Medical Query (Narrow) and Preferred Term; Safety Analysis Set (Study jjcs - core)
Organ Systema
Active Study Agent
Risk Difference (%) (95% CI)
OCMQ (Narrow)
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
Skin and subcutaneous tissue disorders
39 (73.6%)
39 (53.4%)
78 (61.9%)
17 (28.8%)
44.8 (28.2, 61.3)
24.6 (8.3, 40.9)
Pruritus
36 (67.9%)
33 (45.2%)
69 (54.8%)
10 (16.9%)
51.0 (35.2, 66.8)
28.3 (13.4, 43.2)
PRURITUS
20 (37.7%)
14 (19.2%)
34 (27.0%)
6 (10.2%)
27.6 (12.4, 42.7)
9.0 (-2.9, 20.9)
APPLICATION SITE PRURITUS
13 (24.5%)
18 (24.7%)
31 (24.6%)
4 (6.8%)
17.7 (4.5, 31.0)
17.9 (6.1, 29.7)
RASH PRURITIC
2 (3.8%)
1 (1.4%)
3 (2.4%)
0
3.8 (-1.4, 8.9)
1.4 (-1.3, 4.0)
PRURITUS GENERALISED
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
EYE PRURITUS
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Erythema
21 (39.6%)
18 (24.7%)
39 (31.0%)
8 (13.6%)
26.1 (10.3, 41.9)
11.1 (-2.1, 24.3)
APPLICATION SITE ERYTHEMA
10 (18.9%)
11 (15.1%)
21 (16.7%)
2 (3.4%)
15.5 (4.0, 27.0)
11.7 (2.3, 21.1)
ERYTHEMA
12 (22.6%)
8 (11.0%)
20 (15.9%)
6 (10.2%)
12.5 (-1.2, 26.1)
0.8 (-9.7, 11.3)
RASH ERYTHEMATOUS
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Rash
14 (26.4%)
17 (23.3%)
31 (24.6%)
4 (6.8%)
19.6 (6.1, 33.1)
16.5 (4.9, 28.1)
RASH
5 (9.4%)
9 (12.3%)
14 (11.1%)
4 (6.8%)
2.7 (-7.5, 12.8)
5.5 (-4.4, 15.5)
APPLICATION SITE VESICLES
4 (7.5%)
4 (5.5%)
8 (6.3%)
0
7.5 (0.4, 14.7)
5.5 (0.3, 10.7)
BLISTER
1 (1.9%)
2 (2.7%)
3 (2.4%)
0
1.9 (-1.8, 5.5)
2.7 (-1.0, 6.5)
RASH PRURITIC
2 (3.8%)
1 (1.4%)
3 (2.4%)
0
3.8 (-1.4, 8.9)
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)
Urticaria
1 (1.9%)
2 (2.7%)
3 (2.4%)
0
1.9 (-1.8, 5.5)
2.7 (-1.0, 6.5)
APPLICATION SITE URTICARIA
0
2 (2.7%)
2 (1.6%)
0
0.0 (0.0, 0.0)
2.7 (-1.0, 6.5)
URTICARIA
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
Alopecia
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
ALOPECIA
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
General disorders and administration site conditions
20 (37.7%)
22 (30.1%)
42 (33.3%)
12 (20.3%)
17.4 (0.8, 34.0)
9.8 (-4.9, 24.5)
Dizziness
9 (17.0%)
10 (13.7%)
19 (15.1%)
0
17.0 (6.9, 27.1)
13.7 (5.8, 21.6)
DIZZINESS
8 (15.1%)
8 (11.0%)
16 (12.7%)
0
15.1 (5.5, 24.7)
11.0 (3.8, 18.1)
VERTIGO
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
BALANCE DISORDER
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Local Administration Reaction
7 (13.2%)
9 (12.3%)
16 (12.7%)
5 (8.5%)
4.7 (-6.8, 16.3)
3.9 (-6.5, 14.2)
APPLICATION SITE DERMATITIS
4 (7.5%)
7 (9.6%)
11 (8.7%)
5 (8.5%)
-0.9 (-11.0, 9.1)
1.1 (-8.7, 10.9)
APPLICATION SITE PAIN
2 (3.8%)
0
2 (1.6%)
0
3.8 (-1.4, 8.9)
0.0 (0.0, 0.0)
APPLICATION SITE URTICARIA
0
2 (2.7%)
2 (1.6%)
0
0.0 (0.0, 0.0)
2.7 (-1.0, 6.5)
APPLICATION SITE REACTION
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
0.2 (-4.7, 5.1)
-1.7 (-5.0, 1.6)
Fatigue
7 (13.2%)
6 (8.2%)
13 (10.3%)
1 (1.7%)
11.5 (1.8, 21.2)
6.5 (-0.6, 13.6)
FATIGUE
5 (9.4%)
5 (6.8%)
10 (7.9%)
0
9.4 (1.6, 17.3)
6.8 (1.1, 12.6)
MALAISE
2 (3.8%)
1 (1.4%)
3 (2.4%)
0
3.8 (-1.4, 8.9)
1.4 (-1.3, 4.0)
ASTHENIA
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
-1.7 (-5.0, 1.6)
-0.3 (-4.6, 3.9)
LETHARGY
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
LISTLESS
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
Fall
1 (1.9%)
2 (2.7%)
3 (2.4%)
1 (1.7%)
0.2 (-4.7, 5.1)
1.0 (-3.9, 6.0)
FALL
1 (1.9%)
2 (2.7%)
3 (2.4%)
1 (1.7%)
0.2 (-4.7, 5.1)
1.0 (-3.9, 6.0)
Peripheral Edema
1 (1.9%)
1 (1.4%)
2 (1.6%)
2 (3.4%)
-1.5 (-7.4, 4.4)
-2.0 (-7.4, 3.3)
OEDEMA PERIPHERAL
1 (1.9%)
1 (1.4%)
2 (1.6%)
2 (3.4%)
-1.5 (-7.4, 4.4)
-2.0 (-7.4, 3.3)
Pyrexia
0
2 (2.7%)
2 (1.6%)
2 (3.4%)
-3.4 (-8.0, 1.2)
-0.7 (-6.6, 5.3)
BODY TEMPERATURE INCREASED
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
PYREXIA
0
1 (1.4%)
1 (0.8%)
2 (3.4%)
-3.4 (-8.0, 1.2)
-2.0 (-7.4, 3.3)
Decreased Appetite
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
DECREASED APPETITE
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Volume Depletion
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
DEHYDRATION
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Nervous system disorders
12 (22.6%)
14 (19.2%)
26 (20.6%)
5 (8.5%)
14.2 (0.8, 27.5)
10.7 (-0.8, 22.2)
Headache
5 (9.4%)
3 (4.1%)
8 (6.3%)
2 (3.4%)
6.0 (-3.1, 15.2)
0.7 (-5.8, 7.2)
HEADACHE
5 (9.4%)
3 (4.1%)
8 (6.3%)
2 (3.4%)
6.0 (-3.1, 15.2)
0.7 (-5.8, 7.2)
Somnolence
2 (3.8%)
4 (5.5%)
6 (4.8%)
1 (1.7%)
2.1 (-4.0, 8.2)
3.8 (-2.4, 10.0)
SOMNOLENCE
1 (1.9%)
2 (2.7%)
3 (2.4%)
1 (1.7%)
0.2 (-4.7, 5.1)
1.0 (-3.9, 6.0)
HYPERSOMNIA
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
LETHARGY
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
STUPOR
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Confusional State
2 (3.8%)
3 (4.1%)
5 (4.0%)
3 (5.1%)
-1.3 (-8.9, 6.3)
-1.0 (-8.2, 6.2)
CONFUSIONAL STATE
1 (1.9%)
3 (4.1%)
4 (3.2%)
2 (3.4%)
-1.5 (-7.4, 4.4)
0.7 (-5.8, 7.2)
DELIRIUM
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
DISORIENTATION
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Syncope
2 (3.8%)
3 (4.1%)
5 (4.0%)
0
3.8 (-1.4, 8.9)
4.1 (-0.4, 8.7)
SYNCOPE
1 (1.9%)
3 (4.1%)
4 (3.2%)
0
1.9 (-1.8, 5.5)
4.1 (-0.4, 8.7)
SYNCOPE VASOVAGAL
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
Paresthesia
2 (3.8%)
1 (1.4%)
3 (2.4%)
0
3.8 (-1.4, 8.9)
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)
PARAESTHESIA
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
PARAESTHESIA ORAL
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Stroke and TIA
1 (1.9%)
2 (2.7%)
3 (2.4%)
0
1.9 (-1.8, 5.5)
2.7 (-1.0, 6.5)
TRANSIENT ISCHAEMIC ATTACK
1 (1.9%)
2 (2.7%)
3 (2.4%)
0
1.9 (-1.8, 5.5)
2.7 (-1.0, 6.5)
Seizure
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
COMPLEX PARTIAL SEIZURES
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
PARTIAL SEIZURES WITH SECONDARY GENERALISATION
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
Cardiac disorders
11 (20.8%)
12 (16.4%)
23 (18.3%)
8 (13.6%)
7.2 (-6.8, 21.2)
2.9 (-9.3, 15.1)
Arrhythmia
9 (17.0%)
9 (12.3%)
18 (14.3%)
3 (5.1%)
11.9 (0.3, 23.5)
7.2 (-2.2, 16.6)
SINUS BRADYCARDIA
7 (13.2%)
4 (5.5%)
11 (8.7%)
0
13.2 (4.1, 22.3)
5.5 (0.3, 10.7)
ATRIAL FIBRILLATION
1 (1.9%)
2 (2.7%)
3 (2.4%)
0
1.9 (-1.8, 5.5)
2.7 (-1.0, 6.5)
VENTRICULAR EXTRASYSTOLES
1 (1.9%)
2 (2.7%)
3 (2.4%)
0
1.9 (-1.8, 5.5)
2.7 (-1.0, 6.5)
ATRIAL FLUTTER
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
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)
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)
Acute Coronary Syndrome
3 (5.7%)
1 (1.4%)
4 (3.2%)
3 (5.1%)
0.6 (-7.8, 8.9)
-3.7 (-9.9, 2.5)
MYOCARDIAL INFARCTION
3 (5.7%)
1 (1.4%)
4 (3.2%)
3 (5.1%)
0.6 (-7.8, 8.9)
-3.7 (-9.9, 2.5)
Myocardial Infarction
3 (5.7%)
1 (1.4%)
4 (3.2%)
3 (5.1%)
0.6 (-7.8, 8.9)
-3.7 (-9.9, 2.5)
MYOCARDIAL INFARCTION
3 (5.7%)
1 (1.4%)
4 (3.2%)
3 (5.1%)
0.6 (-7.8, 8.9)
-3.7 (-9.9, 2.5)
Myocardial Ischemia
3 (5.7%)
1 (1.4%)
4 (3.2%)
3 (5.1%)
0.6 (-7.8, 8.9)
-3.7 (-9.9, 2.5)
MYOCARDIAL INFARCTION
3 (5.7%)
1 (1.4%)
4 (3.2%)
3 (5.1%)
0.6 (-7.8, 8.9)
-3.7 (-9.9, 2.5)
Cardiac Conduction Disturbance
0
3 (4.1%)
3 (2.4%)
3 (5.1%)
-5.1 (-10.7, 0.5)
-1.0 (-8.2, 6.2)
ATRIOVENTRICULAR BLOCK FIRST DEGREE
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
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)
WOLFF-PARKINSON-WHITE SYNDROME
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
ATRIOVENTRICULAR BLOCK SECOND DEGREE
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
BUNDLE BRANCH BLOCK LEFT
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Palpitations
0
2 (2.7%)
2 (1.6%)
0
0.0 (0.0, 0.0)
2.7 (-1.0, 6.5)
PALPITATIONS
0
2 (2.7%)
2 (1.6%)
0
0.0 (0.0, 0.0)
2.7 (-1.0, 6.5)
Systemic Hypertension
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
-1.7 (-5.0, 1.6)
-0.3 (-4.6, 3.9)
HYPERTENSION
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
-1.7 (-5.0, 1.6)
-0.3 (-4.6, 3.9)
Tachycardia
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)
TACHYCARDIA
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Gastrointestinal disorders
11 (20.8%)
9 (12.3%)
20 (15.9%)
5 (8.5%)
12.3 (-0.7, 25.3)
3.9 (-6.5, 14.2)
Nausea
5 (9.4%)
2 (2.7%)
7 (5.6%)
0
9.4 (1.6, 17.3)
2.7 (-1.0, 6.5)
NAUSEA
5 (9.4%)
2 (2.7%)
7 (5.6%)
0
9.4 (1.6, 17.3)
2.7 (-1.0, 6.5)
Vomiting
5 (9.4%)
2 (2.7%)
7 (5.6%)
0
9.4 (1.6, 17.3)
2.7 (-1.0, 6.5)
VOMITING
5 (9.4%)
2 (2.7%)
7 (5.6%)
0
9.4 (1.6, 17.3)
2.7 (-1.0, 6.5)
Diarrhea
2 (3.8%)
3 (4.1%)
5 (4.0%)
3 (5.1%)
-1.3 (-8.9, 6.3)
-1.0 (-8.2, 6.2)
DIARRHOEA
2 (3.8%)
3 (4.1%)
5 (4.0%)
3 (5.1%)
-1.3 (-8.9, 6.3)
-1.0 (-8.2, 6.2)
Abdominal Pain
2 (3.8%)
2 (2.7%)
4 (3.2%)
1 (1.7%)
2.1 (-4.0, 8.2)
1.0 (-3.9, 6.0)
ABDOMINAL PAIN
0
2 (2.7%)
2 (1.6%)
1 (1.7%)
-1.7 (-5.0, 1.6)
1.0 (-3.9, 6.0)
ABDOMINAL DISCOMFORT
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
STOMACH DISCOMFORT
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
Dyspepsia
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
-1.7 (-5.0, 1.6)
-0.3 (-4.6, 3.9)
DYSPEPSIA
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
-1.7 (-5.0, 1.6)
-0.3 (-4.6, 3.9)
Constipation
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
CONSTIPATION
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Vascular disorders
7 (13.2%)
8 (11.0%)
15 (11.9%)
4 (6.8%)
6.4 (-4.7, 17.6)
4.2 (-5.4, 13.8)
Hemorrhage
3 (5.7%)
4 (5.5%)
7 (5.6%)
1 (1.7%)
4.0 (-3.1, 11.0)
3.8 (-2.4, 10.0)
CONTUSION
2 (3.8%)
1 (1.4%)
3 (2.4%)
0
3.8 (-1.4, 8.9)
1.4 (-1.3, 4.0)
EPISTAXIS
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)
CONJUNCTIVAL HAEMORRHAGE
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
RECTAL HAEMORRHAGE
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
BLOOD URINE PRESENT
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Thrombosis
4 (7.5%)
3 (4.1%)
7 (5.6%)
3 (5.1%)
2.5 (-6.6, 11.5)
-1.0 (-8.2, 6.2)
MYOCARDIAL INFARCTION
3 (5.7%)
1 (1.4%)
4 (3.2%)
3 (5.1%)
0.6 (-7.8, 8.9)
-3.7 (-9.9, 2.5)
TRANSIENT ISCHAEMIC ATTACK
1 (1.9%)
2 (2.7%)
3 (2.4%)
0
1.9 (-1.8, 5.5)
2.7 (-1.0, 6.5)
Thrombosis Arterial
4 (7.5%)
3 (4.1%)
7 (5.6%)
3 (5.1%)
2.5 (-6.6, 11.5)
-1.0 (-8.2, 6.2)
MYOCARDIAL INFARCTION
3 (5.7%)
1 (1.4%)
4 (3.2%)
3 (5.1%)
0.6 (-7.8, 8.9)
-3.7 (-9.9, 2.5)
TRANSIENT ISCHAEMIC ATTACK
1 (1.9%)
2 (2.7%)
3 (2.4%)
0
1.9 (-1.8, 5.5)
2.7 (-1.0, 6.5)
Hypotension
0
1 (1.4%)
1 (0.8%)
2 (3.4%)
-3.4 (-8.0, 1.2)
-2.0 (-7.4, 3.3)
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)
Infections and infestations
8 (15.1%)
6 (8.2%)
14 (11.1%)
10 (16.9%)
-1.9 (-15.4, 11.7)
-8.7 (-20.2, 2.7)
Nasopharyngitis
6 (11.3%)
3 (4.1%)
9 (7.1%)
7 (11.9%)
-0.5 (-12.4, 11.3)
-7.8 (-17.2, 1.7)
NASOPHARYNGITIS
3 (5.7%)
3 (4.1%)
6 (4.8%)
2 (3.4%)
2.3 (-5.5, 10.0)
0.7 (-5.8, 7.2)
UPPER RESPIRATORY TRACT INFECTION
2 (3.8%)
0
2 (1.6%)
5 (8.5%)
-4.7 (-13.5, 4.1)
-8.5 (-15.6, -1.4)
RHINITIS
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
Bacterial Infection
2 (3.8%)
1 (1.4%)
3 (2.4%)
2 (3.4%)
0.4 (-6.5, 7.3)
-2.0 (-7.4, 3.3)
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)
URINARY TRACT INFECTION
1 (1.9%)
0
1 (0.8%)
2 (3.4%)
-1.5 (-7.4, 4.4)
-3.4 (-8.0, 1.2)
Viral Infection
1 (1.9%)
1 (1.4%)
2 (1.6%)
2 (3.4%)
-1.5 (-7.4, 4.4)
-2.0 (-7.4, 3.3)
INFLUENZA
1 (1.9%)
1 (1.4%)
2 (1.6%)
1 (1.7%)
0.2 (-4.7, 5.1)
-0.3 (-4.6, 3.9)
GASTROENTERITIS VIRAL
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Pneumonia
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
PNEUMONIA
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Psychiatric disorders
5 (9.4%)
7 (9.6%)
12 (9.5%)
4 (6.8%)
2.7 (-7.5, 12.8)
2.8 (-6.5, 12.1)
Study Agent Abuse Potential
1 (1.9%)
3 (4.1%)
4 (3.2%)
1 (1.7%)
0.2 (-4.7, 5.1)
2.4 (-3.2, 8.0)
SOMNOLENCE
1 (1.9%)
2 (2.7%)
3 (2.4%)
1 (1.7%)
0.2 (-4.7, 5.1)
1.0 (-3.9, 6.0)
STUPOR
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Irritability
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%)
1 (1.7%)
-1.7 (-5.0, 1.6)
1.0 (-3.9, 6.0)
IRRITABILITY
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Psychosis
2 (3.8%)
0
2 (1.6%)
1 (1.7%)
2.1 (-4.0, 8.2)
-1.7 (-5.0, 1.6)
DELUSION
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
0.2 (-4.7, 5.1)
-1.7 (-5.0, 1.6)
HALLUCINATION, VISUAL
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
Anxiety
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
ANXIETY
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Depression
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
DEPRESSED MOOD
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Insomnia
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
0.2 (-4.7, 5.1)
-1.7 (-5.0, 1.6)
INSOMNIA
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
0.2 (-4.7, 5.1)
-1.7 (-5.0, 1.6)
Parasomnia
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
NIGHTMARE
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
Respiratory, thoracic and mediastinal disorders
4 (7.5%)
5 (6.8%)
9 (7.1%)
1 (1.7%)
5.9 (-2.0, 13.7)
5.2 (-1.5, 11.8)
Cough
4 (7.5%)
4 (5.5%)
8 (6.3%)
1 (1.7%)
5.9 (-2.0, 13.7)
3.8 (-2.4, 10.0)
COUGH
3 (5.7%)
4 (5.5%)
7 (5.6%)
1 (1.7%)
4.0 (-3.1, 11.0)
3.8 (-2.4, 10.0)
PRODUCTIVE COUGH
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
Dyspnea
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
DYSPNOEA
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Musculoskeletal and connective tissue disorders
5 (9.4%)
2 (2.7%)
7 (5.6%)
2 (3.4%)
6.0 (-3.1, 15.2)
-0.7 (-6.6, 5.3)
Back Pain
3 (5.7%)
1 (1.4%)
4 (3.2%)
1 (1.7%)
4.0 (-3.1, 11.0)
-0.3 (-4.6, 3.9)
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)
FLANK PAIN
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
Arthralgia
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
ARTHRALGIA
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
Fracture
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
0.2 (-4.7, 5.1)
-1.7 (-5.0, 1.6)
FACIAL BONES FRACTURE
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
HIP FRACTURE
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Myalgia
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
MYALGIA
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
Osteoporosis
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
HIP FRACTURE
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Reproductive system and breast disorders
3 (5.7%)
0
3 (2.4%)
2 (3.4%)
2.3 (-5.5, 10.0)
-3.4 (-8.0, 1.2)
Sexual Dysfunction
2 (3.8%)
0
2 (1.6%)
2 (3.4%)
0.4 (-6.5, 7.3)
-3.4 (-8.0, 1.2)
ERECTILE DYSFUNCTION
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
0.2 (-4.7, 5.1)
-1.7 (-5.0, 1.6)
LIBIDO DECREASED
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
DISTURBANCE IN SEXUAL AROUSAL
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Abnormal Uterine Bleeding
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
ABNORMAL UTERINE BLEEDING
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
Erectile Dysfunction
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
0.2 (-4.7, 5.1)
-1.7 (-5.0, 1.6)
ERECTILE DYSFUNCTION
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
0.2 (-4.7, 5.1)
-1.7 (-5.0, 1.6)
Excessive Menstrual Bleeding
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
ABNORMAL UTERINE BLEEDING
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
Ear and labyrinth disorders
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
Vertigo
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
VERTIGO
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
Endocrine disorders
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
Hyperglycemia
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
BLOOD GLUCOSE INCREASED
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
Malignancy
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
COLON CANCER
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
PROSTATE CANCER
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
Metabolism and nutrition disorders
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
Lipid Disorder
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
BLOOD CHOLESTEROL INCREASED
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
Renal and urinary disorders
1 (1.9%)
0
1 (0.8%)
2 (3.4%)
-1.5 (-7.4, 4.4)
-3.4 (-8.0, 1.2)
Renal & Urinary Tract Infection
1 (1.9%)
0
1 (0.8%)
2 (3.4%)
-1.5 (-7.4, 4.4)
-3.4 (-8.0, 1.2)
URINARY TRACT INFECTION
1 (1.9%)
0
1 (0.8%)
2 (3.4%)
-1.5 (-7.4, 4.4)
-3.4 (-8.0, 1.2)
Immune system disorders
0
0
0
2 (3.4%)
-3.4 (-8.0, 1.2)
-3.4 (-8.0, 1.2)
Hypersensitivity
0
0
0
2 (3.4%)
-3.4 (-8.0, 1.2)
-3.4 (-8.0, 1.2)
DRUG ERUPTION
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)
Key: FMQ=FDA Medical Query
a Each FMQ is aligned to a single system organ class based on clinical judgment, as defined by FDA. However, some FMQs may contain preferred terms from more than one system organ class. Preferred terms that are not included in any FMQ are not summarized.
Note: Adverse events are coded using MedDRA version 26.0.