# Program Name: tsfae17d.R# Prep Environmentlibrary(envsetup)library(tern)library(dplyr)library(rtables)library(junco)# Define script level parameters:# - Define output ID and file locationtblid <-"TSFAE17d"fileid <- tblidtab_titles <-get_titles_from_file(input_path ='../../_data/', tblid)string_map <- default_str_maptrtvar <-"TRT01A"popfl <-"SAFFL"ocmqclass <-"Broad"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")
TSFAE17d:Subjects With Treatment-emergent Adverse Events by System Organ Class, FDA Medical Query (Broad) and Preferred Term; Safety Analysis Set (Study jjcs - core)
Organ Systema
Active Study Agent
Risk Difference (%) (95% CI)
OCMQ (Broad)
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
Immune system disorders
42 (79.2%)
38 (52.1%)
80 (63.5%)
19 (32.2%)
47.0 (30.9, 63.2)
19.9 (3.3, 36.4)
Hypersensitivity
41 (77.4%)
38 (52.1%)
79 (62.7%)
19 (32.2%)
45.2 (28.8, 61.6)
19.9 (3.3, 36.4)
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)
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
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 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)
RASH PRURITIC
2 (3.8%)
1 (1.4%)
3 (2.4%)
0
3.8 (-1.4, 8.9)
1.4 (-1.3, 4.0)
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)
OEDEMA
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
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)
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)
EYE SWELLING
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Angioedema
1 (1.9%)
0
1 (0.8%)
2 (3.4%)
-1.5 (-7.4, 4.4)
-3.4 (-8.0, 1.2)
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)
EYE SWELLING
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Skin and subcutaneous tissue disorders
24 (45.3%)
22 (30.1%)
46 (36.5%)
12 (20.3%)
24.9 (8.1, 41.8)
9.8 (-4.9, 24.5)
Rash
16 (30.2%)
12 (16.4%)
28 (22.2%)
8 (13.6%)
16.6 (1.5, 31.8)
2.9 (-9.3, 15.1)
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)
SKIN IRRITATION
4 (7.5%)
4 (5.5%)
8 (6.3%)
3 (5.1%)
2.5 (-6.6, 11.5)
0.4 (-7.3, 8.1)
Urticaria
9 (17.0%)
11 (15.1%)
20 (15.9%)
5 (8.5%)
8.5 (-3.8, 20.9)
6.6 (-4.3, 17.4)
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)
RASH PRURITIC
2 (3.8%)
1 (1.4%)
3 (2.4%)
0
3.8 (-1.4, 8.9)
1.4 (-1.3, 4.0)
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)
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)
DRUG ERUPTION
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Erythema
4 (7.5%)
4 (5.5%)
8 (6.3%)
3 (5.1%)
2.5 (-6.6, 11.5)
0.4 (-7.3, 8.1)
SKIN IRRITATION
4 (7.5%)
4 (5.5%)
8 (6.3%)
3 (5.1%)
2.5 (-6.6, 11.5)
0.4 (-7.3, 8.1)
Pruritus
4 (7.5%)
4 (5.5%)
8 (6.3%)
3 (5.1%)
2.5 (-6.6, 11.5)
0.4 (-7.3, 8.1)
SKIN IRRITATION
4 (7.5%)
4 (5.5%)
8 (6.3%)
3 (5.1%)
2.5 (-6.6, 11.5)
0.4 (-7.3, 8.1)
Nervous system disorders
15 (28.3%)
15 (20.5%)
30 (23.8%)
3 (5.1%)
23.2 (9.9, 36.6)
15.5 (4.6, 26.3)
Syncope
8 (15.1%)
8 (11.0%)
16 (12.7%)
2 (3.4%)
11.7 (1.0, 22.4)
7.6 (-1.0, 16.1)
DIZZINESS
8 (15.1%)
8 (11.0%)
16 (12.7%)
0
15.1 (5.5, 24.7)
11.0 (3.8, 18.1)
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)
Somnolence
5 (9.4%)
5 (6.8%)
10 (7.9%)
0
9.4 (1.6, 17.3)
6.8 (1.1, 12.6)
FATIGUE
5 (9.4%)
5 (6.8%)
10 (7.9%)
0
9.4 (1.6, 17.3)
6.8 (1.1, 12.6)
Confusional State
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)
Dysgeusia
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
PAROSMIA
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
Stroke and TIA
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
HEMIANOPIA HOMONYMOUS
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
General disorders and administration site conditions
11 (20.8%)
15 (20.5%)
26 (20.6%)
3 (5.1%)
15.7 (3.4, 27.9)
15.5 (4.6, 26.3)
Fall
10 (18.9%)
12 (16.4%)
22 (17.5%)
2 (3.4%)
15.5 (4.0, 27.0)
13.0 (3.4, 22.7)
DIZZINESS
8 (15.1%)
8 (11.0%)
16 (12.7%)
0
15.1 (5.5, 24.7)
11.0 (3.8, 18.1)
SYNCOPE
1 (1.9%)
3 (4.1%)
4 (3.2%)
0
1.9 (-1.8, 5.5)
4.1 (-0.4, 8.7)
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)
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)
Fatigue
2 (3.8%)
2 (2.7%)
4 (3.2%)
1 (1.7%)
2.1 (-4.0, 8.2)
1.0 (-3.9, 6.0)
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)
Peripheral Edema
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
OEDEMA
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Pyrexia
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)
Cardiac disorders
10 (18.9%)
14 (19.2%)
24 (19.0%)
7 (11.9%)
7.0 (-6.4, 20.4)
7.3 (-4.9, 19.5)
Arrhythmia
9 (17.0%)
11 (15.1%)
20 (15.9%)
0
17.0 (6.9, 27.1)
15.1 (6.9, 23.3)
DIZZINESS
8 (15.1%)
8 (11.0%)
16 (12.7%)
0
15.1 (5.5, 24.7)
11.0 (3.8, 18.1)
SYNCOPE
1 (1.9%)
3 (4.1%)
4 (3.2%)
0
1.9 (-1.8, 5.5)
4.1 (-0.4, 8.7)
PALPITATIONS
0
2 (2.7%)
2 (1.6%)
0
0.0 (0.0, 0.0)
2.7 (-1.0, 6.5)
SYNCOPE VASOVAGAL
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
WOLFF-PARKINSON-WHITE SYNDROME
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Heart Failure
1 (1.9%)
3 (4.1%)
4 (3.2%)
2 (3.4%)
-1.5 (-7.4, 4.4)
0.7 (-5.8, 7.2)
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)
DYSPNOEA
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
OEDEMA
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Myocardial Ischemia
1 (1.9%)
3 (4.1%)
4 (3.2%)
4 (6.8%)
-4.9 (-12.3, 2.5)
-2.7 (-10.5, 5.2)
ELECTROCARDIOGRAM T WAVE INVERSION
1 (1.9%)
1 (1.4%)
2 (1.6%)
2 (3.4%)
-1.5 (-7.4, 4.4)
-2.0 (-7.4, 3.3)
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION
0
1 (1.4%)
1 (0.8%)
3 (5.1%)
-5.1 (-10.7, 0.5)
-3.7 (-9.9, 2.5)
SUDDEN DEATH
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Acute Coronary Syndrome
0
1 (1.4%)
1 (0.8%)
4 (6.8%)
-6.8 (-13.2, -0.4)
-5.4 (-12.4, 1.5)
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION
0
1 (1.4%)
1 (0.8%)
3 (5.1%)
-5.1 (-10.7, 0.5)
-3.7 (-9.9, 2.5)
BLOOD CREATINE PHOSPHOKINASE INCREASED
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Myocardial Infarction
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
SUDDEN DEATH
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Ear and labyrinth disorders
8 (15.1%)
9 (12.3%)
17 (13.5%)
0
15.1 (5.5, 24.7)
12.3 (4.8, 19.9)
Vertigo
8 (15.1%)
9 (12.3%)
17 (13.5%)
0
15.1 (5.5, 24.7)
12.3 (4.8, 19.9)
DIZZINESS
8 (15.1%)
8 (11.0%)
16 (12.7%)
0
15.1 (5.5, 24.7)
11.0 (3.8, 18.1)
BALANCE DISORDER
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Gastrointestinal disorders
12 (22.6%)
4 (5.5%)
16 (12.7%)
1 (1.7%)
20.9 (9.2, 32.7)
3.8 (-2.4, 10.0)
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%)
1 (1.7%)
7.7 (-0.8, 16.3)
1.0 (-3.9, 6.0)
NAUSEA
5 (9.4%)
2 (2.7%)
7 (5.6%)
0
9.4 (1.6, 17.3)
2.7 (-1.0, 6.5)
GASTROENTERITIS VIRAL
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Dyspepsia
5 (9.4%)
1 (1.4%)
6 (4.8%)
1 (1.7%)
7.7 (-0.8, 16.3)
-0.3 (-4.6, 3.9)
CHEST DISCOMFORT
1 (1.9%)
1 (1.4%)
2 (1.6%)
0
1.9 (-1.8, 5.5)
1.4 (-1.3, 4.0)
CHEST PAIN
2 (3.8%)
0
2 (1.6%)
0
3.8 (-1.4, 8.9)
0.0 (0.0, 0.0)
ABDOMINAL DISCOMFORT
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
BURNING SENSATION
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
GASTROOESOPHAGEAL REFLUX DISEASE
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Diarrhea
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)
Psychiatric disorders
6 (11.3%)
4 (5.5%)
10 (7.9%)
2 (3.4%)
7.9 (-1.8, 17.6)
2.1 (-4.9, 9.1)
Anxiety
1 (1.9%)
4 (5.5%)
5 (4.0%)
1 (1.7%)
0.2 (-4.7, 5.1)
3.8 (-2.4, 10.0)
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)
NIGHTMARE
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
RESTLESSNESS
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Mania
0
3 (4.1%)
3 (2.4%)
2 (3.4%)
-3.4 (-8.0, 1.2)
0.7 (-5.8, 7.2)
AGITATION
0
2 (2.7%)
2 (1.6%)
1 (1.7%)
-1.7 (-5.0, 1.6)
1.0 (-3.9, 6.0)
RESTLESSNESS
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)
Psychosis
3 (5.7%)
0
3 (2.4%)
0
5.7 (-0.6, 11.9)
0.0 (0.0, 0.0)
DELIRIUM
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
HALLUCINATION
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)
Study Agent Abuse Potential
3 (5.7%)
0
3 (2.4%)
1 (1.7%)
4.0 (-3.1, 11.0)
-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)
HYPERSOMNIA
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
PSYCHOMOTOR HYPERACTIVITY
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Infections and infestations
4 (7.5%)
2 (2.7%)
6 (4.8%)
10 (16.9%)
-9.4 (-21.3, 2.5)
-14.2 (-24.5, -3.9)
Viral Infection
3 (5.7%)
1 (1.4%)
4 (3.2%)
6 (10.2%)
-4.5 (-14.4, 5.4)
-8.8 (-17.0, -0.6)
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)
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)
CONJUNCTIVITIS
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Pneumonia
2 (3.8%)
1 (1.4%)
3 (2.4%)
1 (1.7%)
2.1 (-4.0, 8.2)
-0.3 (-4.6, 3.9)
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)
LOWER RESPIRATORY TRACT INFECTION
1 (1.9%)
0
1 (0.8%)
0
1.9 (-1.8, 5.5)
0.0 (0.0, 0.0)
Bacterial Infection
1 (1.9%)
1 (1.4%)
2 (1.6%)
3 (5.1%)
-3.2 (-9.9, 3.5)
-3.7 (-9.9, 2.5)
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)
CERVICITIS
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
EAR INFECTION
0
0
0
2 (3.4%)
-3.4 (-8.0, 1.2)
-3.4 (-8.0, 1.2)
Renal and urinary disorders
1 (1.9%)
3 (4.1%)
4 (3.2%)
3 (5.1%)
-3.2 (-9.9, 3.5)
-1.0 (-8.2, 6.2)
Urinary Retention
1 (1.9%)
3 (4.1%)
4 (3.2%)
3 (5.1%)
-3.2 (-9.9, 3.5)
-1.0 (-8.2, 6.2)
BENIGN PROSTATIC HYPERPLASIA
1 (1.9%)
0
1 (0.8%)
1 (1.7%)
0.2 (-4.7, 5.1)
-1.7 (-5.0, 1.6)
DYSURIA
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
-1.7 (-5.0, 1.6)
-0.3 (-4.6, 3.9)
INCONTINENCE
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
MICTURITION URGENCY
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
-1.7 (-5.0, 1.6)
-0.3 (-4.6, 3.9)
Renal & Urinary Tract Infection
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%)
1 (1.7%)
-1.7 (-5.0, 1.6)
-0.3 (-4.6, 3.9)
Musculoskeletal and connective tissue disorders
1 (1.9%)
2 (2.7%)
3 (2.4%)
1 (1.7%)
0.2 (-4.7, 5.1)
1.0 (-3.9, 6.0)
Arthritis
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)
Myalgia
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
MUSCLE SPASMS
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Muscle Injury
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
BLOOD CREATINE PHOSPHOKINASE INCREASED
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Metabolism and nutrition disorders
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Cachexia
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
WEIGHT DECREASED
0
1 (1.4%)
1 (0.8%)
0
0.0 (0.0, 0.0)
1.4 (-1.3, 4.0)
Reproductive system and breast disorders
0
1 (1.4%)
1 (0.8%)
3 (5.1%)
-5.1 (-10.7, 0.5)
-3.7 (-9.9, 2.5)
Abnormal Uterine Bleeding
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
-1.7 (-5.0, 1.6)
-0.3 (-4.6, 3.9)
BLEEDING ANOVULATORY
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
-1.7 (-5.0, 1.6)
-0.3 (-4.6, 3.9)
Erectile Dysfunction
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
DISTURBANCE IN SEXUAL AROUSAL
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Sexual Dysfunction
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
PELVIC PAIN
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Respiratory, thoracic and mediastinal disorders
0
1 (1.4%)
1 (0.8%)
1 (1.7%)
-1.7 (-5.0, 1.6)
-0.3 (-4.6, 3.9)
Bronchospasm
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)
Respiratory Failure
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)
Cough
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
POSTNASAL DRIP
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Eye disorders
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Glaucoma
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
EYE SWELLING
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Hepatobiliary disorders
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Hepatic Injury
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
BLOOD ALKALINE PHOSPHATASE INCREASED
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Vascular disorders
0
0
0
1 (1.7%)
-1.7 (-5.0, 1.6)
-1.7 (-5.0, 1.6)
Hypotension
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)
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.