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 	Active Study Agent 	Active Study Agent 	 	Risk Difference (%) (95% CI) 	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 	
Key: FMQ=FDA Medical Query	
Key: FMQ=FDA Medical Query	
Key: FMQ=FDA Medical Query	
Key: FMQ=FDA Medical Query	
Key: FMQ=FDA Medical Query	
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. 	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.	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.	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.	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.	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.	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. 	: Adverse events are coded using MedDRA version 26.	: Adverse events are coded using MedDRA version 26.	: Adverse events are coded using MedDRA version 26.	: Adverse events are coded using MedDRA version 26.	: Adverse events are coded using MedDRA version 26.	: Adverse events are coded using MedDRA version 26.