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 	Active Study Agent 	Active Study Agent 	 	Risk Difference (%) (95% CI) 	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 	
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.