TSFAE17a:	Subjects With Treatment-emergent Serious 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 	34 (64.2%) 	28 (38.4%) 	62 (49.2%) 	11 (18.6%) 	45.5 (29.2, 61.8) 	19.7 (4.8, 34.7) 	
Pruritus 	24 (45.3%) 	21 (28.8%) 	45 (35.7%) 	6 (10.2%) 	35.1 (19.7, 50.6) 	18.6 (5.7, 31.5) 	
PRURITUS 	12 (22.6%) 	10 (13.7%) 	22 (17.5%) 	3 (5.1%) 	17.6 (5.0, 30.1) 	8.6 (-1.1, 18.3) 	
APPLICATION SITE PRURITUS 	9 (17.0%) 	10 (13.7%) 	19 (15.1%) 	3 (5.1%) 	11.9 (0.3, 23.5) 	8.6 (-1.1, 18.3) 	
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 	16 (30.2%) 	14 (19.2%) 	30 (23.8%) 	5 (8.5%) 	21.7 (7.5, 36.0) 	10.7 (-0.8, 22.2) 	
APPLICATION SITE ERYTHEMA 	8 (15.1%) 	8 (11.0%) 	16 (12.7%) 	1 (1.7%) 	13.4 (3.2, 23.6) 	9.3 (1.4, 17.2) 	
ERYTHEMA 	9 (17.0%) 	6 (8.2%) 	15 (11.9%) 	4 (6.8%) 	10.2 (-1.8, 22.2) 	1.4 (-7.6, 10.4) 	
Rash 	10 (18.9%) 	8 (11.0%) 	18 (14.3%) 	4 (6.8%) 	12.1 (-0.2, 24.4) 	4.2 (-5.4, 13.8) 	
RASH 	2 (3.8%) 	4 (5.5%) 	6 (4.8%) 	4 (6.8%) 	-3.0 (-11.2, 5.2) 	-1.3 (-9.6, 7.0) 	
APPLICATION SITE VESICLES 	4 (7.5%) 	1 (1.4%) 	5 (4.0%) 	0 	7.5 (0.4, 14.7) 	1.4 (-1.3, 4.0) 	
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) 	
BLISTER 	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%) 	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) 	
APPLICATION SITE URTICARIA 	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 	12 (22.6%) 	16 (21.9%) 	28 (22.2%) 	7 (11.9%) 	10.8 (-3.2, 24.7) 	10.1 (-2.5, 22.6) 	
Local Administration Reaction 	5 (9.4%) 	5 (6.8%) 	10 (7.9%) 	4 (6.8%) 	2.7 (-7.5, 12.8) 	0.1 (-8.6, 8.7) 	
APPLICATION SITE DERMATITIS 	3 (5.7%) 	4 (5.5%) 	7 (5.6%) 	4 (6.8%) 	-1.1 (-10.1, 7.8) 	-1.3 (-9.6, 7.0) 	
APPLICATION SITE PAIN 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
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) 	
APPLICATION SITE URTICARIA 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
Dizziness 	4 (7.5%) 	4 (5.5%) 	8 (6.3%) 	0 	7.5 (0.4, 14.7) 	5.5 (0.3, 10.7) 	
DIZZINESS 	4 (7.5%) 	3 (4.1%) 	7 (5.6%) 	0 	7.5 (0.4, 14.7) 	4.1 (-0.4, 8.7) 	
VERTIGO 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
Fatigue 	4 (7.5%) 	3 (4.1%) 	7 (5.6%) 	1 (1.7%) 	5.9 (-2.0, 13.7) 	2.4 (-3.2, 8.0) 	
FATIGUE 	3 (5.7%) 	2 (2.7%) 	5 (4.0%) 	0 	5.7 (-0.6, 11.9) 	2.7 (-1.0, 6.5) 	
MALAISE 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	0 	1.9 (-1.8, 5.5) 	1.4 (-1.3, 4.0) 	
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) 	
ASTHENIA 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
Fall 	1 (1.9%) 	2 (2.7%) 	3 (2.4%) 	0 	1.9 (-1.8, 5.5) 	2.7 (-1.0, 6.5) 	
FALL 	1 (1.9%) 	2 (2.7%) 	3 (2.4%) 	0 	1.9 (-1.8, 5.5) 	2.7 (-1.0, 6.5) 	
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%) 	0 	0.0 (0.0, 0.0) 	2.7 (-1.0, 6.5) 	
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%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
 	 	 	 	 	 	 	
Nervous system disorders 	6 (11.3%) 	8 (11.0%) 	14 (11.1%) 	2 (3.4%) 	7.9 (-1.8, 17.6) 	7.6 (-1.0, 16.1) 	
Headache 	2 (3.8%) 	3 (4.1%) 	5 (4.0%) 	1 (1.7%) 	2.1 (-4.0, 8.2) 	2.4 (-3.2, 8.0) 	
HEADACHE 	2 (3.8%) 	3 (4.1%) 	5 (4.0%) 	1 (1.7%) 	2.1 (-4.0, 8.2) 	2.4 (-3.2, 8.0) 	
Somnolence 	0 	4 (5.5%) 	4 (3.2%) 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	3.8 (-2.4, 10.0) 	
SOMNOLENCE 	0 	2 (2.7%) 	2 (1.6%) 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	1.0 (-3.9, 6.0) 	
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 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	-0.3 (-4.6, 3.9) 	
CONFUSIONAL STATE 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	-0.3 (-4.6, 3.9) 	
Stroke and TIA 	0 	2 (2.7%) 	2 (1.6%) 	0 	0.0 (0.0, 0.0) 	2.7 (-1.0, 6.5) 	
TRANSIENT ISCHAEMIC ATTACK 	0 	2 (2.7%) 	2 (1.6%) 	0 	0.0 (0.0, 0.0) 	2.7 (-1.0, 6.5) 	
Paresthesia 	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) 	
Seizure 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
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) 	
Syncope 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
SYNCOPE 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
 	 	 	 	 	 	 	
Cardiac disorders 	6 (11.3%) 	7 (9.6%) 	13 (10.3%) 	5 (8.5%) 	2.8 (-8.3, 13.9) 	1.1 (-8.7, 10.9) 	
Arrhythmia 	4 (7.5%) 	5 (6.8%) 	9 (7.1%) 	3 (5.1%) 	2.5 (-6.6, 11.5) 	1.8 (-6.3, 9.8) 	
SINUS BRADYCARDIA 	3 (5.7%) 	2 (2.7%) 	5 (4.0%) 	0 	5.7 (-0.6, 11.9) 	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) 	
VENTRICULAR EXTRASYSTOLES 	0 	2 (2.7%) 	2 (1.6%) 	0 	0.0 (0.0, 0.0) 	2.7 (-1.0, 6.5) 	
SINUS ARRHYTHMIA 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
SUPRAVENTRICULAR EXTRASYSTOLES 	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 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	2 (3.4%) 	0.4 (-6.5, 7.3) 	-2.0 (-7.4, 3.3) 	
MYOCARDIAL INFARCTION 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	2 (3.4%) 	0.4 (-6.5, 7.3) 	-2.0 (-7.4, 3.3) 	
Myocardial Infarction 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	2 (3.4%) 	0.4 (-6.5, 7.3) 	-2.0 (-7.4, 3.3) 	
MYOCARDIAL INFARCTION 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	2 (3.4%) 	0.4 (-6.5, 7.3) 	-2.0 (-7.4, 3.3) 	
Myocardial Ischemia 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	2 (3.4%) 	0.4 (-6.5, 7.3) 	-2.0 (-7.4, 3.3) 	
MYOCARDIAL INFARCTION 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	2 (3.4%) 	0.4 (-6.5, 7.3) 	-2.0 (-7.4, 3.3) 	
Cardiac Conduction Disturbance 	0 	2 (2.7%) 	2 (1.6%) 	2 (3.4%) 	-3.4 (-8.0, 1.2) 	-0.7 (-6.6, 5.3) 	
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) 	
Tachycardia 	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 	8 (15.1%) 	4 (5.5%) 	12 (9.5%) 	3 (5.1%) 	10.0 (-1.1, 21.2) 	0.4 (-7.3, 8.1) 	
Diarrhea 	2 (3.8%) 	2 (2.7%) 	4 (3.2%) 	1 (1.7%) 	2.1 (-4.0, 8.2) 	1.0 (-3.9, 6.0) 	
DIARRHOEA 	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 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	1 (1.7%) 	2.1 (-4.0, 8.2) 	-0.3 (-4.6, 3.9) 	
ABDOMINAL DISCOMFORT 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
ABDOMINAL PAIN 	0 	1 (1.4%) 	1 (0.8%) 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-0.3 (-4.6, 3.9) 	
STOMACH DISCOMFORT 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
Vomiting 	3 (5.7%) 	0 	3 (2.4%) 	0 	5.7 (-0.6, 11.9) 	0.0 (0.0, 0.0) 	
VOMITING 	3 (5.7%) 	0 	3 (2.4%) 	0 	5.7 (-0.6, 11.9) 	0.0 (0.0, 0.0) 	
Nausea 	2 (3.8%) 	0 	2 (1.6%) 	0 	3.8 (-1.4, 8.9) 	0.0 (0.0, 0.0) 	
NAUSEA 	2 (3.8%) 	0 	2 (1.6%) 	0 	3.8 (-1.4, 8.9) 	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) 	
 	 	 	 	 	 	 	
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 	4 (7.5%) 	3 (4.1%) 	7 (5.6%) 	5 (8.5%) 	-0.9 (-11.0, 9.1) 	-4.4 (-12.8, 4.1) 	
NASOPHARYNGITIS 	2 (3.8%) 	3 (4.1%) 	5 (4.0%) 	2 (3.4%) 	0.4 (-6.5, 7.3) 	0.7 (-5.8, 7.2) 	
RHINITIS 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
UPPER RESPIRATORY TRACT INFECTION 	1 (1.9%) 	0 	1 (0.8%) 	3 (5.1%) 	-3.2 (-9.9, 3.5) 	-5.1 (-10.7, 0.5) 	
Bacterial Infection 	1 (1.9%) 	1 (1.4%) 	2 (1.6%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	-0.3 (-4.6, 3.9) 	
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 	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) 	
Viral Infection 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	-1.7 (-5.0, 1.6) 	
INFLUENZA 	1 (1.9%) 	0 	1 (0.8%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Vascular disorders 	3 (5.7%) 	6 (8.2%) 	9 (7.1%) 	3 (5.1%) 	0.6 (-7.8, 8.9) 	3.1 (-5.3, 11.6) 	
Thrombosis 	2 (3.8%) 	3 (4.1%) 	5 (4.0%) 	2 (3.4%) 	0.4 (-6.5, 7.3) 	0.7 (-5.8, 7.2) 	
MYOCARDIAL INFARCTION 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	2 (3.4%) 	0.4 (-6.5, 7.3) 	-2.0 (-7.4, 3.3) 	
TRANSIENT ISCHAEMIC ATTACK 	0 	2 (2.7%) 	2 (1.6%) 	0 	0.0 (0.0, 0.0) 	2.7 (-1.0, 6.5) 	
Thrombosis Arterial 	2 (3.8%) 	3 (4.1%) 	5 (4.0%) 	2 (3.4%) 	0.4 (-6.5, 7.3) 	0.7 (-5.8, 7.2) 	
MYOCARDIAL INFARCTION 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	2 (3.4%) 	0.4 (-6.5, 7.3) 	-2.0 (-7.4, 3.3) 	
TRANSIENT ISCHAEMIC ATTACK 	0 	2 (2.7%) 	2 (1.6%) 	0 	0.0 (0.0, 0.0) 	2.7 (-1.0, 6.5) 	
Hemorrhage 	1 (1.9%) 	3 (4.1%) 	4 (3.2%) 	1 (1.7%) 	0.2 (-4.7, 5.1) 	2.4 (-3.2, 8.0) 	
APPLICATION SITE BLEEDING 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
CONTUSION 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
EPISTAXIS 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
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) 	
Hypotension 	0 	0 	0 	2 (3.4%) 	-3.4 (-8.0, 1.2) 	-3.4 (-8.0, 1.2) 	
HYPOTENSION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
ORTHOSTATIC HYPOTENSION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Psychiatric disorders 	1 (1.9%) 	4 (5.5%) 	5 (4.0%) 	4 (6.8%) 	-4.9 (-12.3, 2.5) 	-1.3 (-9.6, 7.0) 	
Study Agent Abuse Potential 	0 	3 (4.1%) 	3 (2.4%) 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	2.4 (-3.2, 8.0) 	
SOMNOLENCE 	0 	2 (2.7%) 	2 (1.6%) 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	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) 	
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) 	
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) 	
Irritability 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
AGITATION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
Psychosis 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
DELUSION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Musculoskeletal and connective tissue disorders 	4 (7.5%) 	0 	4 (3.2%) 	1 (1.7%) 	5.9 (-2.0, 13.7) 	-1.7 (-5.0, 1.6) 	
Back Pain 	3 (5.7%) 	0 	3 (2.4%) 	0 	5.7 (-0.6, 11.9) 	0.0 (0.0, 0.0) 	
BACK PAIN 	2 (3.8%) 	0 	2 (1.6%) 	0 	3.8 (-1.4, 8.9) 	0.0 (0.0, 0.0) 	
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%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
ARTHRALGIA 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
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) 	
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) 	
 	 	 	 	 	 	 	
Respiratory, thoracic and mediastinal disorders 	3 (5.7%) 	1 (1.4%) 	4 (3.2%) 	0 	5.7 (-0.6, 11.9) 	1.4 (-1.3, 4.0) 	
Cough 	3 (5.7%) 	1 (1.4%) 	4 (3.2%) 	0 	5.7 (-0.6, 11.9) 	1.4 (-1.3, 4.0) 	
COUGH 	2 (3.8%) 	1 (1.4%) 	3 (2.4%) 	0 	3.8 (-1.4, 8.9) 	1.4 (-1.3, 4.0) 	
PRODUCTIVE COUGH 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
 	 	 	 	 	 	 	
Reproductive system and breast disorders 	3 (5.7%) 	0 	3 (2.4%) 	1 (1.7%) 	4.0 (-3.1, 11.0) 	-1.7 (-5.0, 1.6) 	
Sexual Dysfunction 	2 (3.8%) 	0 	2 (1.6%) 	1 (1.7%) 	2.1 (-4.0, 8.2) 	-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) 	
LIBIDO DECREASED 	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) 	
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 	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) 	
VERTIGO 	0 	1 (1.4%) 	1 (0.8%) 	0 	0.0 (0.0, 0.0) 	1.4 (-1.3, 4.0) 	
 	 	 	 	 	 	 	
Endocrine disorders 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
Hyperglycemia 	1 (1.9%) 	0 	1 (0.8%) 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
BLOOD GLUCOSE INCREASED 	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) 	
 	 	 	 	 	 	 	
Immune system disorders 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
Hypersensitivity 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
DRUG ERUPTION 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
 	 	 	 	 	 	 	
Renal and urinary disorders 	0 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
Renal & Urinary Tract Infection 	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) 	

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.