Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=96)	(N=72)	(N=254)	
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	21 (24.4%)	51 (53.1%)	36 (50.0%)	108 (42.5%)	
APPLICATION SITE PRURITUS	6 (7.0%)	23 (24.0%)	21 (29.2%)	50 (19.7%)	
APPLICATION SITE ERYTHEMA	3 (3.5%)	13 (13.5%)	14 (19.4%)	30 (11.8%)	
APPLICATION SITE DERMATITIS	5 (5.8%)	9 (9.4%)	7 (9.7%)	21 (8.3%)	
APPLICATION SITE IRRITATION	3 (3.5%)	9 (9.4%)	9 (12.5%)	21 (8.3%)	
APPLICATION SITE VESICLES	1 (1.2%)	5 (5.2%)	5 (6.9%)	11 (4.3%)	
FATIGUE	1 (1.2%)	5 (5.2%)	5 (6.9%)	11 (4.3%)	
OEDEMA PERIPHERAL	2 (2.3%)	1 (1.0%)	2 (2.8%)	5 (2.0%)	
APPLICATION SITE SWELLING	0 (0.0%)	1 (1.0%)	2 (2.8%)	3 (1.2%)	
APPLICATION SITE URTICARIA	0 (0.0%)	2 (2.1%)	1 (1.4%)	3 (1.2%)	
CHILLS	1 (1.2%)	1 (1.0%)	1 (1.4%)	3 (1.2%)	
MALAISE	0 (0.0%)	1 (1.0%)	2 (2.8%)	3 (1.2%)	
PYREXIA	2 (2.3%)	1 (1.0%)	0 (0.0%)	3 (1.2%)	
APPLICATION SITE PAIN	0 (0.0%)	0 (0.0%)	2 (2.8%)	2 (0.8%)	
APPLICATION SITE PERSPIRATION	0 (0.0%)	0 (0.0%)	2 (2.8%)	2 (0.8%)	
APPLICATION SITE REACTION	1 (1.2%)	0 (0.0%)	1 (1.4%)	2 (0.8%)	
ASTHENIA	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)	
CHEST DISCOMFORT	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)	

Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=96)	(N=72)	(N=254)	
CHEST PAIN	0 (0.0%)	0 (0.0%)	2 (2.8%)	2 (0.8%)	
OEDEMA	0 (0.0%)	2 (2.1%)	0 (0.0%)	2 (0.8%)	
PAIN	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)	
APPLICATION SITE BLEEDING	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
APPLICATION SITE DESQUAMATION	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
APPLICATION SITE DISCHARGE	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
APPLICATION SITE DISCOLOURATION	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
APPLICATION SITE INDURATION	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
APPLICATION SITE WARMTH	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
FEELING ABNORMAL	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
FEELING COLD	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
INFLAMMATION	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
SECRETION DISCHARGE	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
SUDDEN DEATH	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
SWELLING	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
ULCER	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
SKIN AND SUBCUTANEOUS TISSUE DISORDERS	20 (23.3%)	39 (40.6%)	39 (54.2%)	98 (38.6%)	
PRURITUS	8 (9.3%)	21 (21.9%)	25 (34.7%)	54 (21.3%)	
ERYTHEMA	8 (9.3%)	14 (14.6%)	14 (19.4%)	36 (14.2%)	

Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=96)	(N=72)	(N=254)	
RASH	5 (5.8%)	13 (13.5%)	8 (11.1%)	26 (10.2%)	
HYPERHIDROSIS	2 (2.3%)	4 (4.2%)	8 (11.1%)	14 (5.5%)	
SKIN IRRITATION	3 (3.5%)	6 (6.3%)	5 (6.9%)	14 (5.5%)	
BLISTER	0 (0.0%)	5 (5.2%)	1 (1.4%)	6 (2.4%)	
RASH PRURITIC	0 (0.0%)	1 (1.0%)	2 (2.8%)	3 (1.2%)	
PRURITUS GENERALISED	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)	
URTICARIA	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)	
ACTINIC KERATOSIS	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
ALOPECIA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
COLD SWEAT	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
DERMATITIS CONTACT	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
DRUG ERUPTION	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
RASH ERYTHEMATOUS	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
RASH MACULO-PAPULAR	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
SKIN EXFOLIATION	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
SKIN ODOUR ABNORMAL	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
SKIN ULCER	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
NERVOUS SYSTEM DISORDERS	8 (9.3%)	22 (22.9%)	23 (31.9%)	53 (20.9%)	
DIZZINESS	2 (2.3%)	9 (9.4%)	10 (13.9%)	21 (8.3%)	

Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=96)	(N=72)	(N=254)	
HEADACHE	3 (3.5%)	3 (3.1%)	5 (6.9%)	11 (4.3%)	
SYNCOPE	0 (0.0%)	5 (5.2%)	2 (2.8%)	7 (2.8%)	
SOMNOLENCE	2 (2.3%)	3 (3.1%)	1 (1.4%)	6 (2.4%)	
TRANSIENT ISCHAEMIC ATTACK	0 (0.0%)	2 (2.1%)	1 (1.4%)	3 (1.2%)	
BURNING SENSATION	0 (0.0%)	0 (0.0%)	2 (2.8%)	2 (0.8%)	
LETHARGY	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)	
AMNESIA	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
BALANCE DISORDER	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
COGNITIVE DISORDER	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
COMPLEX PARTIAL SEIZURES	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
COORDINATION ABNORMAL	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
HEMIANOPIA HOMONYMOUS	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
HYPERSOMNIA	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
PARAESTHESIA	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
PARAESTHESIA ORAL	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
PARKINSON'S DISEASE	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
PAROSMIA	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
PARTIAL SEIZURES WITH SECONDARY GENERALISATION	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	

Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=96)	(N=72)	(N=254)	
PSYCHOMOTOR HYPERACTIVITY	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
STUPOR	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
SYNCOPE VASOVAGAL	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
GASTROINTESTINAL DISORDERS	17 (19.8%)	15 (15.6%)	19 (26.4%)	51 (20.1%)	
DIARRHOEA	9 (10.5%)	5 (5.2%)	3 (4.2%)	17 (6.7%)	
VOMITING	3 (3.5%)	4 (4.2%)	6 (8.3%)	13 (5.1%)	
NAUSEA	3 (3.5%)	3 (3.1%)	6 (8.3%)	12 (4.7%)	
ABDOMINAL PAIN	1 (1.2%)	3 (3.1%)	1 (1.4%)	5 (2.0%)	
SALIVARY HYPERSECRETION	0 (0.0%)	0 (0.0%)	4 (5.6%)	4 (1.6%)	
DYSPEPSIA	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)	
ABDOMINAL DISCOMFORT	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
CONSTIPATION	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
DYSPHAGIA	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
FLATULENCE	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
GASTROINTESTINAL HAEMORRHAGE	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
GASTROOESOPHAGEAL REFLUX DISEASE	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
GLOSSITIS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
HIATUS HERNIA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
RECTAL HAEMORRHAGE	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	

Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=96)	(N=72)	(N=254)	
STOMACH DISCOMFORT	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
CARDIAC DISORDERS	12 (14.0%)	14 (14.6%)	14 (19.4%)	40 (15.7%)	
SINUS BRADYCARDIA	2 (2.3%)	7 (7.3%)	8 (11.1%)	17 (6.7%)	
MYOCARDIAL INFARCTION	4 (4.7%)	2 (2.1%)	4 (5.6%)	10 (3.9%)	
ATRIAL FIBRILLATION	1 (1.2%)	2 (2.1%)	2 (2.8%)	5 (2.0%)	
SUPRAVENTRICULAR EXTRASYSTOLES	1 (1.2%)	1 (1.0%)	1 (1.4%)	3 (1.2%)	
VENTRICULAR EXTRASYSTOLES	0 (0.0%)	2 (2.1%)	1 (1.4%)	3 (1.2%)	
ATRIAL FLUTTER	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)	
ATRIOVENTRICULAR BLOCK FIRST DEGREE	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)	
BUNDLE BRANCH BLOCK RIGHT	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)	
PALPITATIONS	0 (0.0%)	2 (2.1%)	0 (0.0%)	2 (0.8%)	
ATRIAL HYPERTROPHY	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
ATRIOVENTRICULAR BLOCK SECOND DEGREE	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
BRADYCARDIA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
BUNDLE BRANCH BLOCK LEFT	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
CARDIAC DISORDER	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
CARDIAC FAILURE CONGESTIVE	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
SINUS ARRHYTHMIA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
SUPRAVENTRICULAR TACHYCARDIA	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	

Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=96)	(N=72)	(N=254)	
TACHYCARDIA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
VENTRICULAR HYPERTROPHY	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
WOLFF-PARKINSON-WHITE SYNDROME	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
INFECTIONS AND INFESTATIONS	16 (18.6%)	9 (9.4%)	13 (18.1%)	38 (15.0%)	
NASOPHARYNGITIS	2 (2.3%)	4 (4.2%)	6 (8.3%)	12 (4.7%)	
UPPER RESPIRATORY TRACT INFECTION	6 (7.0%)	1 (1.0%)	3 (4.2%)	10 (3.9%)	
INFLUENZA	1 (1.2%)	1 (1.0%)	1 (1.4%)	3 (1.2%)	
URINARY TRACT INFECTION	2 (2.3%)	0 (0.0%)	1 (1.4%)	3 (1.2%)	
CYSTITIS	1 (1.2%)	0 (0.0%)	1 (1.4%)	2 (0.8%)	
EAR INFECTION	2 (2.3%)	0 (0.0%)	0 (0.0%)	2 (0.8%)	
BRONCHITIS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
CELLULITIS	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
CERVICITIS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
GASTROENTERITIS VIRAL	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
HORDEOLUM	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
LOCALISED INFECTION	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
LOWER RESPIRATORY TRACT INFECTION	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
PNEUMONIA	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
RHINITIS	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	

Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=96)	(N=72)	(N=254)	
VAGINAL MYCOSIS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
VIRAL INFECTION	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
PSYCHIATRIC DISORDERS	10 (11.6%)	11 (11.5%)	7 (9.7%)	28 (11.0%)	
CONFUSIONAL STATE	2 (2.3%)	3 (3.1%)	1 (1.4%)	6 (2.4%)	
AGITATION	2 (2.3%)	3 (3.1%)	0 (0.0%)	5 (2.0%)	
INSOMNIA	2 (2.3%)	0 (0.0%)	2 (2.8%)	4 (1.6%)	
ANXIETY	0 (0.0%)	3 (3.1%)	0 (0.0%)	3 (1.2%)	
DELUSION	1 (1.2%)	0 (0.0%)	1 (1.4%)	2 (0.8%)	
IRRITABILITY	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)	
COMPLETED SUICIDE	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
DELIRIUM	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
DEPRESSED MOOD	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
DISORIENTATION	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
HALLUCINATION	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
HALLUCINATION, VISUAL	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
LIBIDO DECREASED	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
LISTLESS	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
NIGHTMARE	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
RESTLESSNESS	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	

Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=96)	(N=72)	(N=254)	
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	8 (9.3%)	9 (9.4%)	10 (13.9%)	27 (10.6%)	
COUGH	1 (1.2%)	5 (5.2%)	5 (6.9%)	11 (4.3%)	
NASAL CONGESTION	3 (3.5%)	1 (1.0%)	3 (4.2%)	7 (2.8%)	
DYSPNOEA	1 (1.2%)	1 (1.0%)	1 (1.4%)	3 (1.2%)	
EPISTAXIS	0 (0.0%)	1 (1.0%)	2 (2.8%)	3 (1.2%)	
PHARYNGOLARYNGEAL PAIN	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)	
RHINORRHOEA	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)	
ALLERGIC GRANULOMATOUS ANGIITIS	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
DYSPHONIA	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
EMPHYSEMA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
HAEMOPTYSIS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
PHARYNGEAL ERYTHEMA	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
POSTNASAL DRIP	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
PRODUCTIVE COUGH	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
RALES	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
RESPIRATORY TRACT CONGESTION	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
INVESTIGATIONS	10 (11.6%)	7 (7.3%)	5 (6.9%)	22 (8.7%)	
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION	4 (4.7%)	1 (1.0%)	0 (0.0%)	5 (2.0%)	
ELECTROCARDIOGRAM T WAVE INVERSION	2 (2.3%)	1 (1.0%)	1 (1.4%)	4 (1.6%)	

Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=96)	(N=72)	(N=254)	
BLOOD GLUCOSE INCREASED	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)	
ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)	
BIOPSY	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
BIOPSY PROSTATE	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
BLOOD ALKALINE PHOSPHATASE INCREASED	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
BLOOD CHOLESTEROL INCREASED	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
BLOOD CREATINE PHOSPHOKINASE INCREASED	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
BLOOD URINE PRESENT	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
BODY TEMPERATURE INCREASED	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
CYSTOSCOPY	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
HEART RATE INCREASED	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
HEART RATE IRREGULAR	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
NASAL MUCOSA BIOPSY	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
WEIGHT DECREASED	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	4 (4.7%)	7 (7.3%)	7 (9.7%)	18 (7.1%)	
BACK PAIN	1 (1.2%)	1 (1.0%)	3 (4.2%)	5 (2.0%)	
ARTHRALGIA	1 (1.2%)	2 (2.1%)	1 (1.4%)	4 (1.6%)	

Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=96)	(N=72)	(N=254)	
SHOULDER PAIN	1 (1.2%)	2 (2.1%)	0 (0.0%)	3 (1.2%)	
MUSCLE SPASMS	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)	
ARTHRITIS	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
FLANK PAIN	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
MUSCULAR WEAKNESS	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
MYALGIA	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
PAIN IN EXTREMITY	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
INJURY, POISONING AND PROCEDURAL COMPLICATIONS	4 (4.7%)	5 (5.2%)	5 (6.9%)	14 (5.5%)	
CONTUSION	1 (1.2%)	1 (1.0%)	2 (2.8%)	4 (1.6%)	
EXCORIATION	2 (2.3%)	1 (1.0%)	1 (1.4%)	4 (1.6%)	
FALL	1 (1.2%)	2 (2.1%)	1 (1.4%)	4 (1.6%)	
HIP FRACTURE	1 (1.2%)	0 (0.0%)	2 (2.8%)	3 (1.2%)	
SKIN LACERATION	1 (1.2%)	2 (2.1%)	0 (0.0%)	3 (1.2%)	
FACIAL BONES FRACTURE	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
JOINT DISLOCATION	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
WOUND	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
RENAL AND URINARY DISORDERS	4 (4.7%)	3 (3.1%)	3 (4.2%)	10 (3.9%)	
MICTURITION URGENCY	1 (1.2%)	1 (1.0%)	1 (1.4%)	3 (1.2%)	
DYSURIA	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)	

Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=96)	(N=72)	(N=254)	
NEPHROLITHIASIS	1 (1.2%)	0 (0.0%)	1 (1.4%)	2 (0.8%)	
CALCULUS URETHRAL	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
INCONTINENCE	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
POLLAKIURIA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
METABOLISM AND NUTRITION DISORDERS	6 (7.0%)	1 (1.0%)	2 (2.8%)	9 (3.5%)	
DECREASED APPETITE	1 (1.2%)	0 (0.0%)	1 (1.4%)	2 (0.8%)	
FOOD CRAVING	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)	
INCREASED APPETITE	1 (1.2%)	0 (0.0%)	1 (1.4%)	2 (0.8%)	
DEHYDRATION	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
DIABETES MELLITUS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
HYPONATRAEMIA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
VASCULAR DISORDERS	3 (3.5%)	3 (3.1%)	1 (1.4%)	7 (2.8%)	
HYPOTENSION	2 (2.3%)	1 (1.0%)	0 (0.0%)	3 (1.2%)	
HYPERTENSION	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)	
HOT FLUSH	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
ORTHOSTATIC HYPOTENSION	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
WOUND HAEMORRHAGE	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
EYE DISORDERS	2 (2.3%)	2 (2.1%)	1 (1.4%)	5 (2.0%)	
VISION BLURRED	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)	

Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=96)	(N=72)	(N=254)	
CONJUNCTIVAL HAEMORRHAGE	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
CONJUNCTIVITIS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
EYE ALLERGY	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
EYE PRURITUS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
EYE SWELLING	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
SURGICAL AND MEDICAL PROCEDURES	2 (2.3%)	1 (1.0%)	2 (2.8%)	5 (2.0%)	
CATARACT OPERATION	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)	
ACROCHORDON EXCISION	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
EYE LASER SURGERY	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
SKIN LESION EXCISION	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
EAR AND LABYRINTH DISORDERS	1 (1.2%)	2 (2.1%)	1 (1.4%)	4 (1.6%)	
VERTIGO	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)	
CERUMEN IMPACTION	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
EAR PAIN	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
CONGENITAL, FAMILIAL AND GENETIC DISORDERS	0 (0.0%)	1 (1.0%)	2 (2.8%)	3 (1.2%)	
VENTRICULAR SEPTAL DEFECT	0 (0.0%)	1 (1.0%)	2 (2.8%)	3 (1.2%)	
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	0 (0.0%)	2 (2.1%)	1 (1.4%)	3 (1.2%)	
COLON CANCER	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	

Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=96)	(N=72)	(N=254)	
MALIGNANT FIBROUS HISTIOCYTOMA	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
PROSTATE CANCER	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
REPRODUCTIVE SYSTEM AND BREAST DISORDERS	2 (2.3%)	0 (0.0%)	1 (1.4%)	3 (1.2%)	
BENIGN PROSTATIC HYPERPLASIA	1 (1.2%)	0 (0.0%)	1 (1.4%)	2 (0.8%)	
PELVIC PAIN	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
HEPATOBILIARY DISORDERS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
HYPERBILIRUBINAEMIA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)	
IMMUNE SYSTEM DISORDERS	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
HYPERSENSITIVITY	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)	
SOCIAL CIRCUMSTANCES	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
ALCOHOL USE	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)	
Subjects are counted once per system organ class and once per preferred term, regardless of how many events they reported.
Percentages are based on the number of subjects in the safety analysis set for each treatment group.
System organ classes and preferred terms are sorted by descending subject count.
The Total column pools all treatment groups; the 5% threshold applied to the in-text variant is evaluated on the treatment columns only, never on Total.	
Source: adae, adsl (pharmaverseadam). Data cut-off: 2014-07-01. open.csr display t-ae-common (post-text variant); generated from the committed ARD.