TSFLAB03:	Subjects With =1 Laboratory Values With Elevated or Low Values Based on Worst On-treatment Value Using NCI-CTCAE Criteria; Safety Analysis Set (Study jjcs - core)						
NCI-CTCAE Category 	Active Study Agent 	Active Study Agent 	 	Risk Difference (%) (95% CI) 	Risk Difference (%) (95% CI) 	
  Laboratory Test 	Xanomeline High Dose 	Xanomeline Low Dose 	Placebo 	Xanomeline High Dose vs Placebo 	Xanomeline Low Dose vs Placebo 	
    Grade, n (%) 	N=53 	N=73 	N=59 	  	  	
Blood and lymphatic system disorders 	 	 	 	 	 	
Anemia 	 	 	 	 	 	
N 	53 	73 	59 	 	 	
Grade 1 	29 (54.7%) 	42 (57.5%) 	35 (59.3%) 	-4.6 (-23.0, 13.7) 	-1.8 (-18.7, 15.1) 	
Grade 2 	16 (30.2%) 	24 (32.9%) 	23 (39.0%) 	-8.8 (-26.3, 8.7) 	-6.1 (-22.6, 10.4) 	
Grade 3 	12 (22.6%) 	18 (24.7%) 	13 (22.0%) 	0.6 (-14.8, 16.1) 	2.6 (-11.9, 17.1) 	
 	 	 	 	 	 	
Leukocytosis 	 	 	 	 	 	
N 	53 	73 	59 	 	 	
Grade 3 	0 	0 	0 	0.0 (0.0, 0.0) 	0.0 (0.0, 0.0) 	
 	 	 	 	 	 	
Metabolism and nutritional disorders 	 	 	 	 	 	
Hyperkalemia 	 	 	 	 	 	
N 	53 	73 	59 	 	 	
Grade 1 	1 (1.9%) 	0 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
Grade 2 	0 	0 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
Grade 3 	0 	0 	0 	0.0 (0.0, 0.0) 	0.0 (0.0, 0.0) 	
Grade 4 	0 	0 	0 	0.0 (0.0, 0.0) 	0.0 (0.0, 0.0) 	
 	 	 	 	 	 	
Hypernatremia 	 	 	 	 	 	
N 	53 	73 	59 	 	 	
Grade 1 	6 (11.3%) 	5 (6.8%) 	9 (15.3%) 	-3.9 (-16.5, 8.6) 	-8.4 (-19.3, 2.4) 	
Grade 2 	1 (1.9%) 	0 	0 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
Grade 3 	0 	0 	0 	0.0 (0.0, 0.0) 	0.0 (0.0, 0.0) 	
Grade 4 	0 	0 	0 	0.0 (0.0, 0.0) 	0.0 (0.0, 0.0) 	
 	 	 	 	 	 	
Hypoalbuminemia 	 	 	 	 	 	
N 	53 	73 	59 	 	 	
Grade 1 	37 (69.8%) 	32 (43.8%) 	40 (67.8%) 	2.0 (-15.2, 19.2) 	-24.0 (-40.4, -7.5) 	
Grade 2 	23 (43.4%) 	21 (28.8%) 	25 (42.4%) 	1.0 (-17.3, 19.4) 	-13.6 (-29.9, 2.7) 	
Grade 3 	11 (20.8%) 	10 (13.7%) 	15 (25.4%) 	-4.7 (-20.2, 10.9) 	-11.7 (-25.4, 1.9) 	
 	 	 	 	 	 	
Hypoglycemia 	 	 	 	 	 	
N 	53 	72 	59 	 	 	
Grade 1 	30 (56.6%) 	33 (45.8%) 	37 (62.7%) 	-6.1 (-24.3, 12.1) 	-16.9 (-33.8, -0.0) 	
Grade 2 	25 (47.2%) 	23 (31.9%) 	23 (39.0%) 	8.2 (-10.1, 26.5) 	-7.0 (-23.5, 9.4) 	
Grade 3 	12 (22.6%) 	17 (23.6%) 	15 (25.4%) 	-2.8 (-18.6, 13.0) 	-1.8 (-16.6, 13.0) 	
Grade 4 	0 	1 (1.4%) 	1 (1.7%) 	-1.7 (-5.0, 1.6) 	-0.3 (-4.6, 4.0) 	
 	 	 	 	 	 	
Hypokalemia 	 	 	 	 	 	
N 	53 	73 	58 	 	 	
Grade 2 	20 (37.7%) 	23 (31.5%) 	20 (34.5%) 	3.3 (-14.6, 21.1) 	-3.0 (-19.2, 13.2) 	
Grade 3 	11 (20.8%) 	11 (15.1%) 	15 (25.9%) 	-5.1 (-20.8, 10.6) 	-10.8 (-24.7, 3.1) 	
Grade 4 	2 (3.8%) 	4 (5.5%) 	2 (3.4%) 	0.3 (-6.6, 7.3) 	2.0 (-5.0, 9.1) 	
 	 	 	 	 	 	
Hyponatremia 	 	 	 	 	 	
N 	53 	71 	59 	 	 	
Grade 1 	36 (67.9%) 	40 (56.3%) 	40 (67.8%) 	0.1 (-17.2, 17.5) 	-11.5 (-28.0, 5.1) 	
Grade 3 	16 (30.2%) 	14 (19.7%) 	12 (20.3%) 	9.8 (-6.2, 25.9) 	-0.6 (-14.4, 13.2) 	
Grade 4 	3 (5.7%) 	0 	0 	5.7 (-0.6, 11.9) 	0.0 (0.0, 0.0) 	

Note: On-treatment is defined as treatment-emergent laboratory values obtained after the first dose and within [30 days] following treatment discontinuation. [Treatment-emergent values are those that worsened from baseline.] 	
Note: On-treatment is defined as treatment-emergent laboratory values obtained after the first dose and within [30 days] following treatment discontinuation. [Treatment-emergent values are those that worsened from baseline.]	
Note: On-treatment is defined as treatment-emergent laboratory values obtained after the first dose and within [30 days] following treatment discontinuation. [Treatment-emergent values are those that worsened from baseline.]	
Note: On-treatment is defined as treatment-emergent laboratory values obtained after the first dose and within [30 days] following treatment discontinuation. [Treatment-emergent values are those that worsened from baseline.]	
Note: On-treatment is defined as treatment-emergent laboratory values obtained after the first dose and within [30 days] following treatment discontinuation. [Treatment-emergent values are those that worsened from baseline.]	
Note: On-treatment is defined as treatment-emergent laboratory values obtained after the first dose and within [30 days] following treatment discontinuation. [Treatment-emergent values are those that worsened from baseline.]	
Note: NCI-CTCAE grades (version 5.0.) are based on the laboratory result and do not take into account the clinical component, if applicable. 	: NCI-CTCAE grades (version 5.) are based on the laboratory result and do not take into account the clinical component, if applicable.	: NCI-CTCAE grades (version 5.) are based on the laboratory result and do not take into account the clinical component, if applicable.	: NCI-CTCAE grades (version 5.) are based on the laboratory result and do not take into account the clinical component, if applicable.	: NCI-CTCAE grades (version 5.) are based on the laboratory result and do not take into account the clinical component, if applicable.	: NCI-CTCAE grades (version 5.) are based on the laboratory result and do not take into account the clinical component, if applicable.