TSFLAB03a:	Subjects With =1 Laboratory Values With Elevated or Low Values Based on Worst On-treatment Value Using NCI-CTCAE Criteria by [Subgroup]; 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 	  	  	
Age: ≥18 to <65 years 	8 	5 	7 	 	 	
 	  	  	  	  	  	
Blood and lymphatic system disorders 	 	 	 	 	 	
Anemia 	 	 	 	 	 	
N 	8 	5 	7 	 	 	
Grade 1 	7 (87.5%) 	5 (100.0%) 	5 (71.4%) 	16.1 (-24.5, 56.6) 	28.6 (-4.9, 62.0) 	
Grade 2 	5 (62.5%) 	5 (100.0%) 	2 (28.6%) 	33.9 (-13.5, 81.3) 	71.4 (38.0, 100.0) 	
Grade 3 	2 (25.0%) 	2 (40.0%) 	0 	25.0 (-5.0, 55.0) 	40.0 (-2.9, 82.9) 	
 	 	 	 	 	 	
Leukocytosis 	 	 	 	 	 	
N 	8 	5 	7 	 	 	
Grade 3 	0 	0 	0 	0.0 (0.0, 0.0) 	0.0 (0.0, 0.0) 	
 	 	 	 	 	 	
Metabolism and nutritional disorders 	 	 	 	 	 	
Hyperkalemia 	 	 	 	 	 	
N 	8 	5 	7 	 	 	
Grade 1 	0 	0 	0 	0.0 (0.0, 0.0) 	0.0 (0.0, 0.0) 	
Grade 2 	0 	0 	0 	0.0 (0.0, 0.0) 	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) 	
 	 	 	 	 	 	
Hypernatremia 	 	 	 	 	 	
N 	8 	5 	7 	 	 	
Grade 1 	0 	0 	1 (14.3%) 	-14.3 (-40.2, 11.6) 	-14.3 (-40.2, 11.6) 	
Grade 2 	0 	0 	0 	0.0 (0.0, 0.0) 	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 	8 	5 	7 	 	 	
Grade 1 	8 (100.0%) 	4 (80.0%) 	6 (85.7%) 	14.3 (-11.6, 40.2) 	-5.7 (-49.3, 37.9) 	
Grade 2 	7 (87.5%) 	4 (80.0%) 	6 (85.7%) 	1.8 (-32.8, 36.4) 	-5.7 (-49.3, 37.9) 	
Grade 3 	2 (25.0%) 	0 	3 (42.9%) 	-17.9 (-65.2, 29.5) 	-42.9 (-79.5, -6.2) 	
 	 	 	 	 	 	
Hypoglycemia 	 	 	 	 	 	
N 	8 	5 	7 	 	 	
Grade 1 	4 (50.0%) 	3 (60.0%) 	7 (100.0%) 	-50.0 (-84.6, -15.4) 	-40.0 (-82.9, 2.9) 	
Grade 2 	6 (75.0%) 	2 (40.0%) 	6 (85.7%) 	-10.7 (-50.4, 28.9) 	-45.7 (-95.9, 4.4) 	
Grade 3 	5 (62.5%) 	3 (60.0%) 	3 (42.9%) 	19.6 (-30.0, 69.3) 	17.1 (-39.3, 73.6) 	
Grade 4 	2 (25.0%) 	0 	1 (14.3%) 	10.7 (-28.9, 50.4) 	-14.3 (-40.2, 11.6) 	
 	 	 	 	 	 	
Hypokalemia 	 	 	 	 	 	
N 	8 	5 	7 	 	 	
Grade 2 	4 (50.0%) 	5 (100.0%) 	5 (71.4%) 	-21.4 (-69.6, 26.7) 	28.6 (-4.9, 62.0) 	
Grade 3 	2 (25.0%) 	2 (40.0%) 	3 (42.9%) 	-17.9 (-65.2, 29.5) 	-2.9 (-59.3, 53.6) 	
Grade 4 	1 (12.5%) 	0 	0 	12.5 (-10.4, 35.4) 	0.0 (0.0, 0.0) 	
 	 	 	 	 	 	
Hyponatremia 	 	 	 	 	 	
N 	8 	5 	7 	 	 	
Grade 1 	7 (87.5%) 	4 (80.0%) 	5 (71.4%) 	16.1 (-24.5, 56.6) 	8.6 (-39.9, 57.0) 	
Grade 3 	3 (37.5%) 	1 (20.0%) 	3 (42.9%) 	-5.4 (-55.0, 44.3) 	-22.9 (-73.6, 27.9) 	
Grade 4 	0 	0 	0 	0.0 (0.0, 0.0) 	0.0 (0.0, 0.0) 	
Age: ≥65 to <75 years 	16 	17 	19 	 	 	
 	  	  	  	  	  	
Blood and lymphatic system disorders 	 	 	 	 	 	
Anemia 	 	 	 	 	 	
N 	16 	17 	19 	 	 	
Grade 1 	11 (68.8%) 	10 (58.8%) 	17 (89.5%) 	-20.7 (-47.3, 5.9) 	-30.7 (-57.8, -3.5) 	
Grade 2 	11 (68.8%) 	8 (47.1%) 	13 (68.4%) 	0.3 (-30.5, 31.2) 	-21.4 (-53.0, 10.3) 	
Grade 3 	9 (56.2%) 	5 (29.4%) 	9 (47.4%) 	8.9 (-24.2, 42.0) 	-18.0 (-49.2, 13.2) 	
 	 	 	 	 	 	
Leukocytosis 	 	 	 	 	 	
N 	16 	17 	19 	 	 	
Grade 3 	0 	0 	0 	0.0 (0.0, 0.0) 	0.0 (0.0, 0.0) 	
 	 	 	 	 	 	
Metabolism and nutritional disorders 	 	 	 	 	 	
Hyperkalemia 	 	 	 	 	 	
N 	16 	17 	19 	 	 	
Grade 1 	0 	0 	0 	0.0 (0.0, 0.0) 	0.0 (0.0, 0.0) 	
Grade 2 	1 (6.2%) 	0 	0 	6.2 (-5.6, 18.1) 	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) 	
 	 	 	 	 	 	
Hypernatremia 	 	 	 	 	 	
N 	16 	17 	19 	 	 	
Grade 1 	2 (12.5%) 	2 (11.8%) 	5 (26.3%) 	-13.8 (-39.4, 11.8) 	-14.6 (-39.6, 10.5) 	
Grade 2 	1 (6.2%) 	0 	0 	6.2 (-5.6, 18.1) 	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 	16 	17 	19 	 	 	
Grade 1 	15 (93.8%) 	10 (58.8%) 	18 (94.7%) 	-1.0 (-16.5, 14.6) 	-35.9 (-61.4, -10.5) 	
Grade 2 	10 (62.5%) 	6 (35.3%) 	14 (73.7%) 	-11.2 (-42.1, 19.7) 	-38.4 (-68.5, -8.3) 	
Grade 3 	7 (43.8%) 	4 (23.5%) 	6 (31.6%) 	12.2 (-19.9, 44.2) 	-8.0 (-37.1, 21.0) 	
 	 	 	 	 	 	
Hypoglycemia 	 	 	 	 	 	
N 	16 	17 	19 	 	 	
Grade 1 	13 (81.2%) 	11 (64.7%) 	18 (94.7%) 	-13.5 (-35.1, 8.1) 	-30.0 (-54.9, -5.2) 	
Grade 2 	11 (68.8%) 	8 (47.1%) 	10 (52.6%) 	16.1 (-15.8, 48.1) 	-5.6 (-38.2, 27.1) 	
Grade 3 	7 (43.8%) 	5 (29.4%) 	6 (31.6%) 	12.2 (-19.9, 44.2) 	-2.2 (-32.3, 27.9) 	
Grade 4 	1 (6.2%) 	2 (11.8%) 	0 	6.2 (-5.6, 18.1) 	11.8 (-3.6, 27.1) 	
 	 	 	 	 	 	
Hypokalemia 	 	 	 	 	 	
N 	16 	16 	19 	 	 	
Grade 2 	12 (75.0%) 	5 (31.2%) 	11 (57.9%) 	17.1 (-13.6, 47.8) 	-26.6 (-58.4, 5.1) 	
Grade 3 	6 (37.5%) 	4 (25.0%) 	10 (52.6%) 	-15.1 (-47.8, 17.5) 	-27.6 (-58.5, 3.3) 	
Grade 4 	1 (6.2%) 	1 (6.2%) 	2 (10.5%) 	-4.3 (-22.5, 13.9) 	-4.3 (-22.5, 13.9) 	
 	 	 	 	 	 	
Hyponatremia 	 	 	 	 	 	
N 	16 	15 	19 	 	 	
Grade 1 	14 (87.5%) 	11 (73.3%) 	17 (89.5%) 	-2.0 (-23.3, 19.3) 	-16.1 (-42.4, 10.2) 	
Grade 3 	5 (31.2%) 	8 (53.3%) 	7 (36.8%) 	-5.6 (-37.0, 25.8) 	16.5 (-16.8, 49.8) 	
Grade 4 	2 (12.5%) 	1 (6.7%) 	0 	12.5 (-3.7, 28.7) 	6.7 (-6.0, 19.3) 	
Age: ≥75 years 	29 	51 	33 	 	 	
 	  	  	  	  	  	
Blood and lymphatic system disorders 	 	 	 	 	 	
Anemia 	 	 	 	 	 	
N 	29 	51 	33 	 	 	
Grade 1 	24 (82.8%) 	41 (80.4%) 	29 (87.9%) 	-5.1 (-22.8, 12.6) 	-7.5 (-23.1, 8.1) 	
Grade 2 	19 (65.5%) 	25 (49.0%) 	21 (63.6%) 	1.9 (-22.0, 25.7) 	-14.6 (-36.0, 6.8) 	
Grade 3 	10 (34.5%) 	23 (45.1%) 	12 (36.4%) 	-1.9 (-25.7, 22.0) 	8.7 (-12.6, 30.1) 	
 	 	 	 	 	 	
Leukocytosis 	 	 	 	 	 	
N 	29 	51 	33 	 	 	
Grade 3 	0 	0 	0 	0.0 (0.0, 0.0) 	0.0 (0.0, 0.0) 	
 	 	 	 	 	 	
Metabolism and nutritional disorders 	 	 	 	 	 	
Hyperkalemia 	 	 	 	 	 	
N 	29 	51 	33 	 	 	
Grade 1 	1 (3.4%) 	0 	1 (3.0%) 	0.4 (-8.4, 9.3) 	-3.0 (-8.9, 2.8) 	
Grade 2 	0 	0 	1 (3.0%) 	-3.0 (-8.9, 2.8) 	-3.0 (-8.9, 2.8) 	
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 	29 	51 	33 	 	 	
Grade 1 	5 (17.2%) 	4 (7.8%) 	4 (12.1%) 	5.1 (-12.6, 22.8) 	-4.3 (-17.6, 9.1) 	
Grade 2 	1 (3.4%) 	0 	0 	3.4 (-3.2, 10.1) 	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 	29 	51 	33 	 	 	
Grade 1 	25 (86.2%) 	38 (74.5%) 	25 (75.8%) 	10.4 (-8.8, 29.7) 	-1.2 (-20.1, 17.6) 	
Grade 2 	17 (58.6%) 	31 (60.8%) 	20 (60.6%) 	-2.0 (-26.5, 22.5) 	0.2 (-21.2, 21.6) 	
Grade 3 	14 (48.3%) 	15 (29.4%) 	12 (36.4%) 	11.9 (-12.6, 36.4) 	-7.0 (-27.6, 13.7) 	
 	 	 	 	 	 	
Hypoglycemia 	 	 	 	 	 	
N 	29 	50 	33 	 	 	
Grade 1 	24 (82.8%) 	36 (72.0%) 	30 (90.9%) 	-8.2 (-25.0, 8.7) 	-18.9 (-34.8, -3.1) 	
Grade 2 	21 (72.4%) 	25 (50.0%) 	21 (63.6%) 	8.8 (-14.3, 31.9) 	-13.6 (-35.1, 7.8) 	
Grade 3 	9 (31.0%) 	17 (34.0%) 	14 (42.4%) 	-11.4 (-35.2, 12.4) 	-8.4 (-29.8, 12.9) 	
Grade 4 	2 (6.9%) 	0 	2 (6.1%) 	0.8 (-11.5, 13.1) 	-6.1 (-14.2, 2.1) 	
 	 	 	 	 	 	
Hypokalemia 	 	 	 	 	 	
N 	29 	51 	31 	 	 	
Grade 2 	22 (75.9%) 	28 (54.9%) 	22 (71.0%) 	4.9 (-17.4, 27.2) 	-16.1 (-37.1, 5.0) 	
Grade 3 	17 (58.6%) 	17 (33.3%) 	15 (48.4%) 	10.2 (-14.9, 35.3) 	-15.1 (-36.9, 6.8) 	
Grade 4 	3 (10.3%) 	5 (9.8%) 	2 (6.5%) 	3.9 (-10.2, 18.0) 	3.4 (-8.5, 15.2) 	
 	 	 	 	 	 	
Hyponatremia 	 	 	 	 	 	
N 	29 	51 	33 	 	 	
Grade 1 	26 (89.7%) 	38 (74.5%) 	29 (87.9%) 	1.8 (-13.9, 17.5) 	-13.4 (-29.7, 3.0) 	
Grade 3 	13 (44.8%) 	19 (37.3%) 	15 (45.5%) 	-0.6 (-25.5, 24.2) 	-8.2 (-29.8, 13.4) 	
Grade 4 	3 (10.3%) 	0 	0 	10.3 (-0.7, 21.4) 	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.