TSFLAB05:	Subjects With [Last/Any] On-treatment Laboratory Values [= Grade 2] Based on NCI-CTCAE Criteria; Safety Analysis Set (Study jjcs - core)						
 	Active Study Agent 	Active Study Agent 	 	Risk Difference (%) (95% CI) 	Risk Difference (%) (95% CI) 	
Laboratory Category 	Xanomeline High Dose 	Xanomeline Low Dose 	Placebo 	Xanomeline High Dose vs Placebo 	Xanomeline Low Dose vs Placebo 	
  Laboratory Test ≥ Grade 2, n (%) 	N=53 	N=73 	N=59 	  	  	
Blood and lymphatic system disorders 	 	 	 	 	 	
Anemia 	28/53 (52.8%) 	36/73 (49.3%) 	33/59 (55.9%) 	-3.1 (-21.6, 15.4) 	-6.6 (-23.7, 10.5) 	
Leukocytosis 	0/53 (0.0%) 	0/73 (0.0%) 	0/59 (0.0%) 	0.0 (0.0, 0.0) 	0.0 (0.0, 0.0) 	
 	 	 	 	 	 	
Investigations 	 	 	 	 	 	
Alanine aminotransferase increased 	0/53 (0.0%) 	0/73 (0.0%) 	1/59 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
Alkaline phosphatase increased 	0/53 (0.0%) 	0/73 (0.0%) 	1/59 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
Aspartate aminotransferase increased 	1/53 (1.9%) 	1/73 (1.4%) 	1/59 (1.7%) 	0.2 (-4.7, 5.1) 	-0.3 (-4.6, 3.9) 	
Blood bilirubin increased 	2/53 (3.8%) 	1/73 (1.4%) 	0/59 (0.0%) 	3.8 (-1.4, 8.9) 	1.4 (-1.3, 4.0) 	
Cholesterol high 	2/53 (3.8%) 	2/73 (2.7%) 	3/59 (5.1%) 	-1.3 (-8.9, 6.3) 	-2.3 (-9.1, 4.4) 	
Creatinine increased 	0/53 (0.0%) 	0/73 (0.0%) 	0/59 (0.0%) 	0.0 (0.0, 0.0) 	0.0 (0.0, 0.0) 	
Platelet count decreased 	26/53 (49.1%) 	32/73 (43.8%) 	24/59 (40.7%) 	8.4 (-10.0, 26.8) 	3.2 (-13.8, 20.1) 	
White blood cell decreased 	24/53 (45.3%) 	25/73 (34.2%) 	33/59 (55.9%) 	-10.6 (-29.1, 7.8) 	-21.7 (-38.4, -5.0) 	
 	 	 	 	 	 	
Metabolism and nutritional disorders 	 	 	 	 	 	
CD4 lymphocytes decreased 	23/53 (43.4%) 	32/73 (43.8%) 	34/59 (57.6%) 	-14.2 (-32.6, 4.1) 	-13.8 (-30.8, 3.2) 	
Hyperglycemia 	4/53 (7.5%) 	1/73 (1.4%) 	0/59 (0.0%) 	7.5 (0.4, 14.7) 	1.4 (-1.3, 4.0) 	
Hyperkalemia 	0/53 (0.0%) 	0/73 (0.0%) 	1/59 (1.7%) 	-1.7 (-5.0, 1.6) 	-1.7 (-5.0, 1.6) 	
Hypernatremia 	1/53 (1.9%) 	0/73 (0.0%) 	0/59 (0.0%) 	1.9 (-1.8, 5.5) 	0.0 (0.0, 0.0) 	
Hypoalbuminemia 	29/53 (54.7%) 	27/73 (37.0%) 	33/59 (55.9%) 	-1.2 (-19.7, 17.2) 	-18.9 (-35.8, -2.1) 	
Hypoglycemia 	35/53 (66.0%) 	32/73 (43.8%) 	35/59 (59.3%) 	6.7 (-11.2, 24.6) 	-15.5 (-32.4, 1.4) 	
Hypokalemia 	29/53 (54.7%) 	32/73 (43.8%) 	29/59 (49.2%) 	5.6 (-12.9, 24.1) 	-5.3 (-22.4, 11.8) 	
Hyponatremia 	30/53 (56.6%) 	37/73 (50.7%) 	25/59 (42.4%) 	14.2 (-4.1, 32.6) 	8.3 (-8.7, 25.4) 	

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.