Summary of Vital Signs Change from Baseline at End of Treatment
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	
	(N=86)	(N=84)	(N=84)	
Systolic Blood Pressure (mmHg)				
After lying down for 5 minutes				
Week 24				
n	58	27	30	
Mean (SD)	-2.1 (14.73)	-0.3 (17.19)	-5.6 (17.18)	
Median	-4.0	2.0	-7.0	
Min, Max	-28.0, 50.0	-48.0, 30.0	-36.0, 26.0	
End of treatment				
n	83	84	82	
Mean (SD)	-2.0 (16.76)	-3.1 (16.57)	-5.8 (14.48)	
Median	-4.0	-2.0	-8.0	
Min, Max	-32.0, 50.0	-48.0, 34.0	-36.0, 29.0	
After standing for 1 minute				
Week 24				
n	58	27	30	
Mean (SD)	-1.7 (16.87)	-0.1 (17.73)	-6.3 (19.49)	
Median	0.0	-1.0	-9.0	
Min, Max	-32.0, 40.0	-30.0, 48.0	-36.0, 42.0	
End of treatment				
n	83	84	82	

Summary of Vital Signs Change from Baseline at End of Treatment
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	
	(N=86)	(N=84)	(N=84)	
Mean (SD)	-1.6 (17.76)	-2.8 (17.40)	-6.7 (16.98)	
Median	0.0	-1.5	-8.0	
Min, Max	-46.0, 48.0	-52.0, 48.0	-44.0, 42.0	
After standing for 3 minutes				
Week 24				
n	58	27	30	
Mean (SD)	-1.0 (15.80)	-0.1 (16.20)	-9.0 (16.88)	
Median	-3.5	0.0	-8.0	
Min, Max	-36.0, 38.0	-30.0, 30.0	-40.0, 30.0	
End of treatment				
n	83	83	81	
Mean (SD)	-2.5 (16.61)	-3.5 (16.51)	-8.3 (15.21)	
Median	-4.0	-4.0	-8.0	
Min, Max	-40.0, 48.0	-52.0, 60.0	-40.0, 30.0	
Diastolic Blood Pressure (mmHg)				
After lying down for 5 minutes				
Week 24				
n	58	27	30	
Mean (SD)	-0.8 (10.82)	-0.9 (7.71)	-2.2 (9.20)	
Median	-0.5	-2.0	-1.0	

Summary of Vital Signs Change from Baseline at End of Treatment
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	
	(N=86)	(N=84)	(N=84)	
Min, Max	-18.0, 41.0	-20.0, 16.0	-20.0, 21.0	
End of treatment				
n	83	84	82	
Mean (SD)	-1.0 (10.99)	-2.0 (8.80)	-3.1 (8.79)	
Median	0.0	-2.0	-4.0	
Min, Max	-34.0, 41.0	-30.0, 18.0	-24.0, 21.0	
After standing for 1 minute				
Week 24				
n	58	27	30	
Mean (SD)	-2.3 (10.08)	1.0 (7.30)	-2.3 (10.85)	
Median	-4.0	2.0	-7.0	
Min, Max	-23.0, 24.0	-20.0, 18.0	-18.0, 22.0	
End of treatment				
n	83	84	82	
Mean (SD)	-2.8 (10.17)	-1.2 (8.93)	-2.1 (12.10)	
Median	-2.0	0.0	-2.0	
Min, Max	-34.0, 24.0	-30.0, 20.0	-34.0, 28.0	
After standing for 3 minutes				
Week 24				
n	58	27	30	

Summary of Vital Signs Change from Baseline at End of Treatment
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	
	(N=86)	(N=84)	(N=84)	
Mean (SD)	-2.3 (9.56)	-1.6 (8.29)	-2.1 (9.77)	
Median	-3.5	0.0	-3.5	
Min, Max	-22.0, 20.0	-20.0, 10.0	-20.0, 16.0	
End of treatment				
n	83	83	81	
Mean (SD)	-2.7 (9.36)	-1.8 (9.69)	-2.6 (10.81)	
Median	-2.0	-1.0	-2.0	
Min, Max	-30.0, 20.0	-24.0, 38.0	-40.0, 27.0	
Pulse (beats/min)				
After lying down for 5 minutes				
Week 24				
n	58	27	30	
Mean (SD)	-0.3 (8.77)	-1.6 (10.53)	-2.0 (11.16)	
Median	-1.0	0.0	-2.0	
Min, Max	-24.0, 24.0	-24.0, 25.0	-34.0, 20.0	
End of treatment				
n	83	84	82	
Mean (SD)	-0.9 (8.69)	-1.0 (11.12)	-1.7 (8.95)	
Median	-1.0	-0.5	-2.0	
Min, Max	-24.0, 24.0	-24.0, 32.0	-34.0, 20.0	

Summary of Vital Signs Change from Baseline at End of Treatment
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	
	(N=86)	(N=84)	(N=84)	
After standing for 1 minute				
Week 24				
n	58	27	30	
Mean (SD)	-1.7 (11.72)	-1.3 (9.05)	-1.8 (13.41)	
Median	0.5	0.0	-3.0	
Min, Max	-53.0, 18.0	-20.0, 12.0	-36.0, 20.0	
End of treatment				
n	83	84	82	
Mean (SD)	-1.8 (11.05)	-0.5 (11.69)	-2.1 (10.43)	
Median	-1.0	0.0	-1.5	
Min, Max	-53.0, 20.0	-24.0, 34.0	-36.0, 22.0	
After standing for 3 minutes				
Week 24				
n	58	27	30	
Mean (SD)	-1.5 (10.47)	-2.1 (8.77)	-2.7 (11.12)	
Median	0.0	-2.0	-2.0	
Min, Max	-46.0, 14.0	-20.0, 16.0	-40.0, 14.0	
End of treatment				
n	83	83	81	
Mean (SD)	-1.0 (9.89)	-0.7 (10.73)	-1.9 (9.49)	

Summary of Vital Signs Change from Baseline at End of Treatment
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	
	(N=86)	(N=84)	(N=84)	
Median	0.0	-1.0	-1.0	
Min, Max	-46.0, 18.0	-22.0, 29.0	-40.0, 20.0	
Treatment groups are PLANNED treatment (TRT01P). Twelve subjects in this study received a treatment other than the one they were randomised to; grouping by actual treatment (TRT01A) would give column sizes of 86, 96 and 72.
Blood pressure and pulse are measured in three positions and each position is summarised as its own series: a subject's baseline after standing for three minutes is not the baseline for their supine measurement.
End of treatment is the last observed measurement of that parameter in that position, at a planned visit after Week 0 up to and including Week 24. Unscheduled visits, the Week 26 follow-up visit and records derived by averaging or carry-forward are never selected.
Change from baseline is the subject's value minus that subject's own observed Week 0 value in the same position. A subject with no Week 0 measurement contributes to no row here, so n can be one below the corresponding n in the vital signs summary.
n is the number of subjects contributing a change; N in the column header is the number of subjects in the safety analysis set.	
Source: advs, adsl (pharmaverseadam). Data cut-off: 2014-07-01. open.csr display t-vitals-change (post-text variant); generated from the committed ARD.