Extent of Exposure to Study Drug
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=96)	(N=72)	(N=254)	
Duration of exposure (days)					
n	86	96	72	254	
Mean (SD)	147.8 (62.13)	85.9 (70.66)	112.2 (65.52)	114.3 (71.17)	
Median	182.0	62.5	96.5	130.5	
Q1, Q3	130.0, 183.0	21.5, 180.5	53.5, 183.0	43.0, 183.0	
Min, Max	0, 210	0, 212	15, 200	0, 212	
Total dose administered (mg)					
Mean (SD)	0.0 (0.0)	4638.9 (3815.6)	8341.5 (5182.9)	4117.8 (4893.8)	
Median	0.0	3375.0	7114.5	2025.0	
Min, Max	0, 0	0, 11448	810, 15417	0, 15417	
Average daily dose (mg)					
Mean (SD)	0.00 (0.00)	54.00 (0.00)	72.89 (9.68)	41.18 (30.85)	
Median	0.00	54.00	75.90	54.00	
Overall dose intensity (%)					
n	0	95	72	167	
Mean (SD)		100.0 (0.00)	135.0 (17.92)	115.1 (20.96)	
Median		100.0	140.6	100.0	
Cumulative exposure, n (%)					
≥ 1 day	85 (98.8%)	95 (99.0%)	72 (100.0%)	252 (99.2%)	

Extent of Exposure to Study Drug
Study CDISCPILOT01 — Safety Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=96)	(N=72)	(N=254)	
≥ 30 days	78 (90.7%)	65 (67.7%)	67 (93.1%)	210 (82.7%)	
≥ 90 days	67 (77.9%)	40 (41.7%)	38 (52.8%)	145 (57.1%)	
≥ 180 days	55 (64.0%)	25 (26.0%)	26 (36.1%)	106 (41.7%)	
Duration, total dose, average daily dose and dose intensity are the overall-study ADEX parameters TDURD, TDOSE, AVDDSE and TDOSINT respectively.
Exposure categories are cumulative: a subject exposed for 200 days is counted in every category up to 180 days.
Q1 and Q3 are type-2 (SAS-compatible) quantiles, as computed by {cards}; they differ from R’s default type-7 quantiles.
Percentages are based on the number of subjects in the safety analysis set for each treatment group.
Placebo subjects have no ADEX dose-intensity (TDOSINT) records because planned placebo dose is zero; the dose-intensity rows are therefore empty for that column.	
Source: adex, adsl (pharmaverseadam). Data cut-off: 2014-07-01. open.csr display t-exposure (post-text variant); generated from the committed ARD.