ADAS-Cog (11) - Change from Baseline to Week 24 - Completers at Week 24, Observed Cases, Windowed
Study CDISCPILOT01 — Efficacy Analysis Set, Week 24 completers
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	
	(N=60)	(N=28)	(N=30)	
Baseline				
n	59	27	30	
Mean (SD)	23.2 (11.74)	24.0 (13.89)	20.5 (11.50)	
Median (Range)	21.0 (5;51)	20.0 (5;57)	18.0 (3;49)	
Week 24				
n	59	27	30	
Mean (SD)	25.3 (13.32)	24.1 (11.87)	21.8 (12.60)	
Median (Range)	23.0 (5;58)	22.0 (8;51)	18.5 (3;44)	
Change from baseline				
n	59	27	30	
Mean (SD)	2.1 (5.89)	0.1 (5.86)	1.3 (4.51)	
Median (Range)	2.0 (-11;16)	1.0 (-11;12)	1.0 (-7;13)	
Statistical comparison of the change from baseline				
p-value (dose response) [1][2]			0.234	
p-value (Xanomeline - Placebo) [1][3]		0.105	0.461	
Difference of LS means (SE)		-2.1 (1.26)	-0.9 (1.22)	
95% CI		(-4.6;0.4)	(-3.3;1.5)	

ADAS-Cog (11) - Change from Baseline to Week 24 - Completers at Week 24, Observed Cases, Windowed
Study CDISCPILOT01 — Efficacy Analysis Set, Week 24 completers
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	
	(N=60)	(N=28)	(N=30)	
p-value (Xanomeline High - Xanomeline Low) [1][3]			0.430	
Difference of LS means (SE)			1.2 (1.47)	
95% CI			(-1.8;4.1)	
[1] Based on an analysis of covariance (ANCOVA) model with treatment and site group as factors and the baseline score as a covariate.
[2] Test for a non-zero coefficient for treatment (dose) as a continuous variable.
[3] Pairwise comparison with treatment as a categorical variable; p-values are not adjusted for multiple comparisons.
Only assessments falling within the Week 24 assessment window are included, and no value is imputed.
Baseline, on-treatment and change statistics are summarised over one record per subject at the analysis visit, so a subject with no assessment in that window contributes to none of the three and n is smaller than the column N.
Treatment columns are planned treatment (TRTP), which is how the CDISCPILOT01 reference report presents them.
CDISCPILOT01 states no data cut-off date. The date shown is the latest ADAS-Cog assessment date present in the vendored ADaM package.	
Source: adqsadas (ADAS-Cog (11) total score, PARAMCD ACTOT) and adsl, from the CDISC pilot's own ADaM package (phuse-org/phuse-scripts, MIT). Analysis as specified in the CDISCPILOT01 statistical analysis plan, section 10.1.1. Reference report display: Table 14-3.07. Data cut-off: 2015-02-17. open.csr display t-eff-adas-wk24-completers (post-text variant); generated from the committed ARD.