CDISC Pilot: Primary Endpoint Analysis: ADAS Cog (11) - Change from Baseline to Week 24 - LOCF
tlf-primary.RmdThe Pilot 1 Team generated the below output using R and it was delivered to the FDA. You can find the source code that generated this output here and a deeper dive of the process here. We delivered the identical output with the R generated ADaM.
# Working directory requires write permission
if (file.access(".", 2) != 0) {
warning(
"The working directory '", normalizePath("."), "' is not writable.\n",
"Please change it to a location with write permission."
)
}## Placebo\line( Xanomeline\li Xanomeline\li
## N=79) ne Low ne High
## Dose\line(N=8 Dose\line(N=7
## 1) 4)
## ──────────────────────────────────────────────────────────────────────────────
## Baseline
## n 79 81 74
## Mean (SD) 24.1 (12.19) 24.4 (12.92) 21.3 (11.74)
## Median (Range) 21.0 ( 5;61) 21.0 ( 5;57) 18.0 ( 3;57)
## Week 24
## n 79 81 74
## Mean (SD) 26.7 (13.79) 26.4 (13.18) 22.8 (12.48)
## Median (Range) 24.0 ( 5;62) 25.0 ( 6;62) 20.0 ( 3;62)
## Change from Baseline
## n 79 81 74
## Mean (SD) 2.5 ( 5.80) 2.0 ( 5.55) 1.5 ( 4.26)
## Median (Range) 2.0 (-11;16) 2.0 (-11;17) 1.0 ( -7;13)
## p-value(Dose Response) 0.245
## [1][2]
##
## p-value(Xan - Placebo) 0.569 0.233
## [1][3]
## Diff of LS Means (SE) -0.5 (0.82) -1.0 (0.84)
## 95% CI (-2.1;1.1) (-2.7;0.7)
##
## p-value(Xan High - Xan 0.520
## Low) [1][3]
## Diff of LS Means (SE) -0.5 (0.84)
## 95% CI (-2.2;1.1)
##
## Column names: row_label, var1_Placebo, var1_Xanomeline Low Dose,
## var1_Xanomeline High Dose