CDISC Pilot: Efficacy Tables

The 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.

##                    Trt N1         Mean1 N2         Mean2 N3         Mean3
## 1 Xanomeline High Dose 84   5.4 ( 1.34) 31   5.8 ( 1.61) 31   0.2 ( 1.47)
## 2              Placebo 86   5.6 ( 2.14) 65   5.8 ( 1.50) 65   0.1 ( 2.08)
##                    CI
## 1  0.16 (-0.31, 0.63)
## 2  0.09 (-0.23, 0.42)

##                               comp                mean       p
## 1 Xanomeline High Dose vs. Placebo  0.07 (-0.50, 0.63)   0.822

##                                       rmse
## 1 Root Mean Squared Error of Change = 1.30