CDISC Pilot: Summary of Demographic and Baseline Characteristics
tlf-demographic.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.
## Protocol: CDISCPILOT01
## Population: Intent-to-Treat
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## Placebo Xanomeline Low Dose Xanomeline High Dose
## (N=86) (N=84) (N=84)
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## Age
## Mean (sd) 75.21 (8.59) 75.67 (8.29) 74.38 (7.89)
## Median 76.00 77.50 76.00
## Min - Max 52.00 - 89.00 51.00 - 88.00 56.00 - 88.00
## Pooled Age Group 1
## <65 14 8 11
## 65-80 42 47 55
## >80 30 29 18
## Race
## WHITE 78 78 74
## BLACK OR AFRICAN AMERICAN 8 6 9
## AMERICAN INDIAN OR ALASKA NATIVE 0 0 1
## Baseline Height (cm)
## Mean (sd) 162.57 (11.52) 163.43 (10.42) 165.82 (10.13)
## Median 162.60 162.60 165.10
## Min - Max 137.20 - 185.40 135.90 - 195.60 146.10 - 190.50
## Baseline Weight (kg)
## Mean (sd) 62.76 (12.77) 67.28 (14.12) 70.00 (14.65)
## Median 60.55 64.90 69.20
## Min - Max 34.00 - 86.20 45.40 - 106.10 41.70 - 108.00
## Baseline BMI (kg/m^2)
## Mean (sd) 23.64 (3.67) 25.06 (4.27) 25.35 (4.16)
## Median 23.40 24.30 24.80
## Min - Max 15.10 - 33.30 17.70 - 40.10 13.70 - 34.50
## MMSE Total
## Mean (sd) 18.05 (4.27) 17.87 (4.22) 18.51 (4.16)
## Median 19.50 18.00 20.00
## Min - Max 10.00 - 23.00 10.00 - 24.00 10.00 - 24.00
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## Program: tlf_demographic.Rmd
## 2024-03-22 19:18:44