Table 3 Results of the two-arm simulation for proportional 1:1 and 1:3 matching.

From: Exploring the feasibility of using real-world data from a large clinical data research network to simulate clinical trials of Alzheimer’s disease

  Original trial Simulated trial
Proportional 1:1 matching Proportional 1:3 matching
  23 mg 10 mg 23 mg 10 mg 23 mg 10 mg
No. of subjects 963 471 24 24 24 72
Mean age (years) 73.9 73.8 79.2 ± 0.1 79.5 ± 0.2 79.1 ± 0.1 79.4 ± 0.2
Gender       
 Female 63.0% 62.4% 70.2 ± 0.6% 69.8 ± 0.7% 70.4 ± 0.6% 69.4 ± 0.6%
 Male 37.0% 37.6% 29.8 ± 0.6% 30.2 ± 0.7% 29.6 ± 0.6% 30.6 ± 0.6%
Race       
 White 73.5% 73.5% 70.8 ± 0.1% 70.3 ± 0.1% 70.8 ± 0.1% 70.2 ± 0.1%
 Hispanic 7.0% 5.5% 8.3 ± 0.1% 7.9 ± 0.3% 8.3 ± 0.1% 8.1 ± 0.3%
 Black 2.3% 1.9% 4.2 ± 0.1% 4.2 ± 0.3% 4.2 ± 0.1% 4.2 ± 0.2%
 Asian & other 17.2% 0.6% 16.7 ± 0.1% 17.6 ± 0.3% 16.7 ± 0.1% 17.6 ± 0.3%
Charlson Comorbidity Index N/A 1.25 ± 0.02 1.17 ± 0.03 1.25 ± 0.02 1.23 ± 0.02
SAEa rates (patient with ≥1 SAE) 9.6% 8.3% 9.8 ± 0.4% 12.6 ± 0.4% 9.4 ± 0.2% 11.2 ± 0.2%
Mean SAE (average SAE per patient) 0.15 0.14 0.99 ± 0.05 0.46 ± 0.05 0.99 ± 0.05 0.47 ± 0.02
SAE event rates by category
 Blood and lymphatic system disorders 0.2% 0 14.5 ± 0.9% 0.052 ± 0.004 0.146 ± 0.10 0.042 ± 0.001
 Cardiac disorders 1.9% 1.3% 6.7 ± 0.3% 0.012 ± 0.001 0.068 ± 0.005 0.016 ± 0.015
 Eye disorders 0 0.2% 0 0 0 0
 Gastrointestinal disorders 2.4% 0.4% 0 0.082 ± 0.004 0 0.059 ± 0.057
 General disorders 0.6% 0.6% 1.1 ± 0.1% 0.006 ± 0.001 0.010 ± 0.001 0.008 ± 0.001
 Hepatobiliary disorders 0.5% 0.4% 0 0.007 ± 0.002 0 0.009 ± 0.001
 Infections and infestations 1.3% 1.9% 20.1 ± 0.1% 0.026 ± 0.002 0.199 ± 0.010 0.037 ± 0.002
 Injury, poisoning, and procedural complications 2.5% 1.9% 0 0.014 ± 0.003 0 0.021 ± 0.004
 Musculoskeletal and connective tissue disorders 0.3% 0.4% 0 0.019 ± 0.001 0 0.013 ± 0.001
 Neoplasms benign, malignant, and unspecified 1.5% 3.2% 0 0 0 0
 Nervous system disorders 1.5% 3.2% 9.8 ± 0.3% 0.039 ± 0.002 0.094 ± 0.003 0.042 ± 0.002
 Psychiatric disorders 1.1% 2.3% 2.0 ± 0.5% 0.019 ± 0.002 0.019 ± 0.001 0.023 ± 0.001
 Renal and urinary disorders 0.4% 0.004 27.9 ± 1.8% 0.011 ± 0.002 0.281 ± 0.018 0.016 ± 0.001
 Reproductive system and breast disorders 0.1% 0 0 0 0 0
 Respiratory, thoracic, and mediastinal disorders 0.1% 0.2% 0 0.011 ± 0.001 0 0.014 ± 0.007
 Vascular disorders 0.5% 0.2% 0 0.003 ± 0.001 0 0.003 ± 0.001
  1. aSAE: serious adverse event.