Table 2 One-arm simulation results for the 10 mg control arm.

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 control arm Simulated control
Random sampling Proportional sampling
No. of subjects 471 400 240
Mean age (years) 73.8 78.5 ± 0.1 78.2 ± 0.1
Gender    
 Female 62.4% 70.1 ± 0.1% 66.1 ± 0.1%
 Male 37.6% 29.9 ± 0.1% 33.9 ± 0.1%
Race    
 White 73.5% 28.1 ± 0.1% 73.3 ± 0.1%
 Black 1.9% 16.0 ± 0.1% 2.1 ± 0.1%
 Hispanic 5.5% 24.5 ± 0.1% 5.4 ± 0.1%
 Asian & other 19.1% 31.3 ± 0.2% 19.2% ± 0.1%
SAEa rates (patient with ≥1 SAE) 8.3% 15.5 ± 0.1% 8.9 ± 0.1%
Mean SAE (average SAE per patient) 0.14 0.64 ± 0.01 0.48 ± 0.01
SAE event rates by category
 Blood and lymphatic system disorders 0/471 (0.00%) 4.9 ± 0.1% 3.2 ± 0.1%
 Cardiac disorders 6/471 (1.23%) 2.9 ± 0.1% 2.0 ± 0.1%
 Eye disorders 1/471 (0.2%) 0 0
 Gastrointestinal disorders 2/471 (0.4%) 7.0 ± 0.1% 5.9 ± 0.1%
 General disorders 3/471 (0.6%) 1.7 ± 0.1% 1.1 ± 0.1%
 Hepatobiliary disorders 2/471 (0.4%) 1.2 ± 0.1% 1.9 ± 0.1%
 Infections and infestations 9/471 (1.9%) 5.8 ± 0.1% 4.7 ± 0.1%
 Injury, poisoning, and procedural complications 8/471 (1.7%) 3.2 ± 0.1% 3.0 ± 0.1%
 Musculoskeletal and connective tissue disorders 2/471 (0.4%) 0.7 ± 0.1% 0.8 ± 0.1%
 Neoplasms benign, malignant, and unspecified 2/471 (0.4%) 0 0
 Nervous system disorders 15/471 (3.3%) 6.6 ± 0.1% 4.8 ± 0.2%
 Psychiatric disorders 11/471 (2.3%) 3.3 ± 0.1% 2.5 ± 0.1%
 Renal and urinary disorders 2/471 (0.4%) 4.2 ± 0.1% 1.9 ± 0.1%
 Reproductive system and breast disorders 0 0 0
 Respiratory, thoracic, and mediastinal disorders 1/471 (0.2%) 1.0 ± 0.1% 1.4 ± 0.1%
 Vascular disorders 1/471 (0.2%) 0.7 ± 0.1% 0.3 ± 0.1%
  1. aSAE: serious adverse event.