Table 1 Population characteristics and SAE statistics of the target trial vs. TP, SP, and NEP from OneFlorida.

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

  23 mg Arm 10 mg Arm
  Original triala Overall TPb Overall SPc Overall NEPd Original trial Overall TPe Overall SPf Overall NEPg
No. of subjects 963 90 38 52 471 2048 782 1266
Age (years), mean (SD) 73.9 (8.53) 74.3 (9.01) 73.3 (9.01) 81.6 (12.37) 73.8 (8.56) 73.4 (11.0) 74.2 (9.67) 77.1 (11.8)
Gender
 Male 356 (37.0%) 24 (26.7%) 10 (26.3%) 14 (26.9%) 177 (37.6%) 727 (35.5%) 234 (29.9%) 493 (38.9%)
 Female 607 (63.0%) 66 (73.3%) 28 (73.7%) 38 (73.1%) 294 (62.4%) 1321 (64.5%) 548 (70.1%) 773 (61.1%)
Race
 White 708 (73.5%) 63 (70.0%) 25 (65.8%) 38 (73.1%) 346 (73.5%) 829 (40.5%) 280 (35.8%) 549 (43.4%)
 Asian/Pacific 161 (16.7%) 0 (0%) 0 (0%) 0 (0%) 87 (18.5%) 22 (1.1%) 11 (1.4%) 11 (0.9%)
 Hispanic 67 (7.0%) 15 (16.7%) 4 (10.5%) 11 (21.2%) 26 (5.5%) 440 (21.5%) 192 (24.6%) 248 (19.6%)
 Black 22 (2.3%) 11 (12.2%) 4 (10.5%) 7 (13.5%) 9 (1.9%) 380 (18.6%) 126 (16.1%) 254 (20.1%)
 Other 5 (0.5%) 1 (1.1%) 5 (13.2%) 7 (13.5%) 3 (0.6%) 377 (18.4%) 173 (22.1%) 204 (16.1%)
CCIh N/A 1.54 1.32 1.53 N/A 2.36 1.64 2.36
Mean SAEi 0.15 1.89 0.92 2.60 0.14 1.68 0.64 2.59
No. of patients with ≥1 SAE 45 (9.6%) 20 (22.2%) 4 (10.5%) 16 (30.7%) 80 (8.3%) 573 (28.0%) 121 (15.5%) 452 (35.7%)
  1. aReported in the original trial on ClinicalTrials.gov.
  2. bTP: Target population—patients who (1) had the disease of interest (i.e., AD), and (2) had used the study drug (i.e., donepezil) for a specific time period according to the study protocol.
  3. cSP: Study population—patients in the TP who met the computable eligibility criteria of the original trial.
  4. dNEP: Trial not eligible population—patients in the TP who did NOT meet the eligibility criteria of the original trial.
  5. eThe original trial reported Hispanic as a race, thus, we followed the same convention to make sure the results are comparable even though race and ethnicity are two different fields in OneFlorida.
  6. fCharlson Comorbidity Index.
  7. gMean SAE: average number of SAEs per patient.
  8. hCCI: Charlson Comorbidity Index.
  9. iSAE: Serious adverse event.