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.
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