Table 2 Baseline descriptions of the pseudonymized and anonymized real-world data and randomized controlled trial data sets
From: Utilization of anonymization techniques to create an external control arm for clinical trial data
Variable | Pseudonymized | Anonymized | RCT |
|---|---|---|---|
RWD | RWD | ||
N | 3,327 | 3,327 | 250 |
Age, mean (SD) | 75.92 (9.19) | 75.84 (10.22) | 74.27 (8.32) |
Anemia, n (%) | 761 (22.9) | 770 (23.1) | 26 (10.4) |
Anti-diabetic medication use, n (%) | 954 (28.7) | 963 (28.9) | 76 (30.4) |
Anti-hypertensive medication use, n (%) | 3,228 (97.0) | 3,229 (97.1) | 247 (98.8) |
Aortic arteriosclerosis, n (%) | < 5 (< 0.2) | < 5 (< 0.2) | < 5 (< 2.0) |
Arterial hypertension, n (%) | 2,226 (66.9) | 2,223 (66.8) | 220 (88.0) |
BMI ≥ 30 kg/m2, n (%) | 470 (14.1) | 485 (14.6) | 84 (33.6) |
Carotid endarterectomy or stent, n (%) | 9 (0.3) | 9 (0.3) | < 5 (< 2.0) |
Chronic heart failure, n (%) | 696 (20.9) | 710 (21.3) | 117 (46.8) |
Chronic kidney disease, n (%) | 477 (14.3) | 477 (14.3) | 41 (16.4) |
COPD, n (%) | 152 (4.6) | 181 (5.4) | 24 (9.6) |
Coronary artery disease, n (%) | 709 (21.3) | 729 (21.9) | 50 (20.0) |
Diabetes mellitus, n (%) | 832 (25.0) | 832 (25.0) | 87 (34.8) |
History of ISTH major bleeding, n (%) | 137 (4.1) | 149 (4.5) | 22 (8.8) |
History of osteoporotic fracture, n (%) | 165 (5.0) | 175 (5.3) | 5 (2.0) |
History of stroke, n (%) | 305 (9.2) | 313 (9.4) | 20 (8.0) |
Hyperlipidemia, n (%) | 565 (17.0) | 579 (17.4) | 92 (36.8) |
Hyperthyroidism, n (%) | 70 (2.1) | 72 (2.2) | < 5 (< 2.0) |
Hypothyroidism, n (%) | 530 (15.9) | 543 (16.3) | 28 (11.2) |
Low body weight (body weight < 60 kg), n (%) | 3,091 (92.9) | 3,063 (92.1) | 221 (88.4) |
Malignancy, n (%) | 441 (13.3) | 442 (13.3) | 45 (18.0) |
Myocardial infarction, n (%) | 161 (4.8) | 165 (5.0) | 36 (14.4) |
Non-steroidal anti-inflammatory drugs, n (%) | 825 (24.8) | 833 (25.0) | 18 (7.2) |
Percutaneous coronary intervention, n (%) | 202 (6.1) | 203 (6.1) | 15 (6.0) |
Peripheral arterial disease, n (%) | 113 (3.4) | 118 (3.5) | 20 (8.0) |
Platelet aggregation inhibitors, n (%) | 3,023 (90.9) | 3,018 (90.7) | 234 (93.6) |
Prior or concomitant use of Histamine-2, n (%) | 18 (0.5) | 18 (0.5) | < 5 (< 2.0) |
Prior or concomitant use of SSRIs, n (%) | 176 (5.3) | 179 (5.4) | 6 (2.4) |
Prior use of heparins, n (%) | 1,059 (31.8) | 1,081 (32.5) | 55 (22.0) |
Prior use of NOACs, n (%) | 1,936 (58.2) | 1,927 (57.9) | 146 (58.4) |
Serum creatinine ≥ 1.5 mg/dL, n (%) | 392 (11.8) | 399 (12.0) | 27 (10.8) |
Sex, Male, n (%) | 1,622 (48.8) | 1,616 (48.6) | 141 (56.4) |
Smoking status, n (%) | 273 (8.2) | 303 (9.1) | 10 (4.0) |
TIA, n (%) | 111 (3.3) | 113 (3.4) | 13 (5.2) |
Time in days since atrial fibrillation (%) | |||
≤ 30 | 693 (20.8) | 696 (20.9) | 99 (39.6) |
> 30 – < 90 | 2,414 (72.6) | 2,415 (72.6) | 135 (54.0) |
≥ 90 | 220 (6.6) | 216 (6.5) | 16 (6.4) |
Use of proton pump inhibitors, n (%) | 1,494 (44.9) | 1,503 (45.2) | 109 (43.6) |