Table 3.
Results of the two-arm simulation for proportional 1:1 and 1:3 matching.
| 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 |
aSAE: serious adverse event.