Table 4.
Relative impact of eligibility criteria specification stringency on number (%) of patients excluded when all other eligibility criteria are also applied
| Eligibility criteria switch | MER cohort (n = 220) | LEO cohort (n = 171) |
|---|---|---|
| Stage (III-IV to II-IV) | 60 (21.4) | 33 (16.2) |
| Renal function (creatinine <2 to <1.5) | 11 (4.8) | 4 (2.3) |
| Performance status (0-2 to 0-1) | 9 (3.9) | 9 (5.0) |
| Hepatic function (total bilirubin <2 to <1.5) | 2 (0.9) | 1 (0.6) |
| Prior malignancy (with exceptions to no exceptions) | 6 (2.7) | 5 (2.8) |
| Hemoglobin (≥8 to ≥9) | 1 (0.5) | 3 (1.7) |
| WBC requirement (≥3 to ≥4) | 8 (3.5) | 8 (4.5) |
| Platelet requirement (≥75 to ≥150) | 20 (8.3) | 25 (12.8) |
Eligibility criteria include stage II, III, and IV, creatinine < 2, performance status < 3, no prior malignancies with exceptions, bilirubin < 2, no self-reported health conditions, treated within 3 mo of diagnosis, hemoglobin ≥ 8, WBC ≥ 3, and platelets ≥ 100 000.