Table 3.
Relative impact of individual eligibility criteria on number of additional people excluded when all other eligibility criteria are also applied
| Eligibility criteria | MER cohort | LEO cohort | ||
|---|---|---|---|---|
| Relaxed (n = 362) | Stringent (n = 220) | Relaxed (n = 276) | Stringent (n = 171) | |
| Stage | 60 (21.4) | 33 (16.2) | ||
| Renal function (creatinine) | 21 (5.5) | 20 (8.3) | 2 (0.7) | 4 (2.3) |
| Performance status | 7 (1.9) | 15 (6.4) | 16 (5.5) | 15 (8.1) |
| Prior malignancy | 22 (6.0) | 23 (9.5) | 14 (4.8) | 12 (6.6) |
| Hepatic function (total bilirubin) | 21 (5.5) | 20 (8.3) | 10 (3.5) | 4 (2.3) |
| Self-reported serious health conditions | 58 (13.9) | 32 (12.7) | 115 (29.4) | 62 (26.6) |
| Hemoglobin | 3 (0.8) | 3 (1.3) | 0 (0.0) | 3 (1.7) |
| WBC | 3 (0.8) | 10 (4.3) | 4 (1.4) | 12 (6.6) |
| Platelet | 3 (0.8) | 23 (9.5) | 3 (1.1) | 27 (13.6) |
Relaxed criteria consist of less stringent specifications of the eligibility criteria, including stage II, III, and IV, creatinine < 2, performance status < 3, no prior malignancies with exceptions, bilirubin < 2, no self-reported health conditions, hemoglobin ≥ 8, WBC ≥ 3, and platelets ≥ 75 000. Stringent criteria consist of stringent specifications of the eligibility criteria, including stage III and IV, creatinine < 1.5, performance status < 2, no prior malignancies, bilirubin < 1.5, no self-reported health conditions, hemoglobin ≥ 9, WBC ≥ 4, and platelets ≥ 150 000.