Table 3.

Relative impact of individual eligibility criteria on number of additional people excluded when all other eligibility criteria are also applied

Eligibility criteriaMER cohortLEO 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) 
Eligibility criteriaMER cohortLEO 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.

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