Table 2:
Individual eligibility criteria overview for relapsed/refractory lymphoma/leukemia sample, follow-up 180 days
| Eligibility Criteria Label | Eligibility Criteria Details | Number of Trials Implementing the Eligibility Criterion N (%) | Number of Patients N (%) | Number of Events N (%) | Incidence Rate per 100 personyears (with 95% CI) | Hazard Ratio (with 95% CI) | |||
|---|---|---|---|---|---|---|---|---|---|
| <Start> | N/A | 23 (100) | 623 (100) | 122 (100) | 49.44 (41.40, 59.04) | N/A | |||
| Q | nQ | Q | nQ | Q | nQ | ||||
| No HIV | No HIV within the past 365 days | 20 (86.96) | 614 (98.56) | 9 (1.44) | 119 (97.54) | 3 (2.46) | 48.87 (40.83, 58.48) | 93.18 (30.05, 288.90) | 0.55 (0.18, 1.73) |
| No HBV/HCV | No HBV/HCV within the past 365 days | 19 (82.61) | 613 (98.39) | 10 (1.61) | 118 (96.72) | 4 (3.28) | 48.44 (40.44, 58.02) | 126.93 (47.64, 338.21) | 0.41 (0.15, 1.12) |
| Not pregnant | No evidence of current pregnancy within the past 60 days | 19 (82.61) | 622 (99.84) | 1 (0.16) | 122 (100) | 0 (0) | 49.54 (41.49, 59.16) | - | - |
| No prior chemotherapy or radiotherapy | No prior chemotherapy or radiotherapy within the past 14 days (excludes index) | 18 (78.26) | 590 (94.70) | 33 (5.30) | 111 (90.98) | 11 (9.02) | 46.99 (39.01, 56.60) | 104.44 (57.84, 188.59) | 0.49 (0.26, 0.91) |
| No prior malignancy | No prior malignancy (beside lymphoma or leukemia related cancers, non-melanoma skin cancer, in-situ cancers, benign tumor, lipomatous tumor, or uncertain behavior) within the past 1095 days | 17 (73.91) | 385 (61.80) | 238 (38.20) | 61 (50.00) | 61 (50.00) | 39.03 (30.37, 50.17) | 67.43 (52.46, 86.66) | 0.60 (0.42, 0.85)* |
| Adequate eGFR | Most recent eGFR measure within the past 180 days ≥ 30 mL/min/1.73m^2 (per MDRD equation) | 11 (47.83) | 612 (98.23) | 11 (1.77) | 118 (96.72) | 4 (3.28) | 48.49 (40.48, 58.07) | 118.49 (44.47, 315.72) | 0.47 (0.17, 1.27) |
| No active infection | No active infection within the past 30 days | 10 (43.48) | 525 (84.27) | 98 (15.73) | 91 (74.59) | 31 (25.41) | 42.39 (34.52, 52.06) | 96.59 (67.93, 137.35) | 0.48 (0.32, 0.72) |
| Adequate ANC | Most recent ANC measure within the past 180 days ≥ 1000/mm3 | 9 (39.13) | 604 (96.95) | 19 (3.05) | 115 (94.26) | 7 (5.74) | 47.74 (39.76, 57.31) | 119.98 (57.20, 251.67) | 0.41 (0.19, 0.88) |
| No prior corticosteroid use | No prior corticosteroid use within the past 7 days (excludes index) | 9 (39.13) | 587 (94.22) | 36 (5.78) | 112 (91.80) | 10 (8.20) | 47.50 (39.47, 57.16) | 91.36 (49.16, 169.80) | 0.56 (0.29, 1.06) |
Q = qualifying cohort; nQ = non-qualifying cohort; HIV = human immunodeficiency virus; HBV = hepatitis B virus; HCV = hepatitis C virus; eGFR = estimated glomerular filtration rate; ANC = absolute neutrophil count; N/A = non-applicable; MDRD = modification of diet in renal disease study. Hazard ratios have nQ as the reference group (* = powered; - = not calculated given no events in a particular group). All eligibility criteria assessment timeframes include the date of the index event unless specified otherwise. For criteria that rely on lab values: if a patient did not have a lab value present or found during the criteria assessment period, that patient was assumed to have an adequate value and thus did not get excluded. Further code details are provided in Supplemental Material 1.