Table 1. Characteristics of Randomized Clinical Trials of Anticancer Drugs Examined for the Exclusion of Patients With Chronic Kidney Disease.
| Trials, No. (%) | Patients, No. | Trials Explicitly Excluding Kidney Disease, No. (%) | P Valuea | |
|---|---|---|---|---|
| Overall | 310 (100) | 282 889 | 264 (85) | |
| Publication, yb | .16 | |||
| 2012 | 58 (19) | 46 567 | 50 (86) | |
| 2013 | 60 (19) | 73 745 | 55 (92) | |
| 2014 | 46 (15) | 35 264 | 37 (80) | |
| 2015 | 47 (15) | 37 437 | 45 (96) | |
| 2016 | 47 (15) | 41 486 | 32 (68) | |
| 2017 | 52 (17) | 48 390 | 45 (87) | |
| Enrollment start, y | .24 | |||
| 1995-2000 | 12 (4) | 32 018 | 8 (67) | |
| 2001-2006 | 91 (29) | 122 789 | 77 (85) | |
| 2007-2012 | 176 (57) | 113 061 | 154 (88) | |
| 2013-2017 | 31 (10) | 15 021 | 25 (81) | |
| Trial enrollment, No. of patients | .52 | |||
| <100 | 14 (5) | 1016 | 11 (79) | |
| 100-200 | 35 (11) | 5282 | 29 (83) | |
| 201-500 | 85 (27) | 28 269 | 77 (91) | |
| 501-1000 | 89 (29) | 61 893 | 75 (84) | |
| >1000 | 87 (28) | 186 429 | 72 (83) | |
| Cancer type | .45 | |||
| Bladder | 4 (1) | 959 | 3 (75) | |
| Breast | 111 (36) | 144 052 | 87 (78) | |
| Colorectal | 52 (17) | 42 619 | 48 (92) | |
| Lung | 96 (31) | 50 175 | 86 (90) | |
| Prostate | 47 (15) | 45 084 | 40 (85) | |
| Intervention type | .02 | |||
| Chemotherapy | 78 (25) | 60 986 | 68 (87) | |
| Biologic or immunotherapy | 87 (28) | 81 802 | 78 (90) | |
| Endocrine therapy | 31 (10) | 65 331 | 18 (58) | |
| Targeted agents | 84 (27) | 43 725 | 78 (86) | |
| Other therapy | 30 (10) | 31 045 | 28 (93) | |
| Trial phase | .82 | |||
| 2 | 55 (18) | 11 094 | 45 (82) | |
| 2/3 | 7 (2) | 7610 | 7 (100) | |
| 3 | 246 (79) | 263 735 | 210 (85) | |
| 4 | 2 (1) | 440 | 2 (100) | |
| Funding source | .61 | |||
| Industry | 208 (67) | 168 941 | 177 (85) | |
| Government | 39 (13) | 32 634 | 34 (87) | |
| Both | 63 (20) | 81 314 | 53 (84) | |
| Journal | .09 | |||
| JAMA | 4 (1) | 6287 | 3 (75) | |
| Journal of Clinical Oncology | 137 (44) | 113 495 | 124 (91) | |
| Journal of the National Cancer Institute | 5 (2) | 4786 | 4 (80) | |
| Lancet | 16 (5) | 36 465 | 12 (75) | |
| Lancet Oncology | 112 (36) | 80 233 | 90 (80) | |
| New England Journal of Medicine | 36 (12) | 41 623 | 31 (86) |
a
The P values presented relate to the effect estimates from the multivariable logistic regression model.
b
The 5-year period prior to initiation of the systematic review was initially selected as the time frame of interest (to assess trials of recent cancer therapies, including novel immunotherapies and targeted agents). The review was subsequently updated to include trials published up to December 31, 2017.